Improve access to PrEP for underserved communities in Rio de Janeiro
Bringing PrEP to Underserved Communities in Rio de Janeiro: the PrEPOUT Rio Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Oswaldo Cruz Foundation Academic / other |
| Locations | 2 sites (Nova Iguaçu, Rio de Janeiro and 1 other locations) |
| Trial ID | NCT07584122 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nova Iguaçu, Rio de Janeiro and 1 other locations
- 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
- Study coordinator: Beatriz Grinsztejn
- Email: beatriz.grinsztejn@gmail.com
- Phone: +55 2138659128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.