HOTSPOT Study: Implement and Evaluate the PrEP Implementation Strategy

Recruiting

• Conditions: PrEP; HIV; Incarceration

• Registration Number: NCT06919419
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV/STI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.

Detailed Description

The objective of Aim 3 is to deploy the multicomponent strategy that was refined in Aim 2 and evaluate its impact on PrEP implementation and related clinical outcomes using iterative quantitative and qualitative assessments. The investigators' approach will be to utilize the EPIS framework (Exploration, Preparation, Implementation, Sustainment) across the jail-to-community continuum. The investigators will use mixed-methods to evaluate implementation process measures and an interrupted time series design to measure clinical outcomes for PrEP evaluations and linkage, as well as HIV/STI testing and diagnoses. The investigators' expected outcome is to define a feasible, acceptable and effective PrEP implementation strategy for jails.

Study Timeline

• Study Start: 2025-02-28
• Study First Submitted: 2025-03-21
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2028-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

• 18 years of age or older
• Incarcerated in Dallas County Jail

Exclusion Criteria

• Severe medical or psychiatric disability making participation unsafe
• Unable to provide consent
• Not remaining in the local area after release from custody

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Linkage to PrEP care	Within 90 days of release from jail	Measure the proportion of individuals (of those who stated that they were interested in PrEP and have been released from jail) who attended a clinic visit with a PrEP provider as confirmed by the PrEP patient navigator or through medical record review.

Trial Locations

Locations (1)

Dallas County Jail; 🇺🇸 Dallas, Texas, United States