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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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 sites (12)

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