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Criminal Justice Coordinated Transitional Care (CJC-TraC)

Primary Purpose

HIV, Hepatitis C, Substance Use Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CJC-TraC
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring incarcerated, transition, release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Oakhill Correctional Institution
  • Robert E. Ellsworth Correctional Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CJC-TraC Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Feasibility Outcome: Proportion of study participants who are retained in follow-up for three months and complete the end-of-study assessment
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
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
Acceptability measured by the Proportion of Department of Corrections (DOC) staff who rated the intervention acceptable, useful, or appropriate

Secondary Outcome Measures

Number of non-emergency outpatient visits observed within 3-months following release
Number days until the first non-emergency outpatient visit following release.

Full Information

First Posted
May 11, 2022
Last Updated
October 18, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05376371
Brief Title
Criminal Justice Coordinated Transitional Care
Acronym
CJC-TraC
Official Title
Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C, Substance Use Disorders
Keywords
incarcerated, transition, release

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Westergaard, MD, PhD, MPH
Organizational Affiliation
UW School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oakhill Correctional Institution
City
Oregon
State/Province
Wisconsin
ZIP/Postal Code
53575
Country
United States
Facility Name
Robert E. Ellsworth Correctional Center
City
Union Grove
State/Province
Wisconsin
ZIP/Postal Code
53182
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Criminal Justice Coordinated Transitional Care

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