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

NCT ID: NCT06439329

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2025-03-31

Brief 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.

Detailed Description

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.

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.

Conditions

Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Patient Navigation (PN)

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 appointment scheduling to brick and mortar services only, and not to MHU or telehealth services.

Group Type: ACTIVE_COMPARATOR

Standard PN

Intervention Type: BEHAVIORAL

Standard of care

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

PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB.

Group Type: EXPERIMENTAL

Standard PN

Intervention Type: BEHAVIORAL

Standard of care

Patient Choice

Intervention Type: BEHAVIORAL

Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Interventions

Standard PN

Standard of care

Intervention Type: BEHAVIORAL

Patient Choice

Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Springer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

135 College St., Suite 280

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R61DA060625-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000037052

Identifier Type: -

Identifier Source: org_study_id