Shared decision-making to prevent or treat HIV for people with recent justice involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized R33 trial compares standard patient navigation (PN) to PN plus a Patient Choice (PC) shared decision-making menu across multiple U.S. sites. Eligible participants are people with justice involvement in the past six months who either have HIV and are not on ART or are HIV-negative and meet CDC PrEP criteria, and who report recent opioid or stimulant use. The primary outcomes are the proportions who initiate PrEP or ART and who start substance use/SUD treatment, and the study also measures implementation outcomes and costs. Study sites include Yale School of Medicine (CT), University of Kentucky (KY), and UT Southwestern Medical Center (Dallas, TX).

Why it matters

Who can join: the full rules

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

Where it's running

• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• College of Medicine at the University of Kentucky
  Lexington, Kentucky, United States Recruiting
• University of Texas Southwestern Medical Center (UTSW)
  Dallas, Texas, United States Recruiting
• Texas Christian University's (TCU) School of Medicine
  Fort Worth, Texas, United States Recruiting

Study contacts

• Principal investigator: Sandra Springer, MD — Yale University
• Study coordinator: Sandra Springer, MD
• Email: Sandra.springer@yale.edu
• Phone: 203-231-2454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.