NCT07584122 Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro
| NCT ID | NCT07584122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oswaldo Cruz Foundation |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07584122 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07584122 currently recruiting?
Yes, NCT07584122 is actively recruiting participants. Contact the research team at beatriz.grinsztejn@gmail.com for enrollment information.
Where is the NCT07584122 trial being conducted?
This trial is being conducted at Nova Iguaçu, Brazil, Rio de Janeiro, Brazil.
Who is sponsoring the NCT07584122 clinical trial?
NCT07584122 is sponsored by Oswaldo Cruz Foundation. The trial plans to enroll 400 participants.
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