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

NCT06439329 | Completed

• 2 other identifiers: 20000370521R61DA060625-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (5)

• Feasibility/acceptability will be assessed using the CAB Community Needs Assessment

  Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation.

  3 months

• Feasibility/acceptability will be assessed using the Organizational Readiness for Implementing Change (ORIC) from the JCOIN Common Measure survey

  Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach.

  3 months

• Participant attitudes toward the interventions will be assessed using the Scales for Participant Alliance with Recovery Coach (SPARC)

  Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.

  3 months

• Percentage of participants with access to PrEP/ART services

  Utilization of Services and PN Engagement data will be used to assess the percentage of participants with access to PrEP/ART services.

  3 months

• Percentage of participants with receipt of treatment

  Defined as participants that have received a prescription for PrEP/ART

  3 months

Secondary Outcomes (1)

• Substance use treatment

  3 months

Study Arms (2)

Standard Patient Navigation (PN)

ACTIVE COMPARATOR

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.

Behavioral: Standard PN

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

EXPERIMENTAL

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.

Behavioral: Standard PN; Behavioral: Patient Choice

Interventions

Standard PN BEHAVIORAL

Standard of care

PN + Patient Choice (PC) (PN+PC); Standard Patient Navigation (PN)

Patient Choice BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• severe medical or psychiatric disability making participation unsafe;
• unable to provide consent.
• persons self-reporting pregnancy
• Implementation portion/CAB members:
• persons self-reporting pregnancy

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

135 College St., Suite 280

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Patient Freedom of Choice Laws

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Legislation as Topic; Social Control, Formal; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sandra Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: October 3, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)