Pharmacist-led Hepatitis C Management (PHARM-C)
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|ClinicalTrials.gov Identifier: NCT04322981|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection||Behavioral: Pharmacist-Led care Behavioral: Standard of Care (Hepatology)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Screening, evaluation and treatment at an outpatient pharmacy compared to referral to hepatology clinics|
|Masking:||None (Open Label)|
|Official Title:||Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Community Pharmacist-Led
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.
Behavioral: Pharmacist-Led care
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
Active Comparator: Academic hepatology
Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.
Behavioral: Standard of Care (Hepatology)
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
- Intention to treat by Completion Rates [ Time Frame: 24 months ]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).
- Sustained Virologic Response by Intention-to-Treat [ Time Frame: 24 months ]Compare Sustained Virologic Response rates by Intention to treat in both sites.
- Sustained Virologic Response by modified Intention-to-Treat [ Time Frame: 24 months ]Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)
- Sustained Virologic Response by Per Protocol analysis [ Time Frame: 24 months ]Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.
- Hepatitis C Community seroprevalence in downtown Toronto [ Time Frame: 18 months ]Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
- Community Pharmacist Fibrosis Identification [ Time Frame: 18 months ]Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
- Community Pharmacist Decompensation Identification [ Time Frame: 18 months ]Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
- Minimum Mean Time-to-Treatment [ Time Frame: 18 months ]Determine the minimum mean time-to-treatment initiation in both groups
- Community Appointment Adherence [ Time Frame: 24 months ]Assess appointment adherence in both arms
- Medication Adherence [ Time Frame: 18 months ]Assess self-reported medication adherence at both sites
- Quality of Life and Substance Use [ Time Frame: 24 months ]Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.
- Substance Use [ Time Frame: 24 months ]Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
- Patient Understanding and Satisfaction [ Time Frame: 24 months ]Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
- Reinfection [ Time Frame: 24 months ]Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
- Patient empowerment [ Time Frame: 24 months ]Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322981
|Contact: Mia Biondi, PhD, NP-PHCemail@example.com|
|Contact: Jordan Feld, MD, MPHfirstname.lastname@example.org|