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Clinical Trials/NCT05397067
NCT05397067CompletedNot Applicable

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

Carilion Clinic1 site in 1 country60 target enrollmentStarted: July 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Attendance at first appointment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Arm 1

No Intervention

patients receive standard of care

Arm 2

Experimental

Patients received PRS support + incentive

Intervention: Peer specialist (PS) (Behavioral)

Arm 2

Experimental

Patients received PRS support + incentive

Intervention: Incentives (Behavioral)

Arm 3

Experimental

Patients received PRS support + incentive + Telehealth visits

Intervention: Peer specialist (PS) (Behavioral)

Arm 4

Experimental

Patients received PRS support + incentive + telehealth visit + phone

Intervention: phone access (Behavioral)

Arm 3

Experimental

Patients received PRS support + incentive + Telehealth visits

Intervention: Incentives (Behavioral)

Arm 3

Experimental

Patients received PRS support + incentive + Telehealth visits

Intervention: telehealth visits (Behavioral)

Arm 4

Experimental

Patients received PRS support + incentive + telehealth visit + phone

Intervention: Peer specialist (PS) (Behavioral)

Arm 4

Experimental

Patients received PRS support + incentive + telehealth visit + phone

Intervention: Incentives (Behavioral)

Arm 4

Experimental

Patients received PRS support + incentive + telehealth visit + phone

Intervention: telehealth visits (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariana Gomez

Principal Investigator

Carilion Clinic

Study Sites (1)

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