What side effects are associated with this type of intervention?

The most common treatments for Hepatitis C are direct-acting antivirals (DAAs). Known side effects of DAAs include fatigue, headache, nausea, insomnia, and diarrhea. These side effects are generally mild and manageable. In some cases, patients may experience more severe side effects such as anemia or liver enzyme abnormalities, but these are less common. It is important for patients to discuss any side effects with their healthcare provider to ensure proper management and adherence to the treatment regimen.

What prior FDA approvals exist?

The FDA has approved several direct-acting antivirals (DAAs) for the treatment of Hepatitis C, including sofosbuvir, ledipasvir/sofosbuvir, and glecaprevir/pibrentasvir. These treatments have revolutionized Hepatitis C care by offering high cure rates with shorter treatment durations and fewer side effects compared to older interferon-based therapies. In the context of transitional care, such as the Coordinated Transitional Care intervention (CJC-TraC), these DAAs can be effectively integrated into comprehensive care plans that address both medical and psychosocial needs, ensuring continuity of care for individuals transitioning from incarceration to community living.

What other types of research exist?

Promising alternatives to Coordinated Transitional Care (CJC-TraC) for Hepatitis C patients include Integrated Care (IC) models, which involve mental health providers offering brief interventions, collaborative consultations, and case management. Another alternative is Recovery Management Checkups (RMC), which provide routine monitoring and active outreach to enhance treatment engagement. Additionally, the use of eHealth and telemedicine services can facilitate remote support and continuity of care during the transition from incarceration to community living.

← Back to Search

Transitional Care Program for HIV, Hepatitis C, and Substance Use Disorders (CJC-TraC Trial)

N/A

Waitlist Available

Led By Ryan Westergaard, MD, PhD, MPH

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unable to provide informed consent form or impaired ability to make decisions

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

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 substance misuse history. The program coordinates their medical care to ensure they continue treatment after release. New treatments have made it easier and faster to cure Hepatitis C.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a care coordination intervention rather than medication, traditional side effects are not applicable. However, participants may experience stress or anxiety related to the transition process.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3-months following release (up to 6 months on study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability assessed by subjective experience of the Participant (Qualitative Measure)

Acceptability measured by the Proportion of study participants who rated specific aspects of the intervention useful and encounter volumes appropriate

Feasibility Outcome: Number of participants who are enrolled and complete the baseline study assessment per month

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CJC-TraC InterventionExperimental Treatment1 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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hepatitis C are direct-acting antivirals (DAAs), which target specific steps in the HCV life cycle. These include protease inhibitors, NS5A inhibitors, and polymerase inhibitors, all of which work by inhibiting viral replication and assembly. Achieving a sustained virologic response (SVR) with these treatments significantly reduces the risk of liver-related complications and improves overall survival. This is particularly important for patients transitioning from incarceration to community living, as facilitated by the Coordinated Transitional Care intervention (CJC-TraC), which ensures continuity of care and support for medical and psychosocial needs.

Knowledge, attitudes, and acceptability of direct-acting antiviral hepatitis C treatment among people incarcerated in jail: A qualitative study.Continuum of hepatitis C care cascade in prison and following release in the direct-acting antivirals era.Treatment guidelines for Hepatitis C in Spain.