Back to resultsEPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV (EPIC)
Primary Purpose
Hepatitis C
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hepatitis C Point of Care Testing and Treatment
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis C focused on measuring hepatitis C, Pharmacy, Testing
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Age > 18 years old
- Documented HCV RNA test, interested in being tested for HCV antibody or at risk for HCV (ie. "Baby boomers": anyone born between 1945-1965, anyone known to currently (past 6 months) or have a history of injecting drugs, including anyone receiving Opiate Agonist Therapy (OAT), any gay or bisexual men who have sex with men (gbMSM))
Exclusion Criteria:
1) Declined to provide informed consent
Sites / Locations
- Cool Aid Community Health Centre
Outcomes
Primary Outcome Measures
HCV access to care for HCV testing and treatment
Number of patients tested for hepatitis C (HCV) antibodies through through the use of rapid diagnostic testing technologies by trained pharmacy staff that are found positive for HCV RNA and treated for HCV
Secondary Outcome Measures
Full Information
NCT ID
NCT05412017
First Posted
May 3, 2022
Last Updated
February 9, 2023
Sponsor
Cool Aid Community Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT05412017
Brief Title
EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
Acronym
EPIC
Official Title
EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cool Aid Community Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research project aims to understand how pharmacies can be involved in the identification and treatment of hepatitis C (hep C). The study will look at the effectiveness of hep C testing and treatment through pharmacies with support from the Cool Aid Community Health Centre (CACHC). The study will also evaluate the readiness of pharmacies to take on these extra tasks at the pharmacy. This information will be used to develop future strategies to better detect, treat and prevent hep C.
Detailed Description
The primary objective of this project is to decrease barriers to care for hepatitis C (HCV) treatment for people who use drugs through the use of rapid diagnostic testing technologies, and task shifting HCV testing and treatment follow up to include trained pharmacy staff. Secondary objectives are to evaluate interest, readiness, and effectiveness of community-based pharmacies as a location for the screening and treatment of HCV.
A prospective, longitudinal interventional cohort design will be used to enrol people who access community-based pharmacies and have tested for HCV RNA. Persons with untreated chronic HCV infection will receive direct acting antiviral treatment. This is a trial of pharmacist-led HCV testing and treatment versus conventional care in HCV positive patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis C, Pharmacy, Testing
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Hepatitis C Point of Care Testing and Treatment
Intervention Description
Pharmacy led hepatitis C point of care testing
Primary Outcome Measure Information:
Title
HCV access to care for HCV testing and treatment
Description
Number of patients tested for hepatitis C (HCV) antibodies through through the use of rapid diagnostic testing technologies by trained pharmacy staff that are found positive for HCV RNA and treated for HCV
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
Age > 18 years old
Documented HCV RNA test, interested in being tested for HCV antibody or at risk for HCV (ie. "Baby boomers": anyone born between 1945-1965, anyone known to currently (past 6 months) or have a history of injecting drugs, including anyone receiving Opiate Agonist Therapy (OAT), any gay or bisexual men who have sex with men (gbMSM))
Exclusion Criteria:
1) Declined to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Fraser, MD
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cool Aid Community Health Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8W 1M8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
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