Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)

Yale University

Status: Enrolling

Conditions: Substance Use Disorders

Treatments: Behavioral: Standard PN; Behavioral: Patient Choice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07223398

2000037052_a

4R33DA060625-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Standard Patient Navigation (PN)

Active Comparator group

Description:

PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.

Treatment:

Behavioral: Standard PN

PN + Patient Choice (PC) (PN+PC)

Experimental group

Description:

PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.

Treatment:

Behavioral: Patient Choice

Behavioral: Standard PN