Clinical trial NCT05376371: Criminal Justice Coordinated Transitional Care
Official title: Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Substance Use Disorders
Keywords: incarcerated
transition
release
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-17
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project aims to enroll 220 incarcerated individuals living with HIV, Hepatitis C (HCV), or history of substance misuse preparing for release into a pilot implementation study to test the feasibility and acceptability of an adapted Coordinated Transitional Care intervention in a Criminal Justice setting (CJC-TraC). Participants can expect to be on study for up to 6 months.

Detailed description: This protocol describes the second, implementation phase of a 5-year NIH-funded research project designed to evaluate post-incarceration health care utilization and outcomes for underserved people living with HIV, HCV and substance use disorder.

In the first study phase, conducted from 2020-21, the investigators analyzed Wisconsin Medicaid data to characterize the baseline level of outpatient care utilization for adults during their first 6 months after release from prison, and conducted formative research necessary to adapt an existing transitional care intervention, called C-TraC, to support individuals leaving prison.

The current project aims to enroll participants in a pilot implementation study to test the feasibility and acceptability of the adapted intervention in a criminal justice setting, which has been given the name "CJC-TraC."

Participants will be enrolled from one of two institutions:

* men from Oakhill Correctional Institute (OCI)
* women from the Wisconsin Women's Correctional System (WWCS)

Primary Objectives: To evaluate the feasibility and acceptability of CJC-TraC when implemented in a state prison system.

Secondary Objectives: To gather preliminary evidence describing the effectiveness of CJC-TraC for improving the rate of outpatient care utilization.

Eligibility criteria: Inclusion Criteria:

* Able to understand and speak in English
* Plans to reside in Wisconsin after release
* Eligible for Wisconsin Medicaid and willing to enroll prior to release
* Has a history of one or more of the following: current HIV infection, current or past HCV infection, identified need for substance use related services based on Correctional Offender Management Profiling for Alternative Sanctions (COMPAS) assessment
* Anticipated release date (must be within 6 months of review)

Exclusion Criteria:

* Unable to provide informed consent form or impaired ability to make decisions
* Planned discharge to another correctional facility or other carceral setting (e.g. release to jail or immigration detention center)

Primary outcomes:
measure: Feasibility Outcome: Number of participants who are enrolled and complete the baseline study assessment per month
timeFrame: at enrollment, up to 1 day
measure: Feasibility Outcome: Number of pre-release CJC-TraC intervention sessions completed with the nurse case manager for each participant
timeFrame: pre-release, up to 3 months
measure: Feasibility Outcome: Number of post-release telephone contacts between the CJC-TraC nurse case manager and study participants
timeFrame: post-release, up to 6 months
measure: Feasibility Outcome: Proportion of study participants who are retained in follow-up for three months and complete the end-of-study assessment
timeFrame: within 3-months following release (up to 6 months on study)
measure: Acceptability measured by the Proportion of study participants who rated specific aspects of the intervention useful and encounter volumes appropriate
timeFrame: within 3-months following release (up to 6 months on study)
measure: Acceptability assessed by subjective experience of the Participant (Qualitative Measure)
timeFrame: within 3-months following release (up to 6 months on study)
measure: Acceptability measured by the Proportion of Department of Corrections (DOC) staff who rated the intervention acceptable, useful, or appropriate
timeFrame: up to 3 months
Secondary outcomes:
measure: Number of non-emergency outpatient visits observed within 3-months following release
timeFrame: within 3-months following release (up to 6 months on study)
measure: Number days until the first non-emergency outpatient visit following release.
timeFrame: within 3-months following release (up to 6 months on study)
Other outcomes:
Locations:
city: Oregon
country: United States
facility: Oakhill Correctional Institution
state: Wisconsin
city: Union Grove
country: United States
facility: Robert E. Ellsworth Correctional Center
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Ryan Westergaard, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: