Recruiting

Point-of-Care Testing

Sponsor:

McGill University

Code:

NCT07095192

Conditions

HCV

HEPATITIS C VIRUS CHRONIC INFECTION

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preimplementation of HCV Point of care testing

Study Details

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.

Conditions

HCV

HEPATITIS C VIRUS CHRONIC INFECTION

Study ID

NCT07095192

Start date

May 20, 2025

Status verified date

Jul, 2025

Completion date

Sep 20, 2028

Anticipated

Primary completion date

Jun 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Preimplementation of HCV Point of care testing

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

Primary outcome measure

  • Measure Barriers and facilitators based on the CFIR Constructs [ Time Frame: 1 year ]
  • Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 2) [ Time Frame: 1 year ]
  • Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 3) [ Time Frame: 1 year ]
  • Sustainability of Point-of-Care Testing Strategies using the Time-driven activity-based costing (TDABC) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Anonyme L'Unite D'Intervention

Recruiting

Montreal, Quebec, Canada, H1N 1W2

Contacts

Principal Investigator:

Mia PhD, NP-PHC, RN, PhD

L'Anonyme

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Guillaume Fontaine, RN, PhD

More Information

Sponsor

McGill University

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • HCV
  • Hepatitis C Virus Chronic Infection
  • Rapid point-of-care testing
  • Implementation science
  • Knowledge translation
  • Marginalized populations
  • Infectious diseases
  • Barriers and facilitators
  • Implementation strategies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2025-07-31.