Skip to main content
OpenTrials
Completed

NCT Number: NCT05397067

Linkage to Care for Persons With Hep C 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer specialist (PS)

Behavioral

These participants will receive PRS support

Incentives

Behavioral

These participants will receive incentives

telehealth visits

Behavioral

These participants will receive telehealth visits

phone access

Behavioral

These participants will receive pre-paid phones

Primary outcomes

  1. Number of Participants With Attendance at First Appointment

    Time frame: Through study completion, within 6 months of diagnosis

    Number of participants who attended their first hepatitis C treatment appointment following diagnosis. Results are reported by study phase (time-based arms)

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 31, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.