Hepatitis C
Conditions
Keywords
Hepatitis C, Telehealth, Injection Drug Use
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.
Interventions
OTHERHepatitis C treatment as chosen by provider
Participants' providers will determine the type of HCV treatment as appropriate.
Sponsors
Gilead Sciences
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Contacts
Primary ContactRebecca Dillingham, MD
Backup ContactChelsea Canan, PhD
Outcome results
None listed