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NCT07223398NARecruiting

Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

Yale University

Start Date

11/24/2025

Completion Date

6/1/2028

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.

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 pilot. The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 12 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 have a PrEP indication in past 12 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 12 months within the community. Exclusion Criteria: * severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy

Interventions

BEHAVIORAL

Standard PN

BEHAVIORAL

Patient Choice

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Conditions

Substance Use Disorders

Locations

Yale School of Medicine

New Haven, Connecticut 06510

United States

College of Medicine at the University of Kentucky

Lexington, Kentucky 40506

United States

University of Texas Southwestern Medical Center (UTSW)

Dallas, Texas 75390

United States

Texas Christian University's (TCU) School of Medicine

Fort Worth, Texas 76109

United States