ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
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
| Condition(s) | Contact With or Exposure to Human Immunodeficiency Virus |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: Ability to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and willingness to comply with the protocol requirements Be a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man Report having engaged in anal sex with a person designated male at birth within the last six months Be between 16 and 30 years of age Have a body weight equal to or greater than 35 kilograms Seek care at a participating study clinic for human immunodeficiency virus testing or initiation of human immunodeficiency virus pre-exposure prophylaxis, either spontaneously or through peer invitation Have a non-reactive result on a rapid test for human immunodeficiency virus Be an individual |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Oswaldo Cruz Foundation |
| Locations | Manaus, Amazonas, Brazil; Salvador, Estado de Bahia, Brazil; Nova Iguaçu, Rio de Janeiro, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Florianópolis, Santa Catarina, Brazil; Campinas, São Paulo, Brazil (+2 more sites) |
| Start date | 2026-02-03 |
| NCT ID | NCT07497594 |
| Official listing | https://clinicaltrials.gov/study/NCT07497594 |