2019 Bioethics Forum Presentation Slides
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Dr. Ernest Ekong, an Assistant Professor and the director of health programs at the Institute of Human Virology, School of Medicine, University of Maryland, seconded to the Institute of Human Virology, Nigeria (IHVN) as Director/Head of Department Clinical Services to head its clinical PEPFAR Nigeria program in scaling up HIV treatment, care, and prevention. He is the former Country Director of the Harvard University’s PEPFAR program in Nigeria. Dr Ekong has had significant national and international experience mentoring for cost-effective interventions in
HIV/AIDS and infectiousdiseases management.
He is passionate about disease causation, promotion, prevention and treatment. He develops regional and country-specific strategies for improving healthcare in the general population, with a specialization in HIV/AIDS, malaria, and tuberculosis. He trains healthcare workers in patient management and research, works to strengthen health systems, and acts as a liaison to the government.
Dr Ekong believes in an improved quality of life through a coordinated positive social change. Through his efforts, in Africaover 350,000 HIV/AIDS patients have been treated with potent antiretroviral drugs and more than 600,000 provided care and support. His research interests are in research design, applied epidemiology, HIV/AIDS,adolescent health and infectious disease epidemiology, qualitative, quantitative and mixed-methods research. He has published in many peer-reviewed and other scientific journals. He is the Vice President, Nigeria HIV/AIDS/STDs Research Network (NARN), Fellow of the Royal Society of Public Health, Fellow of the American College of Physicians (ACP), and Member, International Epidemiological Association (IEA).
Munirat is an experienced international development expert with over 12 years of leadership experience in managing and evaluating large, complex health and related programmes at country and multi-country levels. She holds PhD & MSc degrees in Medical Sociology, and BSc degree in Human Nutrition post her qualification as a registered Nurse Midwife. She possesses strong skills in providing technical assistance to national and sub-national governments and CSOs in her areas of expertise – health, women’s empowerment, institutional development and monitoring and evaluation. Prior to her joining the World Bank as Health Specialist, she has worked in various capacities as: HIV Adviser at UK Department for International Development (DFID), Team Leader, HIV & AIDS unit at UNDP Nigeria, Senior Consultant, Monitoring and Evaluation at ITAD Limited UK, Stewardship and Coordination Manager, on the DFID Enhancing Nigeria Response to HIV & AIDS, and Deputy Team Leader, on the DFID/Voices for Change gender programme. She is skilful in results based planning, value for money analysis and reporting.
Simon Agwale, Ph.D is the founder and CEO of INNOVATIVE BIOTECH LTD, Keffi, Nigeria (www.innovativebiotechng.com) and Innovative Biotech USA Inc (www.innovativebiotechusa.com). He is also the CEO of Minerals for Life LTD (www.mineralsforlifeng.com), Nigeria and Innovative Vaccines LTD, Nigeria (www.innovativevaccines.com). He has been at the forefront of shaping the future direction of vaccine development worldwide. Dr. Agwale is currently working on development of novel vaccines against ebola, cervical cancer, and HIV using innovative viral-like particles (VLPs). With over 20 years experience combining top-level scientific research with the operations of a Biotech companies, he has been involved in academic research at various institutions in Nigeria Brazil, Germany and the United States. He is a recipient of several scholarships, fellowships and grants from reputable organizations around the world. He has also authored and co-authored numerous noteworthy publications.
Professor Olukayode A. Dada PhD, is a Biomedical Scientist with specialization in Laboratory Medicine and Reproductive Health. He has made valuable contributions to research, research training and postgraduate education particularly in the areas of Maternal, newborn, child and adolescent health; fertility regulation; cancers of the reproductive systems; and Ethics in health care and biomedical research.
He serves the World Health Organization (Special Programme of Research Development and Research Training in Human Reproduction) as Temporary Adviser in Reproductive Health from 1978 to date. He also serves as a member of the National Reproductive Health Working Group, an advisory body of the Nigerian Federal Ministry of Health.
Professor Dada is a Fellow of the Nigerian Academy of Science, Fellow of the Academy of Clinical Biochemistry (USA), Foundation member of the Association of Clinical Chemists of Nigeria (ACCN) and recipient in 2009, of the ACCN’s Merit Award for contribution to the practice of clinical chemistry and laboratory medicine in Nigeria.
Until his retirement, he was Professor of Chemical Pathology at the Olabisi Onabanjo University, Ago-Iwoye and Director of the Centre for Research in Reproductive Health (CRRH) Sagamu, a non-governmental institution which also coordinates the research and research training programmes of the Nigerian National Network for Reproductive Health Research and Training.
Pre-exposure prophylaxis, or PrEP, for HIV prevention is a strategy that involves use of antiretroviral medications (ARVs) to reduce the risk of HIV infection in people who are HIVnegative. Truvada (generic tenofovir and emtricitibine) is the only ARV to date to be approved for PrEP.
When cells are infected with HIV, they become little factories that make billions of new HIV viruses every day. ARVs work by blocking entry into the cell or, like Truvada, they block the production steps that HIV uses to make copies of itself once inside the cell. If an HIVnegative person has enough Truvada in his/her blood stream when exposed to HIV (during unprotected sex), the medicine keeps the HIV from making enough copies of itself to “take hold” and cause him/her to become infected.
No. PrEP medication does not work the same way as a vaccine. A vaccine trains the body’s immune system to fight off infection for years. PrEP requires taking a pill during periods of risk for the medication to protect against infection. Unlike a vaccine, PrEP does not work after you stop taking it.
When used consistently and as prescribed, PrEP has been shown to reduce the risk of HIV infection by more than 90 percent among people at high risk for HIV infection, including men who have sex with men and heterosexually-active men and women and people who use drugs.
The most common side effects seen in the studies of Truvada as PrEP include headache, nausea, vomiting, rash and loss of appetite. However these effects usually go away within a few weeks of starting PrEP. There are rare kidney and bone side effects, making it important to get screened by your doctor for any pre-existing conditions. Potential PrEP users need to weigh the benefits of using oral PrEP against the risk of these minor side effects.
PEP, or post-exposure prophylaxis, is an HIV prevention strategy that uses a course of antiretroviral drugs for four weeks to reduce the risk of HIV after exposure to HIV (e.g., unprotected anal or vaginal sex, needle stick pricks, or the sharing of needles.) Ideally PEP should begin within an hour of possible infection and no longer than 72 hours after exposure, whereas PrEP should be taken during (before and after) the time high-risk exposure may take place.
While PrEP is not an option for everybody, it is an option for many people. PrEP can be used by those who are at high risk of becoming infected with the HIV virus. The term used to describe people at such substantial risk for HIV infection is ‘key populations.” In Nigeria, these include adolescent girls and young women, sex workers, men who have sex with men (MSM), discordant couples and people who inject drugs—many of whom face various barriers to access to health including stigma, criminalisation and lack of supportive service delivery infrastructure.
If anyone can answer yes to any of the questions below, then PrEP may be one HIV prevention strategy to consider.
No, PrEP does not protect against other STIs. PrEP only reduces your risk of getting HIV. But STI screening should be a routine part of PrEP care along with HIV testing and counseling.
In Nigeria, the HIV epidemic has remained the second largest in the world and there is urgent need to reduce new infections. The Ministry of Health has also set as its priority the 90:90:90 targets. This is an ambitious UNAIDS treatment target where 90% of people living with HIV know their status, 90% of people living with HIV receive sustained antiretroviral treatment and 90% of people receiving antiretroviral therapy have durable viral suppression. It will be increasingly hard to achieve this if we don’t stop new infections, and in the absence of an effective vaccine, PrEP is one of the ways we can stop new infections.
PrEP advocates are pro-HIV-prevention, not solely pro-PrEP. It is critical that there is scaleup in the delivery of existing options. Once PrEP is implemented in South Africa, it will be one strategy in a comprehensive prevention approach that includes a variety of already proven methods such as male and female condoms, syringe exchange, medical male circumcision, PEP and treatment. If proven to be effective, other prevention options still being researched such as vaccines and microbicides will be added to this prevention package.
PrEP should not compete with, undermine or replace the availability and promotion of other existing HIV prevention methods including treatment. In fact, the introduction of PrEP will complement existing strategies and give people a wider choice of options. The more HIV averted by PrEP, the more feasible it will be to treat all those with HIV. PrEP will not lead to drug shortages. For example it has been documented that drug stockouts in the country are due to poor management, not lack of resources.
Truvada is not currently licensed for prevention in Nigeria; however, it is licensed for treatment of HIV infection as part of combination antiretroviral therapy.
PrEP demonstration projects are carefully planned undertakings or activities that provide information on how to best deliver a new intervention in the real-world South African setting. At the moment, we have adequate data to prove that PrEP works but we need additional information to answer the following questions:
These demonstration projects are being conducted in some of our communities here in South Africa.
More research needs to be done to figure out if hormones interact with Truvada and change its HIV protection effectiveness, but no interactions have been reported to date.
No. It is recognized that people go in and out of “seasons of risk,” where there are certain times it makes sense to take PrEP and then other times where it doesn’t make sense to take PrEP. For instance, an individual might use PrEP at a time when he/she feels they are at higher risk, and then stop taking it and choose another prevention option better suited to their changing needs.
You should not stop using condoms because you are taking PrEP. PrEP, however, is most beneficial when targeted to those not using condoms. It’s important to note that PrEP medications don’t give any protection from other infections you can get during sex, like condoms do. That’s why people taking PrEP are recommended to regularly get screened and treated for STIs.
The highest level of protection against rectal exposure to HIV is achieved after seven daily doses of Truvada PrEP. High-level protection for vaginal exposure comes after 20 days of daily use.
For men, if a daily dose is missed, PrEP is still effective but the level of HIV protection may decrease. It only works if you take it correctly and consistently. It is important to note that there is no evidence that similar missed PrEP doses in women will show any protection.
Available data from completed studies show people have not complained about sexual side effects. On the contrary: many have said sex has improved due to less anxiety and fear of HIV.
Alcohol and recreational drugs are not known to interact with Truvada for PrEP. In fact, PrEP can be taken before drug and alchohol consumption, unlike condoms which are required at the time of sex when judgement might be impaired.
As of right now, we do not know the long-term effects of taking Truvada for PrEP. Truvada can be associated with kidney and bone problems in HIV positive people but these side effects are not significant in HIV negative, healthy people with no previous problems. It is important to work with your doctor to monitor any potential long-term effects as part of regular HIV screening while on PrEP.
Bottoms are already at much greater risk for HIV than tops. One of the great things about Truvada for PrEP is that the drugs are known to be good at protecting people from infection during receptive anal intercourse. After you swallow the pill and Truvada is absorbed into the body, much of it winds up in the colorectal (bowel) tissue—ready to fight any HIV that it encounters. That doesn’t mean that PrEP isn’t a good prevention option for tops—it just means it has even greater benefits for bottoms because they are more biologically vulnerable to HIV.
Most people taking PrEP are HIV negative, therefore, drug resistance is not a problem because there is no HIV to make copies of itself in the body. Studies show no resistance in people who test negative and take PrEP correctly and consistently. Before starting PrEP, it is important to make sure that you are HIV-negative because you run the risk of developing HIV drug resistance if you already are living with HIV. This is because Truvada is not sufficient on its own for treating HIV. To avoid HIV resistance, regular HIV testing while on PrEP is a key component of the PrEP package.
PrEP is real, it works and it should be made available in Nigeria.
Answer :
The various stages of clinical (human) trials would involve several volunteers who would willingly participate in the testing of these candidate vaccines. You can plan to be a volunteer when the trial starts. There are several thousands of volunteers for such trials all over the world with which you can network.
However, before the trials start, you can lend your voice, energy and time to advocate the Nigerian Government keep to its schedule for the development of a vaccine for Nigeria, as contained in the National HIV Vaccine Development Plan. Government must also implement aggreements and commitment it has made with patners at regional and international level towards ensuring speedy development of a HIV vaccine. It is in the intrest of every Nigerian that the Goverment implements the National HIV Development Plan scrupulously and on time. You can contact NVHMAS for more information on how you can join in the global advocacy for the development of a safe and effective vaccine for HIV
Answer :
It is important that Nigerian scientist, researcher and advocates work in collaboration with international partners to develop a safe and affordable preventive HIV vaccine. This would enable the country develop and test HIV vaccine that are specifically designed to be used in West Africa and Nigeria in particular.
The Nigeria government is working through the National Institute for Pharmaceutical Research and Development (NIPRD) Abuja and other institutions to develop a home grown HIV vaccine. Already, the government has drawn up a HIV vaccine Development Plan.
Answer :
Any effective vaccine developed would be made available first to populations with the highest HIV incidence, especially those who have contributed to vaccine development through participation in trials. Many organizations all over the world are currently developing strategies to ensure that caost does not become a barrier to access to an effective HIV vaccines, when developed.
Answer :
Currently, there are no effective HIV vaccines available. However, there are several possible vaccine that may work. Some are undergoing animal trails while some are already undergoing clinical (human) trials. The development of a vaccine takes a while. This is as to ensure it is save and effective. An effective HIV vaccine will cause the body’s defense system to overcome the virus if it enters the body.
Answer :
NHVMAS (pronounced as ‘navmas’) is an acronym for the New HIV Vacccine and Microbicides Advocacy Society. It is a civil society group ccommitted to mobilizing popular participation and public support for vaccine and microbicide research and the development in Nigeria. Its mission is to halt the spread of HIV/AIDS in Nigeria by ensuring the availabilty of safe, effective acceptable and affordable HIV vaccine and microbicides products for all Nigerians. NHVMAS works to ensure the proactive participation of Nigeria and Nigerians in Global effort for the development of HIV vaccine and microbicides. It recognises that there is an ethical imperative to seek, as urgent as possible an effective and acceptable vaccine to complement other existing and emerging provention strategies
NHVMAS is open to all Nigerians and seek to patner with as many group as possible. You can contact NHVMAS for more infomation on how you can join in the national advocacy for the development of a safe effective and affordable HIV vaccine that can put a halt to the HIV/AIDS epidemic
All drug candidates first go through a rigorous program of laboratory screening and testing to ensure that they are safe before being tested in humans. This program of extensive preclinical testing can take several years. Once a candidate is deemed safe, it goes through a series of human clinical trials. These trials are conducted first to determine safety, and then to test efficacy, or the ability to prevent HIV infection. Only after these trials have been completed will a candidate drug be considered for licensure and distribution.
Another prevention option researchers are studying is called Antibody Mediated Prevention (AMP). If successful, this method can also provide protection. However, it will likely require regular injections or infusions, and may not appeal to everyone who needs protection. In addition, cost may be a factor, as with other prevention methods.
Vaccines remain the most effective way to eliminate an infectious disease. They are an effective, affordable and practical option.
A preventive vaccine against the human immunodeficiency virus (HIV) is a top priority for human health, and our best hope for a world without AIDS.
Here’s why: is still here
The decision about whether an individual with HIV begins ART is based on several factors, including the treatment guidelines in a given country. These guidelines look at clinical health, infection with other diseases and opportunistic infections, CD4 cell count and/or viral load tests (where available) to help one make the decision whether to start ART. ART is not initiated with the primary goal of reducing the HIV-positive person’s risk of passing the virus to others except in programs to prevent vertical transmission in pregnant women.
The prevention benefit is there at any CD4 cell count. This is because even when people have high CD4 cell counts and are feeling healthy, they may still have high levels of virus in the blood (high viral load). People with higher viral loads may be more likely to pass the virus—even if they have high CD4 cell counts and feel healthy. So, advocates for treatment as prevention say that it is time to expand eligibility for ART to people with HIV, regardless of their CD4 cell count.
Starting ART is a personal decision. No one with HIV should ever be forced to take medication. No one should ever be denied medication. There are key groups that could be targeted for treatment as prevention:
There is no minimum CD4 cell threshold for using treatment as prevention. Having other infections, especially genital infections, increases the risk than an HIV-positive person will passing HIV to an HIVnegative partner—this is true at any CD4 cell count. An HIV-positive person may get more infections as CD4 cell count drops and immune function reduces. But once CD4 cell count is stabilized, infections have resolved and an individual is confident that he/she can adhere to medication—there is potential for reducing risk of transmission (treatment as prevention!).
The answer is much the same as it is for people taking ART for their individual health. The benefits come if the drugs are taken correctly and consistently. Individuals who feel healthy and want to stop taking ART, need to consult with their health providers. That there is no prevention benefit if your viral load is not controlled.
In the same way that people taking ART do not feel healthy overnight, the prevention benefit of ART is not immediate. It comes after a person has taken treatment for some time and has a very low viral load. It is essential to keep on using other prevention tools like male and female condoms, limiting sexual partners, voluntary medical male circumcision for HIV-negative people, et cetera. People in the HPTN 052 trial are still being followed to see if the prevention effect lasts over time.
That’s one that doesn’t have an easy answer. We know that if you take ART as they are prescribed without missing doses, they are highly effective at controlling the virus. So, in the absence of viral load, you need to be vigilant about adherence and also monitor your health closely—other infections, CD4 cell count and so on.
Using treatment to preserve health and prevent new infections is a two-for-one benefit. It may also reduce tuberculosis risk. If countries expand their treatment targets, they can also reduce rates of new infections—this is key to ending the AIDS epidemic.
Increasingly, women and girls bear the brunt of the HIV/AIDS epidemic. The disease is now considered the leading cause of death for women worldwide between the ages of 15 and 50. More than 15.7 million women are currently living with HIV/AIDS globally, and the number continues to rise. In sub-Saharan Africa, nearly 60 percent of adults living with HIV are women. In some countries, HIV prevalence is three times higher among women ages 15 to 24 than it is among men in that same age group.
Women are becoming infected with HIV at a faster rate than men largely because of a combination of their increased cultural and biological vulnerability. Many women have little or no control over the conditions under which they have sex. They often cannot negotiate the use of condoms. A microbicide will give women the power of protection from HIV infection and save millions of lives.
With proper funding and political commitment, it could be possible to put microbicides into the hands of women in the next five to ten years.
Ongoing support is essential to the success of microbicide development. Funding must be secured before clinical trials can be conducted – and just a single efficacy trial alone can cost as much as $120 million. Between 2000 and 2007, global funding for microbicide research and development tripled, with the United States and European donors continually increasing support. There are signs though that support for microbicide research may be flattening. Between 2006 and 2007, the total investment in microbicide research increased 2 percent to US$226.5 million. Such funding levels are well below the annual $280 million amount recommended by microbicide experts to ensure an optimal research effort.
Microbicides have been proven affective in the CAPRISA 004 study, which found a 39 percent lower HIV infection rate in women using 1% tenofovir gel as compared to those women using a universal placebo gel. Another multi-center trial will be needed to confirm the effectiveness of tenofovir. It is essential to develop a number of safe and effective microbicides that attack HIV at different points in its life cycle and that provide a choice of easy-to-use protection options for women. To this end, dozens of next-generation microbicide candidates are in safety studies and preclinical development, and some are in the beginning stages of efficacy trials.
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) study is an important milestone for HIV prevention. CAPRISA 004 was the first trial to test the efficacy of an ARV-based drug, tenofovir. The study found a 39 percent lower HIV infection rate in women using 1% tenofovir gel as compared to those women using a universal placebo gel.
These efficacy results are statistically significant and represent the first “proof of concept” for a topical microbicide. For the first time, the HIV prevention research community has evidence that topically applied ARVs can offer protection against HIV and potentially other pathogens.
Confirmatory studies may be needed to establish definitive proof of the effectiveness of tenofovir gel. Research on other microbicides must continue. It is important to develop a number of safe and effective microbicides that attack HIV at different points in its life cycle and that provide a choice of easy-to-use protection options for women.
Men play an important role in the fight against HIV. Men are also being included in some clinical trials to help determine if vaginal microbicides are safe and acceptable to male partners. In addition, some researchers are testing rectal microbicides for both men and women to use. A rectal microbicide would also be an important tool to slow the spread of HIV.
Unlike antiretroviral (ARV) therapy, which treats HIV infection throughout the body after an infection has already occurred, vaginal microbicides would prevent infection from taking hold in the first place. HIV’s life cycle presents a number of points at which microbicides act to prevent infection. Some microbicides interfere with the ability of HIV to attach to or enter human cells. Others prevent the virus from reproducing once the virus has already entered the cell. Microbicides will ultimately be delivered in a variety of forms — such as a vaginal rings, gels, films or tablets.
Microbicides are topical products being developed to reduce the transmission of HIV during sexual intercourse. Antiretroviral (ARV)-based vaginal microbicides could take the form of a monthly vaginal ring, daily gel, film or tablet. In an approach known as pre-exposure prophylaxis (PrEP), ARV drugs might be administered systemically to prevent HIV. These products could take the form oral tablets, long-acting injections or other novel formulations. Microbicides will be a useful complement to other HIV-prevention measures. These include education on safer sex, condom use and distribution, voluntary testing and counseling, identifying and treating HIV-positive individuals (test and treat), producing and enacting anti-stigma campaigns and providing access to safe blood supplies.
Mrs. Funmi Doherty is the current President of Society for Women and AIDS in Africa, Nigeria (SWAAN) and the Deputy Secretary General for the International body (SWAA, International). She is also the Director & Head, Medical Social Services, Lagos University Teaching hospital (LUTH). She coordinates the School of Medical and Psychiatry Social Work, LUTH. Her efforts in addressing the HIV/AIDS epidemic in Africa and Nigeria date back to over 25 years. She is well known for her efforts in pushing the agenda of HIV control amongst women, promotion of voluntary counselling and testing (VCT) as well as care and support for PLWHA. A founding member of SWAAN and as the current President, her efforts in facilitating and positioning SWAAN as an embodying organisation for addressing HIV/AIDS in women is well recognised. She has equally served in regional and national bodies including the development of the National Counselling Training Manual and the 2005-2009 National HIV/AIDS Strategic Framework,development of a community mobilisation strategy for microbicide by the Global Campaign for Microbicide amongst others. Her article on home based care (HBC) in the management of HIV/AIDS published in the Archives of Ibadan Medicine remains a reference article to date.
Chibuike Amaechi is a professional social worker with over fourteen years field experience in health programs and over eight years’ experience in global health advocacy, resource mobilization, program policy planning and strategy development. He holds a B.Sc. (Hons) in biochemistry, a post-graduate diploma in social work, and a M.Sc. in social work with focus in healthcare.
Chibuike is a WHO trained consultant on TB/HIV co- infection and TB ENGAGE Approach, a constituent representative of Developing NGOs in the Stop TB Board, Geneva, was a civil society representative in the coordinating committee of scientific activities in the union world conference on lung health, was a member of the international task force that facilitated the formation of the Nigeria Stop TB Partnership, was a member of Communities Delegation to the Global Fund Board, a member of Community Support Delegation to UNITAID Board and Co – initiator of the Africa Coalition on TB.
He has led his organisation to execute social innovative project in the area of access to treatment for TB patients in urban slums of Lagos. This project was listed among the one hundred social innovations of accesses to treatment in a global competition organized by Tropical Disease Research (TDR) Cape Town, South Africa in collaboration with WHO, Geneva. He is the chief executive officer in The Good Neighbour, a non – governmental organisation in Nigeria and a practicing consultant.
Morenike Folayan works as a lecturer and researcher with the Obafemi Awolowo University, Ile-Ife. She has also published extensively on oral health issues in children and adolescents with specific focus on dental anxiety management and caries. She also has published discuss on adolescent sexual and reproductive health, bioethics consideration on community engagement in research and the pros and cons of community engagement in research. She has experience with the use of both qualitative and quantitative research methods and the translation of research into policies and programmes.
Ms Olayide Akanni is the current Chief Executive Officer of Journalists Against AIDS, an aw ard winning Media organisation set to address HIV/AIDS related issue via effective use of the media. A former health reporter with the Punch Newspapers, Layide heads the Policy and Advocacy unit of the organisation and oversees the Abuja Office. She oversees JAAIDS projects and activities within the Federal Capital Territory as well as coordinates specifically, advocacy activities and policy reform projects. Layide is a major voice on HIV treatment access and TB/HIV control in Nigeria and Africa. In 2001, she oversaw the development of advocacy strategies that would help reform certain policies that may impact negatively on the collective efforts towards addressing the national and global AIDS challenge. So much has been achieved in this regard
Concerted actions are required by all stakeholders to end the HIV epidemic by 2030. These actions include expedited use of effective and existing tools to enhance treatment access for people living with HIV, and access to a combination of effective HIV prevention tools by those most at risk of HIV infection. The HIV prevention package should include pre-exposure prophylaxis (PrEP). A stakeholder meeting was therefore held on the 12th and 13th of July, 2016 at Dennis Hotel, Abuja to
Concerted actions are required by all stakeholders to end the HIV epidemic by 2030. These actions include expedited use of effective and existing tools to enhance treatment access for people living with HIV, and access to a combination of effective HIV prevention tools by those most at risk of HIV infection. The HIV prevention package should include pre-exposure prophylaxis (PrEP). A stakeholder meeting was therefore held on the 12th and 13th of July, 2016 at Dennis Hotel, Abuja to (i) to provide update to key stakeholders on the status of PrEP research and PrEP use around the world; (ii) to discuss perspectives on PrEP access and uptake by Key Populations in Nigeria; and (iii) to build consensus on how to create an enabling environment for PrEP roll-out in Nigeria for key populations and advance strong recommendations for a national policy and strategy on PrEP based on evidence.
The red ribbon award is an annual event organsied to recognize the efforts of the journalists and community actors that have carved a niche for themselves in the community education and media advocacy to getting to zero HIV discrimination, zero new infection and zero HIV related death. The event came up on the 11th of December 2012, at the Airport Hotel Ikeja between 10: am-2:00pm. In attendance were representatives of Lagos AIDS Control Agency, Population Council, Society for Family Health, NEBUCCA, journalists from the print and electronic media as well as the civil society actors. NHVMAS recognises the power of the media: the media are essential and powerful tool in educating and sensitizing the community toward engagement in HIV research. The public have confidence in both print and electronic, and they are accessible and available to the community. The community can therefore, be better informed about HIV, AIDS, STI and new Prevention Technologies by active engagement of the media. It is against this background that NHVMAS has continued to build partnership with JAAIDS on the red ribbon award: supporting the best reporting award on New HIV prevention technology. This effort obviously is to encourage journalists reporting on NPT as well as to increase media reporting on NPT research and development efforts in Nigeria so as to increase community awareness and understanding of the issues. The 2012 edition of the red ribbon award was tagged “Getting to zero: a dream or a reality for the Nigeria AIDS response. A panel discussion was held with experts selected from the government agency, international and national NGO and media. NHVMAS was represented on the panel by Durueke Florita. In the panel discussion, NPT as additional prevention tools we
need to achieve the zero targets was emphasized. Government, civil society organization and community were encourage to continue to support HIV related research; mores Nigeria must continue to represent its interest in New HIV prevention technology research. The panel discussion was moderated by the Executive Director of JAAIDS – Akanni Olayide.
The red ribbon award is an annual event organsied to recognize the efforts of the journalists and community actors that have carved a niche for themselves in the community education and media advocacy to getting to zero HIV discrimination, zero new infection and zero HIV related death. The event came up on the 11th of December 2012, at the Airport Hotel Ikeja between 10: am-2:00pm. In attendance were representatives of Lagos AIDS Control Agency, Population Council, Society for Family Health, NEBUCCA, journalists from the print and electronic media as well as the civil society actors. NHVMAS recognises the power of the media: the media are essential and powerful tool in educating and sensitizing the community toward engagement in HIV research. The public have confidence in both print and electronic, and they are accessible and available to the community. The community can therefore, be better informed about HIV, AIDS, STI and new Prevention Technologies by active engagement of the media. It is against this background that NHVMAS has continued to build partnership with JAAIDS on the red ribbon award: supporting the best reporting award on New HIV prevention technology. This effort obviously is to encourage journalists reporting on NPT as well as to increase media reporting on NPT research and development efforts in Nigeria so as to increase community awareness and understanding of the issues. The 2012 edition of the red ribbon award was tagged “Getting to zero: a dream or a reality for the Nigeria AIDS response. A panel discussion was held with experts selected from the government agency, international and national NGO and media. NHVMAS was represented on the panel by Durueke Florita. In the panel discussion, NPT as additional prevention tools we
need to achieve the zero targets was emphasized. Government, civil society organization and community were encourage to continue to support HIV related research; mores Nigeria must continue to represent its interest in New HIV prevention technology research. The panel discussion was moderated by the Executive Director of JAAIDS – Akanni Olayide.
About CROI: The Annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational, and clinical researchers from around the world to share the latest studies, important developments, and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI is a global model of collaborative science and the premier international venue for bridging basic and clinical investigation into clinical practice in the field of HIV and related viruses. CROI 2015 was held from February 23 to February 26, 2015, in Seattle, Washington, at the Washington State Convention Center. The results of several HIV prevention studies were presented, remarkable, the PROUD, IPERGAY, partners PrEP, IPREX OLE studies and the FAACT 001.
Community educator scholarship programme: CROI provided scholarship for community educators who work in community HIV research, prevention, or treatment education programs. The conference also provided opportunity for the community scholars to interface with the researchers’ through the community educator programme and mentorship. The community educator scholarship recipients were expected to share their knowledge and experience with their community and expand community research literacy.
NHVMAS through her Community Educator delegate at the conference organised a one day post CROI update meeting in Lagos on the 29th of April 2015. The objectives were to: update the knowledge of the participants on the latest HIV prevention and treatment research and sensitize them on CROI and the community educators’ programme. The sessions discussed include the PROUD, IPERGAY, Partners PrEP, and the FAACT 001. The mean score for the pre-test was 33.75%+_20.00% and the mean score for the post test was 78.15%+13%. All the participants showed increase in the post-test score in relation to the pre-test score except two participants that did not complete the post-test. There was statistically significant improvement in the participants’ level of knowledge, P-value of 0.0013.
As the HIV/AIDS pandemic enters its third decade, millions more people continue to be infected
with HIV, the virus that causes AIDS. Close to 42 million people worldwide live with HIV. Africa
alone accounts for over two-thirds of the number.
Current treatment and behavioral prevention efforts – such as including condom education and
promotion, peer counseling, needle exchange interventions, safe blood transfusion, and interventions
to reduce mother-to-child transmission – have slowed the spread of HIV, but have not stopped it.
While great strides have been made in the availability of cheaper treatment for people living with HIV,
problems of adherence, drug resistance, side effects, poor medical infrastructures and associated huge
cost outlay make access to treatment still difficult for many. Moreover, the best treatment available do
not cure; at best, they merely slow the progression of the disease
Over the last seven years, NHVMAS has established itself nationally, regionally and
internationally as a watchdog and a community advocacy organization for NPT research and
development efforts. These have been successfully achieved through the concerted efforts of
its members who have pushed the agenda of the organization forward even with restricted
finances. A lot of the successes and programs have been achieved through NHVMAS
partnership with various organizations. The year 2010 was used to further consolidate its
leadership in the field. This report gives details of the implementation of the 2008 to 2010
action plan as designed by the NHVMAS Board of Trustees and Steering Committee.
NHVMAS has partially implemented the grant NG-04-09-01. The training which held from the 23rd-25th of November, 2009 at the Development Support Centre, Iyagankun, Ibadan.
17 members of IRB in Nigeria were trained as research monitoring with emphasis on monitoring of HIV research approved by their IRBs.
The five days training for Institutional Review Board admininstrative secretaries and laypersons
was held on 12th to 16th of April 2010 at the Development Support Centre, Ibadan.
The training aimed at teaching laypersons to provide constructive feedbacks when reviewing
research protocols. The training was conducted using through the engagement of participants
in plenary discussions, presentations, group discussions, case studies, and questions and
answer sessions.
The various sessions exposed the participants to issues of community engagement and
participation in research, basics of clinical trials, challenges of ensuring informed consent,
providing constructive feedback when reviewing protocols, good clinical and laboratory
management and data monitoring and management in research. The group interactions
afforded participants the opportunity to learn from one another’s experience while the case
studies simulated actual practical experiences in clinical research protocol review.
The training for Institutional Review Board Chairpersons on community engagement in
research, using the Good Participatory Practice guidance document as the training
module, was held on the 9th and 10th of April 2010 at the Development Support Centre,
Ibadan.
The goal of the training was on building the capacity of the trainees on how to ensure
effective community engagement in research when evaluating research protocols
submitted to IRBs.
The 22 participants at the workshop were actively engaged throughout the training
session. The training made use of different participatory methods to engage
participants. These include presentations and plenary discussions, brainstorming,
questions and answer sessions, group work, and case studies.
The interactive sessions afforded participants the opportunity to learn new ideas and
ways to effectively operationalise the IRBs. It also provided an opportunity for
networking and sharing lessons between members of the IRBs – an opportunity that had
not had prior to now.
A five days training for MSMs in Lagos on HIV prevention, treatment and research literacy was organised for 25 participants. The training ran for 5 days with 28 participants participating in the five days training. Prior the training, a one day planning meeting was held between NHVMAS and IRMA on the 19th of March 2010. The meeting dicussed about participants’ selection, venue of the training, timing of the training and facilitators. Email and telephone communications between NHVMAS, NARN, NACA and Population Council had also gone on for one week prior to the planning meeting date to discuss on collaboration and inputs to the planning of the training. The NACA draft MSM training manual was used for the training. The training served as a pilot for the training manual. Lessons from the training would feed into the manual review process.
At the end of the training, the pre and post test analysis showed that there was a significant improvement in knowledge and understanding about HIV as a whole. Most importantly, people did come to better understand the need to use condom consistently and correctly. Having trainees share information with peers and bring feedback on their peer outreach to the meeting also helped with understanding and addressing issues.
Lessons learnt include:
The training for Institutional Review Board Chairpersons on community engagement in research, using the Good Participatory Practice guidance document as the training module, was held on the 9th and 10th of April 2010 at the Development Support Centre, Ibadan.
The goal of the training was on building the capacity of the trainees on how to ensure effective community engagement in research when evaluating research protocols submitted to IRBs.
The 22 participants at the workshop were actively engaged throughout the training session. The training made use of different participatory methods to engage participants. These include presentations and plenary discussions, brainstorming, questions and answer sessions, group work, and case studies. The interactive sessions afforded participants the opportunity to learn new ideas and ways to effectively operationalise the IRBs. It also provided an opportunity for networking and sharing lessons between members of the IRBs – an opportunity that had not had prior to now.
The evaluation exercies quite a number of the participants have good knowledge of the need for community engagement in research but did not know how this could be translated to practice. The training and the GPP were therefore a great opportunity to learn new skills not only for use as members of the IRBs but as researchers themselves. The pre and post test results showed a significant increase in knowledge (64.6 vs 70.7).
Overall evaluation of the workshop shows that the conduct was good. The six plenary sessions were higly rated with the session on how to ensure protocol review addresses community engagement rated best. The quality of the training was rated very high with 64% of participants rating it was excellent and 38% rating it as very good. Participants noted that the training acheived its objectives and the knowledge and skills will be stepped down and indeed used in protocol evaluation. Quite a number of participants wants to see the training extended to other members of the IRBs as well as other researchers. The facilitators were also evaluated and they were all scored very highly by participants.
The five days training for Institutional Review Board admininstrative secretaries and laypersons was held on 12th to 16th of April 2010 at the Development Support Centre, Ibadan.
The training aimed at teaching laypersons to provide constructive feedbacks when reviewing research protocols. The training was conducted using through the engagement of participants in plenary discussions, presentations, group discussions, case studies, and questions and answer sessions.
The various sessions exposed the participants to issues of community engagement and participation in research, basics of clinical trials, challenges of ensuring informed consent, providing constructive feedback when reviewing protocols, good clinical and laboratory management and data monitoring and management in research. The group interactions afforded participants the opportunity to learn from one another’s experience while the case studies simulated actual practical experiences in clinical research protocol review.
For participants, the training afforded them the opportunity to acquire new knowledge and build skills to be able to review protocols as well as manage and ethics committee office. It also afforded them the opportunity to learn about national requirements and regulations. Participants rated the entire program high with the quality of the program scoring 76.5%. The facilitations were excellently scored with scoring as high as 87.0%. this difference was statistically significant (p=). All the participants admitted that the training addressed the objectives and suggested that subsequent trainings should be spread over longer periods to make it less cumbersome for participants as a lot was packed into a short space of time in this training.
There were a few recommendations that came from participants:
The members of the Peer Educator Trainers (PET) of the Lagos state National Youth Services Corp organized a one day workshop on HIV/AIDS on the 3rd of August 2010. The programme was held at the state NYSC secretariat, Surulere. The members of PET are trained by UNICEF.
The workshop aimed at equipping PET members with information on recent advances in HIV/AIDS. The workshop theme was “Recent Development in the Fight Against HIV/AIDS”
New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) provided the resource person for the workshop. NHVMAS was represented at the workshop by Durueke Florita, the Programme Manager
A three days training (running from 900am to 200pm each day) was organised for 15 media
representatives and 10 CSOs with the objective of:
A three days training (running from 900am to 200pm each day) was organised for 15 media
representatives and 10 CSOs with the objective of:
The training on ethics of medical care and service provision for teachers of medical and dental students was held on 21st through 23rd September 2010 at the Development Support Centre Ibadan.
The training aimed at building the capacity of the lecturers on medical and research ethics so as to be able to teach and mentor students on how to conduct ethical research
A total of 30 participants were in attendance. Twenty three were teachers of ethics in medical and dental schools. Most of the teachers who teach ethics in the medical and dental school had never had formal training on ethics.
The participants were extensively engaged, analyzing the current situations in the medical and dental schools and proffering solutions to bridge the gaps identified. A participatory learning process was employed. This included slide presentation, brainstorming, plenary discussion, group work and case studies.
The interactive learning process afforded the participants opportunity to acquire new ideas, share experience, and identify ethical dilemmas and best practices in medical care and service provision.
The training also afforded them the opportunity to network.
A communiqué was developed at the end of the workshop which will be distributed to the medical and dental council, media and other relevant authorities.
The workshop evaluation indicated that participants had increased knowledge: pretest and post test average scores were 69% and 82% respectively. The 22 plenary sessions were also scored very high.
The overall evaluation of the workshop was rated high in terms of content, logistics and the conduct.
The quality of the training was rated very high, 53% rated it excellent while 47% rated it very good.
All the participants indicated that the workshop achieved its objective. A workplan post the workshop was developed. The workplan shall serve as a monitoring tool over the next 5 months of the training. Most of the participants wanted an extension of the workshop duration and also getting more of the stakeholders trained.
Next steps: This include wide circulation of training report to stakeholders recommended by trainees; publication of communique; a post workshop evaluation of use of knowledge, skills and tools acquired at the workshop. A second meeting of trainees to evaluate what steps to take as definitive measures to move the agenda forward nationally.
THE NEED FOR PUBLIC DIALOGUE ON ANAL SEX AND ITS IMPLICATION FOR HIV CONTROL IN NIGERIA
A three days training (running from 900am to 200pm each day) was organised for 25 persons from research organisations working with communities.
The objectives of the training were to:
A 3days training workshop on interpreting and communicating trials results for NPT was held in Enugu from 6th to 8th April, 2011. This training was organised by NHVMAS. There were 36 persons in attendance inclusive of the rappouteur. Howver, only 32 persons completed the training.
A three days training (running from 900am to 200pm each day) was organised for 25 CSOs including
2 media personnel with the objective of:
NHVMAS conducted a three days institutional based non-residential training workshop for researchers in Ebonyi University Teaching Hospital Abakaliki and its environment who are engaged in the field of HIV treatment and prevention research, care and service provision. The training was funded by SIDACTION France, under the project grant NG-04-10-03. The training was conducted in collaboration with the Health Research Ethics Commmittee of EBSUTH, Abakaliki. Materials support were provided from AVAC, Global Advocacy, New York.
The workshop aimed at building the capacity of participants on how to ensure ethical conduct of HIV research (especially community engagement in research), care and service provision. The workshop consolidates NHVMAS efforts at developing the capacity within the institution in ensuring human participant protection, protocol review and community engagement in research.
The event was held on the 25th – 27th May 2011 in collaboration with the EBSUTH
Health Ethics committee. The training venue was the auditorium of the teaching hospital. Fourty two participants comprising of nurses, doctors, pharmacists benefited from the programme.
The workshop adopted a participatory approach including brainstorming, group discussion, slide presentations and case studies. Several plenary sessions were taken including among others, the history and evolution of ethics, informed consent, review of protocol, community engagement and how to work with vulnerable populations like FSW, MSM and IDUs.
The pretest and posttest evaluation indicated that participant knowledge improved; mean scores are 40% + 18% and 73% + 18% respectively. There is statistically significant difference in the mean score of the participants’ pre-test and post test. (P<0.001).
Workshop evaluation also indicated that participant were satisfied with the conduct and content of the programme. Most of the participants (90.5%) strongly agreed that the programme provided new insights.
The participants will be followed over the next six months to assess the use of skills and knowledge gained from the workshop.
A three days training was conducted for CSOs working with vulnerable communities on HIV research literacy. The programme was held on the 7th – 9th June 2011 at NHVMAS Secretariat , Lagos. The workshop objective was to equip participants with basic knowledge and skills to understand, interpret and report biomedical HIV prevention research with accuracy and sensitivity. In attendance were 16 field workers from the LGBTI, IDU, FSW and PLHIV communities.
The National Postgraduate Medical College in collaboration with the New HIV Vaccine and Microbicide Advocacy Society organised a 3 days training on ethics in Health Research and
Clinical Practice for 173 participants. The workshop was held at the Sickle Cell Centre, Idi Araba, Lagos between the 6th and 8th of July 2011.
The goal of the training was to enable participants manage the ethical challenges in their routine research and clinical engagement, to equip them with knowledge and skills relevant for successful outcomes of ethical reviews and audit, as well as enhance institutional capacity for undertaking protocol (ethical) review, monitoring and audit. The objectives of the training were to:
• To teach the basic principles and philosophy underlying ethics in health research and clinical practice
• To highlight the ethical issues in various health research and clinical engagements viz: clinical trials patient-doctor relationship, managing terminal illness
• To elucidate the ethical research review process.
The 3 days training consisted of 15 plenary sessions with 21 resource persons. The modalities of training included the use of lectures, groups discussions, brainstorming, quizzes, question and answer session, case studies. The entire three days was entirely participatory in nature. Impact of the training was assessed through the use of the pre and post tests, daily programme evaluation, overall programme evaluation, as well as trainees self assessment of skills gained.
Knowledge and skills gained: The pre and post test shows that the three days session had indeed impacted new knowledge with a highly statistically significant difference in knowledge pre and post workshop (p<0.0001). Participants were also able to identify new skills gained and how they were going to make use of these new skills.
Overall assessment of the programme: All the participants felt the workshop had achieved its objectives. The quality of the training was rated high. The facilitators were all also rated high. A few of the participants shared their concerns about the feeding arrangement as well as the accommodation arrangement. This could well be improved at subsequent trainings.
The Ethics Committee of the Aminu Kano Teaching Hospital in collaboration with the New HIV Vaccine and Microbicide Advocacy Society organised a 3 days training on ethics in Health Research and Clinical Practice for 28 participants. The workshop was held at the Aminu Kano Teaching Hospital, Kano between the 27th and 29th of September 2011.
The goal of the training was to enable participants manage the ethical challenges in their routine research and clinical engagement, to equip them with knowledge and skills relevant for successful outcomes of ethical reviews and audit, as well as enhance institutional capacity for undertaking protocol (ethical) review, monitoring and audit. The objectives of the training were to:
• To teach the basic principles and philosophy underlying ethics in health research and clinical practice
• To highlight the ethical issues in various health and clinical Research
• To elucidate the ethical research review process.
The 3 days training consisted of 15 plenary sessions with 5 resource persons. The modalities of training included the use of lectures, groups discussions, brainstorming, quizzes, question and answer session, case studies. The entire three days was entirely participatory in nature.
Impact of the training was assessed through the use of the pre and post tests, daily programme evaluation, overall programme evaluation, as well as trainees self assessment of skills gained. Knowledge and skills gained: The mean score of the pre-test was 55.9% (CI: 46.2 – 65.5) while the mean post test score was 80.4% (CI: 72.1 – 88.7). The difference in the scores was statistically significant (p=0.0001). The paired t-test score was showed a highly statistical difference in pre and post test scores (56.5 vs 80.2) p<0.00001.
Overall assessment of the programme: all the participants felt the workshop had achieved its objectives. The quality of the training was rated high. The session on addressing the needs of vulnerable populations was also rated high. A few of the participants shared their concerns about the feeding arrangement as well as the publication and communication about the programme arrangement.Participants also wanted their ethics committee to continue the training at a regular interval, and emphasized the need for NHVMAS to monitor the participants to maturity.
With renewed global interest in possible management of acute HIV infections as a tool for facilitating HIV prevention, more and more interest are shifting to African countries including Nigeria for HIV prevention and treatment research. Conversely, capacity of the many stakeholders including policy makers directly engaged with HIV research is not adequately built to meet the global growing need for HIV research. It therefore becomes imperative that policy institutions like NACA should understand the fundamentals of HIV research including the ethics of HIV research. It is in this light that New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) in collaboration with NACA and with certification from the National Health Research Ethics Committee (NHREC), organised a 2.5 days residential training on protocol review, research monitoring and community engagement in HIV/AIDS research in Nigeria. The training aimed at updating the knowledge of participants on current concepts, principles, and application of principles that governs research ethics in general and HIV research specifically. The training also provided participants with state-of-the-art training on ethical considerations in community engagement in research.
The programme was held at the Cheers Hotel, Ikeja, Lagos between the 16th and 18th of November, 2011. Sixteen participants were in attendance, comprising staff of NACA and SACA – 2 Directors inclusive.
The workshop adopted a participatory approach including brainstorming, group discussion, slide presentations and case studies. Some of the topics addressed include: Basics of research and clinical trials, Operationalising ethical review of protocols, Informed consent, providing constructive feedback, research misconduct and standard of care for research participants.
Workshop evaluation also indicated that participant were satisfied with the conduct and content of the programme. All the participants (100%) were of the opinion that the programme met its set objectives.
Although the pretest and posttest evaluation did not show any statistical improvement in level of knowledge (P value=1), participants understanding of the primary responsibility of researchers and type of protocol review process improved.
The next step for NACA is to establish a competent and operational ethics committee that will continue to provide oversight function to the ethical conduct of HIV/AIDS related research in Nigeria. NACA will also need to sustain investment in the capacity building of its human resource in ethics of research and clinical practices and possibly extent
Every year around the world, International Women’s Day (IWD) is celebrated on March 8. It is a day when women irrespective of their ethnic, linguistic, socio-cultural, economic and political differences, come together to celebrate their Day. Organizations, women groups and even governments choice to celebrate these events in separate ways with events occurring to mark the economic, political and social achievements of women. “Empower Rural women – End Hunger and Poverty” was the theme for 2012. NHVMAS in collaboration with some of it partners celebrated this day by giving a lecture on NPTs, the need for dual protection, distribution and demonstration of the female condoms and the demonstration of cycle bead. Rhyming method of family planning was also explained, emphasizing the need to use female or male condom on fertile days and for dual protection from STIs.
Nigeria with a population of 141 million is the most populous nation in Sub-Saharan Africa with a primarily heterosexually transmitted epidemic and an estimated 2.6 million infected being second to South Africa (5.7 million) in HIV/AIDS burden.
Current efforts in the field of HIV prevention technologies indicates that there is hope that HIV epidemic can be tamed, subsequently, expectations are high that HIV prevention will finally mean more than the existing prevention options of Abstinence, been faithful to one partner(s) condom use, male circumcision and prevention of mother to child transmission. These measures will eventual translate into more researches efforts on vaccine, Pre exposure prophylaxis (PreP), treatment as prevention and microbicides.
HIV Research is therefore growing rapidly both in terms of the number of new trial sites as well as the forms and types of research. Unfortunately, while these researches have their implications for Nigeria, there are very little commensurate efforts at building the capacity of stakeholders to engage actively in the research process including understanding, interpreting and communication the outcomes of these researches.
In the light of this, NHVMAS with support from the Nigerian Canadian Collaboration on AIDS vaccine (NICCAV) organized roundtable session on the 21st of June 2012 to facilitate discussions and updates on the HIV research efforts in Nigeria.
The NICCAV study is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria.
The current project is expected to bridge the gap seen with respect to research implementation in the field and community expectations. The programme is organised as a roundtable meeting that brings HIV research communities and researchers in the field together to hear and learn from one another. This is one of two such inter-phase being planned by the collaboration. The programme was implemented in collaboration with The Initiative for Equal Rights (TIER), Christ Against Drug Abuse Ministry (CADAM) and Safehaven Development Initiative. Funding for the project was provided by Sidaction, France.
A five-day workshop was organized by the West African Bioethics Training Program, Ibadan (WAB) in collaboration with Federal Ministry of Health (FMOH), New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) and the National Health Research Ethics Committee (NHREC). The training curriculum was accredited by the National Health Research Ethics Committee (NHREC/TR/24/04/2012).The aim of the work shop is to train lay persons on how to review research protocols and provide constructive feedback to ethics committee and health researchers. The training came up between the 22nd and 27th April, 2012 at the Centre for Bioethics, 102 Bashorun Road, Ibadan. In attendance were 24 participants exclusive of the five facilitators.
15 plenary sessions were taken. Sessions included history and evolution of ethics, Legal, moral and philosophical foundations of research ethics, Principles of research ethics, Informed consent, Community engagement in research, Standard of care in treatment and prevention research, Voluntariness and Vulnerability in Research and Monitoring of clinical trials/research- the role of community representatives amongst others (see Appendix 1). The training used various participatory mechanisms to facilitate learning. These include: brainstorming, question and answer sessions, cases studies, mock HREC session, plenary discussions, group work, games and lectures.
The workshop evaluation showed that participants had indeed acquired new knowledge and skills. The mean pretest score was 44.8%. The scores ranged from 15% to 70%. Fifty-nine percent of those who took the pretest scored less than 50% (see appendix 2). The mean post test score was 52.7%. The scores ranged from 25% to 70% with nine persons scoring less than 50% (see appendix 2). They all could identify new skills they had acquired and the new things they plan to do with the skills acquired.
A three days workshop was organised by the Institute of Public Health, Obafemi Awolowo University in partnership with New HIV Vaccine and Microbicide Advocacy Society. The training curriculum was accredited by the National Health Research Ethics Committee (NHREC/TR/05/02/2012) and the Medical and Dental Council of Nigeria. The theme of the training was ‘Ethics of Biomedical Health Research. The training came up between the 15th and 17th of February, 2012 at the Institute of Public Health, Obafemi Awolowo University, Ile-Ife. In attendance were 26 participants exclusive of the two facilitators. 18 plenary sessions were taken. Sessions included history and evolution of ethics, principles of research ethics, informed consent, community participation in research, standard of care in research, engaging vulnerable communities, and monitoring of research amongst others (see appendix 1). The training used various participatory mechanisms to facilitate learning. These include brainstorming, question and answer sessions, cases studies, mock HREC session, plenary discussions, group work, games and lectures.
The workshop evaluation showed that participants had indeed acquired new knowledge and skills. The mean pretest score was 45.9% + 4.08. The scores ranged from 25% to 85%. Seventy percent of those who took the pretest scored less than 50% (see appendix 2). The mean post test score was 59.0% + 3.5%. The scores ranged from 35% to 85% with seven persons scoring less than 50% (see appendix 2). They all could identify new skills they had acquired and the new things they plan to do with the skills acquired.
