When interviewers raised this discrepancy, almost all women said they were aware of other participants who did not use the products regularly, often citing conversations in the clinic waiting room.
While some women had been motivated to take part in the study by the idea of being protected from a male partner’s infidelity and consequent risk of HIV infection, it was more common for women to enrol in order to access high-quality health care through the study clinic. ” Another said:“You know it’s scary to hear that you will take tablets meant for HIV-positive people if you know very well that you don’t have it.
HIV stigma, the danger of being mistakenly labelled as having HIV, ambivalence about the research process, confusion about the use of antiretrovirals to prevent infection, as well as the need to balance trial participation with other priorities and social relationships all shaped South African women’s experience of using pre-exposure prophylaxis (Pr EP) or a microbicide gel within a clinical trial, according to a qualitative study.
The researchers sought to better understand the reasons for the disappointing results of the VOICE trial – one of the most ambitious studies of biomedical HIV prevention interventions for women ever conducted.
Only a minority of trial participants had actually used the study product they had been given and the qualitative research aimed to find out why.
VOICE’s results have raised significant questions about the applicability and appropriateness of microbicides and Pr EP for women in African countries.
Ariane van der Straten, Jonathan Stadler and colleagues published the qualitative findings last week in the Journal of the International AIDS Society and also in a paper published earlier in the year in PLOS ONE.
The VOICE trial aimed to protect young women in South Africa, Uganda and Zimbabwe from HIV infection by providing either a vaginal microbicide gel containing tenofovir, an oral tablet containing tenofovir, or an oral tablet containing both tenofovir and emtricitabine.However, none of the three prevention methods resulted in fewer HIV infections than a placebo.This was most likely because of poor adherence – fewer than three-in-ten participants had detectable levels of the study drug in their blood or vaginal fluids.For the qualitative research, 102 participants from the main VOICE trial took part in either a focus group discussion, an in-depth interview at the study clinic or in a series of ethnographic interviews, which involved a researcher spending several hours at their homes, engaged in open-ended conversation.Of note, although the VOICE trial was conducted at 15 sites in three African countries, this qualitative study was only conducted with trial participants in Johannesburg, South Africa.The issues affecting adherence could be different in different contexts.