The FEM-PrEP clinical trial was designed to assess whether a daily dose of the antiretroviral Truvada® is safe and effective at preventing HIV infection among women at high risk of HIV exposure. Truvada combines two ARVs — tenofovir disoproxil fumarate and emtricitabine — into a single pill taken once a day. In this Phase III, randomized, placebo-controlled trial in Kenya, South Africa and Tanzania, 2,120 women were assigned to receive either Truvada or a placebo containing no active drug for approximately 12 months and came in for monthly clinic visits for approximately 14 months. Participants who acquired HIV or became pregnant during the clinical trial stopped taking the study pill. They were asked to stay in the trial and continue coming to the clinic for another 12 months.
Results of the FHI 360 FEM-PrEP HIV prevention trial reinforce the role of adherence to in HIV prevention studies and the need to determine better approaches to support adherence in future pre-exposure prophylaxis (PrEP) programs. Despite targeted counseling and support, adherence to the drug regimen was low, suggesting that women in the clinical trial population may have had difficulty adhering to a daily pill regimen. Due to low adherence, FEM-PrEP was unable to determine whether Truvada could reduce the risk of HIV infection, according to the final, primary analysis of the study. FEM-PrEP researchers continue to study a number of behaviors, clinical measures and health outcomes that may have contributed to poor adherence among the trial’s participants.
FEM-PrEP was conducted by FHI 360 under two projects funded by the United States Agency for International Development (USAID): first, the Contraceptive and Reproductive Health Technologies and Research Utilization Program, and then the Preventive Technologies Agreement. Early support was also provided by the Bill & Melinda Gates Foundation. Gilead Sciences, Inc. donated the study pills.