Implementation of Low Cost Solutions to Help Facilitate Linkage to Care for Persons With Hepatitis C Virus Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carilion Clinic
- 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
patients receive standard of care
Arm 2
Patients received PRS support + incentive
Intervention: Peer specialist (PS) (Behavioral)
Arm 2
Patients received PRS support + incentive
Intervention: Incentives (Behavioral)
Arm 3
Patients received PRS support + incentive + Telehealth visits
Intervention: Peer specialist (PS) (Behavioral)
Arm 4
Patients received PRS support + incentive + telehealth visit + phone
Intervention: phone access (Behavioral)
Arm 3
Patients received PRS support + incentive + Telehealth visits
Intervention: Incentives (Behavioral)
Arm 3
Patients received PRS support + incentive + Telehealth visits
Intervention: telehealth visits (Behavioral)
Arm 4
Patients received PRS support + incentive + telehealth visit + phone
Intervention: Peer specialist (PS) (Behavioral)
Arm 4
Patients received PRS support + incentive + telehealth visit + phone
Intervention: Incentives (Behavioral)
Arm 4
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
Mariana Gomez
Principal Investigator
Carilion Clinic
