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

NCT07095192 | Recruiting

• 2 other identifiers: 24-12-038PJT- 517467
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

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. 1.Map current hepatitis C care processes and explore how point-of-care testing could fit into these models;
2. 2.Identify barriers and facilitators to implementing point-of-care hepatitis C testing across settings and provinces;
3. 3.Co-design tools and strategies (such as training guides, standard procedures) to support point-of-care testing;
4. 4.Assess feasibility, acceptability, and costs of the co-designed tools and strategies.

Conditions

HCV; HEPATITIS C VIRUS CHRONIC INFECTION

Keywords

HCV; Hepatitis C Virus Chronic Infection; Rapid point-of-care testing; Implementation science; Knowledge translation; Marginalized populations; Infectious diseases; Barriers and facilitators; Implementation strategies

Outcome Measures

Primary Outcomes (4)

• 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.

  1 year

• 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.

  1 year

• 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)

  1 year

• 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;

  1 year

Study Arms (4)

Consumers

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

Other: Preimplementation of HCV Point of care testing

Provider and manager

Participants must be currently employed at one of the research sites and involved in or supervising the delivery of HCV-related services.

Other: Preimplementation of HCV Point of care testing

Decision-maker

Participants must 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.

Other: Preimplementation of HCV Point of care testing

Laboratory and quality assurance stakeholder

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

Other: Preimplementation of HCV Point of care testing

Interventions

Preimplementation of HCV Point of care testing OTHER

Exploring the pre-implementation of HCV Point of care antibody and RNA tests

Consumers; Decision-maker; Laboratory and quality assurance stakeholder; Provider and manager

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years old

Sponsors & Collaborators

• McGill University: lead
• 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

Study Sites (12)

Anonyme L'Unite D'Intervention

Montreal, Quebec, H1N 1W2, Canada

RECRUITING

McGill University

Montreal, Quebec, H3S 1L8, Canada

ACTIVE NOT RECRUITING

Indigenous Health Centre of Tiohtià:ke

Montreal, Quebec, Canada

NOT YET RECRUITING

L'Anonyme

Montreal, Quebec, Canada

RECRUITING

Centre de réadaptation en dépendance de Québec (CRDQ)

Québec, Quebec, Canada

NOT YET RECRUITING

Medicins du Monde

Montreal, Canada

NOT YET RECRUITING

Okanagan prison

Okanagan, Canada

NOT YET RECRUITING

SABSA Cooperative

Québec, Canada

NOT YET RECRUITING

Sioux Lookout First Nation Health Authority

Sioux Lookout, Canada

NOT YET RECRUITING

Ontario - Provincial correction

Toronto, Canada

NOT YET RECRUITING

Rapid Access Addiction Clinic St Paul's Hospital

Vancouver, Canada

NOT YET RECRUITING

Maamwesying North Shore Community Health Services

Wawa, Canada

NOT YET RECRUITING

Related Publications (1)

• Mooney M, Weight C, Biondi MJ, Grebely J, Kronfli N, Barnett T, Bruneau J, Dunn K, Elakpa DN, Etherington C, Greenaway C, Martel-Laferriere V, Mendlowitz A, Taylor N, Fontaine G. Scaling up point-of-care hepatitis C testing in Canada: protocol for a multilevel implementation science study of clinical processes, barriers, facilitators and implementation strategies (SCALE-POCT study). Implement Sci Commun. 2025 Dec 18. doi: 10.1186/s43058-025-00837-3. Online ahead of print.

  PMID: 41408357 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume Fontaine, RN, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meagan Mooney, RN, MA, BSc

CONTACT

514-994-9298; meagan.mooney@mail.mcgill.ca

Charlene Weight, MSc, BSc

CONTACT

5142340348; charlene.weight@mail.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 31, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): September 20, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)