Scaling up same‑visit hepatitis C testing and treatment in Canada
Official title: 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
Run by McGill University · NCT07095192 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | McGill University Academic / other |
| Locations | 12 sites (Montreal, Quebec and 11 other locations) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | June 20, 2027 |
| Study ends | September 20, 2028 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT07095192 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Anonyme L'Unite D'Intervention
Montreal, Quebec, Canada Recruiting -
L'Anonyme
Montreal, Quebec, Canada Recruiting -
McGill University
Montreal, Quebec, Canada Active not recruiting -
Indigenous Health Centre of Tiohtià:ke
Montreal, Quebec, Canada Not yet recruiting -
Centre de réadaptation en dépendance de Québec (CRDQ)
Québec, Quebec, Canada Not yet recruiting -
Medicins du Monde
Montreal, Canada Not yet recruiting
Show 6 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.