Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia

• Conditions: Hepatitis C
• Interventions: Other: Hepatitis C treatment as chosen by provider

• Registration Number: NCT03876470
• Lead Sponsor: University of Virginia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Study Start: 2019-05-15
• Primary Completion: 2020-11
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Hepatitis C treatment as chosen by provider	All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.

Primary Outcome Measures

Name	Time	Method
Cohort-level Hepatitis C Treatment Progress	12 months	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

Secondary Outcome Measures

Name	Time	Method
Patient Reported Quality-of-Life	12 months	Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response
Depression	12 months	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.
Semi-Structured Qualitative Interview about Impact of HCV Treatment	12 months	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
Health-Related Quality-of-Life	12 months	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.