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

This study will be done in two phases. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot (NCT07223398).

The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties).

Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout the study.

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 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 and have a viral load >200 copies/mL 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 within 12 months prior to being in a controlled setting and/or in the last 6 months within the community

Implementation portion/CAB members:

• able to provide written informed consent in English or Spanish;
• working with persons with a history of justice involvement and substance use in the areas targeted for this project

PN Participants:

• able to provide written informed consent in English or Spanish;
• be employed at a project research site as a Patient Navigator

Exclusion criteria

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

Implementation portion/CAB members:

• persons self-reporting pregnancy