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Taking people in BrazilNo phase

Offering HIV prevention medication through community services in Rio de Janeiro

Tests community-based delivery of HIV prevention pills for underserved groups in Rio de Janeiro.

Plain-language title generated from the registry record
Registry title: Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro

Key facts

Where
Nova Iguaçu and Rio de Janeiro, BrazilSee the 2 sites

Where in Brazil

  • Hospital Geral de Nova IguaçuNova Iguaçu, BrazilTaking people
  • Instituto Nacional de Infectologia Evandro ChagasRio de Janeiro, BrazilTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Oswaldo Cruz Foundation
Trial code
NCT07584122
Record updated
13 May 2026
Original description
This study aims to improve access to HIV prevention using pre-exposure prophylaxis (PrEP) among underserved populations in Rio de Janeiro, including gay and bisexual men, transgender women, and sex workers. Despite the proven effectiveness of PrEP, many people at higher risk of HIV face barriers to accessing and continuing this prevention method, especially those living in socially and economically vulnerable communities.Read full original descriptionShow less

Bringing PrEP to Underserved Communities in Rio de Janeiro: the PrEPOUT Rio Study

This study aims to improve access to HIV prevention using pre-exposure prophylaxis (PrEP) among underserved populations in Rio de Janeiro, including gay and bisexual men, transgender women, and sex workers. Despite the proven effectiveness of PrEP, many people at higher risk of HIV face barriers to accessing and continuing this prevention method, especially those living in socially and economically vulnerable communities.

The study will evaluate whether offering PrEP directly in community-based settings-such as non-governmental organizations, mobile health units, and through telehealth and digital tools-can increase its uptake and continued use. Participants who test negative for HIV will be offered daily oral PrEP, along with counseling and follow-up support. Those who test positive will be referred for appropriate treatment.

The main hypothesis is that delivering PrEP in community settings, combined with supportive strategies like mobile health interventions, will be feasible, acceptable, and more effective in reaching and engaging vulnerable populations, ultimately helping to reduce new HIV infections.

Inclusion: Individuals aged 15 years or older; Gay, bisexual, and other men who have sex with men (MSM); Transgender women and travestis; Other sexual and gender minorities (SGM); Cisgender women in situations of social or economic vulnerability; Sex workers; Individuals seeking HIV testing and/or pre-exposure prophylaxis (PrEP); HIV-negative at screening; Willing and interested in initiating PrEP; Eligible for PrEP according to Brazilian national guidelines.

Exclusion: Positive HIV test result at screening or during study participation; Individuals not eligible for PrEP according to Brazilian national guidelines.

ClinicalTrials.gov NCT07584122