This is an open-label, randomized, three-arm, directly observed therapy, pharmacokinetics study. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy (DOT) TAF-FTC PrEP, to help differentiate poor and modest from perfect adherence. The primary objectives of the study are:~To describe the safety of TAF-FTC-based PrEP in HIV-unifected cisgender women.~To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in DBS and PBMCs using directly observed TAF-FTC therapy at 2, 4, 7 doses per week.~To establish a model to predict adherence rate to TAF-FTC by level of TFV-DP in DBS for cisgender women.~The study will be the first to define TAF-FTC-based PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of safety, adherence, and efficacy of planned or ongoing HIV prevention trials in African women.
The study seeks to assess the safety and define blood and tissue benchmark concentrations of Tenofovir (TFV) and Tenofovir diphosphate (TFV-DP) in Cisgender women using directly observed tenofovir alafenamide (TAF)-emtricitabine (TAF-FTC) pre-exposure prophylaxis (PrEP). These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.