NCT07095192 Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada
| NCT ID | NCT07095192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | HCV |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-05-20 with a primary completion date of 2027-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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
Contact & Investigator
Guillaume Fontaine, RN, PhD
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT07095192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07095192 currently recruiting?
Yes, NCT07095192 is actively recruiting participants. Contact the research team at meagan.mooney@mail.mcgill.ca for enrollment information.
Where is the NCT07095192 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Montreal, Canada, Montreal, Canada and 8 additional locations.
Who is sponsoring the NCT07095192 clinical trial?
NCT07095192 is sponsored by McGill University. The principal investigator is Guillaume Fontaine, RN, PhD at McGill University. The trial plans to enroll 300 participants.