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Pharmacist-led Hepatitis C Management (PHARM-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04322981
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : November 5, 2020
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Behavioral: Pharmacist-Led care Behavioral: Standard of Care (Hepatology) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Sustained Virologic Response by Intention-to-Treat [ Time Frame: 24 months ]
    Compare Sustained Virologic Response rates by Intention to treat in both sites.

  2. 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)

  3. 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.

  4. Hepatitis C Community seroprevalence in downtown Toronto [ Time Frame: 18 months ]
    Determine the seroprevalence of HCV among individuals tested in downtown Toronto.

  5. Community Pharmacist Fibrosis Identification [ Time Frame: 18 months ]
    Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)

  6. Community Pharmacist Decompensation Identification [ Time Frame: 18 months ]
    Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)

  7. Minimum Mean Time-to-Treatment [ Time Frame: 18 months ]
    Determine the minimum mean time-to-treatment initiation in both groups

  8. Community Appointment Adherence [ Time Frame: 24 months ]
    Assess appointment adherence in both arms

  9. Medication Adherence [ Time Frame: 18 months ]
    Assess self-reported medication adherence at both sites

  10. 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.

  11. Substance Use [ Time Frame: 24 months ]
    Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.

  12. Patient Understanding and Satisfaction [ Time Frame: 24 months ]
    Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)

  13. Reinfection [ Time Frame: 24 months ]
    Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.

  14. Patient empowerment [ Time Frame: 24 months ]
    Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. HCV infection
  2. HCV RNA > 1,000 IU/mL
  3. Aged 18 to 80
  4. Willingness and capacity to provide informed consent

Exclusion Criteria:

  1. Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
  2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
  3. History of current or past hepatocellular carcinoma
  4. Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
  5. Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
  6. Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
  7. Significant co-morbid illness that precludes inclusion in the opinion of the investigator
  8. Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
  9. Pregnancy/breast-feeding/inability to use contraception
  10. Use of concomitant contraindicated drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT04322981

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Contact: Mia Biondi, PhD, NP-PHC 6476286471
Contact: Jordan Feld, MD, MPH 4163404584

Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT04322981    
Other Study ID Numbers: 20-5265
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Point-of-care testing
Rapid access to treatment
Service co-localization
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections