Transitional Care Program for HIV, Hepatitis C, and Substance Use Disorders

(CJC-TraC Trial)

No longer recruiting at 2 trial locations

Overseen By Sarah A Dietz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Impaired decision-making, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to assist individuals with HIV, Hepatitis C, or a history of substance misuse as they transition from incarceration back into the community. The focus is on ensuring these individuals can continue their healthcare smoothly after release. The trial aims to determine if this approach is feasible and welcomed by participants. It is suitable for incarcerated individuals who speak English, plan to live in Wisconsin, and are eligible for Wisconsin Medicaid, with release expected within six months. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance healthcare transitions for many.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this protocol is safe for transitioning incarcerated individuals with HIV, Hepatitis C, or substance use disorders?

Research shows that the CJC-TraC program is designed to help people leaving prison manage their health care, especially those with HIV, Hepatitis C, or a history of substance misuse. Although no direct studies have examined the program's safety for this trial, research on similar programs has shown promising results.

Reports suggest that programs like CJC-TraC are generally well-received, and participants tend to adhere to the treatment plan. This indicates that people are likely to complete the program without major problems. Similar programs have reported no serious side effects.

Since this trial is in an early stage, the main goal is to assess the program's practicality and acceptability, rather than test new drugs. This suggests the program itself is considered low risk. Overall, based on available data, the CJC-TraC program appears safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CJC-TraC intervention is unique because it focuses on a transitional care approach specifically designed for individuals with HIV, hepatitis C, or substance use disorders who are about to be released from incarceration. Unlike traditional treatments that might focus solely on medication management, this intervention aims to bridge the gap in healthcare continuity as these individuals re-enter society. Researchers are excited about this approach because it could significantly improve health outcomes by addressing the unique challenges faced during the transition period, providing tailored support that current standard-of-care treatments do not typically offer. This could lead to better adherence to treatment plans and overall health improvements for a particularly vulnerable population.

What evidence suggests that the CJC-TraC intervention is effective for transitioning care for individuals with HIV, Hepatitis C, or substance use disorders?

Research has shown that connecting people from the criminal justice system to healthcare can improve treatment for HIV, Hepatitis C, and substance use disorders. Studies have found that well-coordinated care for these conditions enhances health outcomes, particularly for those released from prison who require ongoing support. This trial will evaluate the CJC-TraC intervention, designed to help individuals transition smoothly to community healthcare. Early results suggest that programs like CJC-TraC can maintain treatment and reduce relapse rates. These interventions aim to close gaps in care and provide continuous support, which is essential for managing these long-term health issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Ryan Westergaard, MD, PhD, MPH

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for incarcerated individuals in Wisconsin who are eligible for Medicaid and will be released within 6 months. They must understand English, plan to stay in Wisconsin post-release, and have HIV, Hepatitis C or a history of substance misuse.

Inclusion Criteria

Plans to reside in Wisconsin after release

Able to understand and speak in English

Eligible for Wisconsin Medicaid and willing to enroll prior to release

Exclusion Criteria

Planned discharge to another correctional facility or other carceral setting (e.g. release to jail or immigration detention center)

I am able to understand and make decisions about my health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-release Intervention

Participants engage in CJC-TraC intervention sessions with a nurse case manager before release

up to 3 months

3 sessions (in-person)

Post-release Intervention

Participants have post-release telephone contacts with the CJC-TraC nurse case manager

up to 6 months

2 sessions (telephone)

Follow-up

Participants are monitored for safety and effectiveness after intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CJC-TraC

Trial Overview The study tests the Coordinated Transitional Care intervention (CJC-TraC) adapted for those transitioning from incarceration back into society. It focuses on people with HIV, Hepatitis C or substance use disorders over a period of up to 6 months.

How Is the Trial Designed?

Group I: CJC-TraC Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05376371

Criminal Justice Coordinated Transitional Care (CJC-TraC) 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 ...

2. ctv.veeva.com ctv.veeva.com/study/criminal-justice-coordinated-transitional-care

Criminal Justice Coordinated Transitional Care (CJC-TraC) 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8568621/

Linking criminal justice-involved individuals to HIV ... This manuscript reviews the literature to explore gaps in HIV, Hepatitis C, and OUD prevention, treatment, and delivery cascades of care for persons involved ...

4. medicine.wisc.edu medicine.wisc.edu/infectious-disease/syndemics-research-group-synrg

Syndemics Research Group (SynRG) The research at SynRG focuses on improving the quality and continuity of care for HIV, viral hepatitis, and substance use disorders among underserved ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25291977/

Cost-effectiveness of rapid hepatitis C virus (HCV) testing and ... Conclusions: On-site rapid hepatitis C virus and HIV testing in substance abuse treatment programs is cost-effective at a <$100,000/quality-adjusted life year ...

6. withpower.com withpower.com/clinical-trials/for-hepatitis-c

Top Hepatitis C Clinical Trials | Power This trial tests a program called CJC-TraC that helps people leaving prison get the medical care they need. It focuses on those with HIV, Hepatitis C, or ...

7. oregon.gov oregon.gov/cjc/CJC%20Document%20Library/2025%20BHD%20Best%20Practices%20Report.pdf

Oregon Behavioral Health Deflection Program Best ... Referrals to treatment for a substance use disorder can be especially complex, when a clinical prescriber must be included on the treatment team ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216679/

Hepatitis C virus and integrated care for substance use ... Research has demonstrated high rates of treatment adherence and sustained virologic response (SVR) in patients with active substance use, ...