RecruitingNCT07095192

Scaling Up Point-of-Care 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


Sponsor

McGill University

Enrollment

300 participants

Start Date

May 20, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to expand access to rapid point-of-care (POC) testing and same-day treatment for hepatitis C virus (HCV) across Canada — particularly for people who are at risk of infection but may not access traditional healthcare settings. Researchers are also gathering feedback from healthcare providers, policymakers, and lab specialists to understand how to scale this approach nationally. **You may be eligible if...** - You are 18 years or older AND at least one of the following applies: - You have a risk factor for hepatitis C (e.g., past or current injection drug use) - You attend a site that serves people at risk for hepatitis C - You are a healthcare worker or manager at a site offering HCV services - You are a government or health authority policymaker involved in HCV testing or treatment decisions - You work in laboratory services or regulatory oversight of point-of-care testing **You may NOT be eligible if...** - You are younger than 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPreimplementation of HCV Point of care testing

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


Locations(12)

Anonyme L'Unite D'Intervention

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Indigenous Health Centre of Tiohtià:ke

Montreal, Quebec, Canada

L'Anonyme

Montreal, Quebec, Canada

Centre de réadaptation en dépendance de Québec (CRDQ)

Québec, Quebec, Canada

Medicins du Monde

Montreal, Canada

Okanagan prison

Okanagan, Canada

SABSA Cooperative

Québec, Canada

Sioux Lookout First Nation Health Authority

Sioux Lookout, Canada

Ontario - Provincial correction

Toronto, Canada

Rapid Access Addiction Clinic St Paul's Hospital

Vancouver, Canada

Maamwesying North Shore Community Health Services

Wawa, Canada

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NCT07095192


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