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

NCT07095192 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-07-31

No results posted yet for this 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.

Conditions

  • HCV
  • HEPATITIS C VIRUS CHRONIC INFECTION

Interventions

OTHER

Preimplementation of HCV Point of care testing

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

Sponsors & Collaborators

  • The University of New South Wales

    collaborator OTHER
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Jewish General Hospital

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • British Columbia Centre for Disease Control

    collaborator OTHER_GOV
  • University of Toronto

    collaborator OTHER
  • York University

    collaborator OTHER
  • Ottawa Hospital Research Institute

    collaborator OTHER
  • University of Ottawa

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    collaborator OTHER
  • Lady Davis Institute

    collaborator OTHER
  • International Network on Health and Hepatitis in Substance Users

    collaborator UNKNOWN
  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV
  • Canadian Association of People who Use Drugs

    collaborator UNKNOWN
  • Action Hepatitis Canada

    collaborator UNKNOWN
  • Canadian Liver Foundation

    collaborator UNKNOWN
  • CATIE

    collaborator UNKNOWN
  • Canadian Network on Hepatitis C

    collaborator UNKNOWN
  • McGill University

    lead OTHER

Principal Investigators

  • Guillaume Fontaine, RN, PhD · McGill University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2027-06-20
Completion
2028-09-20

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095192 on ClinicalTrials.gov