Criminal Justice Coordinated Transitional Care

HIV Clinical Trial

— CJC-TraC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05376371
• Other study ID #: 2022-0398
• Secondary ID: 1R01DA047889-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Oakhill Correctional Institution	Oregon	Wisconsin
United States	Robert E. Ellsworth Correctional Center	Union Grove	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at enrollment, up to 1 day
Primary	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
Primary	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.	post-release, up to 6 months
Primary	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)
Primary	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	within 3-months following release (up to 6 months on study)
Primary	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	within 3-months following release (up to 6 months on study)
Primary	Acceptability measured by the Proportion of Department of Corrections (DOC) staff who rated the intervention acceptable, useful, or appropriate		up to 3 months
Secondary	Number of non-emergency outpatient visits observed within 3-months following release		within 3-months following release (up to 6 months on study)
Secondary	Number days until the first non-emergency outpatient visit following release.		within 3-months following release (up to 6 months on study)