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

Recruiting now

Conditions studied: HCV, HEPATITIS C VIRUS CHRONIC INFECTION

In brief

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.

Key facts

Study ID

NCT07095192

Run by

McGill University

People needed

300

Starts

2025-05-20

Expected to finish

2028-09-20

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• L'Anonyme — Montreal, Quebec, Canada (enrolling)
• Anonyme L'Unite D'Intervention — Montreal, Quebec, Canada (enrolling)
• Indigenous Health Centre of Tiohtià:ke — Montreal, Quebec, Canada
• Centre de réadaptation en dépendance de Québec (CRDQ) — Québec, Quebec, Canada
• Medicins du Monde — Montreal, Canada
• Okanagan prison — Okanagan, Canada
• SABSA Cooperative — Québec, Canada
• Sioux Lookout First Nation Health Authority — Sioux Lookout, Canada
• Ontario - Provincial correction — Toronto, Canada
• Rapid Access Addiction Clinic St Paul's Hospital — Vancouver, Canada
• Maamwesying North Shore Community Health Services — Wawa, Canada
• McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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