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

RecruitingNAAges 18 Years - anyAllYale University
NCT07223398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard PN
  • Patient Choice
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Where

4 sites
Yale School of Medicine
New Haven, United States
College of Medicine at the University of Kentucky
Lexington, United States
University of Texas Southwestern Medical Center (UTSW)
Dallas, United States
Texas Christian University's (TCU) School of Medicine
Fort Worth, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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