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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Anonyme L'Unite D'Intervention
RECRUITING
Montreal
Indigenous Health Centre of Tiohtià:ke
NOT_YET_RECRUITING
Montreal
L'Anonyme
RECRUITING
Montreal
McGill University
ACTIVE_NOT_RECRUITING
Montreal
Medicins du Monde
NOT_YET_RECRUITING
Montreal
Okanagan prison
NOT_YET_RECRUITING
Okanagan
Centre de réadaptation en dépendance de Québec (CRDQ)
NOT_YET_RECRUITING
Québec
SABSA Cooperative
NOT_YET_RECRUITING
Québec
Sioux Lookout First Nation Health Authority
NOT_YET_RECRUITING
Sioux Lookout
Ontario - Provincial correction
NOT_YET_RECRUITING
Toronto
Rapid Access Addiction Clinic St Paul's Hospital
NOT_YET_RECRUITING
Vancouver
Maamwesying North Shore Community Health Services
NOT_YET_RECRUITING
Wawa
Contact Information
Primary
Meagan Mooney, RN, MA, BSc
meagan.mooney@mail.mcgill.ca
514-994-9298
Backup
Charlene Weight, MSc, BSc
charlene.weight@mail.mcgill.ca
5142340348
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2028-09-20
Participants
Target number of participants: 300
Treatments
Consumers
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
Provider and manager
Participants must be currently employed at one of the research sites and involved in or supervising the delivery of HCV-related services.
Decision-maker
Participants must hold a position in local, provincial, or national government, health authority or another organization that influences HCV testing and treatment policies and be able to provide insights into the strategic planning and funding for HCV care.
Laboratory and quality assurance stakeholder
Participants must hold a role in laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Association of People who Use Drugs, Canadian Network on Hepatitis C, McGill University Health Centre/Research Institute of the McGill University Health Centre, The University of New South Wales, University of British Columbia, Canadian Liver Foundation, British Columbia Centre for Disease Control, CATIE, Lady Davis Institute, York University, Public Health Agency of Canada (PHAC), University of Ottawa, International Network on Health and Hepatitis in Substance Users, University of Toronto, Jewish General Hospital, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Ottawa Hospital Research Institute, Action Hepatitis Canada
Leads: McGill University

This content was sourced from clinicaltrials.gov