Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia

Hepatitis C Clinical Trial

— CHIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03876470
• Other study ID #: 21167
• Status: Not yet recruiting
• Start date: May 15, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2019
• Source: University of Virginia
• Contact: Rebecca Dillingham, MD
• Phone: 4349820103
• Email: RD8V[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 30, 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• Hepatitis C treatment as chosen by provider
Participants' providers will determine the type of HCV treatment as appropriate.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Gilead Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Reported Quality-of-Life	Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response	12 months
Secondary	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
Secondary	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
Secondary	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