Study of Lenacapavir for HIV Prevention Using Pre-Exposure Prophylaxis PrEP Across US Clinical Settings

What this Trial Is About

Researchers are evaluating the use of lenacapavir LEN, YEZTUGO as a pre-exposure prophylaxis PrEP option for preventing HIV infections in diverse clinical settings across the United States. This observational study aims to understand how LEN PrEP is started, used, and stopped in routine practice and to assess how well participants continue using LEN PrEP over time. The main focus is to measure persistence on LEN PrEP at 52 weeks. Participants may choose LEN PrEP administered either by subcutaneous injection or orally, or select other available PrEP options such as oral tablets emtricitabinetenofovir disoproxil fumarate FTDF, emtricitabinetenofovir alafenamide FTAF, or intramuscular cabotegravir CAB, or decide not to use PrEP. The study observes these choices and follows participants over time to track how PrEP is used in real-life settings. During the study, participants will be observed at various time points up to 104 weeks to evaluate PrEP uptake, persistence, coverage, interruptions, switching between PrEP methods, and timing of LEN injections. Measurements include the proportion of days protected by PrEP and duration of use. The research team will collect data on participants choices and use of PrEP to better understand real-world PrEP use and adherence.

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention