Actively Recruiting
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
Led by Oswaldo Cruz Foundation · Updated on 2026-03-27
1500
Participants Needed
8
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign the Informed Consent Form and willingness to follow study rules
- Be a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man
- Report having had anal sex with a person designated male at birth within the last six months
- Be between 16 and 30 years old
- Have a body weight of 35 kilograms or more
- Seek care at a participating clinic for HIV testing or to start HIV pre-exposure prophylaxis
- Have a negative HIV rapid test
- Have never used HIV pre-exposure prophylaxis before, or have prior use but remain vulnerable as defined by study criteria
You will not qualify if you...
- Known allergy to study medications or their components
- Severe liver problems or history of decompensated liver cirrhosis
- Known or suspected serious active infection like active tuberculosis
- Need to use medications that cannot be taken with study drugs
- Any medical or psychosocial condition that makes participation unsafe or dosing unreliable
- Confirmed or suspected HIV infection
- Plans to move away from the study area during follow-up
- Prior participation in a Lenacapavir clinical study (PURPOSE study)
- Prior participation in an HIV vaccine study without documentation of placebo use
- Currently in another HIV prevention intervention study that might interfere with this study
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Fundação de Medicina Tropical Heitor Vieira Dourado
Manaus, Amazonas, Brazil, 69040-000
Actively Recruiting
2
CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa
Salvador, Estado de Bahia, Brazil, 40100-010
Actively Recruiting
3
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
Actively Recruiting
4
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
5
CTA/Policlínica Centro
Florianópolis, Santa Catarina, Brazil, 88010-400
Actively Recruiting
6
Centro de Referência em IST/Aids de Campinas (SMS/PMC)
Campinas, São Paulo, Brazil, 13013-000
Actively Recruiting
7
Coordenadoria de IST/Aids da Cidade de São Paulo
São Paulo, São Paulo, Brazil, 01509-020
Actively Recruiting
8
Centro de Referência e Treinamento em DST/Aids de São Paulo
São Paulo, São Paulo, Brazil, 04121-000
Actively Recruiting
Research Team
B
Beatriz Grinsztejn, PhD
CONTACT
V
Valdiléa Veloso, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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