About this trial
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
Qualifiers
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)
Disqualifiers
Positive HIV test result at screening or during study participation
Individuals not eligible for PrEP according to Brazilian national guidelines
Trial design
Treatments tested in this trial
- Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine)
- Community-Based PrEP Delivery Model
- Telehealth and mHealth Support