Nigeria with a population of 141 million is the most populous nation in Sub-Saharan Africa with a primarily heterosexually transmitted epidemic and an estimated 2.6 million
infected being second to South Africa (5.7 million) in HIV/AIDS burden.
Current efforts in the field of HIV prevention technologies indicates that there is hope that HIV epidemic can be tamed, subsequently, expectations are high that HIV prevention will finally mean more than the existing prevention options of Abstinence, been faithful to one partner(s) condom use, male circumcision and prevention of mother to child transmission. These measures will eventual translate into more researches efforts on vaccine, Pre exposure prophylaxis (PreP), treatment as prevention and microbicides.
HIV Research is therefore growing rapidly both in terms of the number of new trial sites as well as the forms and types of research. Unfortunately, while these researches have their implications for Nigeria, there are very little commensurate efforts at building the capacity of stakeholders to engage actively in the research process including understanding, interpreting and communication the outcomes of these researches. In the light of this, NHVMAS with support from the Nigerian Canadian Collaboration on AIDS vaccine (NICCAV) organized roundtable session on the 21st of June 2012 to facilitate discussions and updates on the HIV research efforts in Nigeria.
The NICCAV study is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria.
A one day training was conducted by the New HIV Vaccine and Microbicide Advocacy Society in collaboration with the AIDS, TB and Malaria network in Osun State. The training focused on helping participants understand how to engage with research and researchers. This includes detail information on confidentiality, the importance of ethics clearance, informed consent and community engagement in research in Nigeria. The beneficiaries were civil society organisation who are members of the ATM network in Osun State. The programme was held on the 22nd of August 2012 at the CSO house in Osogbo. In attendance were 42 participants and two resource persons.
Three sessions were taken and these included the nine modules in the research literacy field guide training guide, informed consent and community engagement in research. There was group discussion session were participants shared their concern on the informed consent and community engagement processes of research conducted among their communities. The training used various participatory mechanisms to facilitate learning. These include brainstorming, question and answer sessions, discussions, group work, and lectures. The workshop significantly impacted in the participant level of knowledge, and new skills were acquired. The mean pre-test score was 40.4%. The scores ranged from 19% to 69%. The mean post test score was 49.4%. The scores ranged from 19% to 75%. The participants all agreed that the workshop objectives were met and identified ways they intend to use the skills gained. However they did note that the duration of the training is quite short for effective learning and therefore recommended for longer duration so as to ensure all participants get a better grasp of all that are needed to learn.
The next step is to nurture the participants for better engagement in research literacy campaign in Osun State. In line with this, NHVMAS will be providing technical support for the three networks to develop abstracts for public presentations based on outcomes of the training. This shall be a mentorship programme. Engagement of participants in this mentorship process shall inform their engagement in the proposed 3 days training to be implemented based on the new request for grant support for 2013 from Sidaction, France.
The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) with funding support from Sidaction, France, organised a one day training in Lagos for research communities and a one day interface with research stakeholders (Researchers, IRBs members, NHREC, Media and community gatekeepers) in the field of HIV treatment and prevention in June 2012. The programme was aimed at having researchers and research communities have direct dialogue on what HIV treatment and prevention concerns are, with the following objectives to: (i) inform research priorities in the community (ii) considerations that ought to be taken by the ethics committees during protocol review (iii) empower communities to become more directly engaged with HIV treatment and prevention research conducted within their communities.
The programme was a two day event. The focus of day 1 was to build the capacity of community representatives to understand basic ethical issues. This should enable them interact with interface researchers from an informed perspective. Day 2 was the interactive session between community representatives and the research community. The dialogue was to give community representative an opportunity to share with researchers their concerns and interest with the conduct of HIV research in Nigeria. This meeting is part of the ongoing efforts of NHVMAS and her partners to build the capacity of community members to engage effectively with researchers. The programme came up between the 10th and 11th of September 2012. The venue was Top Rank Hotel Abuja. Collaborative partners were – The Initiative for Equal Rights (TIER), Christ against Drug Abuse Ministry (CADAM), Safehaven Development Initiative and International
Rectal Microbicides Advocacy (IRMA) Nigeria. Funding for the project was provided by SIDACTION, France. Sixteen CSOs were engaged with the first day capacity building event. They were frm from CSO working with MARPs including MSM, FSW, IDUs. Also present were community representatives from Jos, a town hosting the HIV Vaccine demonstration project which is recruiting serodiscordant couples. Participants learnt about basic rules and principles governing research in general, informed consent and community engagement in research. The group deliberated on the current research practice in Nigeria as it relates to informed consent process, community engagement and standard of care. At the end of the meeting, participants
developed a consensus paper (see appendix I).
The evaluation showed that participants did have good basic understanding of concepts discussed at the meeting. The mean pretest score was 64.2% + 12.3% while the mean post test score was 68.0% + 5.4%. While the paired t-test did not show a significant difference in the pre and post test result (P=0.2), the participants did note that they acquired new knowledge and skills that would be used in their HIV prevention and research activities.
The second day was a roundtable session. Researchers and sponsors were present. These include representatives from the Centre for Disease Control, Abuja, ethics committee members, researchers from IHVN and Population Council. The group consensus document from Lagos interface as well as the Abuja consensus document was presented to the audience. There was open discussion on the issues raised by the community. Remarkably parties acknowledged that gaps do exist in terms of the informed consent and community engagement process in research. However, it appears that major culprits are independent researchers who know little about ethics of research conduct. While the group acknowledged that there was the need to continue to promote active community engagement in community based research, special efforts should be made to reach and build the capacity of independent researchers in the academia to conduct research in an ethical manner..
The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) in partnership with the NICCAV study team organized a half day media roundtable meeting in Abuja in support of the NICCAV project. The roundtable session was held on the 12th of September 2012 at NACA secretariat.
The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. It is a demonstration research that aim at building cohort of sero-discordant couples over the next 3years in preparation for future HIV vaccine trial in Nigeria. The NICCAV community engagement programme includes working with the media stakeholders at the local and national level to ensure the media takes its place in the HIV vaccine research process. As part of the effort in engaging the media on this project, NHVMAS did organize media roundtables in Jos and Lagos in April and June 2012 respectively. Also in an effort to reach out to other national media stakeholders NHVMAS did organized the media roundtable session in Abuja to update the media stakeholders on the current efforts on New HIV prevention technology research including HIV vaccine development efforts in Nigeria.
A two days training programme on understanding and communicating New Prevention Technology Research and trial result was conducted by the New HIV Vaccine and Microbcides Advocacy Society in support of the NICCAV project. The training was held between the 27th and 28th of September 2012 at the Plateau State Virology Research Centre. In attendance were the volunteer CSOs and CAB members engaged in the NICCAV community engagement programme and two resource persons from NHVMAS.
The sessions taken include: basic definition, introduction to new prevention technology, Understanding the research process, Understanding prevention trial, Understanding trial result, Interpreting trial result and critical analysis of trial reporting. The participants had a field trip to the research centre (PLASVIREC) where they were familiarized with the study site including the client flow charts and the various department of the laboratory. The training used participatory approach to facilitate learning. These include brainstorming, question and answer sessions, plenary discussions, games and slides presentations. The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pretest score was 54.4% + 10.2%. The scores ranged from 25%-87.5%. Forty one percent of those who took the pretest scored less than 50% (see appendix 2). The mean posttest score was 61.8% + 12.9%.
The scores ranged from 37.5% to 87.5% with 11.8 percent scoring less than 50% (see appendix 2). The paired t-test analysis showed that the difference observed was not statistically significant (p = 0.06).
The programme is part of NHVMAS Corporate Social Responsibility to Lagos State. Lagos State hosts NHVMAS secretariat. The two days training aimed at building the knowledge and skills of teachers that teach religious studies in Lagos State to enable then become resource persons on STI/HIV/AIDS within their communities. These teachers are the least reached with capacity building programmes on STI/HIV/AIDS yet they are a rich set of resource persons. NHVMAS layered information on new prevention technology on education about HIV, AIDS and STIs during the programme. The objective of the training was to promote positive attitude and support of these group of teachers to HIV/AIDS education and NPT research in general.
The programme came up between the 3rd and 4th of October 2012 at the NHVMAS secretariat in Ogba Ikeja. The training was implemented in collaboration with the Lagos State Ministry of Education. The funding for the project was provided through NHVMAS Corporate Social Responsibility Funding Scheme.
Twenty three CRK and IRK teachers from the junior and senior secondary schools in Agege Local Government Area of Lagos State were trained. The participants were taken through six plenary sessions:
overview of HIV and AIDS in Nigeria, the male and female reproductive organ functions, breaking the ice about discussing sex, all you need to know about STI, existing HIV prevention tool, and new prevention technology.
The training adopted a participatory approach to facilitate learning. These approaches included brainstorming on topical issues like anal sex, question and answer sessions, plenary discussions, slides presentations, games and group work.
The mean score for the pretest was 57.6% + 15.0%. The score ranged from 35% to 91%. Eight persons scored below 50%. At the end of the 2 days training, the post-test showed evidence of the trainees acquiring new knowledge: the mean post-test score was 66.5% + 9.6% with scores ranging between 48% and 83%. Only two persons scored below 50%. The paired T-test analysis did show a significant difference in the pretest and posttest score (P=0.001).
The participants developed an action plan that would be implemented in their various schools over the next 12 months with NHVMAS providing technical support. The participants will be followed up over the next six months to assess the training impact.
NHVMAS conducted a three days training programme for representatives of five partner organisations working with communities at high risk for HIV infection in Nigeria on research literacy. The training can up between the 7th and 9th of November, 2012. It was held in Ogba, Lagos. The programme aimed at building the capacity of gatekeepers who work with MSMs, IDUs and Sex workers on how to engage with research and researchers. This was the first phase of a three phased programme. In this first phase of the programme, NHVMAS will train collaborating organisations working with MSMs, IDUs and Sex workers on conduct of research in general and HIV prevention research specifically. The training modules would include understanding research and the clinical trial process, research ethics, research statistics and community engagement in research. This process will hopefully enable these organisations include research literacy efforts in their ongoing organisational programmes. The second phase of the project would be to have those trained to now step down the training to community gatekeepers they engage with regularly. This process should (i) enable those trained in phase 1 build their confidence in their ability to conduct future trainings (ii) build the capacity of community gatekeepers as trainer of trainers for the field. The project anticipates to train 90 gatekeepers (15 each from the six states where the IBBSS survey is usually conducted).
The third phase of the project is to have these trained gatekeepers (the 90 TOTs) to step down the training to their community members over the next 12 months. NHVMAS shall provide support for this step-down training exercise in a future grant. However, voluntary efforts at conducting step down trainings shall be facilitated through this project. The outcome of the monitoring will help NHVMAS design its future plans for conduct of step-down trainings.
The six participants who participated in this training were completely satisfied with the process.
The statistics section was the most challenging of all the sections. All the modules were highly rated by the trainees. Analysis of the test results showed that future training needs to do more on helping participants understand how HIV vaccine works and the PrEP concept.
A three days research literacy training programme was conducted for gatekeepers (FSW, IDU and MSM) in Kano State. The programme commenced on the 20th to 22th February 2013. In attendance were 6 FSWs, 5 IDUs and 5 MSMs making it a total of 16 MARPs.
Participants were taken through research literacy field guide that was developed by NHVMAS using Pidgin and vernacular English and the participants were so happy about it. Using the Pidgin and vernacular English made them to participate fully throughout the sessions.
Participatory approach was used to facilitate learning with group and individual presentation. All participants were provided with copies of the field guide on day one to enable them follow-up and also conduct step down trainings in their communities at the end of the training. They were also provided with a HIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was educating, enlightening and knowledgeable and it will enable them to step down to their peers.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was 45.5% + 11%, the scores ranged from 25.0% to 69.0%. 62.5% of those who took the pre-test scored less than 50.0% (see Appendix 2). The mean post-test score was 47.0 + 25.7% with scores ranging between 19.0% and 81.0%. Only 35.7% of those who took the post-test scored less than 50% (see appendix 2). The paired t-test analysis did showed a significant difference in the pre- and post-test scores (p value= 0.820).
Seventeen participants representing members of ethics committees and researchers from across Nigeria participated in a three days training that addressed ethical and regulatory aspects of clinical trials. There were 15 participants present for the training that ran between the 18th and 20th of February, 2013. Two participants from the Federal Medical Centre, Kebbi however showed up on the 25th of March 2013 (they were not aware of the change of date of the training programme). The two had a crashed 2 days programme organized for them.
One day ethics training was conducted for the CSO/CAB engaged in the NICCAV study. The programme came up on the 26th of March 2013. The programme ran from 10:am to 3:30pm, with 12 participants in attendance. The training session was moderated using the NHVMAS developed laypersons ethics training manual on how to review research protocols. The training was designed to be implemented over three days: one day training per quarter. The trend of the participants’ knowledge will be assessed over the training period.
The objective of the training is to assist participants to understand the issues involved in research ethics as well as highlight the roles of laypersons/CAB in ensuring the the rights and priviledges of trial participants and the communties where the research is being conducted are addressed. The training adopted a participatory approach, including brainstorming, group discussion, lecture presentation and case studies.
The NICCAV community engagement project recognises the need to engage with various levels of stakeholders including the media, CSOs and CAB at the national and host community level. The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS), is saddled with the responsibility of coordinating the NICCAV community engagement programme. It has therefore continued to work with the CSOs and CAB at the host community to promote research literacy and ensure meaningful community engagement in the research process. Also recognizing the significant role of the media in the research process; it identified media engagement strategies ensuring that the media takes its place in the HIV vaccine enterprise. Most importantly, NHVMAS recognizes the synergy the media, CSO and CAB can form for greater community understanding and involvement in the NICCAV study. It is against this background that NHVMAS in partnership with the NICCAV study team organized a one day media roundtable meeting in Jos in support of the NICCAV project. The roundtable session provided a common platform for the media, CSO and the NICCAV clinical team to interface and brief on the entire NICCAV study.
The programme was designed as a two day event. The first day focused on building the capacity of journalists to understand basic scientific concepts of New biomedical HIV prevention technology research and development including HIV vaccine. They were also assisted to understand the basic concept and skills for media reporting on the HIV prevention trials. This training was very beneficial, as it enabled journalists interact better with researchers, CSOs and CAB during the roundtable session the held the next day. The media training came up on the 22nd of April 2013 while the roundtable session with the media, CSO, CAB and the NICCAV study team took place on the 23rd of April 2013.
The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. It is a demonstration research that aim at building cohort of sero-discordant couples over the next 3years in preparation for future HIV vaccine trial in Nigeria. The NICCAV community engagement programme includes working with the media stakeholders at the local and national level to ensure journalists are well informed and engaged with the ongoing HIV vaccine research plan in Nigeria. Past efforts in this respect include media roundtables in Jos, Lagos and Abuja in 2012; and for 2013 there was consensus among the media stakeholders for one day sensitization training on New HIV prevention technology research for journalists prior to the hosting of the joint roundtable sessions. This media programme will be replicated in Abuja-the national host community of the NICCAV study.
The Plateau State Specialist Hospital Management provided support for the two days event.
A three days capacity building was conducted for 34 CSOs in Osun State between the 15th and 17th of April, 2013. The training was residential and held in Ejigbo, Osun State. The objective of the training was to build the capacity of participants so that they can conduct research literacy trainings in their respective communities.
Participants were taken through sessions that addressed basic definition, understanding the research process, research ethics, Interpreting trial result, communicating trial result and critical analysis of trial reporting. The sessions were facilitated using a research literacy field guide manual developed by NHVMAS.
Participatory approach was used to facilitate learning and there was group presentation. All participants were provided with copies of the field guide on day one to enable them follow-up and also conduct step down trainings in their communities at the end of the training. They were also provided with a HIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was empowering as it will enable them to step down to their peers. Over 80% of the trainees felt the workshop provided me with new insights about HIV prevention technologies, and that participating in this workshop was a good use of their time.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was43.1% + 16%, the scores ranged from 19% to 69%. 54.9% of those who took the pre-test scored less than 50% (see Appendix 2). The mean post-test score was 65.2 + 15.3% with scores ranging between 25% and 88%. Only 12.9% of those who took the post-test scored less than 50% (see appendix 2). The paired t-test analysis did show a significant difference in the pre- and post-test scores (p value< 0.0001).
A three days research literacy training programme was conducted for gatekeepers (FSW, IDU and MSM)in Cross-River State. The programme commenced on the 23rdto 25th January, 2013. In attendance were 2FSWs, 5 IDUs and 5MSMs making it a total of 12MARPs. Participants were taken through sessions that addressed basic definition, overview of the ethical trialprocess. The sessions were facilitated using a research literacy field guide and manual developed byNHVMAS. Participatory approach was used to facilitate learning with group and individual presentation. Allparticipants were provided with copies of the field guide on day one to enable them conduct step down trainings in their communities at the end of the training. They were also provided with aHIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration anddiscussion. The pre and post test analysis showed the training resulted in improvement in knowledge. The evaluation also showed participants acquired new skills. The mean pre-test score was 51% +14.7%. The scores ranged from 36% to 75%. The mean post test score was 64.2% +11.9%. The scores ranged from 36% to 81%. The paired t-test score also showed a significant difference in the pre and post test result (P=0.020)
This programme is part of NHVMAS Corporate Social Responsibility to Lagos State. Lagos State hosts NHVMAS secretariat. The two days training aimed at building the knowledge and skills of teachers that teach religious studies in Lagos State to enable then becomeresource persons on STI/HIV/AIDS within their communities. These teachers are the least reached with capacity building programmes on STI/HIV/AIDS yet they are a rich set of resource persons. NHVMAS layered information on new prevention technology on education about HIV, AIDS and STIs during the programme. The objective of the training was to promotepositive attitude and support of these groups of teachers to HIV/AIDS educationand NPT research in general.
The programme came up between the 20th and 21st of June 2013 at the NHVMAS secretariat in OgbaIkeja. The training was implemented in collaboration with the Lagos State Ministry of Education. The funding for the project was provided through NHVMAS Corporate Social Responsibility Funding Scheme.
Twenty five CRK and IRK teachers from the junior secondary schools in Alimosho Local Government Area of Lagos State were trained. The participants were taken through seven plenary sessions:the male and female reproductive organ functions, breaking the ice about discussing sex, HIV, TB and ARV, all you need to know about STI, existing HIV prevention tool, new prevention technology and PMTCT.
The training adopted a participatory approach to facilitate learning. These approaches includedbrainstorming on topical issues like anal sex, question and answer sessions, plenary discussions, slides presentationsand group work.
The mean score for the pretest was 58.2% + 12.7%. The score ranged from 30% to 85%.Fivepersons scored below 50%.At the end of the 2 days training, the post-test showed evidence of the trainees acquiring new knowledge: the mean post-test score was 69.6%+ 9.9% with scores ranging between 50% and 85%.No participant scored below 50% in the pretest. The paired T-test analysis did show a significant difference in the pretest and posttest score (P=0.0004).
The participants developed an action plan that would be implemented in their various schools over the next 12 months with NHVMAS providing technical support. The participants will be followed up over the next six months to assess the training impact.
When NHVMAS studied the methodology section of the 2007 and 2010 IBBSS survey reports, it was clear that though the methodology was sound, there was a gap in the ethics of the conduct of trials – there was no evidence of community engagement in the design of the survey though there were evidence to show that they were engaged in its implementation – simply as gatekeepers who enabled access to the community. This contravenes the position of the Federal Government of Nigeria in its HIV research policy that identified the need to ensure that communities are engaged during community based HIV research. The section 6.2 of the document notes that researchers should ‘ensure that HIV and AIDS research protocols have well defined formal mechanisms such as the Community Advisory Board (CAB), for engaging the community in study design, implementation, monitoring, information and result sharing’. Unfortunately till date, the conduct of these IBBSS surveys does not conform to this policy. The community themselves are also increasing becoming concerned with their continued participation in these surveys which does not translate to interventions being developed and implemented for their communities.
The three days training workshop for health care workers in Bassa Cottage Hospital, Pleateau State was focused on ethics of HIV service delivery for PLHIV and key populations. The training is part of the NHVMAS efforts at promoting ethical standard of practice in our health care system. The project was implemented in partnership with Heartland Alliance Nigeria and in collaboration with Plateau State Hospital Management Board. The workshop was conducted from the 21st of July to 23rd of July at Bassa Cottage Hospital. The programme provided state of the art training on the basic ethical principles and its applications in the delivery of health care services. It also equipped the participants with the basic skills and knowledge on the ethics of HIV services delivery for the key populations-MSM, IDU and FSW and designing comprehensive reproductive health care services for the vulnerable populations.The workshop delivery style includes the adoption of a participatory approach, slide presentations, brainstorming, case study, group work, question and answer session. The workshop provided a platform for the participants and the resource persons to share experiences on the field and also work towards changing the current paradigm of practice in the hospital.
Current national data show that the HIV epidemic in Nigeria, though stabilising, is still a cause for concern. The National HIV sero-prevalence Sentinel Survey Among Pregnant Women shows a current prevalence of 4.1% and the National AIDS and Reproductive Health Survey of 2007 estimated the HIV prevalence at 3.6% in the general population. This figure is however higher amongst populations at high risk of HIV infection being about 1 to 7 folds higher than the national HIV prevalence. Ironically, between 2007 and 2010, only in the MSM population did the HIV prevalence increase (from13.5% to 17.2%). The IBBSS report 2010 reported that condom use is least amongst MSMs when compared with other populations at high risk for HIV – 98% among FSW, 62% among IDU and 52% among MSM for casual partners.
The UNDP supported sexual diversity training was conducted in Lagos State between the 9th and 11th of July 2013 at the secretariat of Shomolu Local Government Area of Lagos State in collaboration with UNFPA, Population Council, Municipal Authority of Shomolu and Ikeja. The training targeted multidisciplinary stakeholders including representatives from the judiciary, healthcare facilities, law enforcement, human rights defenders, Lagos State AIDS Control AgencyJustice Workgroup and civil society organizations-38 participants were in attendance.
There are community concerns and perception that HIV prevention research conducted among MARPs across the country does not translate to the design and implementation of the national programmes for the community. Despite the consistent results and national reports of high HIV and or hepatitis prevalence among the MARPs, the policy environment does not support the translation of this research evidence into programmes for MARPs.
NHVMAS with funding support from amFAR, the AIDS Foundation of USA, is implementing an ongoing project titled “Creating space for MSMs to dialogue with policy makers on National and State Plans for MSM HIV prevention and treatment programmes”. NHVMAS did organised roundtable session in Makurdi, on the 15th and 16th of July 2013. The first phase of the project facilitated the engagement of the MSM gatekeepers to build their capacity to articulate their concerns and discuss this appropriately with programmers, policy makers and researchers; while the second phase was a roundtable session that brought together the MARPs gatekeepers, researchers and programmers in the state. The roundtable session aimed at achieving the following objectives:
This project is an effort on the path of NHVMAS to continue to build grassroot community capacity to engage directly with researchers and policy makers. It is currently building on its past effort in this respect. Specifically, it is building on a gap identified by NHVMAS during its community-researcher interface meeting held on the 12th of September 2012. The meeting brought together representatives of the MSM, IDU, FSW, PLHIV, CABs and CSOs working in research communities to dialogue with research stakeholders (researchers, funders, bioethicists) about concerns they had with the way research was conducted. At that meeting, one of the gaps identified was the need for communities to meet with researchers, policy makers and programmers to discuss the community research priorities, as well as dialogue on how the various data generated from the community over the years have influenced or can influence programming for the community.
The Oyo State HIV prevalence using the national sentinel survey of pregnant women attending antenatal clinic was estimated at 3.0% and the IBBSS 2010, estimated the HIV prevalence among the MSM at 3.3% slightly above the state average. Despite this research evidence on the disproportionate burden of the HIV epidemic among the MSM compared to the general population; the Oyo state do not currently have any programme intervention for the MSM community. This further affirms community concerns and perception that HIV prevention research conducted among MARPs across the country does not translate to the design and implementation of programmes for the community. Despite the consistent results and national reports of high HIV prevalence among the MARPs, the policy environment does not support the translation of this research evidence into programmes for MARPs.
Introduction: The programme entailed working with 8MSM gatekeepers to dialogue on the community concern and interest as it relates to HIV prevention research, policy issues and standard of care and prevention for the community. The programme started at 10:00am with an opening prayer session followed by the introduction of participants and project objectives. The gatekeepers include the MSM that participated in the research literacy training and the additional four that joined the team. They were all from one family-Initiative for the advancement of Humanity.
Partnership: The project was implemented in partnership with the following organisations: TIER, Heartland Alliance, IRMA Nigeria, SMAAN and ICARH. Heartland Alliance supported the programme with additional funding.
Current national data show that the HIV epidemic in Nigeria, though stabilising, is still a cause for concern. The National HIV sero-prevalence Sentinel Survey Among Pregnant Women shows a current prevalence of 4.1% and the National AIDS and Reproductive Health Survey. 2007, estimated the HIV prevalence at 3.6% in the general population. This figure is however higher amongst populations at high risk of HIV infection being about 1 to 7 folds higher than the national HIV prevalence. Ironically, between 2007 and 2010, only in the MSM population did the HIV prevalence increase (from13.5% to 17.2%). The IBBSS report 2010 reported that condom use is least amongst MSMs when compared with other populations at high risk for HIV – 98% among FSW, 62% among IDU and 52% among MSM for casual partners.
In recent times, in a bid to strategically address the epidemic, Nigeria as a country has focused on its most at risk populations – men who have sex with men, male and female sex workers, intravenous drug users, uniformed service men, incarcerated persons, and long distance truck drivers. Increasing strategies are also directed at PLHIV in a bid to contain the infection within the group. While the national constitution may have sections that infringe on the fundamental human rights of MSMs, the newly revised national HIV policy and the new National Strategic Framework for addressing HIV/AIDS (NSF II) recognises the needs of populations most at risk of acquiring HIV infection and addresses tries to address their needs in terms of planning for access to HIV prevention services, treatment, care and support.
