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

Recruiting

• Conditions: HCV; HEPATITIS C VIRUS CHRONIC INFECTION

• Registration Number: NCT07095192
• Lead Sponsor: McGill University

Brief 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.

Detailed Description

Hepatitis C virus (HCV) infection is a major public health threat in Canada (\~204,000 people living with HCV in 2019. HCV therapies with cure \>95% are one of the greatest medical advances in decades and have led the WHO to set a goal to eliminate HCV by 2030. In Canada, achieving elimination will require significant increases in diagnoses and treatment . A major barrier to increasing uptake of HCV testing/treatment is that the current diagnostic pathway requires multiple visits (an HCV antibody test to confirm exposure, an HCV RNA test to confirm current infection, and one or more assessments to start treatment) leading to loss to follow-up and delays in treatment. This is amplified in populations with the highest HCV burden, including people who inject drugs (85% of new infections; 46.1% prevalence) and those in prison (10.7% prevalence). People who inject drugs face barriers to accessing HCV care including stigma/discrimination (leading to avoidance of healthcare), inadequate health service access, and poor venous access (making blood collection for testing difficult), whereas people in prison are often released prior to their antibody or RNA result (2, 4, 5). There is an urgent need to leverage innovations to streamline the diagnostic pathway and enhance access to testing/treatment.

The introduction of finger-stick tests capable of detecting HCV antibodies (results: 5-20 minutes) and HCV RNA (results: 60 minutes) at the point-of-care has revolutionized the clinical approach to HCV. These point-of-care tests enable diagnosis and treatment in a single visit, increase testing acceptability, and reduce loss to follow-up. Research by our team has demonstrated excellent technical accuracy and clinical utility of these tests, with pilot studies showing high treatment uptake compared to standard diagnostic approaches, informing recommendation in the 2022 WHO Guidelines and their forthcoming approval by Health Canada. Our team has developed a program for the implementation of point-of-care HCV testing in Australia, resulting in rapid national scale-up across 90 sites, with 20,000 tests and \>1,500 people treated (79% treatment uptake; 93% in prisons).

Point-of-care HCV antibody and RNA testing is a 'game-changing' solution to address a critical gap in care and increase equity in healthcare access, particularly for marginalized groups, as we seek to achieve our national elimination targets. The impact of point-of-care testing will be greatest in high HCV prevalence settings (those caring for people who inject drugs), such as needle and syringe programs, drug treatment, prisons, and outreach settings. However, implementation challenges persist, including quality assurance and integration of point-of-care tests into diverse laboratory/public health surveillance frameworks. A systematic, implementation science-based approach is essential to comprehensively identify factors that will limit or enable point-of-care HCV testing within the Canadian context. This is critical for developing specific implementation strategies that address barriers and amplify facilitators to point-of-care testing, and informing changes to health service delivery, guidelines, and provincial and national strategies.

Study Timeline

• Study Start: 2025-05-20
• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2027-06-20
• Study Completion: 2028-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• Younger than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure Barriers and facilitators based on the CFIR Constructs	1 year	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.
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 2)	1 year	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.
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 3)	1 year	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)
Sustainability of Point-of-Care Testing Strategies using the Time-driven activity-based costing (TDABC)	1 year	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;

Trial Locations

Locations (12)

Anonyme L'Unite D'Intervention; 🇨🇦 Montreal, Quebec, Canada

McGill University; 🇨🇦 Montréal, Quebec, Canada

Indigenous Health Centre of Tiohtià:ke; 🇨🇦 Montréal, Quebec, Canada

L'Anonyme; 🇨🇦 Montréal, Quebec, Canada

Centre de réadaptation en dépendance de Québec (CRDQ); 🇨🇦 Quebec city, Quebec, Canada

Medicins du Monde; 🇨🇦 Montréal, Canada

Okanagan prison; 🇨🇦 Okanagan, Canada

SABSA Cooperative; 🇨🇦 Québec, Canada

Sioux Lookout First Nation Health Authority; 🇨🇦 Sioux Lookout, Canada

Ontario - Provincial correction; 🇨🇦 Toronto, Canada

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