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NCT07584122Recruiting

Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro

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

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
400 (estimated)
First submitted
21 Apr 2026
Start date
1 Sept 2025
Primary completion date
Dec 2026
Lead sponsor
Oswaldo Cruz Foundation
Diseases
HIV
NCT number
NCT07584122

What you commit to

  • Study type: Interventional
  • Planned participants: 400
  • From 1 Sept 2025 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Positive HIV test result at screening or during study participation

Other

  • Individuals not eligible for PrEP according to Brazilian national guidelines

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Geral de Nova Iguaçu
Coordinator of this site? Confirm its status
Nova IguaçuBrazilRecruiting
Instituto Nacional de Infectologia Evandro Chagas
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.