RecruitingNot ApplicableNCT07223398

Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)

STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations


Sponsor

Yale University

Enrollment

400 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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 standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shared decision-making support program to help people with HIV or at high risk of HIV — particularly those who have been involved in the criminal justice system — make more informed choices about HIV treatment or prevention (such as PrEP, a pill that prevents HIV). The program aims to improve uptake of HIV medications in communities that often face barriers to care. **You may be eligible if...** - You are an adult living in Western Connecticut, Dallas/Tarrant Counties in Texas, or Madison County, Kentucky - You have had involvement with the justice system (jail, prison, or community supervision) in the past 6 months - You are either living with HIV and not currently taking antiretroviral medication, or you are HIV-negative but at high risk and not taking PrEP - You have used opioids or stimulants in the past 6 months - You are willing to have an HIV test and speak English or Spanish **You may NOT be eligible if...** - You have a severe medical or psychiatric condition that makes safe participation impossible - You are unable to provide consent - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStandard PN

Standard of care

BEHAVIORALPatient Choice

Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.


Locations(4)

Yale School of Medicine

New Haven, Connecticut, United States

College of Medicine at the University of Kentucky

Lexington, Kentucky, United States

University of Texas Southwestern Medical Center (UTSW)

Dallas, Texas, United States

Texas Christian University's (TCU) School of Medicine

Fort Worth, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07223398


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