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Linkage to Care for Persons With Hep C Infection

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397067
Enrollment
60
Registered
2022-05-31
Start date
2022-07-12
Completion date
2025-02-04
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic, Substance Use Disorders

Keywords

Hepatitis C, Substance use disorder, Linkage to care

Brief 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 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.

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.

Interventions

BEHAVIORALPeer specialist (PS)

These participants will receive PRS support

BEHAVIORALIncentives

These participants will receive incentives

These participants will receive telehealth visits

BEHAVIORALphone access

These participants will receive pre-paid phones

Sponsors

Carilion Clinic
Lead SponsorOTHER
Virginia Polytechnic Institute and State University
CollaboratorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This study used a quasi-experimental, sequential (interrupted time-series) design. Participants were assigned to one of four time-based cohorts based on when they were enrolled: (1) pre-implementation (standard of care), (2) arm 2 ntervention phase including peer specialist support and incentives (3) intervention phase including peer specialist support and incentives with telehealth, and (4) enhanced intervention phase including peer specialist support, incentives, telehealth, and phone access.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026