HCVSCALE POCTNCT07095192
Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada
An observational study of HCV and HEPATITIS C VIRUS CHRONIC INFECTION, run by McGill University at 12 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV, HEPATITIS C VIRUS CHRONIC INFECTION
- What is being tested?
- Preimplementation of HCV Point of care testing
- How many people
- 300 participants
- Where
- 12 sitesCanada
- Study dates
- 20 May 2025to 20 Sep 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults at risk of HCV (current/past injecting drug use, current/previous incarceration, HIV, having a tattoo/piercing in an unregulated environment). Providers (e.g., physicians, nurses, harm reduction workers, street workers) and managers who work with those at risk of HCV, involved in or supervising the delivery of HCV-related services. Decision-makers: People who 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 stakeholders: People who provide laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level.
Who may be able to join
- 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.
Who cannot join
- Younger than 18 years old
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 11 recruiting
- Recruiting
Anonyme L'Unite D'Intervention
Montreal, Quebec, H1N 1W2
Renee Logan, 416-535-8501, renee.logan@camh.ca
Mia PhD, NP-PHC, RN, PhD
- Active, not recruiting
McGill University
Montreal, Quebec, H3S 1L8
- Not yet recruiting
Indigenous Health Centre of Tiohtià:ke
Montreal, Quebec
Carrie Martin, BA, BSW, PhD, 514-482-8557, carrie@ihct.ca
Guillaume Fontaine, RN, PhD
- Recruiting
L'Anonyme
Montreal, Quebec
Nina Micaleff, 514-842-1488, nmicaleff@anonyme.ca
Guillaume Fontaine, RN, PhD
- Not yet recruiting
Medicins du Monde
Montreal
Renee Boucher Beaulieu, 514 281-8998, infirmiers.mtl@medecinsdumonde.ca
Guillaume Fontaine, RN, PhD
- Not yet recruiting
Okanagan prison
Okanagan
Amanda Slaunwhite, PhD, 604 822 2772, amanda.slaunwhite@phsa.ca
Sofia Bartlett, PhD
- Not yet recruiting
Centre de réadaptation en dépendance de Québec (CRDQ)
Québec, Quebec
Ann-Sophie Allard, MD, 418 663-5008, ann-sophie.allard.med@ssss.gouv.qc.ca
Guillaume Fontaine, RN, PhD
- Not yet recruiting
SABSA Cooperative
Québec
Marie-Christine Leclerc, 418 914-9295, responsable.voletsdeservice@sabsa.ca
Guillaume Fontaine, RN, PhD
- Not yet recruiting
Sioux Lookout First Nation Health Authority
Sioux Lookout
(807) 737-5182, privacy@slfnha.com
Mia Biondi, PhD, NP-PHC
- Not yet recruiting
Ontario - Provincial correction
Toronto
Lori Kiefer, 647-302-9916, lori.kiefer@ontario.ca
Mia Biondi, PhD, NP-PHC
- Not yet recruiting
Rapid Access Addiction Clinic St Paul's Hospital
Vancouver
Julia MacIsaac, MD, MPH, ABIM, FRCPC, 604-806-8867, drmacisaacmd@gmail.com
Sofia Bartlett, PhD
- Not yet recruiting
Maamwesying North Shore Community Health Services
Wawa
Richard Sans Cartier, NP, 705-844-2021, privacy@nmninoeyaa.ca
Mia Biondi, PhD, NP-PHC
About this study
Official title: 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
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:
- Map current hepatitis C care processes and explore how point-of-care testing could fit into these models;
- Identify barriers and facilitators to implementing point-of-care hepatitis C testing across settings and provinces;
- Co-design tools and strategies (such as training guides, standard procedures) to support point-of-care testing;
- Assess feasibility, acceptability, and costs of the co-designed tools and strategies.
