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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439329
• Other study ID #: 2000037052
• Secondary ID: 1R61DA060625-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Sandra Springer, MD
• Phone: 203-687-6680
• Email: Sandra.springer[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

• have a current DSM-5 SUD (opioid and/or stimulant).

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Standard PN
Standard of care
• Patient Choice
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Locations

Country	Name	City	State
United States	135 College St., Suite 280	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percentage of participants with receipt of treatment	Defined as participants that have received a prescription for PrEP/ART	3 months
Secondary	Substance use treatment	Percentage of participants engaged in substance use disorder (SUD) treatment	3 months