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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Brazil
Hospital Geral de Nova Iguaçu
RECRUITING
Nova Iguaçu
Instituto Nacional de Infectologia Evandro Chagas
RECRUITING
Rio De Janeiro
Contact Information
Primary
Beatriz Grinsztejn
beatriz.grinsztejn@gmail.com
+55 2138659128
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 400
Treatments
Experimental: Community-Based PrEP Delivery
Participants will receive HIV prevention services through a community-based delivery model, including HIV testing, counseling, and initiation of daily oral pre-exposure prophylaxis (PrEP) according to national guidelines. Services will be provided in non-traditional settings, such as non-governmental organizations and mobile health units, with additional support through telehealth and mobile health (mHealth) strategies to enhance engagement, adherence, and retention in care. Participants diagnosed with HIV during screening or follow-up will be referred for treatment within the public health system.
Related Therapeutic Areas
Sponsors
Leads: Oswaldo Cruz Foundation

This content was sourced from clinicaltrials.gov