Criminal Justice Coordinated Transitional Care

Not Applicable

Completed

• Conditions: HIV; Substance Use Disorders; Hepatitis C
• Interventions: Other: CJC-TraC

• Registration Number: NCT05376371
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-11-29
• Primary Completion: 2024-12-03
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CJC-TraC Intervention	CJC-TraC	Incarcerated individuals with HIV, hepatitis C, or substance use disorder readying for release will enroll in the CJC-TraC intervention intended to assist in transitioning their health care.

Primary Outcome Measures

Name	Time	Method
Feasibility Outcome: Proportion of study participants who are retained in follow-up for three months and complete the end-of-study assessment	within 3-months following release (up to 6 months on study)
Feasibility Outcome: Number of participants who are enrolled and complete the baseline study assessment per month	at enrollment, up to 1 day	The investigators aim to enroll about 9 people per month over a 2 year study period. Results will be reported in total and per institution.
Feasibility Outcome: Number of pre-release CJC-TraC intervention sessions completed with the nurse case manager for each participant	pre-release, up to 3 months	The investigators plan for 3 pre-release sessions with additional sessions as needed. The results will be reported in total and for each institution.
Acceptability measured by the Proportion of study participants who rated specific aspects of the intervention useful and encounter volumes appropriate	within 3-months following release (up to 6 months on study)	Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness
Feasibility Outcome: Number of post-release telephone contacts between the CJC-TraC nurse case manager and study participants	post-release, up to 6 months	The investigators plan for 2 post-release sessions with additional sessions as needed.
Acceptability measured by the Proportion of Department of Corrections (DOC) staff who rated the intervention acceptable, useful, or appropriate	up to 3 months
Acceptability assessed by subjective experience of the Participant (Qualitative Measure)	within 3-months following release (up to 6 months on study)	Participant responses to qualitative interview questions will be analyzed for themes, responses to questions regarding helpful and liked parts of the intervention and work with the nurse case manager will be particularly meaningful for acceptability

Secondary Outcome Measures

Name	Time	Method
Number of non-emergency outpatient visits observed within 3-months following release	within 3-months following release (up to 6 months on study)
Number days until the first non-emergency outpatient visit following release.	within 3-months following release (up to 6 months on study)

Trial Locations

Locations (2)

Oakhill Correctional Institution; 🇺🇸 Oregon, Wisconsin, United States

Robert E. Ellsworth Correctional Center; 🇺🇸 Union Grove, Wisconsin, United States