Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT07292792
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: