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).