Clinical trial Recruiting at 2 sites Interventional Ages 15 and up

Improve access to PrEP for underserved communities in Rio de Janeiro

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

Run by Oswaldo Cruz Foundation · NCT07584122 · Data updated 2026-11-12

The project will try offering daily oral PrEP plus on-site and digital support to HIV-negative people at higher risk in underserved areas of Rio de Janeiro to see if more people start and stay on PrEP.

Quick facts

Study typeInterventional
Ages15 Years and up
SexAll
Enrollment400 (estimated)
SponsorOswaldo Cruz Foundation
Academic / other
Locations2 sites (Nova Iguaçu, Rio de Janeiro and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMay 13, 2026
Trial IDNCT07584122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

HIV-negative people aged 15 and older at higher risk—including gay and bisexual men, transgender women, sex workers, other sexual and gender minorities, and socioeconomically vulnerable cisgender women—who are eligible for PrEP under Brazilian guidelines.

Probably not a fit

People who are HIV-positive or who do not meet Brazilian national guideline criteria for PrEP are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PrEPOUT Rio program uses a three-phase approach starting with formative qualitative work to identify local barriers and adapt community delivery strategies. In the implementation phase, trained staff will offer on-site HIV testing, counseling, and same-site PrEP initiation at community organizations, mobile health units, and through telehealth. Participants who test negative will be offered daily oral PrEP with mHealth follow-up and adherence support, while those testing positive will be referred for HIV treatment. An evaluation phase will measure uptake, retention, and feasibility of these community-based delivery models.

Why it matters

Potential benefit: If successful, this approach could increase PrEP uptake and retention among high-risk people in underserved areas and reduce new HIV infections.

How similar studies have gone: Previous community-based and mHealth-supported PrEP programs have shown improved uptake and retention in similar populations, although results vary by context and implementation approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

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

Where it's running

  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.