Peer Support + Vouchers for Hepatitis C

Overseen By Mariana Gomez de la Espriella, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Under 18, Prior HCV treatment

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. This same year, the situation was even more dire in Roanoke City which had a rate of 524/100,000 adults. Treatment with antiviral medication is curative and well tolerated. However, gaps remain in the ability of the health system to engage the most vulnerable patients to start and complete treatment. People with HCV infection usually are unaware of the infection, which allows the disease to progress to liver damage, liver cancer and death if left untreated.At each stage of the screening, testing, and treatment process, there is significant patient loss to follow-up. Drop-off most commonly occurs between diagnosis and the first visit to a treating provider. Key barriers to successful engagement include: 1) communication issues, such as lack of phone or limited phone access; 2) lack of transportation; 3) significant social issues such as poverty; 4) substance use disorder; and 5) a limited understanding of the consequences of untreated HCV infection. In this mixed-method design, the investigators propose a pilot study that will provide education and resources, such as vouchers for phone, transportation, and meals, to the most vulnerable patients that will facilitate engagement in treatment as additional factors that may influence dropout rates are evaluated.

Eligibility Criteria

This trial is for adults over 18 with a positive Hepatitis C antibody test and a history of substance use disorder. They must have an elevated Hepatitis C RNA indicating active infection but cannot have had prior treatment for Hepatitis C.

Inclusion Criteria

Elevated Hepatitis C RNA

Positive Hepatitis C antibody test

History of substance use disorder

Exclusion Criteria

I am under 18 years old.

I have been treated for Hepatitis C.

Treatment Details

Interventions

• Peer Specialist and Vouchers

Trial Overview The study tests whether support from peer specialists and vouchers for phone, transportation, and meals can help people with Hepatitis C engage better in their treatment process, potentially reducing the drop-off between diagnosis and care.

Participant Groups

Group I: Peer specialist and Vouchers Experimental Treatment 1 Intervention

Intervention arm

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+