ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
Expanding PrEP Options Among Young MSM, Transgender and Non-binary Persons in Brazil: Incorporating Twice-yearly Lenacapavir for HIV Prevention - The ImPrEP LEN Brasil Study
Oswaldo Cruz Foundation
1,500 participants
Feb 3, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP). The main questions it aims to answer are: How many participants get HIV while using long-acting lenacapavir? How safe is long-acting lenacapavir in real-world health services? How many participants continue using their chosen prevention method over time? What factors help or make it harder for participants to stay on prevention? Researchers will compare two HIV prevention options to understand how they work in routine care: Long-acting lenacapavir, given as an injection under the skin every 6 months, Daily oral pre-exposure prophylaxis (PrEP), taken as a pill containing tenofovir disoproxil fumarate and emtricitabine, Participants will choose the prevention option they prefer after receiving counseling. This is not a randomized study. Researchers will follow participants for up to 2 years. Participants will: Receive either an injection every 6 months or take a daily pill, Visit the clinic regularly for HIV testing and health checkups, Receive testing and treatment for sexually transmitted infections, Answer questions about their health, medication use, and experiences, Receive prevention counseling and condoms. This study will help health services understand how to offer long-acting HIV prevention in Brazil and how to better support people who want to prevent HIV infection.
Eligibility
Plain Language Summary
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Interventions
Approximately 1200 participants who choose long acting Lenacapavir will receive an oral loading dose consisting of 600 milligrams on Day 1 and 600 milligrams on Day 2, followed by 300 milligrams on Day 8, according to the clinical protocol, followed by subcutaneous administration of Lenacapavir at a dose of 927 milligrams per injection, administered at the enrollment visit and repeated every six months, totaling up to four administrations during the follow up period, combined with regular clinical visits for safety assessment, human immunodeficiency virus testing, monitoring of adverse events and serious adverse events, evaluation of injection site reactions, combined prevention counseling, screening and management of sexually transmitted infections, hepatitis B and hepatitis C, and monitoring of adherence to the injection schedule
Approximately 300 participants who choose oral human immunodeficiency virus pre exposure prophylaxis will receive oral tenofovir disoproxil fumarate 300 milligrams combined with emtricitabine 200 milligrams in a fixed dose combination administered once daily on a continuous basis, with regular medication dispensing, periodic clinical follow up, serial human immunodeficiency virus testing, monitoring of adverse events, assessment of self reported adherence, combined prevention counseling, and screening and management of sexually transmitted infections and viral hepatitis, for up to 24 months of follow up
Locations(8)
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NCT07497594