Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia (CHIME)

Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs

The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.

Study Overview

• Status: Unknown
• Conditions: Hepatitis C
• Intervention / Treatment: Other: Hepatitis C treatment as chosen by provider

Detailed Description

The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Rebecca Dillingham, MD; Phone Number: 4349820103; Email: RD8V@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Chelsea Canan, PhD; Phone Number: 4349241987; Email: CC4WD@hscmail.mcc.virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.

Description

Inclusion Criteria:

• 18 years or older
• Detectable HCV viral load
• Attended a clinic appointment at one of our participating sites

Exclusion Criteria:

• Cognitive disability such that informed consent cannot be obtained
• Prisoners
• Unable to understand English

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.	Other: Hepatitis C treatment as chosen by provider; Participants' providers will determine the type of HCV treatment as appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort-level Hepatitis C Treatment Progress	Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Quality-of-Life	Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response	12 months
Depression	Change in Patient Health Questionnaire-2 (PHQ-2) scores from treatment initiation to treatment completion and sustained virologic response. Scale range: 0 to 6 with a higher score indicative of greater depressive symptoms.	12 months
Health-Related Quality-of-Life	Change in Chronic Liver Disease Questionnaire: Hepatitis C version (CLDQ-HCV) scores from treatment initiation to treatment completion and sustained virologic response. Scores range from 1 to 7 with higher scores indicative of better quality of life. CLDQ-HCV includes a total score and 4 sub-scales (activity/energy, emotional, worry, and systemic), each scored from 1 to 7.	12 months
Semi-Structured Qualitative Interview about Impact of HCV Treatment	Qualitative assessment of participants' experience with HCV treatment, including its impact on substance use behaviors, activities of daily living, social interactions, and mental and physical health	12 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Rebecca Dillingham, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Telehealth; Hepatitis C; Injection Drug Use
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 21167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No