CJC-TraC: Criminal Justice Coordinated Transitional Care

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05376371

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

220

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Hepatitis C Substance Use Disorders	Other: CJC-TraC	N/A

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 Taycheedah Correctional Institute (TCI)

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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 of Intervention Measure (AIM) Score [up to 3 months]
The AIM is scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree). Higher scores indicate increased acceptability of the measure.
Intervention Appropriateness Measure (IAM) [up to 3 months]
The IAM is scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree). Higher scores indicate increased appropriateness of the measure.

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)