EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV

Hepatitis C Clinical Trial

— EPIC  

Official title:

EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412017
• Other study ID #: IN-CA-987-5735
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2024
• Source: Cool Aid Community Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to provide informed consent

2. Age > 18 years old

3. 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Diagnostic Test:
• Hepatitis C Point of Care Testing and Treatment
Pharmacy led hepatitis C point of care testing

Locations

Country	Name	City	State
Canada	Cool Aid Community Health Centre	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cool Aid Community Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks