The Women TDF-FTC Benchmark Study

Summary

The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated with HIV protection in cisgender women. Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 16 weeks. The study will also investigate how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.

Timeline

Start

2022-04-25

Primary completion

2024-10-01

Completion

2024-10-01

Publications

• Mugwanya KK, Saina M, Mugo NR, MaWhinney S, Morrow M, Schaafsma TT, Donnell D, Glidden DV, Ngure K, Brown CE, Rechkina EA, Chohan BH, Wu L, Hill E, Koome E, Akelo N, Mbaire S, Morrison SA, Kibatha M, Njeru I, Muriithi M, Coppinger C, Bushman L, Baeten JM, Anderson PL; Women Benchmark Study Team. Adherence thresholds for emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis against HIV acquisition in cisgender women: A randomized directly observed dosing study. PLoS Med. 2025 Sep 9;22(9):e1004732. doi: 10.1371/journal.pmed.1004732. eCollection 2025 Sep.
• Wu L, Saina M, Brown C, Chege D, Donnell D, Glidden DV, Ngure K, Mugo NR, Akelo N, Schaafsma T, Anderson PL, Mugwanya KK. Establishing adherence-concentration-efficacy thresholds of TDF-FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF-FTC Benchmark Study. Front Reprod Health. 2024 May 27;6:1325257. doi: 10.3389/frph.2024.1325257. eCollection 2024.

Drugs

Indications