Criminal Justice Coordinated Transitional Care (CJC-TraC)

Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatitis C; HIV; Substance Use Disorders
• Intervention / Treatment: Other: CJC-TraC

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 Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Oregon, Wisconsin, United States, 53575
      • Oakhill Correctional Institution
    • Union Grove, Wisconsin, United States, 53182
      • Robert E. Ellsworth Correctional Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CJC-TraC Intervention; 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.	Other: CJC-TraC; CJC-TraC utilizes a nurse case manager (NCM) to coordinate the participant's transitional care through release from a correctional facility. The NCM will visit either in person or via telehealth with the participant up to 4 times while incarcerated, and up to 4 times after release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Outcome: Number of participants who are enrolled and complete the baseline study assessment per month	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.	at enrollment, up to 1 day
Feasibility Outcome: Number of pre-release CJC-TraC intervention sessions completed with the nurse case manager for each participant	The investigators plan for 3 pre-release sessions with additional sessions as needed. The results will be reported in total and for each institution.	pre-release, up to 3 months
Feasibility Outcome: Number of post-release telephone contacts between the CJC-TraC nurse case manager and study participants	The investigators plan for 2 post-release sessions with additional sessions as needed.	post-release, up to 6 months
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)
Acceptability measured by the Proportion of study participants who rated specific aspects of the intervention useful and encounter volumes appropriate	Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness	within 3-months following release (up to 6 months on study)
Acceptability assessed by subjective experience of the Participant (Qualitative Measure)	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	within 3-months following release (up to 6 months on study)
Acceptability measured by the Proportion of Department of Corrections (DOC) staff who rated the intervention acceptable, useful, or appropriate		up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ryan Westergaard, MD, PhD, MPH, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: incarcerated; transition; release
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Substance-Related Disorders; Hepatitis; Hepatitis C
• Other Study ID Numbers: 2022-0398; 1R01DA047889-01A1 (U.S. NIH Grant/Contract); A534265 (Other Identifier: UW, Madison); Protocol Version 5/3/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No