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

May 6, 2026 updated by: Oswaldo Cruz Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The PrEPOUT Rio Study is designed to evaluate the implementation of community-based strategies to expand access to and engagement with oral pre-exposure prophylaxis (PrEP) for HIV prevention among underserved populations in Rio de Janeiro and the metropolitan area, including Nova Iguaçu. The study focuses on populations disproportionately affected by HIV, such as gay, bisexual, and other men who have sex with men (MSM), transgender women, other sexual and gender minorities, and sex workers.

The study will be conducted in three phases. The formative phase will use qualitative methods, including focus group discussions with key stakeholders and members of the target population, to identify barriers and facilitators to PrEP uptake and to inform the adaptation of community-based delivery strategies.

In the implementation phase, PrEP will be offered in non-traditional settings, including community-based organizations and mobile health units, aiming to reduce structural and social barriers to access. Trained healthcare staff will provide on-site HIV testing, counseling, and PrEP initiation. Participants who test HIV-negative will be offered daily oral PrEP, while those diagnosed with HIV will be promptly referred for treatment within the public health system. The study will also incorporate supportive strategies such as telehealth consultations and mobile health (mHealth) interventions to enhance adherence, retention, and engagement in care.

The evaluation phase will include both quantitative and qualitative approaches to assess implementation and clinical outcomes. Quantitative data will be collected through structured questionnaires and clinical assessments to evaluate PrEP uptake, adherence, persistence, and HIV incidence, as well as the acceptability and feasibility of the intervention. Qualitative data from follow-up focus groups will provide insights into participants' experiences and perceptions of community-based PrEP delivery models.

The primary objective is to assess the feasibility and acceptability of delivering PrEP in community-based settings. Secondary objectives include evaluating engagement with telehealth and digital tools, identifying barriers and facilitators to PrEP use, and assessing HIV and sexually transmitted infection (STI) outcomes in the study population. The findings are expected to inform scalable strategies to improve equitable access to HIV prevention services in settings with significant social and structural inequalities.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio de Janeiro
      • Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
        • Recruiting
        • Hospital Geral de Nova Iguaçu
        • Contact:
      • Rio de Janeiro, Rio de Janeiro, Brazil, 21040360
        • Recruiting
        • Instituto Nacional de Infectologia Evandro Chagas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Oral 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.
Behavioral: Community-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.
Behavioral: Telehealth 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Community-Based PrEP Delivery
Time Frame: Up to 12 months
Feasibility will be assessed by the proportion of planned community-based PrEP service delivery activities successfully implemented. Indicators will include: (1) number of community-based sites activated, (2) number of individuals screened for HIV, and (3) number of participants initiating PrEP. Results will be summarized using counts and proportions.
Up to 12 months
Acceptability of Community-Based PrEP Delivery
Time Frame: Up to 12 months
Acceptability will be assessed using participant-reported outcomes collected through a structured acceptability questionnaire with Likert-scale items. Scores will range from 1 to 5, with higher scores indicating greater acceptability of the intervention.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Uptake
Time Frame: Up to 12 months
Proportion of eligible participants who initiate PrEP after HIV testing and counseling in community-based settings.
Up to 12 months
PrEP Persistence (Retention in PrEP Care)
Time Frame: Up to 12 months
Proportion of participants who remain engaged in PrEP care over time, including continued use of PrEP and attendance at follow-up visits.
Up to 12 months
HIV Incidence
Time Frame: Up to 12 months
Number of new HIV infections diagnosed among study participants during the follow-up period.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oswaldo Cruz Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84111624.4.1001.5262

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe