RecruitingNot ApplicableNCT07584122

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


Sponsor

Oswaldo Cruz Foundation

Enrollment

400 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Community-Based PrEP Delivery Model, a drug called Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), and others for people with hiv infections. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine)

Participants will receive daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in accordance with Brazilian national guidelines for HIV prevention. PrEP will be offered to eligible individuals who test HIV-negative at enrollment and during follow-up, with clinical monitoring and counseling provided as part of routine care.

BEHAVIORALCommunity-Based PrEP Delivery Model

Participants will receive HIV prevention services through community-based delivery strategies designed to reduce barriers to access. These include provision of services in non-traditional settings such as non-governmental organizations and mobile health units, with on-site HIV testing, counseling, and same-day PrEP initiation by trained healthcare staff.

BEHAVIORALTelehealth and mHealth Support

Participants will have access to telehealth consultations and mobile health (mHealth) interventions to support engagement in care, adherence to PrEP, and retention in follow-up. These strategies may include remote clinical support, digital communication tools, and tailored adherence support interventions.


Locations(2)

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, Brazil

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT07584122


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