Hepatitis CEPICNCT05412017
EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
A study testing Hepatitis C Point of Care Testing and Treatment in people with Hepatitis C, run by Cool Aid Community Health Centre at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C Point of Care Testing and Treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jul 2020to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 1) Declined to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cool Aid Community Health Centre
Victoria, British Columbia, V8W 1M8
About this study
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C Point of Care Testing and Treatment
- Keywords
- hepatitis C, Pharmacy, Testing
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C Point of Care Testing and TreatmentDiagnostic test
Pharmacy led hepatitis C point of care testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start13 Jul 2020
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cool Aid Community Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Fraser, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412017
- Sponsor's protocol ID
- IN-CA-987-5735
- Acronym
- EPIC
- Status last verified
- Feb 2024
- First submitted
- 3 May 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
- ClinicalTrials.gov ID
- NCT05412017
- Acronym / sponsor ID
- EPIC / IN-CA-987-5735
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, Pharmacy, Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cool Aid Community Health CentreUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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))
Key exclusion criteria (1 listed)
- 1) Declined to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C Point of Care Testing and TreatmentPharmacy led hepatitis C point of care testing | Diagnostic test | – |
Primary outcome
HCV access to care for HCV testing and treatment
Time frame: 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Fraser, MD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis C Point of Care Testing and Treatment in people with Hepatitis C, run by Cool Aid Community Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV access to care for HCV testing and treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.