Criminal Justice Coordinated Transitional Care

NCT ID: NCT05376371

Last Updated: 2025-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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HIV Hepatitis C Substance Use Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CJC-TraC

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Westergaard, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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Oakhill Correctional Institution

Oregon, Wisconsin, United States

Site Status

Robert E. Ellsworth Correctional Center

Union Grove, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2022-0398

Identifier Type: -

Identifier Source: org_study_id

1R01DA047889-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 6/9/2024

Identifier Type: OTHER

Identifier Source: secondary_id

A534265

Identifier Type: OTHER

Identifier Source: secondary_id

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