Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada
NCT07095192 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-07-31
Summary
The SCALE-POCT study is a national initiative designed to provide robust evidence for scaling up point-of-care hepatitis C testing for key populations. The study seeks to map current hepatitis C clinical processes, identify barriers and facilitators to implementation, and co-design practical tools and strategies in partnership with stakeholders.
A major obstacle to hepatitis C elimination and increasing treatment uptake is the current multi-step diagnostic process, which leads to loss to follow-up and treatment delays, particularly among high-risk groups such as people who inject drugs. Point of-care hepatitis C antibody tests (results: 5-20 mins) and RNA tests (results: 60 mins), could enable single-visit diagnosis, reducing loss to follow-up. However, integrating these tests into key settings presents challenges. The overarching goal of this study is to generate evidence to inform the scale-up point-of-care hepatitis C testing and treatment in key settings in Canada. This study is observational in nature and does not involve the direct implementation of point-of-care hepatitis C testing. Instead, it aims to understand the contextual, procedural, and operational factors that would support its successful adoption and sustainability. By examining existing care models and engaging with key stakeholders, the study seeks to build a foundation for future implementation efforts. Specific objectives include:
1. Map current hepatitis C care processes and explore how point-of-care testing could fit into these models;
2. Identify barriers and facilitators to implementing point-of-care hepatitis C testing across settings and provinces;
3. Co-design tools and strategies (such as training guides, standard procedures) to support point-of-care testing;
4. Assess feasibility, acceptability, and costs of the co-designed tools and strategies.
Conditions
- HCV
- HEPATITIS C VIRUS CHRONIC INFECTION
Interventions
- OTHER
-
Preimplementation of HCV Point of care testing
Exploring the pre-implementation of HCV Point of care antibody and RNA tests
Sponsors & Collaborators
-
The University of New South Wales
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Jewish General Hospital
collaborator OTHER -
University of British Columbia
collaborator OTHER -
British Columbia Centre for Disease Control
collaborator OTHER_GOV -
University of Toronto
collaborator OTHER -
York University
collaborator OTHER -
Ottawa Hospital Research Institute
collaborator OTHER -
University of Ottawa
collaborator OTHER -
McGill University Health Centre/Research Institute of the McGill University Health Centre
collaborator OTHER -
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
collaborator OTHER -
Lady Davis Institute
collaborator OTHER -
International Network on Health and Hepatitis in Substance Users
collaborator UNKNOWN -
Public Health Agency of Canada (PHAC)
collaborator OTHER_GOV -
Canadian Association of People who Use Drugs
collaborator UNKNOWN -
Action Hepatitis Canada
collaborator UNKNOWN -
Canadian Liver Foundation
collaborator UNKNOWN -
CATIE
collaborator UNKNOWN -
Canadian Network on Hepatitis C
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Guillaume Fontaine, RN, PhD · McGill University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-20
- Primary Completion
- 2027-06-20
- Completion
- 2028-09-20
Countries
- Canada
Study Locations
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