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Completed

NCT Number: NCT05376371

Criminal Justice Coordinated Transitional Care

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.

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Key information

Conditions

HIV Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders RNA Virus Infections Substance Use Disorders Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oakhill Correctional Institution, Oregon, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CJC-TraC

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.

Primary outcomes

  1. Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment

    Time frame: at enrollment, up to 1 day

    The number who successfully enrolled and completed the baseline assessment demonstrates the feasibility of engaging the target population in the prison setting.

  2. Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant

    Time frame: 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.

  3. Feasibility Outcome: Number of Post-release Telephone Contact Attempts Between the CJC-TraC Nurse Case Manager and Study Participants

    Time frame: post-release, up to 6 months

    The investigators plan for 2 post-release sessions with additional sessions as needed.

  4. Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment

    Time frame: within 3-months following release (up to 6 months on study)

  5. Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate

    Time frame: 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.

  6. Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate

    Time frame: 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.

  7. Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate

    Time frame: up to 3 months

  8. Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews

    Time frame: within 3-months following release (up to 6 months on study)

    Exploratory results of qualitative interviews among a subset of intervention participants.

Secondary outcomes

  1. Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release

    Time frame: within 3-months following release (up to 6 months on study)

    Based on review of medical records and Wisconsin Medicaid claims data, the occurrence of outpatient medical care visits, not including emergency department or urgent care visits.

  2. Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days

    Time frame: within 3-months following release (up to 6 months on study)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: CJC-TraC

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 17, 2022
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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