NCT06919419

HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy

The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and PrEP in a Southern Jail

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,600 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• PrEP
• HIV
• Incarceration

Interventions

Type	Name	Description
BEHAVIORAL	Multicomponent strategy	Identify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-02-01
• Completion: 2027-08-31
• First posted: 2025-04-09
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States