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

NCT06919419 | Recruiting

• 2 other identifiers: STU-2024-10961R01MH129185-01
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP; HIV; Incarceration

Outcome Measures

Primary Outcomes (1)

• Linkage to PrEP care

  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.

  Within 90 days of release from jail

Study Arms (1)

PrEP navigation

OTHER

This is a single arm study where people in the Dallas County Jail identified to be at elevated risk for HIV are offered a PrEP navigation visit

Behavioral: Multicomponent strategy

Interventions

Multicomponent strategy BEHAVIORAL

Identify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration

PrEP navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dallas County Jail

Dallas, Texas, 75207, United States

RECRUITING

Study Officials

• Ank Nijhawan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Douglas Krakower, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ank Nijhawan, MD

CONTACT

2146482777; ank.nijhawan@utsouthwestern.edu

Laura Hansen

CONTACT

laura.Hansen@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients identified to be at elevated risk for HIV will meet with the PrEP navigator during incarceration

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 9, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)