In Nigeria, HIV disproportionately affects vulnerable populations. The mode of transmission (MoT) study conducted by the Government of Nigeria in 2009 showed that high risk populations, namely, female sex workers (FSW), men who have sex with men (MSM), and people who inject drug (PWID) account for 23% of new infections, though they comprise only 1% of the population. Moreover, these populations at high risk for HIV infection and their partners account for 40% of new infections. New research indicates that this figure may actually be well above 50%. These estimates are not surprising given that HIV prevalence among FSW is 25.2%, 18.6% among male sex workers, 13.5% among MSM, and 4.2% among IDUs (GARPR, 2013). The importance of providing and ensuring key population’s access to high-quality, bias- free healthcare services including access to proven effective HIV prevention technologies cannot be overemphasized. In Nigeria, most of the key populations are known to have sexual relations with the members of the general population thereby serving as a bridge between their community and the general population. However, little has been done in this regard by the national HIV response to ensure key population have access to proven HIV prevention tools including condom compatible lubricants. Lubricant access remains a challenge in Nigeria. Most information and discussion about lube is limited to HIV prevention programming for MSM and FSW. Lube is also only largely available as a socially marketed product by the Society for Family Health for its Global Fund project. Between 2010 and 2012, Society for Family Health sold 212,795,064 male condoms, and 201,495 lubricant packages. The figures show a disproportionate access to and uptake of lubes. The 2007 IBBSS reports also shows clearly that MSM use many products for lubrication during anal sex with the least frequently used product being commercially available lubes. This is mainly due to lack of knowledge about its possible availability and lack of public access to lubes. Lubes are rarely found on the shelves or spheres where condom can be assessed. The Food and Drug regulation in Nigeria identified lube as a cosmetic product that can be imported and marketed in the country with little or no stringent regulations governing its importation and marketing. Wide public access to lube is therefore possible. The two-day training of CSOs in Jos on New HIV prevention tools and lubricant access for key populations was to build the knowledge of CSO working with women, youths and key populations (MSM, FSW,) on new prevention technology tools and lubricants access, so as to integrate this in the public education programme on HIV thereby creating public demand for lube. The training was conducted between the 24th and 25th of July 2014 at the Plateau State Human Virology Research Center Jos. The training is also part of NHVMAS efforts at building pool of advocates that will mobilize and support the global campaign for lubricant access and advocacy on NPT.
A two days training programme on NPT and Lubricant Access mobilization was conducted for CSOs in Cross River State. The programme was held on the 14th and 15th of August 2014. In attendance were 14 CSOs working with key population (FSWs,MSMs, Youths, Girls and Women).
Participants were taken through sessions that addressed basic facts about new HIV prevention technologies, basic, overview of clinical trial and research process, introduction to GLAM, introduction to key population for HIV programming in Nigeria, how to promote condom and lubricant use among key populations in Nigeria. Participants also brainstormed on how to facilitate lubricant access in Nigeria. Participatory approach was used to facilitate learning. All participants were provided with copies of the training materials. They were also provided with a HIV prevention toolki t which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was very exciting, interactive, educative and they were well informed on some issues about key population. The interactive session made learning easy.The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was 41.44% + 6.21%, the scores ranged from 20% to 86.7%. 71.4% of those who took the pre-test scored less than 50% (see Appendix 1). The mean post-test score was 52.82% + 7.92% with scores ranging between 33.3% and 86.7%. 53.8% scored less than 50% in the post-test (see appendix 2). There was difference in the pre and post-test but there was no statistical significant difference in paired t-test analysis (p value=0.94).
The planning meeting started at 11:39am with a welcome note from the new Medical Officer of Health for the Ikeja LG Dr. Ibukun followed by the introduction of partners facilitated by Florita. The MOH used the platform to familiarize with the municipal action project and the TWG, as he is meeting the team for the first time after assuming office.
The global innovative facility grant for results communication for key affection populations was introduced and is supporting the implementation of the project titled: Scaling up key population access to Treatment, Care and Support Services using social communication system. The purpose of this project is to create awareness on HIV and existing prevention, treatment and care services for key populations (MSM and FSW) and youths in Ikeja and Shomolu LGs of Lagos State, contributing to the Lagos Municipal Action Project strategic objective 2. Scale up Treatment, Care and Support Services for MARPs by (Strategy 2.2) Strengthening capacity of peer led organizations to scale up existing services targeted at key populations most at risk of HIV exposure. The various activities of the project were highlighted.
The meeting had ten partners in attendance including the TWG members and the other participating NGOs, the MoH and the Action AIDS Manager of the Ikeja LG.
The planning meeting started at 11:00am with welcome note from the Project Coordinator, followed by the introduction of participants. The meeting had thirteen participants inclusive of the Action AIDS Manager and the Project Coordinator. The participants were identified by the TWG members representing the community they work with.
The importance of providing and ensuring key population’s access to healthcare services including access to proven effective HIV prevention and treatment services cannot be overemphasized. Given the current unfavourable legal environment that has criminalized association with MSM simply implies the community will become further hidden and harder to reach with HIV services. This supports the need for innovative communication strategies to provide HIV prevention information and educational sessions to the key population and also link them to friendly centers to access reproductive health services. This project adopted a peer led group education intervention and therefore conducted one day training for the peer educators.
The training will focus on building their capacity of peer educators on the basic issues on HIV/AIDS, HIV risk and anal sex, condom and lubricants safety and new HIV prevention technology. The training also sensitized the participants on social media and expected roles as peer educators in information sharing on HIV prevention and treatment among peers.
The training was held between 10:30am to 4:00pm on the 18th of November 2014, at the Ikeja LG secretariat. The training had 15 persons in attendance including the members of the TWG. The opening session commenced with the conduct of training formalities – brief overview of the workshop aims and objectives, introduction of participants, laying down of ground rules.
About CROI: The Annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational, and clinical researchers from around the world to share the latest studies, important developments, and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI is a global model of collaborative science and the premier international venue for bridging basic and clinical investigation into clinical practice in the field of HIV and related viruses. CROI 2015 was held from February 23 to February 26, 2015, in Seattle, Washington, at the Washington State Convention Center. The results of several HIV prevention studies were presented, remarkable, the PROUD, IPERGAY, partners PrEP, IPREX OLE studies and the FAACT 001.
Community educator scholarship programme: CROI provided scholarship for community educators who work in community HIV research, prevention, or treatment education programs. The conference also provided opportunity for the community scholars to interface with the researchers’ through the community educator programme and mentorship. The community educator scholarship recipients were expected to share their knowledge and experience with their community and expand community research literacy.
NHVMAS through her Community Educator delegate at the conference organised a one day post CROI update meeting in Lagos on the 29th of April 2015. The objectives were to: update the knowledge of the participants on the latest HIV prevention and treatment research and sensitize them on CROI and the community educators’ programme. The sessions discussed include the PROUD, IPERGAY, Partners PrEP, and the FAACT 001. The mean score for the pre-test was 33.75%+_20.00% and the mean score for the post test was 78.15%+13%. All the participants showed increase in the post-test score in relation to the pre-test score except two participants that did not complete the post-test. There was statistically significant improvement in the participants’ level of knowledge, P-value of 0.0013.
As part of a sponsored project which tries to bridge the identified gap observed with respect to research implementation in the field and community expectations, NHVMAS hosted an interface meeting between researchers and HIV research communities in Nigeria. The programme was organised as a roundtable meeting, bringing HIV research communities and researchers in the field together to hear and learn from one another. This is one of two such interfaces being planned by the collaboration: NHVMAS, The Initiative for Equal Rights (TIER), Christ against Drug Abuse Ministry (CADAM) and Safehaven Development Initiative. Funding for the project was provided by Sidaction, France.
On the first day, the 28th of June 2012, 16 representatives of the different research communities in Southwest Nigeria – Ibarapa, Ifo, MSMs, FSWs, PLHIV and Drug Users – were brought together to discuss and identify issues that were of concern to them when it comes to HIV research being conducted in their communities. Attention was paid to 3 main areas: informed consent, community engagement in research, and standard of care packages during research.
On the second day, 29th June 2012, 35 persons present for the interface meetings. There were representatives of the Nigeria Institute of Medical Research Ethics Committee (it evaluates protocols of national importance); NAFDAC; researchers from LUTH, NIMR, Population Council andNeuropsychiatry Hospital, Yaba; journalists, and the representatives of the research communities. The discussion was rewarding as so many issues were raised, discussed and clarifications made. Below are some of the highlights of the discussions:
Next steps
The Lagos group will meet again in August to finalise the recommendations they will like to share with the larger national community. These issues, when articulated, will be shared at the Abuja roundtable scheduled to hold in September, 2012. The Abuja roundtable meeting should ensure representatives of national donor agencies that fund research eg USAID, World Bank, Global Funds, ENR as well as national stakeholders and partners (NAFDAC, NACA, NHREC) are present for dialogue. he Abuja meeting would have stakeholders from research communities identified in Abuja and Jos.
A one day training was conducted by the New HIV Vaccine and Microbicide Advocacy Society in collaboration with the AIDS, TB and Malaria network in Osun State. The training focused on helping participants understand how to engage with research and researchers. This includes detail information on confidentiality, the importance of ethics clearance, informed consent and community engagement in research in Nigeria. The beneficiaries were civil society organisation who are members of the ATM network in Osun State. The programme was held on the 22nd of August 2012 at the CSO house in Osogbo. In attendance were 42 participants and two resource persons.
Three sessions were taken and these included the nine modules in the research literacy field guide training guide, informed consent and community engagement in research. There was group discussion session were participants shared their concern on the informed consent and community engagement processes of research conducted among their communities.
The training used various participatory mechanisms to facilitate learning. These include brainstorming, question and answer sessions, discussions, group work, and lectures.
At the end of the training, participants were able to identify some gaps in the way researches were conducted within their communities which they consider unethical. These include: (i) inadequate time allocated to community education about the research prior to implementation (ii) conduct of research without ethical clearance (ii) failure to administer informed consent forms on the field (iv) use of community inappropriate language in the development of study questions (v) poor sensitivity to community culture and concerns when conducting research.
The workshop significantly impacted in the participant level of knowledge, and new skills were acquired. The mean pre-test score was 40.4%. The scores ranged from 19% to 69%. The mean post test score was 49.4%. The scores ranged from 19% to 75%.
The participants all agreed that the workshop objectives were met and identified ways they intend to use the skills gained. However they did note that the duration of the training was quite short for effective learning and recommended that NHVMAS conducts another training for longer duration. Prior to the organisation of a more extensive training, NHVMAS will be providing technical support for the three networks to develop abstracts for public presentations based on outcomes of the training. This shall be a mentorship programme. Engagement of participants in this mentorship process shall inform their engagement in the proposed 3 days training to be implemented based on the new request for grant support for 2013 from Sidaction, France.
The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) in colaboration with The National Agency for the Control of HIV/AIDS (NACA) and funding support from African Microbicide Advocacy Group (AMAG) organised a one day microbicde research dissmeination meeting in Abuja on the 16th of December, 2008. Nigerian researchers presented excellent reports on their various works in the field of HIV Vaccine and Microbicide research
The two microbcide studies in Nigeria (the SAVVY and CS3) showed no effectiveness. However, there are new research interest as noted by Drs Adeiga and Obunge due to outcomes of the trial. The two PIs intend to pursue some further STI based on secondary outcomes from the research. Dr Obunge however categorically stated that ‘even though the products did not work, the study demonstrated that HIV prevention messaging works”. This was because of the demonstrated decrease in HIV prevalence (total number of HIV infection) and incidence (number of new infections) reduced throughout the study period.
The preparedness study for a phase III IPM microbicide study conducted by Dr Simon Agwale of the Innovative Biotech, Nasarawa also showed startling revelations: HIV prevalence is as high as 100% in some brothels in Nasarrawa State. The general prevalence rate for HIV amongst sex workers in Nasarawa state is 37.5% .HIV incidence is as high as 8.4% in sex workers in this same region. This thus means that it is possible to conduct microbicide research amongst this cohort in Nigeria.
Innovative Biotech plans to conduct HIV Vaccine research in the near future as well as produce vaccine when possible.
Hello friends and Colleagues,
One is so happy with the array of very useful information,websites on
Microbicides and related issues flooding in to all of us(on this linkserve) on daily bases.At least all of us can now boast of invaluable resources to continue our research and grassroots education and mobilisation on Microbicides.
A week and there-about ago a very impressive Round Table/Press
Conference on Clinical Trial was organised by Nigeria HIV Vaccine
and Microbicide Advocacy Group(NHVMAG)in collaboration with
JAAIDS.The venue was at JAAIDS Office Ogba,Lagos.The program was attended by most reputable electronic and print media across the country.
The meaning of Clinical Trial to the level that non scientist understood without any stress.Dr Ukpong explained that clinical trials are important and are needed to help improve health and medical practice. Clinical trials are the best form of evidence to establish the effectiveness of a drug or product for human use.
The various stages on the trial starting from 1 to Phase 4 were explained in the most understandable manner.Common examples were used to explain these phases of studies and why they continue to be relevant. Other resource persons are Ms.Marie from France, a NAFDAC Representative. Kingsley of JAAIDS who also double as a moderator.In fact and indeed,i will always remain happy as a participant to this powerful outing. Questions were asked by the journalists, CS members and other researchers and students from Archeology who made up the participants. There were a lot of interest in efforts of NAFDAC at curbing various herbal cure claims and their efforts at monitoring clinical trials. NAFDAC noted that not all NAFDAC registrations means NAFDAC approval. A number of a drug product may simply mean that this drug is known to be safe BUT needs to re-register in another year when there are evidence to support its effectiveness as per ability to do what it claims it should do. The public therefore needs to be aware of this differences.
Marie spoke on the concept of freedo to leave trials and noted that in Africa, most often, trial participants participate in trials because of the associated health benefit rather than altruism. There is therefore a need to advocate for clinical trials to be conducted in a way that can ensure trial participants who leave trials can surely have access to the same level of care within the trials. This and only this an then ensure true liberty to leave trials for clinical trial participants
There were 43 persons in attendance at the 3 hour enriching round table discussions. There have been several print and electronic media reports on the outcome of the roundtable after that
Prince Goodluck Obi
National Executive President
United Nations Of Youth Network Nigeria(UNOY)
This is to update you about plans and activities that NHVMAG would be engaged with during the M2008 conference
Pre-Conference Advocates Workshop (Sunday, 24 February, 0900 – 1500)
The M2008 Pre-Conference Workshop has become an important part of all microbicides conferences. It provides an introduction to new advocates and a refresher to more seasoned advocates. It also offers an opportunity to engage on critical and emerging issues for the field, for skills-building, and to network with other advocates. For more information and to register, please write to kwest@path.org.
Hosts: The African Microbicides Advocacy Group (AMAG), the Global Campaign for Microbicides (GCM), the Indian Network of NGO’s ( INN ), the National Coalition on Health Initiative (NCHI) and the Positive Women’s Network (PWN+)
NHVMAG would be represented during the programme. We would be sharing our experence as a country level advocacy group
Advocates Corner Daily, sunrise to sunset
This is a shared space in the M2008 Exhibition Hall co-sponsored by AMAG, GCM, NHVMAG, IRMA and INN . It is space to for delegates from community, advocacy and civil society groups to dialogue, network, and build solidarity. The Corner will also host a number of skills-building and speakers’ panels, display resources from various groups, and provide a …refuge from the conference. Other groups will also be able to display their materials (on request) and to use the space for their own meetings. Please make sure to spend some time with us there.
Launch of the Omololu Falobi Award for Advocacy
M2008 Closing Ceremony
Together with AMAG, AVAC, GCM, JAAIDS, and TAM-Nigeria, we are pleased to launch the Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy. We will be launching the award and recognising the first ever recipient of this award at the Closing Ceremony. Please join us to support the recipient, and honour Omololu’s memory.
Skills-building workshop: Media training for Advocates The Media — Microbicide Friend or Foe? (Monday 25th February. 1730-1830 )
This workshop is designed to provide a skills-based media training for microbicide researchers, advocates and community members from research sites. It will give you the chance to practice key skills and will introduce you to some effective tools for communication. NHVMAG is helping to coordinate this workshop.
Skills-building workshop: Enhancing CAB Member Roles
‘Challenges, needs and opportunities for enhancing the role of Community Advisory Board members
Tuesday 26 February: 1730-1830
This workshop is designed to provide CAB members and others linked to various HIV prevention trial communities the opportunity to share experiences and to identify gaps for enhancing meaningful community participation in shaping the research and development process of microbicides. NHVMAG is helping to coordinate this workshop.
Round table: Community participation and ethics
27th from 1-2 PM (Lunch will be provided)
Community participation and ethics are topics of great importance but never seem to get the attention of scientists until they hit a problem. NIH feels that both topics were important and offering the roundtable simultaneously would deny the participants important information. To address these two concerns, NIH wish to combine the two topics into one roundtable and to moderate the discussion so that both topics would get addressed. NHVMAG would be one of the discussant at this session. We would be sharing our experiences and insights with the participants who wish to learn more.
NHVMAG Presentations at M2008
Oral presentation: Tues Feb 26, 2008
Community vs researcher’s perspctives on community demand from trials
-NHVMAG
Poster Presentations
“Report on a community post trial monitoring visit of microbicide clinical trial sites”.
– NHVMAG & NEPWHAN
The Role of Advocates in Responding to Trial Results: Different Reactions to the N9, CS & Savvy Trial Results
– AMAG, Gender AIDS Forum & NHVMAG
“Adolescent advocacy participation in microbicide trials: resolving the impasse’
– NHVMAG
“Microbicide by 2010: yes or no?”
– NHVMAG
“Less than 10 cents: how much would a microbicide truly cost?”
– NHVMAG
NHVMAG Meeting at M2008
We are hoping to have a general meeting for NHVMAG members present at M2008. More information coming on this coming soon!
Looking forward to meeting you there!
Best regards
Morenike Ukpong
When clinical trials recruit knocks at your door step
Skills Building Session – ICASA – Dakar 2008
Friday decembre 6th. 2008 – 10.30 to 12 am – Room Village 1
Contact : Marie de Cenival,
m.decenival@sidaction.org, +331 53 26 45 32
Session Topic
To build capacity of AIDS organization members regarding HIV-related medical research: to have a first look at how it works, participants’ rights and expectations, the basic rules and tenets that researchers are expected to follow and important information to provide to potential participants.
Audience: Organization leaders (AIDS organizations, Human Rights NGOs, Health NGOs, etc.). Current or potential participants in clinical trials
Session Goals
For 30 organization leaders to show interest in ethical issues around clinical research, and to understand how important it is to be empowered when collaborating with researchers, in order to:
better advise organization members in places where trials recruit
promote a constructive collaboration between researchers and organizations, and minimize potential abuses and/or constraint attached to people’s participation.
Educational and sensitivity training tools refined by SIDACTION’s partners will be shared.
Content
1. Short presentation of basic ethics principles through concrete examples.
2. Case studies: « they knock at your door, what do you do? »
We will cover real HIV-related clinical trials (1) a therapeutic trial, 2) a plant-based immune boosters trial, 3) a prevention of mother-to-child transmission trial:
Two work groups, coached by community-organization experts, will discuss each kind of trial and cover key questions to ask, demands to formulate, potential benefits and how to minimize potential risks, recourse (legal or other) to take in the event of problems, and modes of collaboration with researchers.
The workshop will present its conclusions, which will then be compared to concrete experiences of community experts who have already worked on these kinds of trials.
Participants/Trainers:
Calice Talom (REDS, Cameroon), Rose Dossou (CHIGATA, Cote d’Ivoire), Morenike Ukpong (NHVMAS, Nigeria), Oliver Ezechi (NHVMAS, Nigeria). Facilitater: Marie de Cenival (SIDACTION, France).
The rationale for this project is the realization that the capacity of potential researchers in the field of HIV/AIDS research needs to be strategically built. This involves addressing science and ethics of research, including HIV/AIDS research, at the foundation. Equally so, to ensure accountability, these trials need to be monitored and the capacity of those who should be conducting the monitoring exercise needs to be built. This project therefore focused on training and further building the skills and capacity of laypersons on ethics committes in Nigeria on how to monitor research in general and HIV related researches specifically. The 3 days training was conducted between the 23rd and 25th of November, 2009.
The training curriculum for this project was be adapted from the WHO/TDR training curriculum on clinical trial monitoring. Prior to this training there existed no training curriculum appropriate for laypersons’ training on research monitoring. This is the first such curriculum in the field.
NHVMAS provided a six months mentorship programme for all the trainees. NHVMAS kept in touch with trainees via phone calls and emails trying to address possible technical challenges in the implementation of their roles and functions. Emails on update materials were also sent to trainees. An impact assessment of the project on the HREC functions was also conducted. The assessment instrument was administered to the trainees, and chairpersons and/or the secretary of ethics committee so as to have their own assessment of the performances of the trainees. The assessment showed that the training had made significant impact on the operations and functions of ethics committees.
1, Trainees have since been fully engaged with protocol review following the training. Trainees are able to read through protocols, review and provide comments.
I have had to addess issues on methodology especially with respect to helping the committee assess if the research process will produce harm to the study participants; quality of the informed consent given to participants, the liability of the participants and the researchers in any research; the standard of care to be provided. These comments are often adopted since the two of us who went for training actually concur on the issues raised. Mr Sa’ad Deen, layperson, AKTH, Kano
I think the Chairman of the board has been very impressed with the performance of we laypersons on the board since the training. Our contributions have been significant and are often adopted. Hardly are the comments we made not adopted. Mrs Mafe, Layperson, NIMR, Lagos
The HREC has since taken a decision to have supervisors of students who submit proposals to the ethics board liable to the committee so as to ensure the committee received feedback on all protocols reviewed. In the past, our HREC do not receive any feedback on approved protocol. This way the feedback can inform practices in the institution also. LAUTECH, Osogbo
There was a research protocol that required policemen to escort researchers to the field. The layperson was very concerned about the issue of confidentiality and asked the researchers to address this as this was of concern. The protocol was engaging MSMs.
Mr Bolarinwa, NIMR secretary
There was a research assessing efficacy of malaria drugs and comparing the North of Nigeria and the South of Nigeria. I had to ask the protocol to be revised to address the issue of drug safety and the need to ensure community dissemination of result. I also asked that participants must be followed up in the long and short term to assess effect of the drugs post research. Rev Ryemshak, Evangel
The Project was adjudged HIGHLY effective as significant changes were brought about in all the IRBs as a result of the training. Trainees were more confident, discharged their duties with enthusiasm, and evaluated research protocols and conducted monitoring exercises (where this was instituted) objectively. This also had a rub on effect on the entire ethics committee. Below is the comment of one of the trainees:
I have used the trainings extensively beyond my work in the IRB. The training on protocol review enabled me respond to a prequalification tests. I was thus selected for the AMANET training. The research monitoring training built on the foundation received. I am now so confident. I use the NHVMAS training as a yardstick to assess other trainings and many fall short. NHVMAS training is a gold reference standard other trainings need to aspire to be. Mrs Mafe, NIMR IRB Member
Training was funded by SIDACTION, France through grant no NG-04-09-01
NHVMAS trains chairpersons of Ethics committees in Nigeria on the use of the Good Participatory Practice Guidelines
The training for Institutional Review Board Chairpersons on community engagement in research, using the Good Participatory Practiceguidance document as the training module, was held on the 9th and 10th of April 2010 at the Development Support Centre, Ibadan.
The goal of the training was on building the capacity of the trainees on how to ensure effective community engagement in research when evaluating research protocols submitted to IRBs.
The 22 participants at the workshop were actively engaged throughout the training session. The training made use of differentparticipatory methods to engage participants. These include presentations and plenary discussions, brainstorming, questions and answer sessions, group work, and case studies.
The interactive sessions afforded participants the opportunity to learn new ideas and ways to effectively operationalise the IRBs. It also provided an opportunity for networking and sharing lessons between members of the IRBs – an opportunity that had not had prior to now.
The evaluation exercies quite a number of the participants have good knowledge of the need for community engagement in researchbut did not know how this could be translated to practice. The training and the GPP were therefore a great opportunity to learn new skills not only for use as members of the IRBs but as researchers themselves. The pre and post test results showed a significant increase in knowledge (64.6 vs 70.7).
Overall evaluation of the workshop shows that the conduct was good. Participants noted that the training acheived its objectives and the knowledge and skills will be stepped down and indeed used in protocol evaluation.
Participants were followed up three months after the workshop to assess how they had been using the skills acquired including the use of the GPP. The following were observed:
Recently, we had a protocol from the USA and he insisted that he (the researcher) engage the community on the protocol before the researcher can be allowed to implement the protocol. Chairman, AKTH IRB
As a layperson, I have insisted on having research result disseminated to communities after research conclusion. Layperson, LAUTECH, IRB
I have had to address community engagement issues. There was one HIV related protocol that had to involve PLWHIV and another sentinel survey report. I asked them to consult with and engaged PLWHIV organizations prior to project implementation. Laypersons. AKTH IRB
….. There was a 3rd study on Diabetes Mellitus. The PI was in the USA and obviously did not understand the community she wanted to conduct the study in. she was advised to engage the community in the design of her protocol. Layperson, NIMR IRB
The constitution of the IRB did not include a layperson. Following the training on the GPP for members of the IRB, we have now created a position for laypersons on our board. Chairman, IRB, Abia
Training was funded by AVAC.
The five days training for Institutional Review Board admininstrative secretaries and laypersons was held on 12th to 16th of April 2010 at the Development Support Centre, Ibadan.
The training aimed at teaching laypersons to provide constructive feedbacks when reviewing research protocols. The training was conducted using through the engagement of participants in plenary discussions, presentations, group discussions, case studies, and questions and answer sessions. The training manual developed through a similar training in 2008 was also pilot tested.
The various sessions exposed the participants to issues of community engagement and participation in research, basics of clinical trials, challenges of ensuring informed consent, providing constructive feedback when reviewing protocols, good clinical and laboratory management and data monitoring and management in research. The group interactions afforded participants the opportunity to learn from one another’s experience while the case studies simulated actual practical experiences in clinical research protocol review.
For participants, the training afforded them the opportunity to acquire new knowledge and build skills to be able to review protocols as well as manage and ethics committee office. It also afforded them the opportunity to learn about national requirements and regulations.
Participants rated the entire program high with the quality of the program scoring 76.5%. The facilitations were excellently scored with scoring as high as 87.0%. All the participants admitted that the training addressed the objectives and suggested that subsequent trainings should be spread over longer periods to make it less cumbersome.
NHVMAS will be publishing the manual used for the conduct of this 5 days training. It will be available for public use in 2011.
This training was the second in the series. It was funded by the European Developing Countries Clinical Trial Partnershop (EDCTP). The earlier training conducted in 2008 was funded by SIDACTION, France.
Report on training on New HIV prevention technology organised by NHVMAS for Medical Studemts at Obafemi Awolowo University, Ile-Ife.
Number of participants: About 60 men and women
Professionals: Medical Students and nurses
Time alloted: one hour
Facilitator: Morenike Ukpong
Programme: The facilitator started by correcting the notion about the safety of anal sex highlighted by an earlier speaker. She highlighted the fact that anal sex was 18 times more risky than vagina sex with respect to HIV transmission.
She then showed a slide discussing all efforts at identifying new HIV prevention tools. These include HIV vaccine, Microbicides, PreP, and STI management.
She concluded on the note that these tools are needed and are complimentary because of their complimentary nature. In addition, the tools help to increase the range of HIV prevention options available for everyone.
Lessons learnt: There are indeed poor assumptions about the safety of anal sex even amongst proessionals who teach about HIV. It is important to include discussion about the risk of contracting HIV infection in all NHVMAS discussions especially when discussing microbicides. This is important.
Report on training on Research Literacy organised by NHVMAS for HIV Positive Women in Leadership Training organised by PATA.
Number of participants: 11
Gender distribution: 9 females and 2 males
Time alloted: Four hours
Facilitator: Morenike Ukpong
Programme: NHVMAS latched unto a two weeks training organised by PATA for HIV Positive women leadership training prorgamme. The training focused on helping participants identify their roles, responsibilities and rights in research.
Facilitator discussed extensively on the eight issues that needs to be disccused in any informed consent form and the reasons why they need to understand these issues.
There were extensive discussions around the need for ethical clearance before researchers could discuss with a potential research volunteer about their recruitment. Also, participants learnt about other questions they need to ask and understand before being engaged in a research. These include the study objective, risks and benefits of the research, time to be spent on the research, compensation package, and the study sponsor.
The session was concluded with participants identifying the need to (i) share this information further with their peers as there were lots of research being conducted within their community (ii) need for indepth training so as to build their capacity to be able to build the capacity of their peers to discuss around research
Issues raised: lots of research do go on amongst PLWHIV in treatment centres but they are not informed and consents are not taken for this research participation.
The dependency of PLHIV in the treatment gives room for abuse of their rights
Lessons learnt: NHVMAS needs to raise funds to organise a full course on research literacy for selected members of the PLHIV community. Best to select persons who already have identified mechanisms to step down these trainings eg leaders of functional support groups and PLHIV in the position of training. NHVMAS to also explore possible strategic alliance with NEPWHAN to conduct such training.
Report on NHVMAS engagement at the 18th AIDS conference, Vienna, Austria
Events NHVMAS participated in:
NHVMAS Facilitators: Olayide Akanni, Damilare Adeyemo, Morenike Ukpong, Oliver Anene
Opportunities: The booth gave NHVMAS an opportunity to displace her IEC materials for others the public to pick from. The uptake of materials at this booth was poorthe booth was located in the global village. Materials had to be moved to the Nigeria Exhibition booth about the third day. Uptake was much better there.
The session with SIDACTION gave NHVMAS an opportunity to share with attendance at the session work NHVMAS was engaged with. There were about 30-50 participants at this session. The discussion on the need for CSOs to function independent of the community-researcher relationships so as to watch for possible abuse in a trust relationship between the two parties was highlighted and picked up as a point for deliberation.
The session with ICAD was attended by about 12 -15 participants. It was indeed an engaging sessions. However, the session did not provide an opportunity for each partner to discuss about its work.
Finally, Dare Adeyemo did have opportunities to discuss about his S4M project. he was on two youtube recordings at the conference where he shared about the S4M project.
The discussion session on NPT in countries were there are few or no NPT trials was facilitated by San Patten and Andre Marc-Blanc. It was a session that gave NHVMAS a great opportunity to share with the other 11 participants present about its work. NHVMAS efforts in the field was well acknowledged and commended by Andre Marc-Blanc.
The discussion on rectal microbicide was held with some other NHVMAS members present eg Oliver Anene. Morenike Ukpong could not identify where the session was holding and so missed this. Oliver Anene is currently following up by planning a roundtable discusssion on rectal microbicide in Abuja.
New Alliances: None.
Lessons learnt: NHVMAS has to work concentiously to use these conferences to project its own image independent of partner efforts. This will include putting in requests to organise skills building sessions, taking up a booth were feasible or being located as strategic alliance in any partnershio based on NHVMAS work (this will allow NHVMAS to project itself and its ongoing work).
Introduction
The members of the Peer Educator Trainers (PET) of the Lagos state National Youth Services Corp organized a one day workshop on HIV/AIDS on the 3rd of August 2010. The programme was held at the state NYSC secretariat, Surulere. The members of PET are trained by UNICEF.
The workshop aimed at equipping PET members with information on recent advances in HIV/AIDS. The workshop theme was “Recent Development in the Fight Against HIV/AIDS”
New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) provided the resource person for the workshop. NHVMAS was represented at the workshop by Durueke Florita, the Programme Manager
Understanding the New HIV Prevention Technologies
Durueke Florita made a slide presentation titled understanding the new HIV prevention Technologies. In her presentation, she reminded the PET on the existing prevention strategies, abstinence, mutual fidelity, consistent and correct condom use, PMTCT, and post-exposure prophylaxis.
The new HIV prevention technologies discussed included HIV preventive vaccines, microbicides and pre-exposure prophylaxis. These preventive technologies are undergoing clinical trial. The result of the CAPRISA 004, was shared. CAPRISA 004 is an ARV based microbicide found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during vaginal intercourse and 51% effective in preventing genital herpes infection.
Questions and answer session
The following questions were asked:
The questions were addressed.
The workshop was well attended by over 200 PET members, the Head of Department, UNICEF PET project, the Coordinator UNICEF PETproject, a representative of the Community Development Services -a department of the NYSC, and media persons from the NTA channel 10 Lagos.
Feedback from PET members
Lessons learnt
Recommendation
Though new HIV prevention technologies are non existing, there is need to sensitize the community and educate them so they coul bebetter prepared for an eventual product. There is the need to integrate NPT into the UNICEF-PET curriculum to address the recent advances in HIV/AIDS research. This can be an advocacy agenda for NHVMAS collaboration with UNICEF in this area.
Report written by:
Durueke Florita.
Programme Manager,
NHVMAS
Report on training on New HIV prevention technology organised by NHVMAS for youths and adolescents attending the Life builders Camp at Olashore International School, Iloko.
Number of participants: 89
Age range: 9 to 29years
Time alloted: one hour
Facilitator: Morenike Ukpong
Programme: Six participants were asked to first share their vision of the world. The facilitator then shared her vision of a Nigeria freee of HIV infection. She noted the importance of HIV prevention, discussed on existing tools for HIV prevention – the ABC of prevention of sexual transmission of HIV infection – and the need for the D component. The D is developing new HIV Prevention
She described and discussed about the importance of a Vaccine and how Vaccine had changed the history of diseases. It is expected that a HIV vaccine will also change the face of the HIV
She discussed about the vulnerability of women to HIV infection and the need to enhance the ability of women to protect themselved from HIV infection. A microbicide is being developed so as to enable women have the option of discretely protecting themselves from HIV infection if they choose
She finally described the problems associated with HIV serodiscordants, and the need for PreP. She gave analogies on existing PreP such as malaria therapy.
Questions: Will a HIV vaccine cure HIV infection?
Will a therapeutic HIV vaccine prevention HIV infection in those with infection? How soon will a HIV vaccine be available for the public to use?
What will a microbicide be like?
If HIV is found in the blood, then how do you have the virus in the sperm?
Will a PreP also prevent a HIV positive mother to transmit the infection to her child?
Lessons learnt: Children, adolescents and youths can be reached with the basics of NPT so that they are equally prepared for the future.
The training on ethics of medical care and service provision for teachers of medical and dental students was held on 21st through 23rd September 2010 at the Development Support Centre Ibadan. The training aimed at building the capacity of the lecturers on medical and research ethics so as to be able to teach and mentor students on how to conduct ethical research. A total of 21 participants were in attendance. Most had never had formal training on ethics.
The participants were extensively engaged, analyzing the current situations in the medical and dental schools and proffering solutions to bridge the gaps identified. A participatory learning process was employed. This included slide presentation, brainstorming, plenary discussion, group work and case studies.
The interactive learning process afforded the participants opportunity to acquire new ideas, share experience, and identify ethical dilemmas and best practices in medical care and service provision. The training also afforded them the opportunity to network.
A communiqué was developed at the end of the workshop which will be distributed to the medical and dental council, media and other relevant authorities.
The workshop evaluation indicated that participants had increased knowledge The 22 plenary sessions were also scored very high. The overall evaluation of the workshop was rated high in terms of content, logistics and the conduct.
The quality of the training was rated very high, 53% rated it excellent while 47% rated it very good. All the participants indicated that the workshop achieved its objective. A workplan post the workshop was developed. The workplan shall serve as a monitoring tool over the next 5 months of the training. Most of the participants wanted an extension of the workshop duration and also getting more of the stakeholders trained.
Thetraining was supported by funding from SIDACTION, France through grant number NG-04-10-01.
NHVMAS organised a three days training on understanding and communicating NPT trial results for journalists and CSOs
NHVMAS organised a three days training for 15 media representatives and 10 CSOs with the objective of Increasing the capacity of media representatives to report on NPT trials with accuracy and sensitivity; Raising skills amongst community-based organizations to critically analyze media discourse about HIV prevention trials; and Increasing the capacity of community representatives to understand and communicate NPT trial results effectively.
The training held between the 1st and 3rd of September, 2010. Thirthy two participants were in attendance with 21 attending the entire 3 days, 9 attending for 2 days and a few others only attending for one day.
Participants were taken through seven modules developed for the training. The modules were developed by ICAD, Canada. The training was made as participatory as possible and engaging. There were also multiple opportunities to reinforce information.
Participants comments about the training was very positive with all participants acknowledging that they had acquired new knowledge. However, by the 3rd day, 24% of participants who filled the post test evaluation form gave a neutral response with respect to their ability to use the information gained in their everyday life.
There was a difference between the pretest and post test score (53% vs 65%). The pretest scores ranged between 20% and 75% while the post test score ranged between 35% and 90%. There was only one person scoring below 50% in the post test while seven persons scored less than 50% in the pre test.
Outcomes of the training
The training was organised in partnership with ICAD Canada and SAT, SouthAfrica with funding support from CHAVI, Canada. The grant number is 6279-15-2009/10080002.
NHVMAS, in its efforts to drive NPTs visibility and reporting, initiated an award on best reporting on New HIV Prevention Technology in the print media. This was done in collaboration with JAAIDS. The award was given at the 10th edition of the Red Ribbon Award Night which held on the 5th of December 2010.
For the best reporting on NPT the winner is Mr. KAYODE ODUMBONI, of the Nations Newspaper and the runner up is Ms. OLAYINKA LATONA of the Vanguard Newspaper.
These two awardees are young and have both benefited from NHVMAS organised capacity building trainings. They were awarded a plaque and cash prizes.
The aim of the award is to encourage journalists to better understand and report more on New Prevention Technologies (NPTs). Entries are critically assessed for quality of content and issue based reporting.
The 2011 edition will be open to both the print and electronic media.
NHVMAS builds the capacity of 25 CSOs, and 2 journalists in Kaduna on how to interprete and communicate NPT research results – 12th to 14th of April, 2011
A threes days training workshop on interpreting and communicating trials results for NPT was held in for 27 persons. In Kaduna. Participants were taken through the same modules and topics highlighted in previous trainings.
The majority of the participants were learning about NPT for the first time. The training was thought provoking for them and it generated a lot of curious questions such as the possible effect of microbicides on oral mucosa for those who engage in oral sex.
All the participants noted that they learnt new things for at the training. As high as 40% of the participants were seeing the female condom for the first time. Most of the participants were hearing about biomedical HIV prevention technology for the first time also.
NHVMAS realises that there is much effort that needs to be invested in community literacy about biomedical HIV prevention technology. With new and evolving evidences about HIV prevention, still having major players in the field just learning about Male circumcision and Female condoms as HIV prevention tools is not acceptable.
NHVMAS builds the capacity of 28 members of the CSOs working with research sites in Abuja on how to interprete and communicate NPT research results – 22nd to 24th April 2011
A three days training was organised for 28 persons from research organisations working with communities. These included six representatives from Government Agencies, two Students, two Media practitioners, four Researchers and 12 members from NGOs. The objectives of the training were to (i) Increase the capacity of media representatives to report on NPT trials with accuracy and sensitivity (ii) Raise skills amongst community-based organizations to critically analyze media discourse about HIV prevention trials and (iii) Increase the capacity of community representatives to understand and communicate NPT trial results effectively. Participants were taken through 8 modules which updated knowledge on HIV prevention tools and biomedical HIV prevention technology, clinical trial processes, research ethics, how to interprete research result and how to communicate same to specific communities. In addition, participants were asked to analyse media reports and evaluate the accuracy of the contents of the reports.
Participants comments about the training was very positive with all participants acknowledging that they had acquired new knowledge. There was a significant difference in the pretest and post test score (60% vs 61.7%). The pretest scores ranged between 25% and 100% while the post test score ranged between 20% and 95%. Four persons scoring below 50% in the post test while three persons scored less than 50% in the pre test. Certificate of attendance were award only to those that attended for the entire 3 days. Others will take a 4 weeks online training starting from the 6th of September, 2010 to be able to pick up their certificate of attendance. The online training has since commenced.
At the end of the training, (i) Participants capacity on NPTs and interpretation of trail result was built (ii) Participants promised to step down the training programme in their organization and communities with colleagues, friends and family (iii) Capacity of participants in community messaging was built, participants promised to reflect this new knowledge in their write ups and communication in communities (iv) Participant’s knowledge on ethics of research was greatly improved with many persons on ethic boards promising to reflect this knowledge in handling ethics related issues in their communities (v) Media reporting of the training was promised by the two media representatives who were at the training. Details will be obtained (vi) A few participants wanted follow up trainings
NHVMAS hosts a Media and CSO roundtable in commemoration of the HIV vaccine day
20th May, 2011. NHVMAS secretariat
Global HIV vaccine development efforts: implications for Nigeria
AIDS continues to be a major public health priority as AIDS related illnesses remain one of the leading causes of death. Although the HIV epidemic in Nigeria is reported to be stable, the country play host to 3.3million people living with HIV/AIDS making it the second country with the largest HIV burden in the world.
These global statistics on the HIV epidemic indicate the urgent need for continued efforts at addressing the epidemic. There are high hopes in the discoveries of new technologies that will lead to more effective tools in the control of the epidemic. Resent events in the field of HIV prevention technologies indicates hope that the HIV epidemic can be controlled. Subsequently, expectations are high that HIV prevention methodologies will expand beyond the existing prevention options of abstinence, been faithful to one partner(s) condom use, male circumcision and prevention of mother to child transmission. These mean more researches, including HIV vaccine research.
In the light of this, there is need for advocacy to promotr HIV vaccine research and development. The roundtable provided a platform for dialogue and discussion on how to further strengthen the national HIV vaccine advocacy efforts in Nigeria.
Three presentations were during the roundtable discussion namely:
• Global HIV Vaccine Development Efforts: Implications for Nigeria. The preseantation by Ms Florita Durueke highlighted global efforts and challenges to developing a HIV vaccine. The session also enumerated the challenges for Nigeria if it does not engage in the HIV Vaccine research process. It also highlighted current efforts by IHVN for future HIV vaccine research.
• Community Engagement with HIV Vaccine Development: The presentation by Ms Aisha Adaranijo identified the role of the community in advocacy and engaging in HIV vaccine research. She also highlighted NHVMAS efforts to date at building local capacity to understand the issues involved with biomedical HIV prevention research.
• The Place of the Media in HIV Vaccine Research Advocacy. Mr Kingsley Obom-Egbulem enumerated the numerous roles of the media on setting the agenda for HIV research. He identified the barriers and challenges for the media to play this role adequately. He concluded by challenging journalists to ask the hard questions about HIV research.
At the end of the meeting, a call for action was placed to both the media and the CSO. Journalists were encouraged to build their capacity so as to be able to ctively engage in HIV research processes. They need to become research literate to be able to package HIV research news with human angles. CSOs on the other hand need to do more work at reaching out to the grassroot to help them understand about new HIV prevention tools.
The 23 participants in attendance did conclude that the media and CSOs are very critical in promoting advocacy for HIV vaccine research and other biomedical HIV prevention technology research. Investing in their capacity development will add value to stepping up advocacy, awareness and education on NPT among the Nigerian communities.
Training of researchers in Ebonyi State on ethics of community engagement in research – 25th to 27th May, 2011
NHVMAS conducted a three days workshop for researchers in Ebonyi University Teaching Hospital Abakaliki and its environ. The workshop aimed at building the capacity of participants on how to ensure ethical conduct of HIV research (especially community engagement in research), care and service provision. The event was held on the 25th – 27th May 2011 in collaboration with the EBSUTH Health Ethics committee.
Forty two participants comprising of nurses, doctors, pharmacists benefited from the programme. The workshop adopted a participatory approach including brainstorming, group discussion, slide presentations and case studies. Several plenary sessions were taken including among others, the history and evolution of ethics, informed consent, review of protocol, community engagement and how to work with vulnerable populations like FSW, MSM and IDUs.
The pretest and posttest evaluation indicated that participant knowledge improved; mean scores are 40% + 18% and 73% + 18% respectively. There is statistically significant difference in the mean score of the participants’ pre-test and post test. (P<0.001).
Workshop evaluation also indicated that participant were satisfied with the conduct and content of the programme. Most of the participants (90.5%) strongly agreed that the programme provided new insights.
The participants will be followed over the next six months to assess the use of skills and knowledge gained from the workshop.
Report on the training of field workers working with communities of vulnerable persons on how to understand, interprete and report HIV research results – June 7th to 9th, 2011
A three days training was conducted for CSOs working with vulnerable communities on HIV research literacy. The programme was held on the 7th – 9th June 2011 at NHVMAS Secretariat , Lagos. The workshop objective was to equip participants with basic knowledge and skills to understand, interpret and report biomedical HIV prevention research with accuracy and sensitivity. In attendance were 16 field workers from the LGBTI, IDU, FSW and PLHIV communities.
Topics discussed include research ethics, informed consent, payment and research participation, confidentiality, understanding statistics, understanding trial results, communicating trial results, and community engagement in research.
The average pretest score is 45.5% + 9.07. The lowest and highest scores were 36.4% and 63.6% respectively. The average post-test score was 59.9% +18.7. The lowest and highest scores were 40.9% and 86.4% respectively. The difference in the pre and post rest result was statistically significant (p=0.0489).
All the participants felt the training provided them with new insights about new HIV prevention technologies, all also felt the workshop was a good use of their time.
Below are the comments of a few participants at the training workshop
The training was simply educative, expository and interesting – Richard Gbenga
Organised and empowering comes readily to mind when I think about the training – Okwuegbunam Eken
This training has given me powerful insight into the horizons of research literacy. I am grateful to have been part of it. Austine Afaha
It was a well spent time. I acquired knowledge about research literacy abd how I can be useful in my community – Mary Affiong
The research literacy workshop was packaged to equip and reposition participants to be relevant in the research field. The NHVMAS message cannot be faulted. Pelemo Babatunde
The training was quite informative and useful. More organisations should be given opportunity to be equipped with the skill. Dr Dora Ofobrukweta
Report on the training of field workers in vulnerable communities on New HIV Prevention research literacy
A three days training was conducted for CSOs working with vulnerable communities on new HIV prevention research literacy. The programme was held on the 7th to 9th of June 2011 at NHVMAS Secretariat, Lagos.
The workshop objective was to equip participants with basic knowledge and skills on how to understand, interpret and report biomedical HIV prevention research with accuracy and sensitivity. In attendance were 16 field workers from the LGBTI, IDU, FSW and PLHIV Communities.
Several modules were taken which included: why the need for research, new prevention technologies, understanding and interpreting basic research statistics, understanding trial results, how to communicate
HIV prevetion trial results to communities, media analysis of research reports and Community engagement payment and confidentially in research, the clinical research process etc
It was a participatory training with the use of case studies, role plays and game to help to reinforce what participants had learnt.
Discussions and concerns were centered on MSM and anal sex, the process of obtaining approval for protocols, Pre-exposure prohylaxis, availability and utilization of the female condom amongst others.
Participants’ noted that the training was highly relevant to their needs, attendance at the workshop was good use of their time, and that they had gained a lot of new knowledge and understanding of the on the research processes.
Based on objective assessment, it was apparent that the training had made significant impact on the knowledge of participants.. The mean score for pretest was 45.9% +13.7% while the mean score for post test was 63% + 20.8%.
Participants also identified the following as new knowledge and skills they had gained from the training:
• Research processes, need for the development of research protocol
• Ethical standards and informed consent process
• Need for research protocol and the role of ethics committee
• Female condom use
• Better presentation skills
• How to get communities involved in research
• How to advocate to people to take part in research
Comment from one of the participants “I’m already seeing myself as a future field worker, lecturing and teaching with life example to human subject about the research”
NHVMAS as a civil society also felt obliged to continue to build the capacity of local communities to be able to participate in future trials in the country as well as engage meaningfully with ongoing international and regional efforts. In this respect, with funding support from CHAVI and in partnership with ICAD Canada SAT South Africa, human and financial resources were invested resources in developing a training curriculum that will ensure that capacity of civil society members and the media could be built to interprete, understand and communicate HIV prevention research results.
In all, NHVMAS was able to build the capacity of 102 (60.8% were females) in this respect. This comprised of CSO representatives, the media, policy makers, health care workers and students. Five three days training were organised for groups of persons in Lagos, Abuja, Kaduna, Enugu and Sagamu. The group also organised trainings at the 2010 IAS conference in Austria as well as the 2011 ICASA conference. Pre and post test analysis showed that there was significant improvement in the knowledge of trainees. A post workshop assessment was conducted for trainees in Nigeria. The assessment showed that all participants (100%) made use of skills and knowledge acquired from the training.
The 1st of December is slated as the World AIDS Day. The day is dedicated to increasing public awareness about HIV and AIDS, fighting prejudice and discrimination and raising money for (research, care, prevention and treatment). World AIDS Day is also important for reminding people that HIV has not gone away, and that there are many things still to be done.
For the year 2011, a collaborative activity was undertaken between The Good Neighbour, Safe haven, TIER, HAGIA, CADEF, CisHAN, Dohealth Foundation, The Eagle Eye, People Empowerment Organisation and HYGIE Enwerem Foundation and The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) to commemorate the World AIDS Day. The occasion was also used by NHVMAS to share with its immediate community and the CSO community in Lagos State about its activities over the last four years.
Activities for the day included a public rally to increase public awareness on HIV prevention, HCT services, and a public discussion on NHVMAS activities over the last four years. Specifically, the meeting aimed to sensitise the public on HIV/AIDS based on the theme for this Year getting to ground Zero as well as disseminate and share with CSOs the activities of NHVMAS over the past years. The public discussion was also to enable the CSO community in Lagos State to develop a collaborative plan of activity for 2012 with respect to HIV prevention and HIV treatment and prevention research literacy.
1. Rally: The programme started at 9:45 am with members dressed in their various organisational T-shirts and Caps. The awareness raising procession started from HAGAI office at Oke-Ira Aguda Ogba, through the major roads to Aguda by Excellence Hotel to Ogba by Area G Police Command and stopped at NHVMAS office at Ogba where other NGOs joined the train. The train moved through Ogba bus-stop and Aguda. The final stop was at the taxi pack at Ogba Bus-stop where a canopy was set up to conduct HCT. During the procession, NHVMAS leaflet Learn something new was distributed. Hagai and other partner NGOs also provided IEC materials for information sharing. One on one information sharing was conducted by trained persons who participated in the rally. Information was shared in Hausa, Yoruba and English.
2. Testing: Two tests were conducted: HIV tests and malaria tests. Turn up for the tests was quite impressive with the stand for HIV recording the highest number. Some of the participants did both of the test, but majority were for HIV testing. At the end of the two hour testing about 120 persons had been tested while over a hundred people did not get to conduct the test because the kit ran out. Two persons were confirmed as positive. They were counselled and referred to NIMR and Gbadamosi General Hospital, Ogba for confirmatory tests and further management.
3. Public talk and demonstration: At the end of the rally, a public talk was given. There were specific discussions on existing HIV prevention options and future HIV prevention options. There was also public demonstration of the proper use of the male and female condoms. Demonstration involved the use of the phallus and vulva models. Members of the public were encouraged to also practice the use of the condoms on the models. The activity generated a lot of interest and participation from the public.
