Study of Twice-Yearly Lenacapavir Injection Versus Daily Oral PrEP for HIV Prevention in Young Men, Transgender, and Non-binary People in Brazil

What this Trial Is About

Researchers are evaluating how well long-acting lenacapavir works to prevent HIV infection in people at higher risk in Brazil. The study aims to assess safety, continued use over time, and participant preference compared to daily oral pre-exposure prophylaxis PrEP. It focuses on how many participants get HIV while using lenacapavir, its safety in real-world health settings, and factors affecting ongoing prevention use. Participants can choose between two prevention options injections of long-acting lenacapavir under the skin every six months or daily oral PrEP pills containing tenofovir disoproxil fumarate and emtricitabine. Those choosing lenacapavir receive an oral loading dose followed by subcutaneous injections at enrollment and every six months, up to four injections during follow-up. Those choosing oral PrEP take daily pills with regular medication dispensing and follow-up visits. Both groups receive prevention counseling, regular HIV testing, and screening for sexually transmitted infections and viral hepatitis. Participants will visit clinics regularly for HIV testing, health checkups, and safety monitoring. They will answer questions about their health, medication use, and experiences, while researchers evaluate adherence, injection site reactions, and adverse events. The study will track persistence on lenacapavir over 24 months and time to discontinuation. This research will help health services understand how to offer and support long-acting HIV prevention in Brazil, with follow-up lasting up to two years.

ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention