The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services
NCT ID: NCT07292792
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-05-21
2026-11-21
Brief Summary
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Detailed Description
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Conduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP.
Use rapid qualitative analysis to adapt the health coach intervention and workflows.
Implement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV/syphilis testing, and linkage to PrEP care and other services.
Enroll up to 600 consented/screened individuals to achieve a target of 100 participants in the intervention.
Assess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time.
The study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health Coach Intervention Group
Participants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study.
Health Coach Intervention
The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.
Interventions
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Health Coach Intervention
The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.
Eligibility Criteria
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Inclusion Criteria
2. Client of Unlocking Doors
3. Able to provide informed consent
4. Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP
5. Willing to complete health screening and eligibility assessment
6. For qualitative interview participants:
* Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.
Exclusion Criteria
2. Unable to provide informed consent
3. Not receiving services at Unlocking Doors
4. Non-English speakers
5. Diagnosed with HIV
6. Incarcerated individuals at the time of recruitment
18 Years
99 Years
ALL
Yes
Sponsors
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Unlocking Doors
UNKNOWN
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Ank Nijhawan
Professor- Internal Medicine
Principal Investigators
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Ank E Nijhawan, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ank E Nijhawan, MD
Role: primary
Other Identifiers
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STU-2024-0736
Identifier Type: -
Identifier Source: org_study_id