Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Hepatitis C treatment as chosen by provider


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>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<br>* Participants' providers will determine the type of HCV treatment as appropriate.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Telehealth, Injection Drug Use