NCT04322981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 27, 2022

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

February 20, 2020

Last Update Submit

April 19, 2022

Conditions

Hepatitis C Virus Infection

Keywords

Point-of-care testingRapid access to treatmentPharmacist-ledService co-localization

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

Community Pharmacist-Led

EXPERIMENTAL

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

Academic hepatology

ACTIVE COMPARATOR

Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.

Behavioral: Standard of Care (Hepatology)

Interventions

Pharmacist-Led careBEHAVIORAL

Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led

Community Pharmacist-Led
Standard of Care (Hepatology)BEHAVIORAL

Rapid testing in a community pharmacy, with standard of care referral to academic hepatology

Academic hepatology

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV infection
  • HCV RNA \> 1,000 IU/mL
  • Aged 18 to 80
  • Willingness and capacity to provide informed consent

You may not qualify if:

  • 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.
  • Platelets \< 75,000/mm3, total albumin \<35 g/L, total bilirubin (total and direct) \>34.2 μmol/L, International Normalized Ratio (INR) \>1.5
  • History of current or past hepatocellular carcinoma
  • Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
  • Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
  • Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
  • Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
  • Pregnancy/breast-feeding/inability to use contraception
  • Use of concomitant contraindicated drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialty Rx Solutions

Toronto, Ontario, M4Y 1G7, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Mia Biondi, PhD, NP-PHC

CONTACT

6476286471mia.biondi@mail.mcgill.ca

Jordan Feld, MD, MPH

CONTACT

4163404584jordan.feld@uhn.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Screening, evaluation and treatment at an outpatient pharmacy compared to referral to hepatology clinics
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 26, 2020

Study Start

April 13, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

April 27, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)