Status:
NOT_YET_RECRUITING
Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Substance Use Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A s...
Detailed Description
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilo...
Eligibility Criteria
Inclusion
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- Having a history of opioid and/or stimulant use in the last 6 months within the community.
Exclusion
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07223398
Start Date
November 1 2025
End Date
June 1 2028
Last Update
October 31 2025
Active Locations (4)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
2
College of Medicine at the University of Kentucky
Lexington, Kentucky, United States, 40506
3
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, United States, 75390
4
Texas Christian University's (TCU) School of Medicine
Fort Worth, Texas, United States, 76109