Twice-yearly lenacapavir injections to prevent HIV in young people in Brazil

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

This will test whether lenacapavir injections given under the skin every six months prevent HIV in people at higher risk in Brazil compared with daily TDF/FTC pills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 16 Years to 30 Years
• Sex: All
• Sponsor: Oswaldo Cruz Foundation (Academic / other)
• Locations: 8 sites (Manaus, Amazonas and 7 other locations)
• Trial ID: NCT07497594 on ClinicalTrials.gov

What this trial studies

This interventional program compares long-acting lenacapavir injections every six months with daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) delivered in routine clinics in Brazil. Eligible participants are HIV-negative people aged 16–30 who are cisgender men, transgender men or women, or non-binary people designated male at birth and who report recent anal sex with someone designated male at birth; they will choose which prevention option to start. Researchers will monitor how many participants acquire HIV, collect safety data, measure how long people stay on their chosen prevention method, and identify factors that help or hinder continued use. Data are gathered through clinic visits and routine health services to reflect real-world implementation and preferences.

Who should consider this trial

Good fit: Ideal candidates are HIV-negative cisgender men, transgender men or women, or non-binary people designated male at birth aged 16–30 in Brazil who have had anal sex with someone designated male at birth in the past six months and who seek PrEP at participating clinics.

Not a fit: People already living with HIV, those without the specified risk behaviors, those outside the age or weight criteria, or those unable to attend the participating clinics are unlikely to benefit from joining.

Why it matters

Potential benefit: If successful, this could offer a long-acting prevention option that reduces the need for daily pills, improves adherence, and may lower new HIV infections.

How similar studies have performed: Other long-acting injectable PrEP (notably cabotegravir) has shown strong protection in trials, while long-acting lenacapavir for prevention has more limited human data and is currently being tested.

Eligibility criteria

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

Where this trial is running

Manaus, Amazonas and 7 other locations

• Fundação de Medicina Tropical Heitor Vieira Dourado — Manaus, Amazonas, Brazil (Recruiting)
• CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa — Salvador, Estado de Bahia, Brazil (Recruiting)
• Hospital Geral de Nova Iguaçu — Nova Iguaçu, Rio de Janeiro, Brazil (Recruiting)
• Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
• CTA/Policlínica Centro — Florianópolis, Santa Catarina, Brazil (Recruiting)
• Centro de Referência em IST/Aids de Campinas (SMS/PMC) — Campinas, São Paulo, Brazil (Recruiting)
• Coordenadoria de IST/Aids da Cidade de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
• Centro de Referência e Treinamento em DST/Aids de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Beatriz Grinsztejn, PhD

Conditions Contact With or Exposure to Human Immunodeficiency Virus