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

Inclusion Criteria6

  • 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 Criteria3

  • severe medical or psychiatric disability making participation unsafe;
  • unable to provide consent.
  • persons self-reporting pregnancy

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

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NCT07223398


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