Linkage to Care for Persons with Hep C Infection

NCT05397067 | Completed

• 2 other identifiers: IRB-21-1472UL1TR003015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 same year, the situation was even more dire in Roanoke City which had a rate of 524/100,000 adults. Treatment with antiviral medication is curative and well tolerated. However, gaps remain in the ability of the health system to engage the most vulnerable patients to start and complete treatment. People with HCV infection usually are unaware of the infection, which allows the disease to progress to liver damage, liver cancer and death if left untreated.At each stage of the screening, testing, and treatment process, there is significant patient loss to follow-up. Drop-off most commonly occurs between diagnosis and the first visit to a treating provider. Key barriers to successful engagement include: 1) communication issues, such as lack of phone or limited phone access; 2) lack of transportation; 3) significant social issues such as poverty; 4) substance use disorder; and 5) a limited understanding of the consequences of untreated HCV infection. In this mixed-method design, the investigators propose a pilot study that will provide education and resources, such as vouchers for phone, transportation, and meals, to the most vulnerable patients that will facilitate engagement in treatment as additional factors that may influence dropout rates are evaluated.

Conditions

Hepatitis C, Chronic; Substance Use Disorders

Keywords

Hepatitis C; Substance use disorder; Linkage to care

Outcome Measures

Primary Outcomes (1)

• Attendance at first appointment

  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 Outcomes (1)

• Semi-structured qualitative interviews

  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.

Study Arms (2)

Peer specialist and Vouchers

EXPERIMENTAL

Intervention arm

Behavioral: Peer specialist (PS) and vouchers

Standard of care

NO INTERVENTION

Interventions

Peer specialist (PS) and vouchers BEHAVIORAL

this participants will receive vouchers from PS

Peer specialist and Vouchers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Substance-Related Disorders; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two types of intervention will be tested. The first is the provision of a Peer Specialist (PS), and the second is the use of vouchers (food, transportation, phone)

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 31, 2022
• Study Start: July 12, 2022
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)