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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Feasibility of Community-Based PrEP Delivery [Time frame: Up to 12 months]
• Acceptability of Community-Based PrEP Delivery [Time frame: Up to 12 months]

Secondary outcome measures (3)

• PrEP Uptake [Time frame: Up to 12 months]
• PrEP Persistence (Retention in PrEP Care) [Time frame: Up to 12 months]
• HIV Incidence [Time frame: Up to 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Brazil · 2 centers

• Hospital Geral de Nova Iguaçu — Nova Iguaçu
• Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro

Identifiers

NCT: NCT07584122 · 84111624.4.1001.5262

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