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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcGill University

About this trial

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.

Eligibility criteria

Qualifiers

Individuals aged ≥18 years who have a risk factor for HCV acquisition or are attending a site that provides services to people with an HCV acquisition risk.

Service providers and managers who are currently employed at a site providing HCV-related services, involved in or supervising the delivery of HCV-related services.

Policymaker must hold a position in local, provincial, or national government or a health authority that influences HCV testing/treatment policies and be able to provide insights into the strategic planning and funding for HCV care.

Laboratory and quality assurance stakeholders must hold a role in laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level.

Disqualifiers

Younger than 18 years old

Trial design

Treatments tested in this trial

  • Preimplementation of HCV Point of care testing

Treatment groups

300 Participants
are divided into 4 treatment groups

Sponsors and collaborators

McGill University

Lead sponsor

The University of New South Wales

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Jewish General Hospital

Collaborator

University of British Columbia

Collaborator

British Columbia Centre for Disease Control

Collaborator

University of Toronto

Collaborator

York University

Collaborator

Ottawa Hospital Research Institute

Collaborator

University of Ottawa

Collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Collaborator

Lady Davis Institute

Collaborator

International Network on Health and Hepatitis in Substance Users

Collaborator

Public Health Agency of Canada (PHAC)

Collaborator

Canadian Association of People who Use Drugs

Collaborator

Action Hepatitis Canada

Collaborator

Canadian Liver Foundation

Collaborator

CATIE

Collaborator

Canadian Network on Hepatitis C

Collaborator