Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada

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.

NCT Number	NCT07095192
Lead Sponsor	McGill University Collaborators: The University of New South Wales, Canadian Institutes of Health Research (CIHR), Jewish General Hospital, University of British Columbia, British Columbia Centre for Disease Control, University of Toronto, York University, Ottawa Hospital Research Institute, University of Ottawa, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Lady Davis Institute, International Network on Health and Hepatitis in Substance Users, Public Health Agency of Canada (PHAC), Canadian Association of People who Use Drugs, Action Hepatitis Canada, Canadian Liver Foundation, CATIE, Canadian Network on Hepatitis C
Conditions	HCV, HEPATITIS C VIRUS CHRONIC INFECTION
Enrollment	300 participants
Start Date	2025-05-20
Primary Completion	2027-06-20 (estimated)
Study Completion	2028-09-20 (estimated)
Updated on ClinicalTrials.gov	2025-07-31