Study of Event-Driven HIV Prevention Using TAFFTC Compared to TDFFTC in HIV-Negative Men Who Have Sex With Men in Thailand and France

What this Trial Is About

Researchers are evaluating the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis PrEP using oral emtricitabine and tenofovir alafenamide FTAF in HIV-uninfected cisgender men who have sex with men MSM. The study aims to assess how well FTAF, taken before and after sexual activity, reduces the risk of HIV infection compared to the background HIV incidence rate. This Phase 3 trial includes participants from Thailand and France and is sponsored by ANRS, Emerging Infectious Diseases. Participants will be randomly assigned to one of two groups. The experimental group will take one tablet of FTAF 2 to 24 hours before sex followed by a second tablet 24 hours later. The control group will take two tablets of emtricitabine and tenofovir disoproxil fumarate FTDF before sex followed by two additional tablets over the next 48 hours. In cases of daily sexual activity, dosing instructions differ slightly to maintain protection. The study will last up to 3 years, with up to 15 visits including physical exams and collection of blood, urine, and swabs. During the study, participants will attend regular visits every three months to monitor safety and adherence. Assessments include clinical exams and laboratory tests to check for HIV and other health markers. Researchers will measure the efficacy of both PrEP regimens, their acceptability, and safety throughout the study. After completing the trial, all participants will be connected to local HIV prevention services, including ongoing PrEP if available.

Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.