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
This trial does not accept healthy volunteersQualifiers
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 population
Adults at risk of HCV (current/past injecting drug use, current/previous incarceration, HIV, having a tattoo/piercing in an unregulated environment). Providers (e.g., physicians, nurses, harm reduction workers, street workers) and managers who work with those at risk of HCV, involved in or supervising the delivery of HCV-related services. Decision-makers: People who hold a position in local, provincial, or national government, health authority, or another organization that influences HCV testing and treatment policies and be able to provide insights into the strategic planning and funding for HCV care. Laboratory and quality assurance stakeholders: People who provide laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Preimplementation of HCV Point of care testing
Other interventionExploring the pre-implementation of HCV Point of care antibody and RNA tests
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Consumers1 intervention
Group B: Provider and manager1 intervention
Group C: Decision-maker1 intervention
Group D: Laboratory and quality assurance stakeholder1 intervention
Trial outcomes
Primary outcomes
1
Measure Barriers and facilitators based on the CFIR Constructs
Using the ERIC Taxonomy and the CFIR-ERIC Matching Tool, we will link identified barriers and facilitators to evidence-based implementation strategies. The ERIC Taxonomy includes 73 strategies across 9 clusters, such as training stakeholders, supporting clinicians, engaging consumers, and changing infrastructure. This step will produce a matrix that maps each barrier and facilitator to one or more relevant strategies.
Time frame
1 year2
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 2)
The questionnaire adapts the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) to assess acceptability and feasibility. Each strategy is evaluated with 8 Likert-scale questions (1-5). Data will be aggregated as mean scores, with higher scores (minimum score: 8, maximum score: 40) indicating greater perceived acceptability/feasibility.
Time frame
1 year3
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 3)
The questionnaire adapts the Organizational Readiness for Implementing Change (ORIC) tool to assess feasibility by evaluating if the organization has the commitment and confidence in its ability to implement change. Feasability is assessed through with 12 Likert-scale questions (1-5, minimum score: 12, maximum score: 60)
Time frame
1 year4
Sustainability of Point-of-Care Testing Strategies using the Time-driven activity-based costing (TDABC)
Time-driven activity-based costing methodology will guide assessment of costs incurred by health resource use during the patient care cycle to determine the sustainability of the point-of-care testing. This will be done by: 1) determining the frequency, capacity, and average duration of each implementation action by actors, as well as actors' total time spent on each action; 2) determine the price per hour of each actor; 3) determine non-personnel, fixed resources, and their associated expenses; 4) creation and use of a TDABC resource costing matrix to blueprint site-specific implementation processes and calculate total costs;
Time frame
1 yearSponsors and contacts
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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
Source ClinicalTrials.gov