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

NCT07584122 | Recruiting

• 1 other identifier: 84111624.4.1001.5262
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Feasibility of Community-Based PrEP Delivery

  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

  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 Outcomes (3)

• PrEP Uptake

  Up to 12 months

• PrEP Persistence (Retention in PrEP Care)

  Up to 12 months

• HIV Incidence

  Up to 12 months

Study Arms (1)

Community-Based PrEP Delivery

EXPERIMENTAL

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); Behavioral: Community-Based PrEP Delivery Model; Behavioral: Telehealth and mHealth Support

Interventions

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

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.

Community-Based PrEP Delivery

Community-Based PrEP Delivery Model BEHAVIORAL

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.

Community-Based PrEP Delivery

Telehealth and mHealth Support BEHAVIORAL

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.

Community-Based PrEP Delivery

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Positive HIV test result at screening or during study participation
• Individuals not eligible for PrEP according to Brazilian national guidelines

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (2)

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

RECRUITING

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, Rio de Janeiro, 21040360, Brazil

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Pre-Exposure Prophylaxis; Tenofovir; Emtricitabine; Telemedicine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Beatriz Grinsztejn

CONTACT

+55 2138659128; beatriz.grinsztejn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm interventional study in which all participants are offered HIV prevention services, including HIV testing, counseling, and initiation of daily oral pre-exposure prophylaxis (PrEP), delivered through community-based strategies. These strategies include services provided at non-governmental organizations, mobile health units, and the use of telehealth and mobile health (mHealth) tools to support engagement and adherence. The study evaluates the feasibility, acceptability, and outcomes of this integrated community-based delivery model without a comparison group.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 13, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04

Locations

BR (2)