Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia
CHIME
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
1 other identifier
observational
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedApril 17, 2019
April 1, 2019
1.5 years
February 25, 2019
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Patient Reported Quality-of-Life
12 months
Depression
12 months
Health-Related Quality-of-Life
12 months
Semi-Structured Qualitative Interview about Impact of HCV Treatment
12 months
Study Arms (1)
All Participants
All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.
Interventions
Participants' providers will determine the type of HCV treatment as appropriate.
Eligibility Criteria
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.
You may qualify if:
- years or older
- Detectable HCV viral load
- Attended a clinic appointment at one of our participating sites
You may not qualify if:
- Cognitive disability such that informed consent cannot be obtained
- Prisoners
- Unable to understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- Gilead Sciencescollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Dillingham, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Center for Global Health
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 15, 2019
Study Start
May 15, 2019
Primary Completion
November 1, 2020
Study Completion
November 30, 2020
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share