SAVVY trial result dissemination efforts in Lagos, Nigeria

The SAVVY trial was a phase 3 randomised controlled trail of 1% C31G Microbicides gel. The trial was to assess the effectiness of the gel to prevent HIV infection in women with high risk behaviour. The
trial was conducted in two sites in Nigeria – Lagos and Ibadan. It
The study commenced in 2005 and was concluded in 2007.

The Lagos team organised a trial result dissemination exercise in
two phase. The first effort was to inform stakeholders about the
result of the trial. This meeting held on the 18th of September,
2008. On the 25th of September, 2008, a second meeting was held with trial participants. In all there were

1. 7 stakeholders present representing the State Ministry of Health,
Lagos State Action Committee on AIDS Control and NHVMAS, drug and regulatory agency, the institutional review Board

2. Aproximately 200 past trial participants

Result of study: 2153 were enrolled both in the Lagos and Ibadan arm of the study. 2082 were found eligible for effectiveness of the gel evaluation. 2088 were evaluated for gel safety. 286 of the
participants did not complete the study due to study termination as
a result of the DSMB declaring study futility. 65 participants
discontinued for other reasons. There were seroconversion: 22 in the
SAVVY group and 11 in the Placebo group. No notable safety concerns resulted from the use of SAVVY gel by high risk, HIV negative participants for up to 12 months. No significant differences in frequencies of adverse events were soon between treatment groups. No serious adverse was attributed to product use. No death was related to product use. Two participants discontinued from study due to medical reasons. Also all participants that seroconvert were given adequate counseling and referred for HIV care support service ands ensured future access to ARV through the PEPFAR programme in the institution. There was a 100% registration of all seroconverters on the PEPFAR treatment programme. There was also intensified follow-up those participants referred to PEPFAR to ensure drug use compliance and continuous counseling. The gel was not found effective in preventing HIV infection though many participants reported reduction in STI incidence while using the gel. Condom use was also reported to be high during the study Community Concerns were:

  1.  Why were trial participant seperated from other stakeholders
    during result dissemination?
  2. Why were other community leaders and gatekeepers not invited for
    the dissmeination exercises moreso they were reached when then research commenced?
  3. After this result, what next?
  4. The PI was requested to conduct post trial analysis of the past trial participants who reported reduced STI incidence due to gel use. An assessment of condom use and STI incidence before, during and after the trial should be studied and reported back to the stakeholder
  5. NAFDAC requested that the PI conduct a proper disposal and
    destruction of all trial samples like the drugs, placebo and condom.
  6. Future trials should incorporate programmes that facilitate
    skills acquisition and poverty reduction intervention.
  7. Other PIs were requested to conduct a result dissemination
    meeting for their stakeholders and trial participants.

Trial participants questions were:

  1. The Gel was also associated with allergic reaction like rash
    where ever the gel contacted her skin
  2. Any future microbicide studies being planned?
  3. How were they to continue accessing regular HIV testing?
  4. How do you address possible HIV infection when a HIV negative person has sex with a HIV positive individual and the condom breaks?
  5. Is it true that HIV status cannot be detected before 21days and above?
  6. Is it possible to have sex with someone who is HIV positive and you will not be infected?
  7. What is the difference between placebo and SAVVY?
  8. What next after this trial?
  9. How can they still have access to condoms?
  10. How are the skills of the trained staff being used post trial?
  11.  Is the SAVVY gel no longer good for use?

All participants left satisfied with NAFDAC noting that the SAVVY study was the first study to ever report protocol violation to their office. This was impressive the official noted.

Reported compiled from reports sent in by Dr Adeiga (PI of the study), Mr
Chibuke Ameachi (NHVMAS collaborator), Ms Augustina Amumuziam (NHVMAS programme officer) and Mr Tubosun Obileye (NHVMAS associate).

NHVMAS members make it to the IRMA Board

Two NHVMAS members made it into the the IRMA SC after an exhaustive process which took several months. The process resulted in the selection of 13 new members bringing the IRMA SC membership to 23.NHVMAS has a long history of  advocating for rectal microbicide research and development knoing very well the high prevalence of unprotected anal sex amongst heterosexuals men and women and MSM. Unprotected anal intercourse is 5 to 80 times more likely to result in HIV transmission compared to unprotected vaginal intercourse. It is imperative that a safe, effective and acceptable rectal microbicides for women and men is developed for use commented Jim Pickett, Chair of IRMA

We congatulate Kadiri Audu and Lanre Onigbogi on their nominations.

The thrill about the HPTN 035 study

The results of the HPTN 035 provide the first indication that a microbicide gel can at least partially reduce women’s risk of HIV. This study represents an important step forward for HIV prevention research. Very briefly, these results are summarized as follows [as described by Sharon Hillier, the MTN PI]:

 

  1. PRO 2000 gel (0.5%) was found to be 30 percent effective in preventing HIV infection. While encouraging, this result is not statistically significant.

 

  1. BufferGel was found to have no detectable effect on preventing HIV infection.

 

  1. Both gels were found to be safe. This results provides the first signal of the possibility that the microbicide as a concept is feasibile and a topical application of a product in the vagina could actually prevent HIV infection. This is a signal of hope for the field

As for PRO 2000, more evidence will be needed before we can determine more conclusively its effectiveness. We will eagerly await the results of the MDP 301 trial, which are due by the end of the year.

 

What would the face of HIV control be in the next 25 years?

  • Over the next 25years, there would be increased emphasis on
    harnessing host factor to prevent or control HIV infection. Current approaches focus on interfering with viral attachment or
    replication. Future efforts would seek to harness anti-viral factors and co-factors to stop or reduce HIV infection. This would provide a pipeline of novel targets for drug development with reduced possibility of resistance. But because HIV attacks innate factors in your body, there may be an increased risk of untoward effects and cellular toxicity with this approach.• HIV infection has been associated with premature aging. Efforts would be directed at investigating links between aging and HIV.
    HIV disease including its impact on premature aging in multiple body systems. Perhaps the HIV field can harness the global interest in prolonging youthfulness to revitalize the global HIV research infrastructure.

    • Efforts shall be directed at developing simple test to identify
    acute HIV infection. Probably half of all transmission occurs in
    the “window period” before people develop antibodies that show up on today’s rapid HIV tests. It should be possible to develop a test that has 3 windows: one that indicates no infection, acute infection and seroconvertion. Such a test would allow the world to identify pockets of high transmission and thereby help plan and target prevention efforts better, conduct routine surveillance of incidence rather than prevalence, and counsel people at high risk of transmitting virus to their sexual partners. This appears “doable” but needs to be prioritized.

    • There is increasing interest in the possibility of developing
    certain ARVs only for prevention. There are currently other
    efforts in disease prevention fields where certain drugs are
    reserved for prevention versus treatment eg in tuberculosis
    management This may possibly be explored for PreP when proven effective

Community calls for improved ethical practices in research

Community calls for improved ethical practices in research

COMMUNITY CALLS FOR IMPROVED ETHICAL PRACTICES IN RESEARCH

At the just concluded project organised by the New HIV Vaccine and
Microbicides Advocacy Society (NHVMAS) in collaboration with The
Initiative for Equal Rights (TIER), Christ against Drug Abuse Ministry
(CADAM), Safehaven Development Initiative and International Rectal
Microbicides Advocacy (IRMA) Nigeria, and with funding support from
Sidaction, France, participants specifically requested that the
outcome of the meeting should be widely.

The meeting conveyed members of the community resident in Lagos,Ilesa,
Osogbo, Ife, Ifon in Ogin State, Ibarapa in Ibadan, Jos and members of
vulnerable communities (FSWs,MSM, IDUs, PLHIV) to discuss about
research and how to improve research conducts within these
communities. Also, two  roundtable dialogues that facilitated
discussions between research stakeholders (researchers, bioethicists,
research sponsors, policy makers, journalists, and community members)
were conveyed in June and September 2012 in Lagos and Abuja
respectively also.

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.

The community made several observations with respect to informed
consent process, community engagement in research and standard of care
in research. Please find attached the summary of the outcome of the
meetings. Some of the findings and recommendations are enumerated
below:

1.0 Informed consent and other ethical considerations in research
•      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
•      There is little research literacy efforts on the field.
Communities therefore only respond to what researchers share with
them.
•      CSO engagement is often mistaken for community engagement.
•      Ethics committees do not monitor researches they approve to
ensure that community engagement happens in the field.

3.0.    Concern on standard of care
•      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
managingchronic illnesses that develop during the course of
implementing
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

B. RECOMMENDATION
• Informed consent form should be available in local languages for
easy understanding. Verbal translation of English to local language is
not acceptable.

• 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.

• 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.

• 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.

• All research should make effort 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.

• The  standard of care package for research participants should align
with global standards.

• Researchers should make significant efforts to facilitate mechanisms
that will increase the translation of their research findings to
policies and programmes.