Achievements
1. 166 CSO and community members were directly reached through this dissemination activity.
2. Well over 1,000 community members were reached with information on HIV prevention and new HIV prevention technology. Also, over 120 and over 50 community members had access to HIV and malaria testing.
3. NHVMAS was able to actively engage five of its partners in planning and implementing activities. This networking activity reinforces and strengthens the partnership.
4. New allies were made with new interest shown by some new organisations.
5. The activity provided an opportunity for NHVMAS to reach out to its immediate environment and educate them about HIV prevention, HIV treatment and new HIV prevention technologies.
6. The opportunity to conduct HIV and malaria tests for the community was an unforeseen output of this event. Though testing was planned, the community desire to know their status was overwhelming and unanticipated such that the provided test kits was not sufficient for the demand. Organising the programme in partnership with others enabled the NHVMAS immediate community benefit from this benefit. 120 persons in the Ijaye community benefited from a HIV test. Many others benefited from malaria screening
NHVMAS, in partnership with the Institute of Public Health, implemented its annual research ethics training for researchers. The theme of the first annual training was Ethics of Biomedical Health Research. The 3 days programme was held at the Institute of Public Health Seminar room between the 15th and 17th of February, 2012. There were 26 participants in attendance.
18 plenary sessions were taken. Sessions included history and evolution of ethics, principles of research ethics, informed consent, community participation in research, standard of care in research, engaging vulnerable communities, and monitoring of research amongst others.
The training used various participatory mechanisms to facilitate learning. These include brainstorming, question and answer sessions, cases studies, mock HREC session, plenary discussions, group work, games and lectures.
The workshop evaluation showed that participants had indeed acquired new knowledge and skills. The mean pretest score was 45.9% + 4.08. The scores ranged from 25% to 85%. Seventy percent of those who took the pretest scored less than 50%. The mean post test score was 59.0% + 3.5%. The scores ranged from 35% to 85% with seven persons scoring less than 50%. They all could identify new skills they had acquired and the new things they plan to do with the skills acquired.
The training was considered a huge success as participants continue to commend the high quality of the training and materials shared during the training. A few asked for the training to be repeated once again in 2012 for the benefit of many others who could have benefited from attending.
Over the next eight months, NHVMAS shall follow up participants to learn how the skills and knowledge acquired were used. NHVMAS shall also continue to provide technical support and updates for all trainees in an effort to address their continue capacity needs.
The next annual training is scheduled for February 2013. The theme is ‘Ethical and Regulatory Aspect of Clinical Research’. Watch out for announcements.
At the end of 2012, NHVMAS worked and conducted extensive consultations with MSM, IDU, FSW and PLHIV communities on what the need of the community was with respect to research literacy. Based on the identified agenda, NHVMAS worked with other partners in the field including engaging with the Lagos State technical Working Group for MARPS to develop the Lagos Municipal Action Plan on AIDS and MARPS for 2012 and 2013. It also sought support from its long term funding partner, Sidaction to enable NHVMAS facilitate engagement of MARPS with the research community in some strategic research locations in Nigeria.
In view of these, NHVMAS met with three stakeholders from the community on the 19th of February 2012 to design a course of action for the year 2012. The outcome of the meeting includes:
• Revision and pilot testing of the research literacy training manual which commenced in 2011 through funding support from Sidaction, France. The training manual will be pilot tested within each of the communities, finalised, produced and distributed by the end of March 2012. This will be funded by RESPECT. Through the Lagos Municipal project, capacities of peer educators within these communities would be built to use the manual for peer education within the framework of HIV prevention programmes.
• The seven months training of one of NHVMAS staff through funding support from IDRC South Africa should result in the development of simple messages on new biomedical HIV prevention technologies that can be readily assimilated by members of the community. Also, the social media networks and NHVMAS website can be better used to disseminate information on research and new prevention technologies that can be accessed and used by the communities.
• Future grants should address specific capacity building activities for the communities. This should include the capacity to advocate with research that addresses priority health needs, advocate with policy makers to translate relevant research to programmes for the communities, and advocate for more HIV funding to address the community needs.
As a way forward, NHVMAS shall facilitate a face to face meeting and engagement of MARPS with the research community within the second quarter of 2012 through a grant received from Sidaction, France. It has sent in a proposal that shall specifically address capacity building of the communities to engage with researchers on HIV prevention related research. It is currently working on a proposal that will address the need to build the capacity of the community on advocating for their health needs that can be addressed via the implementation of researches, and the translation of these health research outcomes to programmes.
In December, 2011, NHVMAS with funding support from Sidaction, France, was able to meet at various times with groups of MSMs (55 persons), IDUs (30 persons), PLHIV (38 persons) and female sex workers (43 persons) through her partners namely TIER, CADAM, PATA, and Safehaven. The meeting was to provide stakeholders with information on efforts of NHVMAS within the community. It also provided an opportunity for stakeholders to learn more about HIV, the efforts of NHVMAS within the communities and peculiar issues that need to be addressed within each community.
At the end of each meeting, participants took time to have group work and identify how NHVMAS can better work with each of the community for the year 2012. The following are common themes that evolved from discussions with the groups:
• The need to build the capacity of each respective community cannot be overemphasied as they are often visited on multiple occasions by researchers who collect information from them, take blood samples and never feed them back with research results. The need for research literacy training is quite crucial.
• There is the need for NHVMAS to partner with each stakeholder community to be able to conduct sensitisation of the community on how to engage with research and researchers. NHVMAS can play a role in this respect. Such community sensitisation programme should include updates on what researches have been conducted and its relevance to the community.
• NHVMAS should work with researchers to promote community engagement in the various research they do. These should include their engagement in the design and implementation of research, compensation for time expended with researchers, communities need to benefit from these researches, communities need to be properly educated about these researches, and maintaining confidentiality, and promote the human rights of MARPS.
• NHVMAS to work with the media to discuss the benefits of research, address human right violation in the community and discuss about sexual diversity and the need for this.
• Other communities NHVMAS needs to work with include government agencies, CSOs, religious organisations and policy makers.
• There is low awareness about new biomedical prevention technologies. Knowledge about old and new prevention tools need to be further built. Build the capacity of the gatekeepers who can then effectively reach the community through their peers.
• Medical jargons need to be simplified so that community members can understand the issues being discussed.
• Use of social network is important to help disseminate information on HIV prevention tools and new biomedical HIV prevention technologies. Bulk sms could also be sent to help the general public understand more about these tools. The public also need to know more about engaging with research, the various benefits of research, and sexual diversity issues
In response to these issues, NHVMAS shall be working extensively with MARPs in the year 2012. Efforts have commenced to try and map out an action plan for project implementations especially working together with the media, researchers.
Background
Every year around the world, International Women’s Day (IWD) is celebrated on March 8. It is a day when women irrespective of their ethnic, linguistic, socio-cultural, economic and political differences, come together to celebrate their Day. Organizations, women groups and even governments choice to celebrate these events in separate ways with events occurring to mark the economic, political and social achievements of women.
“Empower Rural women- End Hunger and poverty” is the theme for 2012. NHVMAS in collaboration with some of it partners celebrated this day by giving a lecture on NPTs, the need for dual protection, distribution and demonstration of the female condoms and the demonstration of cycle bead. Rhyming method of family planning was also explained, emphasizing the need to use female or male condom on fertile days and for dual protection from STIs.
Activity
1.1 – Thursday 8th March, 2011:
Participants were taken through a presentation on existing tools for HIV prevention, this includes
• Behaviour change-adopting ABC
• Counselling and testing-know your HIV status and living a positive life style.
• Male and female condoms- dual protection, prevention against STI including HIV and unintended pregnancy.
• Medical male circumcision
• Prevention of mother to child transmission- PMTCT.
Participants were also taken through new prevention technology NPTs. This includes:
• HIV Vaccine
• Microbicide
• Pre- exposure –prophylaxis
• Treatment as prevention
Discussions and Questions
Discussions centered on whether microbicides were meant for only women, what types or forms microbicides will be, if microbicides will be safe for men and issues on acceptability and affordability. There were also discussions on why the female condom was so cumbersome, that women complain that the female condom was not stable except if it is held in place by the female during intercourse.
The form and types of microbicides were explained to the participants. They were also informed that different types of clinical trials were ongoing on the safety, efficacy and effectiveness of vagina and rectal microbicides. A sample of the Caprisa 004 microbicide gel was shown to the participants.
The female condom was distributed and demonstrated. In the course of this, it became obvious that some of the participants did not know how to insert the female condom well, which may be a reason why it slips during intercourse. Some of the participants shared their experience with it and gave recommendation of how it can be used. The facilitators used the opportunity to emphasize on the need for CSOs to include the discussions on female condom in their HIV prevention messages.
The bead/rhythm method of family planning was also demonstrated. This gave male participants room for discussions on how to use the method for family planning. Participants were informed that for this method to be effective, couple have to use it with female or male condoms during the fertile period of the woman. There were also discussions on this type of family planning being more acceptable amongst the catholic faithful.
There were plans to discuss the importance of dual protection for HIV prevention amongst HIV positive persons in view of the emerging evidence. However, there was little or no time to discuss this as facilitators were engaged with discussions on basic facts and issues that were still poorly understood even within the CSO community.
Lessons learnt
1. The need for NHVMAS to incorporate some discussions on reproductive health in its NPT curriculum cannot be overemphasized. Discussions about microbicides often generate a lot of discussions. This also leads to the issue of reproductive health such as STI prevention and control. Also with emerging evidence on hormonal contraceptive promoting HIV infection, discussions on SRH becomes pertinent for HIV prevention work
2. NHVMAS should partner with organizations that are engaged in gender issues so as to be able to mainstream and reach out more effectively to the communities already engaged with SRH work in Nigeria
A Two days training on research literacy using a 9 module training manual was organised for 20 peer educators for IDUs, MSMs ,PLHIV, FSWs , CSOs and the media between the 7th to 8th of March , 20112. The objectives of the training were:
• To build the capacity of the CSOs on research literacy
• Conduct a 2nd pilot test of the field guide.
Participants about how to plan and conduct research, updates on existing and new HIV prevention technology, informed consent, payment for research participation, confidentiality in research, community engagement in research and how to get involved in research.
The mean pretest score was 55.5 + 18.4 with 36.8% (7/19) scoring less than 50%. The post test score was 67.6 + 14.9 with 14.3% (3/21) scoring less than 50%. There was a statistically significant difference in the pre and post test score (p=0.04). the paired t test result showed significant change in knowledge post training (p=0.005).
All the participants felt the training had indeed built their capacity as they all learnt new things and new information to incorporate into their ongoing work in the field. The training was rated as excellent.
Full details of the training and the training manual can be obtained from the NHVMAS secretriat (info@nhvmas-ng.org)
NHVMAS HOSTS ITS 2012 MEDIA FORUM
On the 21st of June 2012, NHVMAS hosted its second media forum. This is in view of the recognition of the essential role of the media in creating public awareness and education on HIV prevention research and development. The Nigeria public have confidence in the media, both print and electronic,and more so they are accessible and available to the community. In view of this, NHVMAS has continued to invest in efforts at building the capacity of its media allies to understand and remain updated about biomedical HIV prevention and research issues.
At the meeting, there was general consensus of the need for nhvMas to build working relationship with the health and science writers’ since the issues being discussed is health focused. However the house recognizes the need to engage entertainment and feature writer as NPT story seems to be abstract and needed to be told from a lighter mood. This includes getting media Editors on board the forum so as to empower them to understand issues on NPT and enable them appreciate the stories sent to their tables. It is also important to ensure gender mainstreaming in the media engagement plan.
Media partners are also to make efforts in reporting on NPT while NHVMAS should try and simplify its online resource materials to enable laypersons understand and possibly assist journalist to tell the story from human angle. Journalists were encouraged to document their work as they could fall back on it for media
The forum would put together the 2012 NPT reporting award and so the need to start putting together plans to raise the needed funds for the event.Some of the previously trained journalists shared with the team what they have been able to do with the skills and knowledge gained over the years.
NHVMAS held its gender forum meeting on the 21th of June 2012, with the objective of forming a coalition of CSOs that are focused on gender issues in order to foster greater partnership on issues relating to gender. This was important in view of the need to address critical sexual and reproductive issues identified in the National HIV Strategic Plan, and build collaboration and partnership with civil society organizations and AIDS service organization focus on sexual reproductive health and gender issues with wider geographic coverage to drive the identified national agenda. In the light of this, NHVMAS felt it was important to stimulate the formation of a Gender focused coalition an therefore organized a one day stakeholders meeting with some identified gender based organizations in Lagos. The objective of the meeting was to deliberate with the group on gender issues within the NPT context in Nigeria and develop a common work agenda for the 2012/13.
This meeting was a follow up to the programme organised by NHVMAS to celebrate the International Women’s Day. Discussion at that meeting focused on highlighting about contraceptive options for all groups of women – PLHIV, adolescents, youths, pregnant women, FSW, those in serodiscordant relationship, widows and the elderly – in light of the evolving evidence on the increased risk for transmission of HIV and acquisition of HIV infection by women who use hormonal contraceptives; thus the need for women living with HIV to use condoms along with hormonal contraceptives in line with recommendations by WHO. For NHVMAS, the focus of the gender forum is to ensure further public education on the need to reduce the risk of HIV infection from the use of hormonal contraceptives in line with the WHO recommendation so as to promote primary HIV prevention especially amongst those at high risk. This project will therefore target women living with HIV, women in HIV serodiscordant relationships and female sex workers with the aim of understanding what informs their choice of and use of contraceptives and HIV prevention tools, and how an educational model can help inform these high risk groups about the need for dual protection even when using injectable hormonal contraceptives.
There was consensus on the need to move this agenda forward for the Nigerian public. The forum developed a framework of activities for the way forward in 2012. The next meeting of the forum will come up in August 2012. For interested persons, please contact Ms Florita Durueke (chichiflorita@yahoo.com) and Aisha Adaranijo (aishatuabdullahi@yahoo.com) for more details and a copy of the detailed report.
With funding support from Sidaction, France through the Project RESPECT, NHVMAS developed a simple field guide to help laypersons understand about research and how to engage with research. The field guide addresses nine topics namely:
1.2.1 What is research
1.2.2 Why is research important
1.2.3 Why should you care about research
1.2.4 HIV prevention: existing tools
1.2.5 HIV Prevention: new tools
1.2.6 Informed consent
1.2.7 Payment for participation in research
1.2.8 Confidentiality
1.2.9 Community engagement in research :GET INVOLVED
Along with the field guides comes a demonstration tool kit. The toolkit was put together through support of funds from Sidaction, France and materials provided by AVAC, Anna Forbes and IRMA. The content of the toolkit consists of:
o Different sizes, texture and colours of the male condoms
o The female condom
o Dental dam for oral sex
o Lubes for anal sex
The use of the field guide was demonstrated and shared at the 2012 International Microbicide Conference. Also, on the 21st of June 2012, 24 CSO representatives engaged with the 2 pilot workshops designed for the preliminary testing of the field were shown the field guide and taken through its use. Participants were excited about the simplicity of the field guide. Also, the inclusion of the toolkit was found most helpful and useful as this can help their community members visualise the items being discussed. Hopefully, this project will compliments the current efforts of Project ARM hosted by IRMA International and IRMA Nigeria to promote access to lubricants for all interested persons – male and female – for vagina and anal sex use. For more information about Project ARM, please visit http://sciencespeaksblog.org/2011/04/11/arming-africa-with-rectal-microbicides-project-arm/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+ScienceSpeaksHivTbNews+%28Science+Speaks%3A+HIV+%26+TB+News%29#axzz21ZHKyxHx
For more information and copies of the field guide or samples of the toolkit, please contactchichiflorita@yahoo.com. For full report, please contact chichiflorita@yahoo.com. The toolkit can also be downloaded from the NHVMAS website.
NHVMAS, in collaboration with JAAIDS, hosted a media roundtable on the 21st of June 2012. The roundtable was aimed at updating partners on ongoing efforts in Nigeria on New HIV prevention research and its importance or HIV control for key populations.
Present was the Nigeria Canadian Collaborative AIDS Vaccin Project (NICCAV) study Coordinator – Dr Eva okpokoro – who discussed about what HIV vaccine is, the global and national efforts in HIV vaccine development including the ongoing plan on NICCAV study. He noted that HIV vaccine will benefit both HIV negative people (preventive vaccine) and those living with HIV (therapeutic vaccine). Also, the recombinant viruses are unique to West Africa with sub Saharan hosting 43% of the HIV Subtype G and CRF02 A/G. This presents a complex epidemic for the region. There are ongoing national efforts to facilitate the development of a HIV vaccine. This include the review of National HIV Vaccine development plan and the implementation of the NICCAV study. The NICCAV study aims at creating an internationally certified HIV clinical research site capable of conducting HIV vaccine clinical trials in populations with defined risk of HIV infection. It is a clinical trial that focuses on developing a sero-discordant couples’ cohort. The project is currently being implemented in Plateau State Virology Research Centre Jos (PLASVIREC).
Lolade Abiodun from Population Council discussed outcomes of the Integrated Biological and Behavioural Surveillance Survey (IBBSS) pre-assessment study among MSM and IDUs in six states, the result of the audio computer assisted self interview (ACASI), population based estimation of Male Sex Workers in 3 States in Nigeria and the geo-mapping and exploratory study of female drug users in 4 states. The major findings from the 2010 IBBSS were: HIV prevalence for MSM in the country was 17.2%: an increase from the 13.5% reported in 2007. The IBBSS report shows that HIV prevalence among IDU was 4.2%. However the ACASI study revealed that the prevalence among male IDU is 0.9% but as high as 20% for female IDUs. The main route of HIV acquisition for female IDU was transactional sex. The speaker emphasised that these indices indicates the need for HIV programming for the key position irrespectively of individuals’ beliefs and values. She stressed that MSM in Nigeria are bisexual and so they serve as a bridge of infection from their community to the general population.
NACA in the person of James Anenih in absentia, also shared with the forum, ongoing plans to conduct a feasibility study on the use of ARVs for the prevention of HIV infection in serodiscordant couples. PrEP – the use of ARVs for HIV prevention – shall be part of a toolbox of HIV prevention strategies that shall be prescribed for HIV prevention for couples whom one partner is HIV positive and the other is HIV negative. The plans for this is ongoing with current visit to possible implementation sites.
51 participants were present for the media roundtable.
The full report is available for your review. Please feel free to contact florita Durueke (chichiflorita@yahoo.com) for further details on the programme
The Abuja meeting came up between the 10th and 11th of September 2012. The venue was Top Rank Hotel Abuja. Collaborating partners were The Initiative for Equal Rights (TIER), Christ against Drug Abuse Ministry (CADAM), Safehaven Development Initiative and International Rectal Microbicides Advocacy (IRMA) Nigeria. Funding for the project was provided by SIDACTION, France.
Day 1 was invested in the process of building the capacity of community representatives to understand basic ethical issues. This should enable them interact with interface researchers from an informed perspective. The interactive session between community representatives and the research community came up on day 2. The dialogue was to give community representative an opportunity to share with researchers their concerns and interest with the conduct of HIV research in Nigeria. This meeting is part of the ongoing efforts of NHVMAS and her partners to build the capacity of community members to engage effectively with researchers.
Sixteen CSOs working with MARPs including MSM, FSW, IDUs and working within Jos Metropolis (a community that hosts a research institution) were engaged in the programme. Participants learnt about basic rules and principles governing research in general, informed consent and community engagement in research. The group deliberated on the current research practice in Nigeria as it relates to informed consent process, community engagement and standard of care. At the end of the meeting, participants developed a consensus paper (see appendix I).
The evaluation showed that participants did have good basic understanding of concepts discussed at the meeting. The mean pretest score was 64.2% + 12.3% while the mean post test score was 68.0% + 5.4%. While the paired t-test did not show a significant difference in the pre and post test result (P=0.2), the participants did note that they acquired new knowledge and skills that would be used in their HIV prevention and research activities.
The second day was a roundtable session. Researchers and sponsors were present. These include representatives from the Centre for Disease Control, Abuja, ethics committee members, researchers from IHVN and Population Council. The group consensus document from Lagos interface as well as the Abuja consensus document was presented to the audience. There was open discussion on the issues raised by the community. Remarkably, both parties acknowledged that gaps do exist in terms of the informed consent and community engagement process in research. However, it appears that major culprits are independent researchers who know little about ethics of research conduct. While the group acknowledged that there was the need to continue to promote active community engagement in community based research, special efforts should be made to reach and build the capacity of independent researchers in the academia to conduct research in an ethical manner.
The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) in partnership with the Nigeria Canadian Collaboration on AIDS Vaccine (NICCAV) study team organized a half day media roundtable meeting in Abuja in support of the NICCAV project. The roundtable session was held on the 12th of September 2012 at NACA secretariat. The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. It is a demonstration research that aim at building cohort of sero-discordant couples over the next 3years in preparation for future HIV vaccine trial in Nigeria.
The NICCAV community engagement programme includes working with the media stakeholders at the local and national level to ensure the media takes its place in the HIV vaccine research process. As part of the effort in engaging the media on this project, NHVMAS did organize media roundtables in Jos and Lagos in April and June 2012 respectively. This Abuja roundtable meeting is a build up on efforts to actively build and engage journalists in New HIV prevention technology research reporting.
There were updates on the NICCAV project, its achievements and future plans, updates on the global and national HIV Vaccine development initiatives, discussions on ongoing and past researches involving Most at Risk Populations in Nigeria, and the role of the media to engage with biomedical HIV prevention research efforts in Nigeria.
At the end of the training, 15 journalists committed to the long term process of actively engaging with the NICCAV community engagement programme throughout the duration of the study.
A two days training programme on understanding and communicating New Prevention Technology Research and trial result was conducted by the New HIV Vaccine and Microbcides Advocacy Society in support of the NICCAV project. The training was held between the 27th and 28th of September 2012 at the Plateau State Virology Research Centre. In attendance were the volunteer CSOs and CAB members engaged in the NICCAV community engagement programme and two resource persons from NHVMAS.
The sessions taken include: basic definition, introduction to new prevention technology, Understanding the research process, Understanding prevention trial, Understanding trial result, Interpreting trial result and critical analysis of trial reporting. The training used participatory approaches to facilitate learning. These include brainstorming, question and answer sessions, plenary discussions, games and slides presentations.
The training participants took a study tour to the research centre (PLASVIREC) where they taking through the process of study participant recruitment and investigational procedure. They also visited all the sections in the laboratory where study samples were processed.
Participants really wanted to see samples of the HIV prevention tools being discussed – microbicide gels and rings as well as pREP. They requested for this samples to be brought during future trials. CABs and CSOs also gave feedback on their community engagement efforts. Referrals were also made to the study site. In all, 2,175 persons were reached with information on the NICCAV project and on biomedical HIV prevention tools for the month of September, 2012.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pretest score was 54.4% + 10.2%. The scores ranged from 25%-87.5%. Forty one percent of those who took the pretest scored less than 50%. The mean posttest score was 61.8% + 12.9%. The scores ranged from 37.5% to 87.5% with 11.8 percent scoring less than 50%. The paired t-test analysis showed that the difference observed was not statistically significant (p = 0.06).
For the second year running, NHVMAS trained teachers in Lagos State on HIV/AIDS/STI/NPT as part of its Corporate Responsibility. It runs this programme in collaboration with the Lagos State Ministry of Education. The programme is completely funded by funds raised locally by NHVMAS.
The two days training aimed at building the knowledge and skills of teachers that teach religious studies in Lagos State to enable then become resource persons on STI/HIV/AIDS within their communities. These teachers are the least reached with capacity building programmes on STI/HIV/AIDS yet they are a rich set of resource persons. NHVMAS layered information on new prevention technology on education about HIV, AIDS and STIs during the programme. The objective of the training was to promote positive attitude and support of these group of teachers to HIV/AIDS education and NPT research in general.
The programme came up between the 3rd and 4th of October 2012 at the NHVMAS secretariat in OgbaIkeja. The training was implemented in collaboration with the Lagos State Ministry of Education. The funding for the project was provided through NHVMAS Corporate Social Responsibility Funding Scheme.
Twenty three CRK and IRK teachers from the junior and senior secondary schools in Agege Local Government Area of Lagos State were trained. The participants were taken through six plenary sessions: overview of HIV and AIDS in Nigeria, the male and female reproductive organ functions, breaking the ice about discussing sex, all you need to know about STI, existing HIV prevention tool, and new prevention technology.
The training adopted a participatory approach to facilitate learning. These approaches included brainstorming on topical issues like anal sex, question and answer sessions, plenary discussions, slides presentations, games and group work.
The mean score for the pretest was 57.6% + 15.0%. The score ranged from 35% to 91%. Eight persons scored below 50%. At the end of the 2 days training, the post-test showed evidence of the trainees acquiring new knowledge: the mean post-test score was 66.5% +9.6% with scores ranging between 48% and 83%. Only two persons scored below 50%. The paired T-test analysis did show a significant difference in the pretest and posttest score (P=0.001).
The participants developed an action plan that would be implemented in their various schools over the next 12 months with NHVMAS providing technical support. The participants will be followed up over the next six months to assess the training impact.
NHVMAS conducted a three days training programme for representatives of five partner organisations working with communities at high risk for HIV infection in Nigeriaon research literacy. The training can up between the 7th and 9th of November, 2012. It was held in Ogba, Lagos. The programme aimed at building the capacity of gatekeepers who work with MSMs, IDUs and Sex workers on how to engage with research and researchers. The programme was funded by Sidaction, France.
This was the first phase of a three phased programme. In this first phase of the programme, NHVMAS will train collaborating organisations working with MSMs, IDUs and Sex workers on conduct of research in general and HIV prevention research specifically. The training modules would include understanding research and the clinical trial process, research ethics, research statistics and community engagement in research. This process will hopefully enable these organisations include research literacy efforts in their ongoing organisational programmes.
The second phase of the project would be to have those trained to now step down the training to community gatekeepers they engage with regularly. This process should (i) enable those trained in phase 1 build their confidence in their ability to conduct future trainings (ii) build the capacity of community gatekeepers as trainer of trainers for the field. The project anticipates to train 90 gatekeepers (15 each from the six states where the IBBSS survey is usually conducted).
The third phase of the project is to have these trained gatekeepers (the 90 TOTs) to step down the training to their community members over the next 12 months. NHVMAS shall provide support for this step-down training exercise in a future grant. However, voluntary efforts at conducting step down trainings shall be facilitated through this project. The outcome of the monitoring will help NHVMAS design its future plans for conduct of step-down trainings.
The six participants who participated in this training were completely satisfied with the process. The statistics section was the most challenging of all the sections. All the modules were highly rated by the trainees. Analysis of the test results showed that future training needs to do more on helping participants understand how HIV vaccine works and the PrEP concept.
The 2012 NHVMAS New Prevention Technology Journalists of the Year is MsBunmiYekini of the Radio Nigeria Metro FM. MsBunmiYekini is the producer of the radio programme “My Doctor and 1”. For the last two years, MsYekini had used this platform to run radio programmes on New HIV prevention technology, an effort that has won her NPT Ambassador award for 2012. As the media Ambassador, she would be working with NHVMAS to develop the media NPT action plan that would be implemented over the next 12months.
The first runner is MrJustice KaluAma of Solid FM Radio, Enugufor the best radio reporting on New HIV Prevention Technology category. This year, there was no announcement for the print media as the entries were adjudged poor.
This is the second edition of the New Prevention Technology Journalists of the Year award organized by NHVMAS in conjunction with JAAIDS. The award is given through the JAAIDS Annual Red Ribbon Award. The last edition was held in 2010 and the winner was MsOlayinkaLatona. The 2011 edition could not hold due to logistic challenges.
This is the NHVMAS recognises the power of the media and will continue to engage directly with the media to build its capacity to report on New Prevention Technology Research and Development. It currently works with some partners in Abuja and Jos through the Nigeria Canada Collaboration on AIDS Vaccine development (NICCAV) community engagement project to build the capacity of 30 identified journalists. In Lagos, it works with the NHVMAS Media Forum headed by Journalists. NHVMAS shall provide all the needed support for these fora to address the needs of journalists in the field to report on New HIV Prevention technologies in the coming years as we acknowledge the media are essential and a powerful resource for educating and sensitizing the community toward engagement in HIV research.
NHVMAS had been actively engaged since the beginning of the year to mobilise and plan for the 2012 World AIDS Day. The programme was put together by the Community Mobilisation Committee of NHVMAS in collaboration with Lagos State CISHAN and the Lagos State Agency for the Control of AIDS. Participating organisations included 10 CSOs and two media representatives: EKO FM and Nigeria Tribune.
The 2012 WAD programme was implemented on the 5th of December 2012.It started with a motor rally from Berger roundabout to the Oba’s (Ojodu Berger) palace. The rally led to an open space in the community. There, a talk was given on microbicide, HIV, AIDS was given to people that gathered around for the programme. Also, male and female condoms use was demonstrated. IEC materials were shared with 163 persons. 1008 pieces of male condoms and 20 packs of female condoms were also shared. After this, HCT was conducted by two partner organisations – SWAAN and HAGAI. Seventy (70) people took and HIV test.
Prior to the commencement of the programme, the team made a visit to the Oba in his palace telling him about our purpose of coming to his palace and community. He was very happy and he accepted us in his community.
The media interviewed the Oba of Ojodu Berger and four other partners that were present at the venue of the programme.
As part of its ongoing programme to empower community members to actively engage with research and researchers, NHVMAS trained 15 community gate keepers on the fundamentals of research. A three days research literacy training programmewas conducted for community gatekeepers representing the FSW, IDU and MSM communities in Lagos State. This training was the one of the six programmes planned for the second phase of a three phased programme designed to empower communities at high risk of HIV infection to engage actively with research and researchers. The training was the programme was funded by SIDACTION France. The programme came up between the 12th and 14th of December 2012 in Lagos. In attendance were 15 MARPs community gatekeepers.
Participants were taken through sessions that addressed basic definition, understanding the research process, research ethics, Interpreting trial result, communicating trial result and critical analysis of trial reporting.The sessions were facilitated using a research literacy field guide manual developed by NHVMAS with funding support through the project RESPECT.
The training used participatory approach to facilitate learning. These include brainstorming on thorny issues and discussions, question and answer sessions, group presentations, plenary discussions, and slides presentations. All participants were provided with copies of the field guide to enable them conduct step down trainings in their communities. They were also provided with a HIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was empowering, and enabling them do the training themselves was and extremely important piece of the training. The discussion was rich including discussions on how to address community feedback following conduct of research, addressing human rights issues. One participant noted that the training made research came alive and intricacies were understood.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was 53.5% + 21.8%,, the scores ranged from 13.0%to 88%. More than 46.0% of those who took the pre-test scored less than 50% (see Appendix 2). The mean post-test score was 58.8 + 21.9% with scores ranging between13.0% and 88%. Just 30.7% of those who took the post-test scored less than 50% (see appendix 2). The paired t-test analysis did showed a significant difference in the pre- and post-test scores (p value= 0.01).
NHVMAS received a 12 months training grant from Sidaction, France to implement a research literacy training for 30 gatekeepers of the MSM, FSW and IDU community in Nigeria respectively. The research literacy training will reach out to these 90 community gate keepers in the six states were the national biological and behavioural sentinel surveys are usually conducted. These trained gatekeepers are also to reach out to their peers.
While the research literacy training hopefully shall support a capacity building process that will enable MARPS engage actively with research, the project shall also serve as an operation research where it will assess the role incentives play in facilitating research literacy education programmes by peers for other members of the community. This project shall specifically be looking at the impact of providing only technical support to gate keepers on how they implement their proposed workplan to educate their peers using a research literacy tool kit developed by NHVMAS. It shall compare this outcome with a future study that shall look at the difference financial incentives made in peer education efforts.
The training was able to reach out to 12 MARPs in Cross River State. The training was conducted in January 2013. The pre and post test analysis showed the training resulted in improvement in knowledge. The evaluation also showed participants acquired new skills. The mean pretest score was 51% +14.7%. The scores ranged from 36% to 75%. The mean post test score was 64.2% +11.9%. The scores ranged from 36% to 81%. The paired t-test score also showed a significant difference in the pre and post test result (P=0.020).
The trainees plan to reach out to 140 peers of their peers over the next 6 months. NHVMAS shall provided the needed technical support to facilitate the step down of the trainings to their peers.
The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) is currently actively engaged with implementing the community engagement programme for the Nigeria Canadian AID Vaccine implementation project. At the inception of the project in May 2012, NHVMAS consulted extensively with 40 CBO/FBO/NGO working in Jos. A community mapping exercise was conducted.
Following the community mapping exercise, it was clear that Jos needed to be segmented, and there were prevailing cultural and religious sentiments which necessitated the need to have groups with similar religious and cultural ethos work in specific communities. In view of this, Jos metropolis was segmented into four areas and 16 CSOs volunteered to work with these segments of the population to reach the community and share information about the project. A CAB of 10 members were also constituted.
This extensive community support for the project has been remarkable. Over a seven months period (May to November, 2012) 13 of the 16 CBOs engaged on the project had reached 10,983 (6,091 males and 4,892 females) community members with information on the NICCAV project as well as conducted research literacy awareness. In September 2012 alone, over 2000 community members were reached.
NHVMAS continue to work extensively with the local and national civil society to create awareness and community mobilisation for the project. The organisation is vested with building the capacity of the CSOs, the media and CAB members directly engaged with the project to enable them engage actively with the ongoing research activities while also building the capacity of the local community about the project.
NHVMAS shall continue to work with the project over the next 2 years with the objective of creating wide public awareness, understanding and support for the NICCAV project.
The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. The three years NICCAV community engagement projects recognised the need to engage with various levels of stakeholders – community, national and global. The project currently implements a community engagement plan that acknowledges and engages all stakeholders. It continue to work towards the achievement of the following goals (1) constitute a Community Advisory Board which shall have its capacity built to effectively engage with the research team on its HIV vaccine research programme; (2) build the capacity of identified CSOs within the Jos metropolis to enable them effectively engage with the research team through the CAB as well as address the research literacy needs of potential research volunteers to be engaged with future HIV vaccine research; (3) build the capacity of the media to effectively educate the general public in Jos Metropolis and other stakeholders on HIV vaccine research; (4) implement the Good Participatory Practice Guidelines for this project.
With the successful implementation of the first year life span of the NICCAV community engagement programme, the team recognized the need to share the project efforts in the field with the stakeholders and solicit for their continuous support in providing community voices in HIV research enterprise.
On the 30th of January, 2013, advocacy visits were paid to the Commissioner for Health, Plateau State, the Executive Director, Plateau AIDS Control Agency and the civil society networks in Jos. The team also facilitated the monthly meeting of CSOs and CAB to debrief on experience from the field as well as set the programme plan for the 2013 on the 31st of January, 2013. While the meeting was meant for the volunteered CSO and the CAB members, there were observers from the newly constituted CiSHAN-caretaker committee and the Ministry of Health. The meeting also provided platform to debrief with the Jos media focal person and set the 2013 media plan for Jos community.
For the period December to January 2013, 743 community members were reached with research literacy information and education about the NICCAV project. There were concerns about the need to have funding support for the community engagement programme, the need for community friendly literacy materials amongst others. The community engagement programme shall continue actively despite the fact that the project had discontinued enrolment.
A three days research literacy training programme was conducted for gatekeepers (FSW, IDU and MSM) in Kano State. The programme held between the 20th and 22th February 2013. In attendance were six FSWs, five IDUs and five MSMs making a total of 16 trained gatekeepers.
Participants were taken through research literacy field guide that was developed by NHVMAS using Pidgin and vernacular English. Participants were really happy to learn and be taught in a language they could relate with. Using Pidgin and vernacular English made them to participate fully throughout the sessions.
Participatory approach was used to facilitate learning with group and individual presentation. All participants were provided with copies of the field guide on day one to enable them follow-up and also conduct step down trainings in their communities at the end of the training. They were also provided with a HIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was educating, enlightening and knowledgeable and it will enable them to step down to their peers.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was 45.5% + 11%, the scores ranged from 25.0% to 69.0%. 62.5% of those who took the pre-test scored less than 50.0%. The mean post-test score was 47.0 + 25.7% with scores ranging between 19.0% and 81.0%. Only 35.7% of those who took the post-test scored less than 50%. The paired t-test analysis did showed a significant difference in the pre- and post-test scores (p value= 0.820).
The score outcomes may mean that for community gatekeepers with lower level of education, it may be necessary to spend more days conducting the research literacy training with them to be able to have significant changes in their test scores. It may also imply that the test need to be conducted using a tool that is more sensitive to their literacy level. The implication of this test score will be further reviewed.
The Nigerian Canadian Collaborative AIDS Vaccine research project (NICCAV) community engagement project recognises the need to engage with various levels of stakeholders including the media, CSOs and CAB at the national and host community level. The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS), is saddled with the responsibility of coordinating the NICCAV community engagement programme. It has therefore continued to work with the CSOs and CAB at the host community to promote research literacy and ensure meaningful community engagement in the research process. Also recognizing the significant role of the media in the research process; it identified media engagement strategies ensuring that the media takes its place in the HIV vaccine enterprise. Most importantly, NHVMAS recognizes the synergy the media, CSO and CAB can form for greater community understanding and involvement in the NICCAV study. It is against this background that NHVMAS in partnership with the NICCAV study team organized a one day media roundtable meeting in Jos in support of the NICCAV project. The roundtable session provided a common platform for the media, CSO and the NICCAV clinical team to interface and brief on the entire NICCAV study.
The programme was designed as a two day event. The first day focused on building the capacity of 15 journalists to understand basic scientific concepts of New biomedical HIV prevention technology research and development including HIV vaccine. They were also assisted to understand the basic concept and skills for media reporting on the HIV prevention trials. This training was very beneficial, as it enabled journalists interact better with researchers, CSOs and CAB during the roundtable session the held the next day with 34 persons in attendance. The media training came up on the 22nd of April 2013 while the roundtable session with the media, cso, CAB and the NICCAV study team took place on the 23rd of April 2013. The Site PI – Dr Datong – was present to provide updates on the NICCAV project during the interactive session.
Full report the programme can be assessed in the NHVMAS report webpage in the NHVMAS publication section of its website.
A three days capacity building was conducted for 34 CSOs in Osun State between the 15th and 17thof April, 2013. The training was residential and held in Ejigbo, Osun State. The objective of the training was to build the capacity of participants so that they can conduct research literacy trainings in their respective communities.
Participants were taken through sessions that addressed basic definition, understanding the research process, research ethics, Interpreting trial result, communicating trial result and critical analysis of trial reporting. The sessions were facilitated using a research literacy field guide manual developed by NHVMAS.
Participatory approach was used to facilitate learning and there was group presentation. All participants were provided with copies of the field guide on day one to enable them follow-up and also conduct step down trainings in their communities at the end of the training. They were also provided with a HIV prevention toolkit which contained a variety of condoms and lubricants for public demonstration and discussion.
Participants commented that the training was empowering as it will enable them to step down to their peers. Over 80% of the trainees felt the workshop provided me with new insights about HIV prevention technologies, and that participating in this workshop was a good use of their time.
The workshop evaluation showed that participants did acquired new knowledge and skills. The mean pre-test score was 43.1% + 16%, the scores ranged from 19% to 69%. 54.9% of those who took the pre-test scored less than 50%. The mean post-test score was 65.2+ 15.3% with scores ranging between 25% and 88%. Only 12.9% of those who took the post-test scored less than 50%. The paired t-test analysis did show a significant difference in the pre- and post-test scores (p value< 0.0001).
http://www.iasociety.org/Abstracts/A200719404.aspx
http://www.iasociety.org/Default.aspx?pageId=11&abstractId=200717969
http://www.iasociety.org/Abstracts/A200714020.aspx
http://www.iasociety.org/Abstracts/A200722015.aspx
http://www.aidsimpact.com/2009/Academics/Programme/abstract/?id=344
http://www.aidsimpact.com/2011/Academics/Programme/abstract/?id=242
http://www.aidsimpact.com/2011/Academics/Programme/abstract/?id=64
Background: There has been a lot of interest and efforts at promoting community engagement in new Biomedical HIV prevention research and development. However, to effectively engage communities, community voices and representatives should be able to understand the issues. Only then can they contribute meaningfully in a sustained manner to the New HIV Prevention Research Agenda. This abstract reports on the impact of training of community representatives on New HIV biomedical interventions (NPT) in Nigeria.
Methodology: NHVMAS in collaboration with its partner in Canada (ICAD) and South Africa (SAT) organised five 3-day training sessions for members of the community and the media in Nigeria on how to interprete, understand and communicate NPT results. Participants were taken through 8 modules namely basic definitions of NPTs, NPTs in context, overview of prevention research, Who Who in the field of biomedical HIV prevention research, State of NPT research, ethics of NPT research, media analysis of past reports and how to communicate these results. A 12 question pre test and a post test was administered. An analysis of the test results was conducted. An impact assessment was also conducted. This entailed visits and an indepth interviews with 10% of the training participants and their supervisors.
Results: Sixty four members of CSOs, 23 journalists, 18 health workers, one researcher, one policy maker and four students through the five training workshops organized during the period. There were statistically significant differences in the pre and post scores of all the participants (p<0.05). Paired t-test analysis showed highly statistical significant changes (p<0.001). were over 50% changes in the pre and post test scores on questions related to ‘how a vaccine works’ and ‘what a placebo is’. There were over 30% changes in the pre and post test scores on questions related to ‘randomisation’, ‘phase I and III trials’. 100% of trainees showed evidence of use of the skills and knowledge acquired from the training. Conclusion: The structured training did make significant impact on the ability of community representatives to understand and discuss about NPTs with their communities. More of such structured training is needed to build the capacity of community representatives to engage constructively with NPT research.
Background: There is increasing interest in addressing the ethical issues and dilemma related to adolescents engagement in research – especially sexual and reproductive health research. This is in view of the need to design and implement research that address peculiar needs of adolescents including STDs and HIV. Many of the decision for engaging research participants have been defined by age and less so by psychological development. Unfortunately, protection of adolescents from participation in research has been adduced to the potential to be coerced or pressurised to participate, and not fully comprehending the issues related to the risk they may be taking when engaged with research. This abstract takes a good look at the various potential ethical issues that may impact on stakeholders’ decision making when considering engaging adolescents in microbicide research in Nigeria.
Methodology: The authors reviewed relevant literatures on the subject matters (21 references) including all the various Nigerian ethicolegal frameworks. They assessed if adolescent issues were sufficiently different from that of adults to warrant separate data, special concerns about adolescent engagement in microbicide research in Nigeria such as informed consent, parental consent, confidentiality, engagement of communities, and the limitations within the current Nigeria ethicolegal framework.
Result: While the Nigerian policies and document spells out specifically the age limits for consenting in research, evolving evidence points to a need to lower the current age for consenting to enable younger adolescents engage in research that can inform programme development and programming apt to address their needs. A clause in the National research ethics code makes provision for engaging adolescent in health research without reference to age. The authors were able to make some specific recommendations on addressing therapeutic misconceptions, adolescent recruitment and retention, reimbursements, community engagement, and protocol review process in the light of the extensive literature review.
Conclusion: While there is some consensus that it is possible to extrapolate adolescent relevant information from adult studies, some studies are still needs to be conducted in adolescents. The peculiar challenges of applying fundamental ethical principles for adolescents engaged in research especially in cultures sensitive to open and public discussions about sex and sexuality will only become clearer as more studies are conducted in adolescents.
Background: Evidence showed that building the capacity of teachers in Lagos State was an important mechanism to enable secondary school students understand about HIV prevention and management. In view of this, NHVMAS then designed an annual programme to invest in building the capacity of secondary school teachers in one of the 33 local government area of Lagos State on HIV and STI prevention including discussion on NPTs.
Methodology: NHVMAS undertook a two days training of 23 secondary school teachers in Lagos State. The training was focused on building their capacity to understand HIV and STI prevention. The curriculum developed discussed existing and future HIV prevention tools. Efforts were made to address knowledge and skills around male and female condoms, PEP, PreP, male circumcision, STI, PMTCT, HCT and BCC. Information were given on rectal and vagina microbicide research, and HIV vaccine research. Multiple participatory learning tools were used including group work, games, discussion, brainstorming, reading assignments. A 12 item questionnaire pre and post test was administered. Analysis of the pre and post test was conducted so see how participants faired on acquiring new knowledge on STI, HIV, PreP, HIV Vaccine and microbicide.
Results: There was significant difference in the pre and post test scores (62.0 vs 74.3; p=0.0006). The cohort of trainees had good understanding of STIs. However, their understanding of PreP and HIV vaccine was poor: only 9% and 22.7% understood about HIV vaccine and PreP respectively. About 86% of participants were aware of the potential of microbicides to prevent HIV infection yet, just about 50% understood the mechanisms of action of microbicide in preventing HIV infection. Less than 60% understood its potential role for STI and pregnancy prevention. About 60% had understanding about vagina microbicides but less than 40% knew about rectal microbicides. The training was able to improve the understanding of HIV vaccine and PreP in 78% and 43% of participants respectively. With respect to microbicides, participants understanding about the potential mechanism of action of microbicide in preventing HIV infection as well as its potential role for STI and pregnancy prevention improved in about 20% of participants. Their understanding about rectal microbicide did not improve.
Conclusion: While participants’ attendance at this workshop improve their understanding of HIV transmission through the anus (81.6% pre workshop vs 100% post workshop), and their overall knowledge post the workshop was significantly improved, their understanding of the role and importance of rectal microbicide still remain unaddressed. There may be a need to design a training curriculum that focuses attention on building skills and knowledge about rectal microbicide.
Background: In late 2011, new HIV prevention technology (NPT) trials were running in 22 countries across 5 continents. Consequently, the vast majority of countries around the world were not hosting NPT trials. Yet combined, these non-trial countries represent a very significant proportion of global HIV incidence. In these settings, it can be a major challenge to generate and maintain engagement in NPT research, preparedness and implementation without the catalyzing effect of a trial. Some have argued that attention should focus on making existing interventions more widely available without being “uselessly distracted” by hypothetical new technologies, despite evidence of the potential positive impact of these tools on their country’s epidemic.
Methods: A consultative meeting was held in conjunction with the 2010 International AIDS Conference with 9 participants from 5 countries around the world. Community advocates, social researchers and policy-makers exchanged strategies used in promoting NPT education, and discussed challenges and lessons learned from doing NPT-related work in contexts where few/no NPT trials are taking place.
Results: Participants observed that even in countries with few/no NPT trials, multiple stakeholders (community-based organizations, researchers, policy makers, public health, people living with HIV, vulnerable populations) must: raise awareness to ensure appropriate NPT use; build capacity to ensure that research findings are adapted to local settings and that NPTs are integrated into existing comprehensive HIV prevention efforts; address policy and regulatory challenges to facilitate NPT availability and implementation; and, maintain robust funding and research pipelines to ensure ongoing developments in HIV prevention have benefits both domestically and globally.
Conclusions: There is an urgent and ongoing need to create broader opportunities for stakeholders to: 1) exchange strategies to overcome the challenges of engaging stakeholders on NPTs where there are few/no clinical trials; 2) identify common elements of effective engagement strategies that can be adapted for multiple contexts (i.e. generalized vs. concentrated epidemics); 3) identify directions for future research, community engagement and policy development. This will ensure the potential of NPTs is fully realized, including in countries with significant HIV epidemics, but with few/no NPT trials.
Aim: Over the years, there has been increased investment in building the capacity of the media to accurately report on HIV including HIV prevention research. NHVMAS has also made it a priority to invest in building the capacity of journalists (print and electronic) to report on New HIV prevention technologies so that information about these tools can continually reach the wider public. Between 2009 and 2011, NHVMAS organized five media roundtables, organized three trainings for journalists on NPT reporting, held a media award on media reporting of NPTs and invited journalists to all its NPT trainings conducted during the period. It also sent over 18 NPT reports to the media listserv run by NHVMAS. This report is an analysis of the pattern observed with print media report on new HIV prevention technology in Nigeria.
Method: NHVMAS conducted a secondary data analysis of the media report on HIV in four dailies for the years 2009 to 2011. The authors re-evaluated the number of reports on microbicides, HIV Vaccine, Medical circumcision and post exposure prophylaxis during the 3 years period. For year 2009, reports from January to December were analysed. For 2010 and 2011, reports from January to September were analysed.
Result: In 2009, 25 (2.8%) of the HIV related reports in the four dailies focused on New prevention technologies. The main report (40%) was on microbicide research and development. There was no report on PreP. In 2010, while the number of pages on HIV report increased by 114% over the 2009 period, the number of NPT report over the same period increase by only 20%. This represents 1.6% of the report on HIV for the same period. The main report was on HIV Vaccine (63.3%) In 2011, the number of pages on HIV report increased by 7.3% over 2010. However, NPT reports constitute only 0.83% of the report with the main report focused on HIV vaccine (41.2%). The year also witnessed an upsurge in reports on PreP (from 0% to 3.3% to 47.1% of all NPT reports in 2009, 2010 and 2011 respectively). There is an observed decrease in media reporting on microbicides and an increase reporting on PreP between 2009 and 2011.
Conclusion: Despite the investment in building the capacity of the media to report on NPT, the interest of the print media on printing such report appear to be low. There was an observed decrease in media report on microbicides and an increase report on PreP over the study period. Report on HIV Vaccine appears to continue to interest the media in Nigeria.
We the members of Network of HIV Vaccine and Microbicide Advocacy Society, having firmly and solemnly resolved to unite as a people under the Almighty God dedicated to ensure the proactive participation of Nigerians in the global effort for the development of HIV vaccine, microbicides and other New HIV Prevention tools and having perceived the need for proactive measures against the spread of HIV/AIDS, therefore offer ourselves to serve Nigerians as an NGO. For the purpose of achieving our aims and objectives towards supporting the development and use of effective and accessible HIV vaccines, microbicide products and other New HIV Prevention tools to complement existing prevention strategies, we hereby enact, formulate, constitute and give to ourselves this CONSTITUTION
During the conducted capacity assessment analysis and strategic planning meeting organised for the Steering Committee of NHVMAS, a project focus was defined for the organisation for the period 2010. As the activity year 2006 – 2008 was reviewed, the NHVMAS Steering Committee and Board of Trustee identified some priority issues which would inform the organisation’s support and service work for the next three years.
These issues would form the basis for the yearly defined workplan which will be reviewed and adapted at the end of each year.
The purpose of this manual is to set out the accounting procedures and guidelines for NHVMAS in Nigeria. It is designed to serve as a useful reference for all personnel in the organisation .Revised editions of this manual may be distributed in the future as needed.
This personnel policy is a documentation of the procedures, values, standards and practices, which, grouped together, can be regarded as part of the organizational culture of the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS).
The personnel policy aims at ensuring efficiency, integrity and excellence in the pursuit of the achievement of the organization’s vision, mission, aims and objectives. The policy also aims at promoting commitment, loyalty and job satisfaction among staff in performance of their duties.
The issues articulated in this policy document are by no means exhaustive. The policy is to be viewed as a living document, and from time to time, will be reviewed to meet with current developments, and may be complemented by official memos as the need arises.
This is a modern effective and socially responsible learning and development policy. Policy is becoming an increasingly important part of any organisation’s visibility and image in the eyes of the staffs, potential new employees and the community they service as a whole.
The NICCAV community engagement project recognises the need to engage with various levels of stakeholders including the media, CSOs and CAB at the national and host community level. The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS), is saddled with the responsibility of coordinating the NICCAV community engagement programme. It has therefore continued to work with the CSOs and CAB at the host community to promote research literacy and ensure meaningful community engagement in the research process. Also recognizing the significant role of the media in the research process; it identified media engagement strategies ensuring that the media takes its place in the HIV vaccine enterprise. Most importantly, NHVMAS recognizes the synergy the media, CSO and CAB can form for greater community understanding and involvement in the NICCAV study. It is against this background that NHVMAS in partnership with the NICCAV study team organized a one day media roundtable meeting in Jos in support of the NICCAV project. The roundtable session provided a common platform for the media, CSO and the NICCAV clinical team to interface and brief on the entire NICCAV study.
The programme was designed as a two day event. The first day focused on building the capacity of journalists to understand basic scientific concepts of New biomedical HIV prevention technology research and development including HIV vaccine. They were also assisted to understand the basic concept and skills for media reporting on the HIV prevention trials. This training was very beneficial, as it enabled journalists interact better with researchers, CSOs and CAB during the roundtable session the held the next day. The media training came up on the 22nd of April 2013 while the roundtable session with the media, CSO, CAB and the NICCAV study team took place on the 23rd of April 2013.
The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. It is a demonstration research that aim at building cohort of sero-discordant couples over the next 3years in preparation for future HIV vaccine trial in Nigeria. The NICCAV community engagement programme includes working with the media stakeholders at the local and national level to ensure journalists are well informed and engaged with the ongoing HIV vaccine research plan in Nigeria. Past efforts in this respect include media roundtables in Jos, Lagos and Abuja in 2012; and for 2013 there was consensus among the media stakeholders for one day sensitization training on New HIV prevention technology research for journalists prior to the hosting of the joint roundtable sessions. This media programme will be replicated in Abuja-the national host community of the NICCAV study.
The Plateau State Specialist Hospital Management provided support for the two days event.
NHVMAS research literacy leaflets – series 1 to 6
There has been a lot of disappointing news with respect to the outcomes of some first generational microbicide trials. One of the contributing factors to the poor outcomes of the trials has been reported low HIV incidence at the trial sites. Members of the Nigerian community – a country that hosted both the SAVVY and Cellulose Sulphate trials – discussed on the possible contributory factors and way forward for future microbicide trials.
A structured discussion on the issue, involving researchers involved with these trials as well as some national, regional and international community stakeholders was facilitated as a 2 weeks email discussion. This culminated in a GCM facilitated teleconference.
The discussion focused on trial design and trial participant recruitment as well as peculiar individual variabilities that could have contributed to the observed results. Suggestions for future trial include modification of recruitment strategies and current trial implementation process.
In conclusion, there is a need to continue to review current efforts and practices so as to make judicious use of existing global resources where competing needs abound. Microbicide research is becoming more and more difficult with increasing ethical challenges, emerging new evidence and information about the virus and renewed interest by the community in setting research agenda. Evaluation of past efforts in the field and sharing this information widely would help contribute to defining new directions for the microbicide research and development enterprise.
The NICCAV community engagement project recognises the need to engage with various levels of stakeholders including the media, CSOs and CAB at the national and host community level. The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS), is saddled with the responsibility of coordinating the NICCAV community engagement programme. It has therefore continued to work with the CSOs and CAB at the host community to promote research literacy and ensure meaningful community engagement in the research process. Also recognizing the significant role of the media in the research process; it identified media engagement strategies ensuring that the media takes its place in the HIV vaccine enterprise. Most importantly, NHVMAS recognizes the synergy the media, CSO and CAB can form for greater community understanding and involvement in the NICCAV study. It is against this background that NHVMAS in partnership with the NICCAV study team organized a one day media roundtable meeting in Jos in support of the NICCAV project. The roundtable session provided a common platform for the media, CSO and the NICCAV clinical team to interface and brief on the entire NICCAV study.
The programme was designed as a two day event. The first day focused on building the capacity of journalists to understand basic scientific concepts of New biomedical HIV prevention technology research and development including HIV vaccine. They were also assisted to understand the basic concept and skills for media reporting on the HIV prevention trials. This training was very beneficial, as it enabled journalists interact better with researchers, CSOs and CAB during the roundtable session the held the next day. The media training came up on the 22nd of April 2013 while the roundtable session with the media, CSO, CAB and the NICCAV study team took place on the 23rd of April 2013.
The NICCAV project is a collaborative project between the Nigerian government and the Canadian government in an attempt to prepare the country for future HIV Vaccine research in Nigeria. It is a demonstration research that aim at building cohort of sero-discordant couples over the next 3years in preparation for future HIV vaccine trial in Nigeria. The NICCAV community engagement programme includes working with the media stakeholders at the local and national level to ensure journalists are well informed and engaged with the ongoing HIV vaccine research plan in Nigeria. Past efforts in this respect include media roundtables in Jos, Lagos and Abuja in 2012; and for 2013 there was consensus among the media stakeholders for one day sensitization training on New HIV prevention technology research for journalists prior to the hosting of the joint roundtable sessions. This media programme will be replicated in Abuja-the national host community of the NICCAV study.
The Plateau State Specialist Hospital Management provided support for the two days event.
The place and importance of use of HIV self-test (HIVST) kits s growing with many African nations planning on the introduction of self-tests kits. Nigeria is also considering the introduction of HIV self-test kits as a possible mechanism to help increase the uptake of HIV testing. The opinion of respondents in this survey showed that there were divided opinions about the benefits that could be derived from the introduction of HIVST. A significant number were concerned about possible health risk especially suicidal tendencies following a positive test results and increased partner violence. Others were concerned about linkages to care. A significant number however felt that the introduction of HIVST would increase the number of those who would take a HIV test.In conclusion, respondents felt HIVST is a great concept but too early for introduction in Nigeria. Before introduction into the country, there should be stringent regulations for importation of the kits. With introduction, there should be intense media campaign and education about its use. If the kits are to be introduced, they should contain leaflets that counsel the users of the product.
When I reflect back on the beginning of NHVMAS, I am humbled at the story we have the Grace to share today. If I had ever imagined the daunting efforts it takes to make dreams come true, NHVMAS would never have been conceived. Yet, we did as young minds who believe changing the world comes easy. Today I know better. But I have also learnt that despite the challenges along the path to any dream, there are people willing to share the vision with you, to bear the burden with you, and most importantly, to continue from where you stop. These allies and partners give life to a small dream, grow the dream as they make it theirs, and also would hand over the torch to others who would continue to grow the dream themselves.
The 10 years story of NHVMAS is a story of small steps towards a larger dream. A dream as daunting as setting a goal as ambitious as eradicating HIV infection in Nigeria. How then does one evaluate the impact of NHVMAS’ work against such a large goal? The thought of how far we still have to go can easily overshadow the appreciation of how far we have come. I do however acknowledge that after 10 years of work, we need to pause, take stock of how far we have gone, review and define new steps to take, and press forward collectively with old friends and new allies toward a vision for the next decade.
This document is an effort at taking stock of what we have done in the last 10 years. We have taken a moment to gather and acknowledge the efforts we have made, and to trace them to outcomes that have had an impact. This process has also helped us coalesce our thoughts and plans as we see how we are best positioned to move forward and reach further to achieve our collective vision and mission.
For everyone who has contributed blocks in various sizes and shapes to building our collective vision, I hope this piece of work will enable you to also see how your work has contributed to a success story. For me, this process has allowed me to see how our influence has been broadened in-country, regionally and internationally while passionately working for Nigerians. Our collective efforts to address the challenges HIV pose to our generation is serving as an example to organizations working in other countries and regions, and helping shift researchers’ attitudes toward advocacy and community partnership throughout the field of HIV research. The new world of collective action for HIV prevention research is further influencing the field of research in other fields – tuberculosis, genomics and much more.
I am very proud of what we have been able to achieve collectively. This 18-page document cannot tell all the stories of our collective actions; it can only help us reflect on some. It helps me to remember the beginning with a friend whose vision and dreams are larger than life; and whose heart made it possible to start NHVMAS. As we continue to pass the NHVMAS dream to other peers, colleagues and friends, I hope that in another 10 years’ time that we will be remembered as fondly as we remember Omololu Falobi today.
This report looks at the capacity in the country to conduct clinical research. A review of the research environment was conducted. Interviews of stakeholders in the research field in Nigeria were also conducted. This included policy makers, researchers, heads of research institutions and some donor agencies. The report highlighted that for most part, the absence of policies on research and the lack of interest of policy makers in the conduct of research has hampered research in Nigeria. Most large scale researches been conducted in the country are donor driven or driven by Northern partners. Where in-country research is conducted, they are mostly for obtaining promotions in the university or for the conduct of theses for the purpose of obtaining a degree. While human capacity still needs to be built to enhance the capacity to conduct good clinical research, there are existing training opportunities in the country to address some of these human capacity needs. Ongoing short term training programmes in the country can be strengthened and scaled up to address these human capacity needs. Infrastructural capacity also needs to be addressed. When the government increases its funding support for research in Nigeria, this gaps can very well be addressed.
I am the ICASA meeting in Ethiopia and I sat down through a 2 days session listening to data presentation about the HIV context and situation in Africa. As usual, I was all out to hear and listen about what the data was saying about Nigeria.
One key issue was the place and role of anal sex in driving the HIV epidemic in Nigeria. This can no longer be ignored. As per statistics, yes there are statistics from Nigeria that shows that anal sex is practiced by 12% of public secondary schools students. There was another presentation that showed that 12.1% of university students and 15.2% in-school adolescents in Northern Nigeria practice anal sex.
http://www.ncbi.nlm.nih.gov/pubmed/24975983
Sexual and Reproductive Health (SRH) consequences disproportionately affect children, adolescents, and young persons. They account largely for morbidity and mortality in these groups in many African countries including Nigeria and have slowed down or reversed the gains of the child survival efforts of the last decade. The need to mainstream children and adolescents in national reproductive health programmes has become even more significant because children profoundly depend on adults for participation in research and access to SRH services that affect their survival and development. As part of efforts of the Federal Government, to strengthen SRH interventions across the country the need for the Federal Ministry of Health to develop a guidance document to address gaps currently inhibiting participation of children in SRH research and their access to services has become pertinent. This document is designed out of the need to provide guidance in determining the age at which children, adolescents and young persons can give consent for SRH research and access to services without parental consent and in addition, establish standards of practice with regards to management of confidentiality for SRH research and service provision in the best interest of the child. Also some ethical considerations become necessary when engaging children with special conditions in SRH research and service provision. The Federal Government of Nigeria expects that all health professionals and organizations in the country involved with engaging children, adolescents and young persons in SRH research and their access to services will uphold the standards prescribed in this guidance document. This document is expected to be implemented along with the National Health Research Ethics Council and eventually adopted as a policy document
PrEP community information and education material in support of national prep demonstration project.
PrEP community information and education material in support of national prep demonstration project.
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There are so many names of studies you have to know in the field. Many of us simply cannot keep track of them. For some of us, it puts us off – HPTN 035, CAPRISA 004, MTN 003, MDP 301, IAVI 001, RV 144. What does this all mean?
I call them NPT research jargons. They are ways that researchers within their institutions/organisations/Network keep track of their studies. For the researches, the letter – HPTN, MTN, IAVI, IPM – tells you the institution conducting the study. The figure that apears after this is helps the institutions/organisations/Network keep track of the number of trials they are conducting. For example, CAPRISA 004, which is the name (or label) of the recently reported study of a microbicide gel using 1% tenofivr, means that microbicide study is the 4th study (004) being conducted by the CAPRISA. The MTN 003 study is a phase 2B study looking at the efficacy of ARV based vagina gel and PreP. The label MTN 003 simply means this study is the third study being conducted by the Microbicide Trial Network (MTN).
A few of these institutions/organisations/Network are trying to be more label friendly. For example, the MTN 003 study is also called the VOICE study. VOICE is the acronym for Vaginal and Oral Intervention for the Control of the Epidemic. So the MTN 003 study is also called the VOICE study.
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A rectal microbicide developed as a lubricant will help the ease of penetration. It will be an addition feature for lubricants and a most welcome development for many men and women who engage in anal sex.
Some people empty the rectum with a disposable enema before anal intercourse. A rectal microbicide in the form of an enema will be an added advantage for these people. A suppository will also have its advantage as a long term delivery mechanism for product.
The field of rectal microbicide (RM) research is more vibrant than ever. Researchers are developing and testing products in laboratory tests and animal studies. Safety trials look to see if the RM does not cause harm and is well tolerated. One safety trial has been completed, and other safety trials have begun. Once candidate RMs are shown to be safe, they can move into efficacy trials to determine if they actually work to prevent HIV infection.
Acceptability and behavioural studies help determine the characteristics of products people would most likely use, and determine who is engaging in AnaI sex. Baseline studies investigate what normally happens physiologically during Anal sex. Formulation studies explore how different chemicals and substances would be put together to create a safe and effective rectal microbicide. Distribution studies ask the question – where do rectal microbicides need to go in the human body?
Lubricant safety studies seek to establish whether currently available lubricants are safe to use rectally. The lubricants being tested are not designed to specifically block the transmission of HIV, but it is important to know whether they are causing any harm.
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Approximately 5 –10% of the world’s general population engages in anal intercourse. Among women with multiple risk behaviours for HIV acquisition, an estimated 30 –50% engage in anal intercourse.
Anyone who engage in anal sex is encourged to use a lubricant to easy physical discomfort and tear of the rectal lining. Having a lubricant like substance that has the additional advantage of protecting against HIV infection will be a welcome development. A safe, effective, acceptable and accessible rectal microbicide could provide that profile. Rectal microbicides could offer both primary protection in the absence of condoms and back-up protection if a condom breaks or slips off during anal intercourse.
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Anal sex is associated with increased risk of HIV because the lining of the rectum tears more easily than the vagina. The resulting skin breaks and bleeding increase the possibility of the transmission of bodily fluids containing the virus that causes AIDS. STIs can also occur in the anus and thus increase the risk of HIV infection through anal sex.
The risk for HIV infection is greater for the partner who is the receptor (who is penetrated by the penis) due to the increased risk for tear of the lining of the rectum.
Although anal sex is often thought of as a strictly homosexual activity, many heterosexual couples enjoy it too. Anal penetration can be pleasurable, but it can also be a source of physical discomfort
Answer :
The risk of HIV amongst gay men and MSM arises from unprotected anal sex in which there is insertion of a man’s penis into his partner’s rectum. Anal penetration can be a source of physical discomfort. If penetration into the anus is forced, injury is possible. It is helpful to use a lubricant liberally and to relax and gradually dilate the sphincter by gentle manual stimulation before attempting penetration. HIV can be transmitted through anal sex, especially anal intercourse. The risk of HIV transmission is greater than in vaginal intercourse because the lining of the rectum tears more easily than the vagina. The resulting skin breaks and bleeding increase the possibility of the transmission of bodily fluids containing the virus that causes AIDS. STIs can also occur in the anus and thus increase the risk of HIV infection through anal sex. Condoms and lubricants should therefore be used when engaging in anal sex.
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The Nigerian penal code does not prohibit one from being gay or lesbian. Gay men or lesbians cannot be arrested for having sexual feelings for a person of the same sex – their sexual feelings and sexual identities are not illegal – but sexual activities between individuals of the same sex are illegal. The penalty is seven years in prison. Section 214 of the penal code states that “any person who has carnal knowledge of any person against the order of nature ……. is guilty of an offence and is liable for imprisonment.’’ Carnal knowledge is not defined, but the accepted definition is ‘sexual intercourse against the order of nature’, which is defined as anal penetration, and the other party involved may be a man or woman. This has been interpreted by the courts to prohibit sexual relations between persons of the same sex, whether male or female.
This code was derived from the Briish constitution. Britain has since expunged this part of its constitution as it is recognised as an infringement on the individual’s human rights who should have the right to freedom of sexual expression amongst consenting adults.
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The conduct of HIV prevention research usually lead to the improvement and upgrade of infrastructures because of the need to generate data that are of high quality, dependable and useable. This often implies the upgrade of laboratories and study clinics in addition to the continued training of study staff. This translates to improved quality of health care services for trial participants.
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The minimum prevention package provided to participants in HIV prevention trials for sexual transmission should include intensive condom and safer sex counseling, access to free male and female condoms, and regular screening and treatment for STIs. All HIV prevention trials make effort to ensure participants have access to currently available HIV prevention tools. Efforts are made to prevent exposure to HIV infection. There should therefore be intense counselling on regular and correct use of the male and female condoms. Condom use should also be demonstrated and condoms made freely available for study participants and their partners. Participants are also regularly screened and treated for STIs. Ideally the study sites should also make this service available to sex partners of study participants free.
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It is a process by which a participant voluntarily confirms his or her willingness to participate in a particular study after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate. Informed consent is a continuing process throughout the study life-cycle which helps to ensure participants understand the purpose, procedure, benefits and risk of the research study.
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People are different and what works for one person in one situation may not be applicable for another person in another situation. Also, people change over time and may need different options at different stages of their life. Finally, public health emphasizes that multiple prevention options should be available in order to provide a comprehensive response to the epidemic.
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The CAPRISA 004 is the first ever trial to show that an ARV based microbicde is able to reduce HIV infection when applied topically to the vagina. The study was conducted in one rural and one urban site in South Africa. 889 women were recruited into the study. The study showed that the gel, when applied 12 hours before and 12 hours after vagina sex, was 39% efficacious in reducing HIV infection.
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The first generation of new HIV prevention technologies will likely be partially effective. It will therefore be important to compliment or reinforce HIV prevention through sex by the use of condom in combination with these products.
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The female condom is a thin sheath or pouch worn by a woman during sex. It entirely lines the vagina and helps to preventpregnancy and sexually transmitted diseases (STDs) including HIV. Two types of female condom are available.
The FC female condom has been available in Europe since 1992 and was approved by the US Food and Drug Administration (FDA) in 1993. It is a polyurethane sheath or pouch about 17 cm (6.5 inches) in length. At each end there is a flexible ring at the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place. At the other open end of the sheath, the ring stays outside the vulva at the entrance to the vagina. This ring acts as a guide during penetration and it also stops the sheath bunching up inside the vagina.There is silicone-based lubricant on the inside of the condom, but additional lubrication can be used. The condom does not contain spermicide.
VA w.o.w. Condom Feminine (or VA for short) has been distributed as part of HIV prevention efforts in South Africa since 2004.Like most male condoms, the VA is made of latex. When not stretched it is much shorter than the FC – around 9 cm (3.5 inches) – though it is highly elastic. It has a rounded triangular frame at the open end and a sponge inside the closed end, which helps to anchor it inside the vagina. The VA is lubricated and does not contain spermicide. Oil-based lubricants should not be used with this female condom as they can damage latex.
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There are epidemiological evidence from over 40 studies which shows that male circumcision provides significant protection against HIV infection; circumcised males are two to eight times less likely to become infected with HIV. Furthermore, circumcision also protects against other sexually transmitted infections, such as syphilis and gonorrhoea, and since people who have a sexually transmitted infection are two to five times more likely to become infected with HIV, circumcision may be even more protective. Compared with the dry external skin surface, the inner mucosa of the foreskin has less keratinization (deposition of fibrous protein), a higher density of target cells for HIV infection (Langerhans cells), and is more susceptible to HIV infection than other penile tissue in laboratory studies. The foreskin may also have greater susceptibility to traumatic epithelial disruptions (tears) during intercourse, providing a portal of entry for pathogens, including HIV. In addition, the microenvironment in the preputial sac between the unretracted foreskin and the glans penis may be conducive to viral survival.
The CAPRISA 004 study proved that 1% tenofovir gel when placed in the vagina 12 hours before and 12 hours after vagina sex reduced the chance for HIV infection. The study was a proof of concept study – a study to show that ARV based gel when applied into the vagina could protect from HIV infection. It is not an efficacy study.
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The South African study was conducted at the Oral Farm. It recruited 3274 uncircumcised men. The study population were randomised to a cicumcision arm or the non circumcision arm. The study showed 60% protection from HIV infection for men who were HIV negative and engaged in vagina sex. The study was discontinued early by the DSMB in 2005 due to the strong evidence of benefit from male circumcision.
Similarly, randomized controlled clinical trials were conducted in Kenya and Uganda and was stopped in 2006 after interim analyses found a statistically significant reduction in male participants’ risk for HIV infection from medical circumcision. The men who had been randomly assigned to the circumcision group had a 60% (South Africa), 53% (Kenya), and 51% (Uganda) lower incidence of HIV infection compared with men assigned to the wait-list group to be circumcised at the end of the study.
In an earlier large prospective study of couples in Uganda, in which the male partner was HIV infected and the female partner was initially HIV-seronegative, the infection rates of the female partners differed by the circumcision status and viral load of the male partners. If the male’s HIV viral load was <50,000 copies/mL, there was no HIV transmission if the man was circumcised, compared with a high transmission rate if the man was uncircumcised. This showed a significant protective effect; infection were 42% lower for circumcised men. When viral load was not controlled for, there was a nonsignificant trend toward a reduction in the male-to-female transmission rate from circumcised men compared with uncircumcised men. Such an effect may be due to decreased viral shedding from circumcised men or to a reduction in ulcerative STDs acquired by female partners of circumcised men. The study was reported in 2000.
A clinical trial in Uganda to assess the impact of circumcision of HIV positive men on male-to-female transmission reported that, its first interim safety analysis showed a nonsignificant trend toward a higher rate of HIV acquisition in women partners of HIV-seropositive men in couples who had resumed sex prior to certified postsurgical wound healing, and did not detect a reduction in HIV acquisition by female partners engaging in sex after wound healing was complete.
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Peru took part in the STEP vaccine trial. The Step trial showed that HIV infection increased amongst participants who were receiving the active ingredient (not the placebo) especially amongst men who were Ad5 positive and uncircumcised. The trial was discontinued prematurely by the DSMB because of this. Other countries involved in that trial were US, Australia, Brazil, Canada, Haiti, Jamaica, Puerto Rico and Dominic Republic. Trial was discontinued in Spetember 2007.
Peru was also involved in the HSV 2 suppression study conducted by University of Washington. The study examined if the use of Valacyclovir in HSV2 positive individuals – an antivirus used to manage HSV 2 infection – would reduce HIV infection possibility. It was designed as a proof of concept study. 20 MSM were recruited into the study. The study showed no evidene of benefit. The study result was announced in 2008.
Peru is also involved in the iPrEx trial where participants use Truvada once a day (PrEP) to see if it will reduce HIV infection amongst MSMs.
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South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council – one of multiple centres with capacity to conduct HIV prevention trials – conducted four phase III (CS3, MIRA diaphragm study, Carraguard, MDP 301) and one phase IIb (HPTN 035) trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated.
The CAPRISA site also enrolled 889 women for its 1% tenofovir microbicide study. The study showed that a 1% tenofovir gel was 39% effective in preventing HIV infection in women when applied topically in the vagina.
There are about 15 sites in South Africa that was engaged in VOICE, iPrEx and FEMPREP studies; studies that will evaluate oral and topical (microbicide) ARV based prevention tools in women, and MSMs. These studies are currently enrolling participants.
It continues to conduct male circumcision related studies at the Orange farm. The first trial recruited 3274 uncircumcised men. The study population were randomised to a cicumcision arm or the non circumcision arm. The study showed 60% protection from HIV infection for men who were HIV negative and engaged in vagina sex. The study was discontinued early by the DSMB due to the strong evidence of benefit from male circumcision. The site continues to conduct male Circumcision projects based on the result of this study. An example is the Bophelo Pele Project.
South Africans were also engaged in the Pambili HIV Vaccine trial and had enrolled 801 participants prior to discontinuation based on the observed associated increase HIV infection in the STEP trial. The STEP trial was using the same kind of candidate vaccine as the Phambili trial. The Phambili trial was conducted in the Perinatal HIV Unit at Chris Hani-Baragwanath Hospital. This site was also one of the eleven sites for the Niverapine study for prevention of mother to child transmission of HIV infection. The site was also engaged in the Partners in Prevention Study that evaluated the efficacy of twice daily use of acylcovir by individuals co-infected with both HSV-2 and HIV to reduce the risk of transmitting HIV to their uninfected partners. The study was conducted amongst serodiscordant couples.
South Africa is also to engaged in the iPrEx trial where participants use Truvada once a day (PreP) to see if it will reduce HIV infection amongst MSMs. This study is collaborating with the Desmond Tutu Foundation.
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Uganda has been committed to HIV/AIDS vaccine research as an integral part of a comprehensive response to the epidemic since the early 1990s. The country launched the first AIDS vaccine trial in sub-Saharan Africa in 1999. Its first AIDS Vaccine Plan for Uganda was developed in 1992. This was revised in 2001 and has now been updated in light of recent developments. The focus of its HIV Vaccine plan is to develop a HIV Vaccine relevant for Ugandans and others.
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No, they cannot. The candidate vaccines presently undergoing trials are artificially made and carry no risk of transmminting HIV. They do not cointain killed or weakened HIV, or any material from HIV-Infected individuals or form individuals found to be resistant to HIV. Neither do they contain blood or blood product.
Answer :
Vaccine development is a lengthy process of testing ideas and products. The concept are tested and improved many times before they are ready to be tested in humans. Initial tests are done on the product in the laboratory and in animals. If the candidate accine is promising(when extensive studies in animals show no significant side effects), a pkan is then developed for its test in humans. This plan is subbmitted to appropriate national regulatory bodies in order to futher ascetain its safety in humans.
Answer :
A vaccine is a preparation that teaches the body to recognize and defend itself against bacterial and viruses that can cause disease. A vaccine for the human immunodeficiency virus(HIV the virus that causes AIDS), will protect uninfected people against HIV in avariety of ways e.g by stimulating the body’s immune system of fight and kill HIV as soon as it enters the body
