ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NCT07497594) | Clinical Trial Compass
RecruitingNot Applicable
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
Brazil1,500 participantsStarted 2026-02-03
Plain-language 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.
Who can participate
Age range
16 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 without prior use of human immunodeficiency virus pre-exposure prophylaxis, or an individual with prior use who remains in a situation of vulnerability, characterized by:
a history of oral human immunodeficiency virus pre-exposure prophylaxis with at least two prior dispensations without return for a new pickup in the six months preceding the enrollment visit, or
a history of long-acting cabotegravir use with a delay of at least one scheduled reload dose
Exclusion Criteria:
Known hypersensitivity to the study medication, its metabolites, or formulation excipients
Severe hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascite…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months
Timeframe: From enrollment to 24 months of follow-up
2
Time to discontinuation of Lenacapavir pre-exposure prophylaxis