An interventional study of Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine) and Community-Based PrEP Delivery Model in HIV Infections, sponsored by Oswaldo Cruz Foundation. Recruiting at 2 sites in Brazil. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Oswaldo Cruz Foundation · Not applicable, Interventional, and Health services research
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 400 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Oswaldo Cruz Foundation is the lead sponsor of 42 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
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.
Time frame: 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.
Time frame: Up to 12 months
PrEP Uptake
Proportion of eligible participants who initiate PrEP after HIV testing and counseling in community-based settings.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
HIV Incidence
Number of new HIV infections diagnosed among study participants during the follow-up period.
Time frame: Up to 12 months
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Oswaldo Cruz Foundation