ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (ImPrEP LEN)

March 24, 2026 updated by: Oswaldo Cruz Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Amazonas
      • Manaus, Amazonas, Brazil, 69040-000
        • Recruiting
        • Fundação de Medicina Tropical Heitor Vieira Dourado
        • Contact:
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40100-010
        • Recruiting
        • CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa
        • Contact:
    • Rio de Janeiro
      • Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
        • Recruiting
        • Hospital Geral de Nova Iguaçu
        • Contact:
      • Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88010-400
    • São Paulo
      • Campinas, São Paulo, Brazil, 13013-000
        • Recruiting
        • Centro de Referência em IST/Aids de Campinas (SMS/PMC)
        • Contact:
      • São Paulo, São Paulo, Brazil, 01509-020
        • Recruiting
        • Coordenadoria de IST/Aids da Cidade de São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 04121-000
        • Recruiting
        • Centro de Referência e Treinamento em DST/Aids de São Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 ascites, encephalopathy, or variceal bleeding

Known or suspected severe active infection, such as active tuberculosis

Need for continuous use of contraindicated concomitant medications

Any clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements

Confirmed or suspected infection with the human immunodeficiency virus

Plans to move outside the study area during the follow-up period

Prior participation in a clinical study using Lenacapavir in the PURPOSE study

Prior participation in a human immunodeficiency virus vaccine study, except in cases where the participant provides documentation demonstrating receipt of placebo and not the active product

Current participation in another interventional human immunodeficiency virus prevention study that, in the opinion of the investigator, may interfere with the conduct of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenacapavir
Drug: Lenacapavir long-acting
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
Active Comparator: Tenofovir disoproxil fumarate combined with Emtricitabine
Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months
Time Frame: From enrollment to 24 months of follow-up
Persistence will be defined as the proportion of participants who initiate Lenacapavir pre-exposure prophylaxis and continue receiving scheduled Lenacapavir injections according to the recommended dosing schedule during the follow-up period. Participants will be considered non-persistent if they permanently discontinue Lenacapavir or fail to receive a scheduled injection within the allowable visit window. Persistence will be assessed using study clinic records documenting administration of Lenacapavir injections.
From enrollment to 24 months of follow-up
Time to discontinuation of Lenacapavir pre-exposure prophylaxis
Time Frame: Up to 24 months
Time from initiation of Lenacapavir pre-exposure prophylaxis to permanent discontinuation of Lenacapavir. Discontinuation will be defined as failure to receive a scheduled injection within the allowable visit window or documented decision to stop Lenacapavir.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oswaldo Cruz Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88846725.0.1001.5262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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