Scaling up same‑visit hepatitis C testing and treatment in Canada
Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada: A Multilevel Implementation Science Study of Clinical Processes, Barriers, Facilitators and Implementation Strategies
This project will test whether offering rapid on-site hepatitis C antibody and RNA tests in settings that serve people at risk can speed diagnosis and enable earlier treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 12 sites (Montreal, Quebec and 11 other locations) |
| Trial ID | NCT07095192 on ClinicalTrials.gov |
What this trial studies
This observational implementation project maps current hepatitis C testing and treatment workflows, identifies barriers and facilitators, and co-designs practical tools with stakeholders to support point-of-care testing. The team will work across key settings that serve people at higher risk (e.g., harm-reduction sites, correctional settings, Indigenous health centres) to pilot integration of rapid antibody and RNA tests. Methods include process mapping, qualitative interviews with patients, providers and policymakers, and development of implementation strategies and knowledge-translation resources. Findings will inform national scale-up plans for single-visit diagnosis and treatment initiation.
Who should consider this trial
Good fit: Adults (≥18 years) who have risk factors for hepatitis C or who attend participating sites serving people at risk are the primary candidates, alongside service providers, laboratory stakeholders and policymakers involved in HCV care.
Not a fit: People under 18, those without HCV risk and individuals who cannot access participating sites are unlikely to receive direct benefit from this project.
Why it matters
Potential benefit: If successful, the approach could enable same-day diagnosis and faster treatment starts, reducing loss to follow-up and improving cure rates in high-risk groups.
How similar studies have performed: Smaller studies of point-of-care HCV antibody and RNA testing have shown promise for same-visit diagnosis, but large-scale implementation evidence across diverse settings remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec and 11 other locations
- Anonyme L'Unite D'Intervention — Montreal, Quebec, Canada (Recruiting)
- McGill University — Montreal, Quebec, 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)
Study contacts
- Principal investigator: Guillaume Fontaine, RN, PhD — McGill University
- Study coordinator: Meagan Mooney, RN, MA, BSc
- Email: meagan.mooney@mail.mcgill.ca
- Phone: 514-994-9298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.