Clinical trial NCT06439329: STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
Official title: STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-06-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility/acceptability will be assessed using the CAB Community Needs Assessment
timeFrame: 3 months
measure: Feasibility/acceptability will be assessed using the Organizational Readiness for Implementing Change (ORIC) from the JCOIN Common Measure survey
timeFrame: 3 months
measure: Participant attitudes toward the interventions will be assessed using the Scales for Participant Alliance with Recovery Coach (SPARC)
timeFrame: 3 months
measure: Percentage of participants with access to PrEP/ART services
timeFrame: 3 months
measure: Percentage of participants with receipt of treatment
timeFrame: 3 months
Secondary outcomes:
measure: Substance use treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: 135 College St., Suite 280
state: Connecticut
Study officials:
affiliation: Yale University
name: Sandra Springer, MD
role: PRINCIPAL_INVESTIGATOR
References: