HIV InfectionsNCT07584122
Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro
A study testing Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Community-Based PrEP Delivery Model and Telehealth and mHealth Support in people with HIV Infections, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Community-Based PrEP Delivery Model and Telehealth and mHealth Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Positive HIV test result at screening or during study participation
- Individuals not eligible for PrEP according to Brazilian national guidelines
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, 26030-380
José Henrique Pilotto, PhD, pilotto@uninet.com.br
- Recruiting
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040360
Emilia Jalil, PhD, 55 2138659128, emiliajalil@gmail.com
About this study
Official title: Bringing PrEP to Underserved Communities in Rio de Janeiro: the PrEPOUT Rio Study
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Community-Based PrEP Delivery Model, Telehealth and mHealth Support
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ModelBehavioural
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.
Telehealth and mHealth SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine); Behavioral: Community-Based PrEP Delivery Model; Behavioral: Telehealth and mHealth Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (3)
PrEP Uptake
Proportion of eligible participants who initiate PrEP after HIV testing and counseling in community-based settings.
Measured: 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.
Measured: Up to 12 months
HIV Incidence
Number of new HIV infections diagnosed among study participants during the follow-up period.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584122
- Sponsor's protocol ID
- 84111624.4.1001.5262
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing PrEP to Underserved Communities in Rio de Janeiro: the PrEPOUT Rio Study
- ClinicalTrials.gov ID
- NCT07584122
- Acronym / sponsor ID
- 84111624.4.1001.5262
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Community-Based PrEP Delivery | Experimental | Drug: Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Behavioral: Community-Based PrEP Delivery Model, Behavioral: Telehealth and mHealth SupportParticipants 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Positive HIV test result at screening or during study participation
- Individuals not eligible for PrEP according to Brazilian national guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine)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. | Drug | Community-Based PrEP Delivery |
| Community-Based PrEP Delivery ModelParticipants 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. | Behavioural | Community-Based PrEP Delivery |
| Telehealth and mHealth SupportParticipants 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. | Behavioural | Community-Based PrEP Delivery |
Primary outcome
Feasibility of Community-Based PrEP Delivery
Time frame: Up to 12 months
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
Time frame: Up to 12 months
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.
3 secondary outcomes
PrEP Uptake
Time frame: Up to 12 months
PrEP Persistence (Retention in PrEP Care)
Time frame: Up to 12 months
HIV Incidence
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Community-Based PrEP Delivery Model and Telehealth and mHealth Support in people with HIV Infections, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Grinsztejn (+55 2138659128, beatriz.grinsztejn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Community-Based PrEP Delivery (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.