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.
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)
Positive HIV test result at screening or during study participation
Individuals not eligible for PrEP according to Brazilian national guidelines
Single group
Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine)
DrugParticipants 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 Model
BehavioralParticipants 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.
Telehealth and mHealth Support
BehavioralParticipants 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.
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.
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.
PrEP Uptake
Proportion of eligible participants who initiate PrEP after HIV testing and counseling in community-based settings.
PrEP Persistence (Retention in PrEP Care)
Proportion of participants who remain engaged in PrEP care over time, including continued use of PrEP and attendance at follow-up visits.
HIV Incidence
Number of new HIV infections diagnosed among study participants during the follow-up period.
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