Communiques

INTERNATIONAL WOMEN’S DAY: NHVMAS press for changes in adolescents sexual and reproductive health and rights practices in Nigeria
March 8th, 2018:
The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) joins the world in commemorating the International Women’s Day. We call on all stakeholders in Nigeria engaged with family planning, sexual and reproductive health and rights, and HIV and AIDS response to join forces to press for change in the way adolescents’ sexual and reproductive health and right is managed.
We amplify the #MeToo campaign against all forms of sexual harassment and sexual violence against women and female adolescents. We are aware that female adolescents are disproportionately affected by many forms of sexual harassment and sexual violence including forced sexual initiation.
It is disheartening the result of a study conducted in Nigeria that showed that as high as 31.4% of sexually active females adolescents had experienced forced sexual initiation [1]. Another study highlighted that 22% of cases of forced sexual initiation occur before the age of 13 years [2].Sadly, those adolescents who were HIV positive were more likely to have experienced forced sexual initiation when compared with adolescents who were HIV negative. Rape, is a risk factor for HIV infection in Nigeria.
Also, adolescents in Nigeria with a history of forced sex initiation were more likely to engage in unprotected anal sex and in transactional sex They also were more likely to adopt mental and emotional avoidance strategies and religion to cope with the stress of rape due to negative labelling and stigma of rape survivors [2].

Ongoing studies on biomedical HIV prevention tools for use in adolescents are also not encouraging. Adherence to use of HIV prevention tools – including the use of male and female condoms, Pre-exposure prophylaxis, and the vaginal ring that prevents sexual transmission of HIV infection through the vagina – has been poor for adolescents for many reasons. This does not preclude the need for these tools by adolescents. Adolescents are a lot more concerned about pregnancy than HIV. Yet, the risk of rape increases their risk for both pregnancy and HIV infection.
NHVMAS CALL FOR ACTION
1. Public and private institutions/organisations in the Nigeria – including schools and offices – should develop and make public its zero tolerance policy on sexual harassment. Such policies should create an open platform or the reporting of harassments and abuse of authority or unethical behavior in these institutions/organisations.
2. The National Agency for the Control of AIDS in Nigeria should officially recognize rape as a risk factor for HIV infection in females in Nigeria. Structural prevention and treatment interventions to address the growing menace of
rape is needed as an integral component of the HIV and AIDS response for adolescents in Nigeria
3. Adolescent friendly centres should include rape prevention strategies in their training programmes for all adolescents. These strategies should not exclude the provision of safe spaces for the provision of abortion for girls (many girls become pregnant from rape). We therefore denounce the global gag rule that pushes to silence organisations that provide abortion counselling or referrals, advocates to decriminalize abortion or expand abortion services to address the needs of adolescents.
4. We also ask for continued global investment in research and development of multipurpose technologies that reduces the risk of female adolescents to pregnancy, sexually transmitted infection and HIV infection.
NHVMAS PRESS STATEMENT
WORLD CONTRACEPTIVES DAY – 26TH SEPT. 2017
 
For immediate release
Lagos, Nigeria
26th September, 2017
 
The Nigeria government and international community needs to eliminate barriers to access of contraception by adolescents
September 26th, 2017: The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) joins the world in Commemorating the World Contraceptives Day. We recognize that access and use of effective contraception provides both health and social benefits by reducing unintended pregnancies and abortions. These critical benefits of contraception use is of importance to adolescents in Nigeria, especially female adolescents.
Female adolescents are more at risk of having unintended pregnancies and unwanted births which can lead to nonpsychotic major depression (postpartum depression), feelings of powerlessness, and a reduction in overall physical health. For adolescents who have unintended pregnancies, school drop-out and complications of illegally induced abortion are some of the complications reported with dare consequences. Pregnant adolescents also have greater risks than adults for sexually transmitted infections, especially HIV-1 infection.
Access of sexually active adolescents to contraception can make a difference. Nigeria has the highest rates of adolescent fertility in sub-Saharan Africa. Over 900 000 births to adolescents occur annually and 150 out of every 1000 women who give birth in Nigeria are 19 years old or under.
Sadly in Nigeria, contraception access and its promotion is limited to married women. Its association with family planning makes the public, community and health care providers thing of contraception for use only among couples who are thinking of spacing children. While there are clear guidelines and programmes that promote access of women to contraception, there are conflicting guidelines on access and programmes for sexually active adolescents to contraception. Family planning centres also have limited competency to education and support adolescents’ use of contraception. Finally, the concept of parental consent prior to sexually active adolescents’ access to contraception creates a barrier to access of adolescent to education and uptake of contraception services.
Nigeria is a signatory to the FP2020 targets. It made a commitment at the 2012 London Summit on Family Planning to achieve a modern contraceptive rate of 27% among all women by 2020; and updated this commitment in 2017. It however did not make clear statements on promoting access of adolescents to contraception within its framework for increasing contraceptive rates.
 
NHVMAS CALL FOR ACTION
·         The Nigeria government needs to develop policies and clear guidelines that promote access of adolescents to contraception in Nigeria.
·         The government should support the conduct of more implementation research to identify how adolescents’ access to contraception can be improved in ways that are culturally sensitive. We agree that some evidence about the underlying determinants of unintended pregnancy among adolescents exist, what we know remain inadequately understood. Studies have shown that delaying adolescent births could significantly lower population growth rates, potentially generating broad economic and social benefits, in addition to improving the health of adolescents. The government needs to explore how to enhance this benefits of preventing unwanted pregnancies among adolescents.
·         The competency of health care providers to provide contraceptives to adolescents need to be built. The country needs to review and adopt the A360 programme that explores service delivery models to increase access of adolescents to contraceptives in Nigeria.  
·         The FP2020 target for Nigeria should develop targets for contractive access by adolescents; and this targets should be monitored by national and international monitors.
·         Global monitoring targets for contraceptive access should include targets for adolescents.
·         We also ask for continued global investment in research and development of multipurpose technologies that reduces the risk of female adolescents to pregnancy, sexually transmitted infection and HIV infection.

 

Press release
HIV Vaccine development in Nigeria: need for dedicated action

This year marks the 20th anniversary of hope and inspiration for the development of an HIV vaccine. Although we do not have an HIV
vaccine, the field has indeed gone far with efforts to develop one. In 2016, a large HIV vaccine efficacy clinical trial known as HVTN 702 started in South Africa, and later this year another one, testing a different product, is expected to start in several African countries. It will be the first time in nearly a decade that two HIV vaccine efficacy trials (large studies to see if a product works to prevent HIV in real life settings) are running simultaneously. We know that vaccine research is always a long-term endeavor. Many of the vaccines
we have today for other diseases took decades to develop. The discovery of the polio vaccine, for example, took 47 years.

Read More…

Now More Than Ever: A call for effective responses to
provision of hormonal contraceptives in the context of HIV,
women’s sexual and reproductive health and rights

On March 2, 2017, World Health Organization (WHO), released updated recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV1. The recommendations for use of progestogen-only injectables (DMPA and NET-EN) among women at high risk of HIV changed from Medical Eligibility Criteria (MEC) 1* to MEC 2. Recommendations for all other methods of hormonal contraception remained unchanged. This development comes at the precise moment when, as WHO and other UN agencies have just noted, “the promotion, protection and fulfilment of sexual and reproductive health and rights are currently experiencing marked resistance around the world.2” We stand with the stakeholders who developed this statement and with women around the world in saying “now more than ever” action is needed

Read More…

Advocacy briefs on hormonal contraceptive and HIV

Advocacy briefs on Hormonal contraceptive and HIV

Issues: Sexual and reproductive health programmes include the need to reduce the burden and risk of women to morbidity and mortality arising from sexually transmitted infections, pregnancy and child birth. Effective family planning services are central to initiatives to slow population growth, promote economic development, and improve the health of women and children worldwide.The 2012 National Adolescents Reproductive Health Survey showed that only 10% of married women and 29% of sexually active women were using a form of modern contraceptive. Overall, about 2.1% of women use injectable contraceptives: a 0.6% increase from 2007.

Hormonal contraceptives and risk of HIV infection: There are evolving evidence on the association between hormonal contraceptive and increased risk of HIV infection and HIV transmission. A prospective cohort study on use of hormonal contraceptives and risk of HIV-1-transmission conducted by Heffron et al and published in Lancet 2012, reported that the use of hormonal contraceptives might double the risk of HIV transmission among women and their partners Studies have reportedassociation between the risk of HIV-1 infection and oral contraceptive use. Similarly studies also reported that women using either injectable hormonal contraceptives or oral contraceptives pills were at increased risk of HIV-1 acquisition. Hormonal contraceptive use is not only linked with HIV acquisition and transmission for HIV positive women but also with increased risk of STIs. Data of a study conducted in 2004 by Lavreys et al showed increased risk of of cervicitis and cervical chlamydia infection in HIV positive women who use hormonal contraceptives. In addition, on a cellular level, hormonal contraceptives have been associated with cervical and vaginal inflammation, increased genital tract expression of the HIV-1 co-receptor CCR5, mucosal and systemic immune responses that could mediate susceptibility to HIV-1 and hormones may directly enhance the replication of the virus itself, which could affect both early infection and the subsequent disease course.

The association between STI, HIV infection and hormonal contraceptive was further strengthened by the result of Naguchi et al’sreport that showed that Herpes simplex infection increases the differential risk of women to HIV infection when using hormonal contraceptive: women using Depo-Provera, which lasts three months) were twice at risk of having HIV infection compared to women who used NET-EN (another injectable method that lasts for two months and uses different hormones from Depo-Provera). When the analysis was limited to women without HSV-2, there was no difference in HIV risk according to contraceptive use.

However, current data still leaves unanswered questions about the link between hormonal contraceptives and women’s risk of acquiring HIV.  The World Health Organization’s Technical Note on Hormonal Contraceptives and HIV says that these methods can be used without restriction but also states that, “Because of the inconclusive nature of the body of evidence on possible increased risk of HIV infection, women using progestogen-only contraception should be strongly advised to always use condoms, male or female, and other HIV preventive measures.”

Progestogen-only contraceptives like Depo-Provera (also known as DMPA) are widely used, therefore we know more about them. We are starting to learn about other long-acting methods, including injectables and implants with different doses and types of synthetic hormones, which appear safer.

In spite of this uncertainty, most Nigerian women are not receiving more options or more information. In the two years since WHO issued this technical note, there has been no communications training or guidance from relevant agencies  for service providers to help them explain the risks and benefits, known and unknowns of different methods.  Similarly, there has not been any form of  education on contraceptives use and HIV risk for women especially, women living with HIV and AIDS, female sex workers and women in sero-discordant relationship to help them to make informed decisions about contraceptives use.

Lesson from South Africa: South Africa’s recently updated Contraceptive Policy provides an example of how to act on the uncertainty. One key conclusion is: “In light of recent research relating to the possible increased risk of HIV acquisition with injectable progestins, emphasis has shifted from injectable progestins to alternative long-acting reversible contraceptives (IUD, IUS, sub-dermal implants), with particularly attention paid to the importance of condom use for women who choose to use injectable progestins.”The country recently rolled out the subdermal implant as an alternative long-acting method.

 

Call to action:

Now is the time to act!  We don’t have to wait for more research to act. The question of whether Depo-Provera increases HIV risk has not been answered conclusively. The current uncertainty, combined with the unpopular side effects and the range of options that appear to carry less risk, support shifting away from Depo now, without waiting for more research.

We the under listed members of the “Gender Partners Forum” in collaboration with New HIV Vaccine and Microbicides Advocacy Society hereby note that addressing issues about use of hormonal contraceptive is an issue of equity. Women in Nigeria have the right to a wider array of safe, long-acting family planning methods that address concerns about HIV prevention and preventing unintended pregnancies. We therefore call for the following immediate action:

  • Mobilization and sensitization of civil society organizations working in the field of gender and HIV/AIDS for a stronger voice for the proactive change in the contraceptive policy addressing the uncertainty in hormonal contraceptive use and HIV

 

  • Public education especially high risk groups –women living with HIV, female sex workers and women in sero-discordant relationship on contraceptives should be targeted with information on possible HIV risk associated with use of hormonal contraceptives help them to make informed decisions on contraceptives use.

 

  • NACA, FMoH and other relevant international agencies (UNFPA, UNAIDS, WHO) should provide the technical leadership to update Nigeria contraceptive policies that proactively seek to expand mix in ways that will benefit all women, and address the unanswered questions related to DEPO and HIV risk just as countries like South Africa and Zimbabwe have already updated contraceptive policies. They should also mobilize local and international financial resources to support the country to expand and deliver contraceptive method mix.

 

  • NACA, FMoH and other relevant agencies should develop and implement communications, training and guidance for services providers to help them explain the risks and benefits, knowns and unknowns of different methods of family planning to clients and allow them to make informed decisions on contraceptives use.

