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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis C treatment as chosen by provider | Other | Participants' providers will determine the type of HCV treatment as appropriate. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Dillingham, MD | Contact | 4349820103 | RD8V@hscmail.mcc.virginia.edu | |
| Chelsea Canan, PhD | Contact | 4349241987 | CC4WD@hscmail.mcc.virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Dillingham, MD | University of Virginia | Principal Investigator |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| 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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |