Peer specialist (PS) and vouchers for Hepatitis C, Chronic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carilion Clinic, Roanoke, VA
Hepatitis C, Chronic+5 More
Peer specialist (PS) and vouchers - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Hepatitis C, Chronic
  • Substance Use Disorders (SUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 6 months

Month 6
Semi-structured qualitative interviews
Month 6
Attendance at first appointment

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of care
1 of 2
Peer specialist and Vouchers
1 of 2
Active Control
Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Peer specialist (PS) and vouchers · No Placebo Group · N/A

Peer specialist and Vouchers
Behavioral
Experimental Group · 1 Intervention: Peer specialist (PS) and vouchers · Intervention Types: Behavioral
Standard of careNoIntervention Group · 1 Intervention: Standard of care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months
Closest Location: Carilion Clinic · Roanoke, VA
Photo of virginia 1Photo of virginia 2Photo of virginia 3
2019First Recorded Clinical Trial
1 TrialsResearching Hepatitis C, Chronic
35 CompletedClinical Trials

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityOTHER
108 Previous Clinical Trials
25,462 Total Patients Enrolled
Carilion ClinicLead Sponsor
61 Previous Clinical Trials
12,156 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive Hepatitis C antibody test.
You have a positive test for hepatitis C.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.