HIV prevention breakthrough? Twice-Yearly shot could replace daily pills

NCT ID NCT07497594

Recruiting now Prevention Sponsor: Oswaldo Cruz Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study in Brazil offers young men who have sex with men, transgender, and non-binary people a choice between a daily pill or a twice-yearly injection to prevent HIV. Researchers will follow 1,500 participants for up to two years to see how well each option works in real life, how safe it is, and whether people stick with it. The goal is to expand prevention options and make it easier for high-risk groups to stay protected.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lenacapavir (long-acting injection) and daily oral tenofovir disoproxil fumarate/emtricitabine
What this could lead to: If successful, this could provide a convenient twice-yearly injection option for HIV prevention, potentially improving adherence and reducing new infections among high-risk groups.
What could go wrong: This is an observational study without randomization, so results may be less definitive. Participants choose their own prevention method, which could introduce bias. Long-term safety and effectiveness in real-world settings are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONTACT WITH OR EXPOSURE TO HUMAN IMMUNODEFICIENCY VIRUS

Contacts and locations

Locations

CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa
RECRUITING

Salvador, Estado de Bahia, 40100-010, Brazil
CTA/Policlínica Centro
RECRUITING

Florianópolis, Santa Catarina, 88010-400, Brazil
Centro de Referência e Treinamento em DST/Aids de São Paulo
RECRUITING

São Paulo, São Paulo, 04121-000, Brazil
Centro de Referência em IST/Aids de Campinas (SMS/PMC)
RECRUITING

Campinas, São Paulo, 13013-000, Brazil
Coordenadoria de IST/Aids da Cidade de São Paulo
RECRUITING

São Paulo, São Paulo, 01509-020, Brazil
Fundação de Medicina Tropical Heitor Vieira Dourado
RECRUITING

Manaus, Amazonas, 69040-000, Brazil
Hospital Geral de Nova Iguaçu
RECRUITING

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil
Instituto Nacional de Infectologia Evandro Chagas
RECRUITING

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil