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The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services

Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07292792
Enrollment
100
Registered
2025-12-18
Start date
2025-05-21
Completion date
2026-11-21
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Disease, HIV Prevention

Keywords

PrEP

Brief summary

This 18-month study, Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals, aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.

Detailed description

This 18-month study, Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals, aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will: 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.

Interventions

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.

Sponsors

Unlocking Doors
CollaboratorUNKNOWN
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 18 years or older 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

1. Under 18 years of age 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Integrating a PrEP-Focused Health Coach18 MonthsFeasibility will be assessed by the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.
Acceptability of the Health Coach Model18 MonthsAcceptability will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale, and which will be asked of clients and staff. These questions will assess satisfaction, comfort, and perceived usefulness of health coach interactions. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of acceptability. Qualitative feedback will supplement these ratings to capture overall acceptability.
Appropriateness of the Health Coach Model18 MonthsAppropriateness will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale. These questions assess perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of appropriateness. Qualitative feedback will supplement these ratings to capture overall appropriateness.

Countries

United States

Contacts

Primary ContactLaura A Hansen, MA
Laura.Hansen@UTSouthwestern.edu7133057882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026