Criminal Justice Coordinated Transitional Care

NCT05376371 | Completed Results

• 4 other identifiers: 2022-03981R01DA047889-01A1Protocol Version 6/9/2024A534265
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Hepatitis C; Substance Use Disorders

Keywords

incarcerated; transition; release

Outcome Measures

Primary Outcomes (8)

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

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

  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 Contact Attempts 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: Number 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 Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as 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 Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as 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 Measured by the Number 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) Reported Here as Number of Participants Completing Acceptability Interviews

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

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

Secondary Outcomes (2)

• Attendance at Non-emergency Outpatient Care Visits 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, Reported Here as Number of Participants With Visits Occurring Within 60 Days

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

Study Arms (1)

CJC-TraC Intervention

EXPERIMENTAL

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

Interventions

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.

CJC-TraC Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Oakhill Correctional Institution

Oregon, Wisconsin, 53575, United States

Location

Robert E. Ellsworth Correctional Center

Union Grove, Wisconsin, 53182, United States

Location

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ryan Westergaard
• Organization: University or Wisconsin-Madison

rpw@medicine.wisc.edu

6082657927

Study Officials

• Ryan Westergaard, MD, PhD, MPH

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: November 29, 2022
• Primary Completion: December 3, 2024
• Study Completion: March 31, 2025
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)