Linkage to Care for Persons With Hep C Infection

July 3, 2026 updated by: Mariana Gomez, Carilion Clinic

Implementation of Low Cost Solutions to Help Facilitate Linkage to Care for Persons With Hepatitis C Virus Infection

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 study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.

This study evaluated whether community-based interventions, including peer support, incentives, telehealth, and phone access, improve linkage to care among individuals with hepatitis C and substance use disorders in Appalachia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.

The primary component of the study was a prospective interventional evaluation in which participants (N=60) were sequentially assigned to one of four cohorts: a control group and three intervention groups. All participants received peer support, with additional interventions introduced iteratively across cohorts, including incentive vouchers (e.g., food, transportation, phone), telehealth access, and provision of prepaid mobile phones to facilitate communication and engagement in care.

The primary outcome was attendance at the first HCV treatment visit.

The study used a pragmatic, quasi-experimental approach to evaluate the impact of these interventions on linkage to care. The goal was to assess whether addressing structural barriers such as transportation, communication access, and care navigation would improve engagement in HCV treatment among a high-risk population.

A qualitative component was conducted to inform intervention development and better understand barriers and facilitators to care. This included semi-structured interviews with patients and healthcare providers. Findings from the qualitative phase were used to refine intervention strategies but were not part of the interventional study population or quantitative outcome analyses.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 18 years or older, positive Hepatitis C antibody test,
  • elevated Hepatitis C RNA
  • history of substance use disorder

Exclusion criteria:

  • under 18 years old,
  • history of treatment of Hepatitis C infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 1
patients receive standard of care
Experimental: Arm 2
Patients received PRS support + incentive
Behavioral: Peer specialist (PS)
These participants will receive PRS support
Behavioral: Incentives
These participants will receive incentives
Experimental: Arm 3
Patients received PRS support + incentive + Telehealth visits
Behavioral: Peer specialist (PS)
These participants will receive PRS support
Behavioral: Incentives
These participants will receive incentives
Behavioral: telehealth visits
These participants will receive telehealth visits
Experimental: Arm 4
Patients received PRS support + incentive + telehealth visit + phone
Behavioral: Peer specialist (PS)
These participants will receive PRS support
Behavioral: Incentives
These participants will receive incentives
Behavioral: telehealth visits
These participants will receive telehealth visits
Behavioral: phone access
These participants will receive pre-paid phones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance at first appointment
Time Frame: Through study completion, an average of 6 months
Attendance at first appointment for HCV treatment will be compared between the control and intervention arms
Through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured qualitative interviews
Time Frame: Interviews will be conducted through study completion, an average of 6 months for the selected participants and care providers. Interviews will be collected throughout the study.
10 participants and 10 care providers undergo interviews to determine additional barriers and facilitators to HCV care. The output of these interviews will be a list of barriers and facilitators to care.
Interviews will be conducted through study completion, an average of 6 months for the selected participants and care providers. Interviews will be collected throughout the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University
National Center for Advancing Translational Sciences (NCATS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

February 4, 2025

Study Completion (Actual)

February 4, 2025

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-21-1472
  • UL1TR003015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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