Evaluating a PrEP implementation strategy for incarcerated individuals
The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and PrEP in a Southern Jail
This study is testing a new way to help people in jail get access to PrEP and learn about HIV prevention to see if it can improve their health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06919419 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a multicomponent strategy for implementing PrEP among individuals incarcerated at the Dallas County Jail. It involves using an electronic medical record HIV prediction model to identify at-risk individuals, who will then receive education about PrEP, HIV/STI testing, and referrals to community-based providers through a patient navigator. The study employs a mixed-methods approach to evaluate both the implementation process and clinical outcomes, utilizing the EPIS framework to ensure a comprehensive evaluation of the strategy's impact on PrEP uptake and related health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who are currently incarcerated in Dallas County Jail.
Not a fit: Patients with severe medical or psychiatric disabilities that make participation unsafe or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve access to PrEP for incarcerated individuals, thereby reducing the risk of HIV transmission.
How similar studies have performed: Other studies have shown promising results in implementing PrEP strategies in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- Dallas County Jail — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ank Nijhawan, MD — University of Texas Southwestern Medical Center
- Study coordinator: Ank Nijhawan, MD
- Email: ank.nijhawan@utsouthwestern.edu
- Phone: 2146482777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.