 

Nigeria must build invest in efforts to monitoring of uptake and safety of hormonal contraceptive use and participate in the global discourse on defining the research agenda on hormonal contraceptives and HIV.

Heffron R et al. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet. 2012; 12(1): 19-26.

Plummer FA et al. Cofactors in male-female sexual transmission of human immunodeficiency virus type 1. J Infect Dis 1991; 163: 233-239

Lavreys L et al. Hormonal contraception and risk of HIV-1 acquisition: results of a 10-year prospective study. AIDS. 2004;18(4):695-7

Lavreys LM et al. Hormonal contraception and risk of cervical infections among HIV-1-seropositive Kenyan women.AIDS. 2004;18(16):2179-84; Cottingham J and Hunter D. . Chlamydia trachomatis oral contraceptive use: a quantitative review. Genitourin Med 1992;68:209-16; Avonts D et al. Incidence of uncomplicated genital infections in women using oral contraception or an intrauterine device: a prospective study. Sex Transm Dis 1990;17:23-9; Louv WC et al. Oral contraceptive use the risk of chlamydial gonococcal infections. Am J Obstet ynecol 1989;160:396-402; Morrison CS et al. Hormonal contraceptive use, cervical ectopy, the acquisition of cervical infections. Sex Transm Dis 2004;31:561-7.

Ghanem KG et al. Influence of sex hormones, HIV status, concomitant sexually transmitted infection on cervicovaginal inflammation. J Infect Dis 2005;191:358-66.

Prakash M et al. Oral contraceptive use induces upregulation of the CCR5 chemokine receptor on CD4(+) T cells in the cervical epithelium of healthy women. J Reprod Immunol 2002;54:117-31; Prakash M et al. Ex vivo analysis of HIV-1 co-receptors at the endocervical mucosa of women using oral contraceptives. BJOG2004;111:1468-70.

Hunt JS et al. Hormonal regulation of uterine macrophages. Dev Immunol 1998;6:105-10; Zang YC et al. Regulatory effects of estriol on T cell migration cytokine profile: inhibition of transcription factor NF-kappa B. J Neuroimmunol 2002;124:106-14;Gillgrass AE et al. Prolonged exposure to progesterone prevents induction of protective mucosal responses following intravaginal immunization with attenuated herpes simplex virus type 2. J Virol2003;77:9845-51

Naguchi LS et al. Injectable Contraception and HIV Acquisition in the VOICE Study (MTN-003). 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014). Boston, March 3-6, 2014. Abstract 847.

http://whqlibdoc.who.int/hq/2012/WHO_RHR_12.08_eng.pdf

http://www.wrhi.ac.za/Lists/ReportsAndPublications/ViewForm.aspx?ID=6&ContentTypeId=0x0104009C84F75916DC67499D70B22D21773640;http://www.mm3admin.co.za/documents/docmanager/3C53E82B-24F2-49E1-B997-5A35803BE10A/00037761.pdf

http://www.sanews.gov.za/south-africa/government-unveils-free-contraceptive-device-wome

International Women’s day: a call for more investment for the development of women controlled options for HIV prevention

8th March 2014, Nigeria. The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) calls for increased investment and support for the development of women controlled options for HIV prevention. HIV continues to have a woman’s face. This fact has not changed over the years despite the seemingly changing dynamics of the HIV epidemic.

The results of the VOICE study and Fem-PrEP study that showed failure of an effective HIV prevention tool (PrEP) to confer protection for HIV infection in studies conducted among women of reproductive age – those worst affected by the HIV epidemic – due to poor adherence. The results of these two studies show very clearly that the use of PrEP would prove a challenge for African women. This is a call for action. For African women, the world needs to help develop a HIV prevention tool that can overcome the current challenges of adherence.

NHVMAS applauds the reports of the two early clinical studies of novel HIV prevention products for women reported at CROI — the first combination ARV vaginal ring that slowly releases the ARV dapivirine over the course of a month, and a vaginal film study which evaluated the release of ARV dapivarine for use around the time of sex. These studies show the products to be safe and open the door to product improvements that could expand options for women-initiated prevention tools.

NHVMAS continues to support ongoing research on the development multipurpose prevention technologies (MPTs) in the form of long-acting rings that would protect against unintended pregnancy and sexually transmitted infections, including HIV. We also support ongoing studies on vagina microbicide and the development of rectal microbicides that can be used safely by women who practice anal sex.

 

We urge donors and sponsors to continue to support research for the development of women controlled HIV prevention, including those that can improve the overall sexual and reproductive health of women in Africa.  Women’s health is a human rights issue and an agenda that needs to be pursued with a sense of urgency.

Global Day of Action: Call for the repealing of Nigeria’s Same Sex Marriage Prohibition Act 2013

12.01am, 7th March 2014, Nigeria: The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) calls for the repealing of the Same Sex Marriage Prohibition Act 2013. NHVMAS notes that this act has caused escalation of human right abuses and violence for men who have sex with men (MSM) in many communities in Nigeria. It has led to individuals taking laws into their hands and unleashing terror on others who they assume or know to be homosexuals. An example is the attack on 14 men in Abuja in February. There had been other reports of attack in Portharcourt and Nassarawa following the Act. At least 10 detentions in four of Nigeria’s 36 states have been recorded.

NHVMAS notes with sadness that since the signing of the bill into law by the President of the Federal Republic of Nigeria, President Goodluck Jonathan, individuals and organisations working with the LGBTI community have felt a sense of loss: particularly regarding n the gains made in recent years in addressing the HIV epidemic concentrated within this  community. The 1999 Constitution of the Federal Republic of Nigeria already contains clauses that prohibit same sex relationships. The Same Sex Prohibition Marriage Act further aggravates the anti-human right stance of the clause in the constitution.

The HIV response and the public health good of working with MSM have only started to gain momentum in recent years. The national HIV prevalence of 17.2% within the MSM community based makes provision of HIV prevention, treatment, care and support services to the community a top priority: MSM have heightened risk of HIV infection and are a critical population for HIV interventions.

Criminalising MSM and those that associate with MSM as contained in the Same Sex Marriage Prohibition Act implies that ongoing work within the community which focuses on ensuring access to prevention and treatment services would ground to a halt: uptake would be poor even when services are provided, and less NGOs/CBOs would likely be working with the community in view of the provision of the Act.  Health-care workers are not assured of protection to treat homosexual patients in confidence and will have to deal with actual or perceived duress to report members of the homosexual community to authorities. The Act holds implications not only for the HIV/AIDS community, but the medical community as a whole. ‘They threaten both the trust placed in health-care professionals and their efforts to achieve universal health coverage’ writes Aston Bernett-Vanes in his Lancet publication.

Beyond the public health good, the Act also infringes on the rights of members of the LGBTI community. It contravenes the provision of the 1999 Constitutions that upholds the rights of all Nigerians. It also contravenes the various treaties that promotes the peace and security of lives and properties of Nigerians to which the country is a signatory.

NHVMAS hereby calls on:

  1. The Nigeria Bar Association and the Human Rights Commission to review the Same Sex Marriage Prohibition Act and advice the President on its implication as per the infringement on the rights of men and women in Nigeria.
  2. The Nigeria Medical Association of Nigeria to review the Same Sex Marriage Prohibition Act and advice the President on its public health implication.
  3. The media to create spaces for public dialogue on the Same Sex Marriage Prohibition Act and its implications on the rights of citizens in the country.

 

  1. The President of the Federal Republic of Nigeria to repeal the Same Sex Marriage Prohibition Act and uphold the Spirit of the Country’s 1999 Constitution.

Africa Civil Society Challenge African Leaders to Invest in HIV Research & Development

(Cape Town, December 6th 2013) The world is at a historic moment in the fight to defeat Aids. It is a time of great scientific breakthroughs. Civil Society in Africa continue to celebrate the evidence that HIV treatment, if initiated early for someone living with HIV, can reduce the risk of transmission to their partners by 96%; that Voluntary Medical Male Circumcision can reduce the risk of infection by 60%; that  pre exposure prophylaxis can reduce the risk of acquiring new HIV infection also.

In Africa, however, the sense of hope that comes with such scientific breakthroughs is often shadowed by doubt and despair.  Rosemary Mburu, Executive Director of World AIDS Campaign says, ‘When science delivers new innovations to the world, Africa is often the last place to benefit from such innovations. African governments can change that by investing in health research and development’. Her comments came during the 17th International Conference on AIDS and STIs in Africa (ICASA) at a pre-conference on new prevention technologies co-organized by World AIDS Campaign, International AIDS Vaccine Initiative, AVAC, JAAIDS(Journalists Againsts AIDS) and NHVMAS (New HIV Vaccine and Microbicide Advocacy Society) in Cape Town, South Africa.

At this pre-conference Civil Society representatives called for unprecedented political will by African governments to prioritize and invest in health including HIV Prevention Research.  Maureen Milanga, a lawyer and activist with AIDS Law Project said, ‘we will not get to the end of AIDS if African governments don’t prioritize and invest in it.’

Morenike Ukpong notes that research is required to provide the needed evidence to make cost effective changes. ‘With our little resources, we can gain giant strides if we invest in evidence based responses; evidence derived from systematic studies’ she noted.

African leaders should invest in health to facilitate: (1) delivery of the already proven HIV prevention options to end AIDS such as early initiation of treatment for those infected and male circumcision for the uninfected. (2) clinical demonstrations for potential prevention options including female controlled options such as microbicides. (3) discovery of an AIDS vaccine.

ICASA is an opportunity for African leaders to discuss the status of the epidemic and to renew their commitment to defeating AIDS. It is an opportunity for the international community, and all Africans, to join efforts in committing to achieving an AIDS-free Africa.

Now more than ever bold leadership demonstrated through health and R&D investments is needed to get to Zero New HIV infections and Zero AIDS related deaths.

For further inquiries:

Rosemary Mburu: mburur@worldaidscampaign.org; +27 84 4776162

Morenike Ukpong: toyinukpong@yahoo.co.uk

Olayide Akanni: olayide@gmail.com

Prince Bahati: PBahati@iavi.org

Manju Chatani: manju@avac.org

Research Community request for better process of community engagement, informed consent and standard of care in HIV research in Nigeria.

The New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) in collaboration with TIER, CADAM, Safe haven and IRMA, with funding support from Sidaction, France, conveyed a roundtable/interface with research stakeholders in June, August and September 2012 to facilitate direct dialogue between researchers engaged with HIV research and the research communities. The following were the objectives of the meeting: (i) to identify priorities considerations by research communities when HIV research is conducted in their community (ii) identify considerations that should be of concern to ethics committees during protocol review (iii) identify measures to take to empower communities to become more directly engaged with HIV treatment and prevention research conducted within their communities.

 

  1. CONSIDERATIONS RESEARCHERS SHOULD TAKE WHEN CONDUCTING HIV RESEARCH WITH COMMUNITIES:

Often times, HIV prevention and treatment research are conducted with communities that are often stigmatised, vulnerable and disempowered. Within this context, the possibility for research abuses is high. Community representatives present at the round table considered the following issues of considerable importance when conducting research in their communities.

1.0 Informed consent and other ethical considerations in research

1.1. Observations

  • A number of researches conducted in the country either do not consent research participants or do not conduct the consent process properly when there are attempts to do so even though protocol approved by the IRB included the need to obtain informed consent form.
  • Inadequate details of research purpose in the background of the consent form.
  • Use of highly technical words to present research purpose in consent form.
  • Overemphasis of benefits over risks when discussing research with study participants. This happens too often in the field.
  • Ethics committees do not provide proper oversight function for the researches they approve.
  • Negotiation of research reimbursements often takes place at the time of research implementation.
  • Poor information dissemination about the research to the research community and individuals involved with a research.

 

2.0. Community engagement in research

2.1. Observations

  • Communities are generally poorly engaged in the design and monitoring of research, but extensively engagement during the implementation.
  • There is little research literacy efforts on the field. Communities therefore only respond to what researchers share with them.
  • Communities are often not educated enough about the research they conduct among them.
  • CSO engagement is often mistaken for community engagement.
  • Security agents are not often considered as necessary representative on Community Advisory Boards engaged with research involving vulnerable communities.
  • CSOs also conduct researches without any oversight being provided by ethics committees. This often introduces bias in the reports generated.
  • Where CSOs are formally engaged on projects, Terms of References are not drawn for the group to guide their work.
  • Researches are often mistaken for public health interventions.
  • The community is often ‘used’ as a means of recruiting research participants. CSO engagement in research should not replace researchers’ responsibilities. Researchers should be the ones to directly engage research communities for data collection.
  • Research protocols often show no evidence of community involvement in its development. Yet approvals are given by ethics committees.
  • Ethics committees do not monitor researches they approve to ensure that community engagement happens in the field.

