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Study identifier: NCT07497594 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention

Condition: Contact With or Exposure to Human Immunodeficiency Virus  ·  Sponsor: Oswaldo Cruz Foundation

PhaseNA
Planned participants1500
Who can joinAll sexes, 16 Years to 30 Years
Healthy volunteersYes

About this study

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 s…

This description comes directly from the study's public registry record.

Talk to the study team

Beatriz Grinsztejn, PhD  ·  +55 2138659128  ·  gbeatriz@ini.fiocruz.br

Valdiléa Veloso, PhD  ·  valdilea.veloso@ini.fiocruz.br

Always discuss trial participation with your own doctor first.

Locations (8)

Fundação de Medicina Tropical Heitor Vieira DouradoManaus, Amazonas, BrazilRecruiting
CEDAP - Centro Especializado em Diagnóstico, Assistência e PesquisaSalvador, Estado de Bahia, BrazilRecruiting
Hospital Geral de Nova IguaçuNova Iguaçu, Rio de Janeiro, BrazilRecruiting
Instituto Nacional de Infectologia Evandro ChagasRio de Janeiro, Rio de Janeiro, BrazilRecruiting
CTA/Policlínica CentroFlorianópolis, Santa Catarina, BrazilRecruiting
Centro de Referência em IST/Aids de Campinas (SMS/PMC)Campinas, São Paulo, BrazilRecruiting
Coordenadoria de IST/Aids da Cidade de São PauloSão Paulo, São Paulo, BrazilRecruiting
Centro de Referência e Treinamento em DST/Aids de São PauloSão Paulo, São Paulo, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT07497594