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PHARM-C
Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
Sponsor study identifier
interventional
108
1 country
1
Study Start
April 13, 2022
Actual (reported)Primary Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade. Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use. Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap. Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care. Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings. While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight. If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues. The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 20, 2020
Actual (reported)March 26, 2020
Actual (reported)April 13, 2022
Actual (reported)June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intention to treat by Completion Rates
Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).
24 months
Sustained Virologic Response by Intention-to-Treat
24 months
Sustained Virologic Response by modified Intention-to-Treat
24 months
Sustained Virologic Response by Per Protocol analysis
24 months
Hepatitis C Community seroprevalence in downtown Toronto
18 months
Community Pharmacist Fibrosis Identification
18 months
Patients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight.
Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
Specialty Rx Solutions
Toronto, Ontario, M4Y 1G7, Canada
First Submitted
February 20, 2020
First Posted
March 26, 2020
Study Start
April 13, 2022
Actual (reported)Primary Completion
June 1, 2023
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 27, 2022
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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