 

3.0.            Concern on standard of care

3.1.      Observations.

  • The standard of care provided for research participants may conform to national standards which are less than global standards.
  • Some research participants in hospital based research are made to bear the cost of research related investigations.
  • Study participants may be asked to defray the cost of managing chronic illnesses that develop during the course ofimplementing researches with long duration the onset of which researchers consider not to study related.

 

4.0.            Other concerns

  • There is minimal government investment in HIV research conducted in Nigeria.
  • A number of HIV researches are repeated due to poor coordination of the field.
  • Often, researches do not inform intervention and policy formulation

 

  1. RECOMMENDATION

5.0. Informed consent and other ethical considerations in research

  • Informed consent form should be available in local languages for easy understanding. Verbal translation of English to local language is not acceptable.
  • Researchers should discontinue overemphasis of benefits over risks when discussing research with study participants.
  • There are persons who truly want to withdraw consent and participation in researches and programmes but do not know how to do this. Also, when participants withdraw from studies, there must assurance that all the data related to the individual is withdrawn from the data collected. While it may be important to withdraw quantitative data collected, it may be important to identify how qualitative data collected are withdrawn from the pool of data.
  • HRECs must ensure that the eight (8) minimum requirements of informed consent are addressed in all informed consent they approve. The 8 minimum requirements include: The goal of the research, procedures and schedules, Study duration,Compensation, Confidentiality and anonymity, the risks and benefits associated with study participation, the study product and voluntary nature of the research.
  • There is the need to have a platform that facilitates communities and researcher interaction dialogue. This will also help ethics committee identify what to address with respect to community concerns when they review research protocols.
  • Ethics committees should monitor all the researches they approve including monitoring of the informed consent process. The community considers it unethical not to do so. The current level of research monitoring is extremely low and very unacceptable. This gives room for research participants’ abuse. Unfortunately the vulnerable – including those that do not understand their rights when it comes to research – are preys to multiple unethical practices including paying for research related investigations in disguise for treatment.
  • Ethics committees have the responsibility to educate their communities about their role and responsibility in research. This is a responsibility identified already in the national ethics code. Ethics committees need to be alive to this responsibility
  • All ethics committees should have an online database of all researches approved and a summary of the research outcome so as to reduce duplication of research.
  • Research protocols should include timelines for planned project implementations so as to ensure appropriate time is allocated for study implementation. This will reduce the tendency to compromise on proper study implementation processes when they are faced with pressure of time for project completion.
  • All negotiations including adequacy of reimbursement should take place prior to ethics committee approval of studies.
  • For HIV treatment research, study participants must be assured of continued access to ARV drugs even after completing or voluntarily withdrawing from the research.

 

6.0 Community engagement

  • Community engagement should happen throughout the lifecycle of research – from the design to the dissemination stage in line with the requirements of national ethics code and national HIV research policy.
  • NGOs need to be funded to actively support community research literacy so as to promote informed community engagement with research. Researchers are encouraged to engage CSOs in all community based research as community educators. This would encourage mutual trust for the research and sustained community education on the subject matter even after the project is concluded.
  • Informal community engagement is equally important but should not replace formal engagement mechanisms.
  • Engagement with the communities should be an ongoing process with regular feedback mechanisms in place.
  • CSO engagement should not be considered as community engagement. Researchers should work with CSO as gatekeepers only: discussion and recruitment of research participants should be done directly from the community after duly providing information to the community.
  • Communities should be engaged in all forms of research. The types and levelof community stakeholders to be engaged however differs with the type of research. Ethics committees need to review and monitor research protocols to ensure this happens. Researchers need to collectMemorandum of Understanding from communities as evidence of community permission to work within the communities. This MOU should be the  evidence research ethics committees seek for when reviewing research protocols
  • Regulatory agencies (Ethics Committee and research monitors) should use a participatory approach for the monitoring and evaluation process for research and programmes. They need to interact with research communities during their monitoring exercises to evaluate level of community engagement in the research process.
  • Wide range of stakeholders should be engaged in community research implementation.
  • Proper community entry processes must be done prior to commencement of research programmes.
  • There should be a clear plan on how research findings will be disseminated to the research participants and the communityand this should be part of the research protocol. There must be a system of monitoring that ensures it happens.
  • All research should make efforts to promote research literacy. Ethics committees should see that the information sheet for all the research they approve should have an educational component. This way, at the minimum, research participants get to learn something about the research subject.
  • Researchers must make efforts to keep reminding study participants engaged in drug research that such research should not be mistaken for health interventions. Efforts must be made to prevent therapeutic misconceptions.
  • When researches are conducted by the community themselves, external oversight needs to be provided so as to address the potential for bias reporting by the community. This can be done through partnership with other organisations that can play this role.

 

7.0 Standard of Care

  • Researchers will need to own up to their obligation to pay for all forms of research related injuries: When chronic illnesses aredetected during the course of long term researches (those that go on for 2 – 3 years), researchers should be obliged to manage theseillnesses.
  • Thestandard of care package for research participants should align with global standards.

 

8.0  Other recommendations

  • Nigerian government and institutions should support research in Nigeria by setting up foundations rather than leave funding for research in the hand of international partners.
  • Researches implemented in Nigeria but initiated by foreign investigators should always benefit the Nigerian community.
  • Researchers should make significant efforts to facilitate mechanisms that will increase the translation of their research findings to policies and programmes.

 

  • There is the need to create a national data base on HIV research conducted in the country. This is very critical to avoid repetition and wastage of resources as well as facilitate research driven programming in Nigeria.

Advocates in Nigeria disappointed with the Carraguard study result

Researchers and Community advocates under the aegis of the New HIV Vaccines and Microbicide Advocacy Society (alias NHVMAG) have expressed disappointment over recently released results that showed that Carraguard, a microbicide candidate undergoing Phase 3 trials   failed to effectively
protect women against the risk of HIV infection.

Population Council, an international non-profit research institution had tested Carraguard, (a microbicide candidate developed as an odorless, clear gel made from carrageenan, a derivative of seaweed for its) effectiveness in a study conducted between 2004-2007. The study enrolled
6,202 women participants in South Africa. Trial results showed that the product was safe and acceptable to women, but did not reduce their risk of acquiring HIV.

Coordinator of NHVMAG, Dr Morenike Ukpong noted that result of the Carraguard study comes as a disappointment to the Nigerian advocates who have continued to wait for good news from the field.

“We applaud the efforts of the researchers at completing the first large-scale effectiveness microbicide trial. We also appreciate the efforts the researchers are making in ensuring transparent communication with trial participants and with African stakeholders about the trial. We
also are aware of the hard work of the trial site staff at ensuring effective community participation in the Carraguard study and this we find exemplary.”

NHVMAG and the community of Nigerian advocates continue to applaud the current partnership observed between researchers and the community: Dr Bode-Law Faleyimu of NHVMAG noted that “this is truly an effort at true stakeholders involvement and teamwork. If this mutual respect, sharing and involvement continues, we believe we will see less futile research and more successful trials in the future”.

Ukpong however noted that the disappointment on the part of the advocates only reinforces the need to invest expediently in future microbicide researches. Quoting Lori Heise of the Global Campaign for Microbicides a leading US based Microbicides Advocacy Organization,  “New drug development is always a long term struggle and typically hundreds of product leads fail for every one that succeeds, but discouragement is a luxury we can’t afford.” Ukpong noted  that “Our  responsibility now is to
learn as much as possible from this trial to inform and guide future research, improve future trials, better predict efficacy and understand how best to partner with communities and improve the standard of care offered to participants”.

Nigeria had hosted two phase III microbicide trials in the immediate past (SAVVY and CS3). The disappointing results from the two studies has however not dampened the , enthusiasm of researchers and advocates  who are hopeful that other ongoing global  research efforts will yield
positive results for a safe, effective and affordable microbicide in the not too distant future.

Though the HIV prevalence in Nigeria is decreasing based on the 2001, 2003 and antenatal clinic Sentinel Survey results from the Federal Ministry of Health, the statistics still indicate that women are worse affected by the epidemic.

Vaginal microbicides which are being developed as a female-initiated method for reducing male-to-female transmission of HIV and possibly other sexually transmitted infections (STI) when used during sex, would therefore be a welcome intervention that will boost the quality of currently existing HIV prevention tools in Nigeria

The New HIV Vaccine and Microbicide Advocacy Society (alias NHVMAG) is a coalition of stakeholders (advocates, researchers, policy makers, media persons, academia and ethicists) engaged directly and indirectly with New HIV Prevention Technology Research and Development in Nigeria
www.nhv-mag.org
Contact: Morenike Ukpong,
+ 234 803 2459 256;
toyinukpong@yahoo..co.uk

For more information on the Carraguard trial visit: www.popcouncil.org/mediacenter/dmks/carraguard.html

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