Read the detailed description
Hepatitis C virus (HCV) infection is a major public health threat in Canada (~204,000 people living with HCV in 2019. HCV therapies with cure >95% are one of the greatest medical advances in decades and have led the WHO to set a goal to eliminate HCV by 2030. In Canada, achieving elimination will require significant increases in diagnoses and treatment . A major barrier to increasing uptake of HCV testing/treatment is that the current diagnostic pathway requires multiple visits (an HCV antibody test to confirm exposure, an HCV RNA test to confirm current infection, and one or more assessments to start treatment) leading to loss to follow-up and delays in treatment. This is amplified in populations with the highest HCV burden, including people who inject drugs (85% of new infections; 46.1% prevalence) and those in prison (10.7% prevalence). People who inject drugs face barriers to accessing HCV care including stigma/discrimination (leading to avoidance of healthcare), inadequate health service access, and poor venous access (making blood collection for testing difficult), whereas people in prison are often released prior to their antibody or RNA result (2, 4, 5). There is an urgent need to leverage innovations to streamline the diagnostic pathway and enhance access to testing/treatment.
The introduction of finger-stick tests capable of detecting HCV antibodies (results: 5-20 minutes) and HCV RNA (results: 60 minutes) at the point-of-care has revolutionized the clinical approach to HCV. These point-of-care tests enable diagnosis and treatment in a single visit, increase testing acceptability, and reduce loss to follow-up. Research by our team has demonstrated excellent technical accuracy and clinical utility of these tests, with pilot studies showing high treatment uptake compared to standard diagnostic approaches, informing recommendation in the 2022 WHO Guidelines and their forthcoming approval by Health Canada. Our team has developed a program for the implementation of point-of-care HCV testing in Australia, resulting in rapid national scale-up across 90 sites, with 20,000 tests and >1,500 people treated (79% treatment uptake; 93% in prisons).
Point-of-care HCV antibody and RNA testing is a 'game-changing' solution to address a critical gap in care and increase equity in healthcare access, particularly for marginalized groups, as we seek to achieve our national elimination targets. The impact of point-of-care testing will be greatest in high HCV prevalence settings (those caring for people who inject drugs), such as needle and syringe programs, drug treatment, prisons, and outreach settings. However, implementation challenges persist, including quality assurance and integration of point-of-care tests into diverse laboratory/public health surveillance frameworks. A systematic, implementation science-based approach is essential to comprehensively identify factors that will limit or enable point-of-care HCV testing within the Canadian context. This is critical for developing specific implementation strategies that address barriers and amplify facilitators to point-of-care testing, and informing changes to health service delivery, guidelines, and provincial and national strategies.
- Conditions
- HCV, HEPATITIS C VIRUS CHRONIC INFECTION
- Being tested
- Preimplementation of HCV Point of care testing
- 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
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplementation of HCV Point of care testingOther
Exploring the pre-implementation of HCV Point of care antibody and RNA tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Preimplementation of HCV Point of care testing | |
| 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. Receives: Other: Preimplementation of HCV Point of care testing | |
| 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. Receives: Other: Preimplementation of HCV Point of care testing | |
| 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. Receives: Other: Preimplementation of HCV Point of care testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Barriers and facilitators based on the CFIR Constructs
Using the ERIC Taxonomy and the CFIR-ERIC Matching Tool, we will link identified barriers and facilitators to evidence-based implementation strategies. The ERIC Taxonomy includes 73 strategies across 9 clusters, such as training stakeholders, supporting clinicians, engaging consumers, and changing infrastructure. This step will produce a matrix that maps each barrier and facilitator to one or more relevant strategies.
Measured: 1 year
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 2)
The questionnaire adapts the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) to assess acceptability and feasibility. Each strategy is evaluated with 8 Likert-scale questions (1-5). Data will be aggregated as mean scores, with higher scores (minimum score: 8, maximum score: 40) indicating greater perceived acceptability/feasibility.
Measured: 1 year
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 3)
The questionnaire adapts the Organizational Readiness for Implementing Change (ORIC) tool to assess feasibility by evaluating if the organization has the commitment and confidence in its ability to implement change. Feasability is assessed through with 12 Likert-scale questions (1-5, minimum score: 12, maximum score: 60)
Measured: 1 year
Sustainability of Point-of-Care Testing Strategies using the Time-driven activity-based costing (TDABC)
Time-driven activity-based costing methodology will guide assessment of costs incurred by health resource use during the patient care cycle to determine the sustainability of the point-of-care testing. This will be done by: 1) determining the frequency, capacity, and average duration of each implementation action by actors, as well as actors' total time spent on each action; 2) determine the price per hour of each actor; 3) determine non-personnel, fixed resources, and their associated expenses; 4) creation and use of a TDABC resource costing matrix to blueprint site-specific implementation processes and calculate total costs;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start20 May 2025
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales, Canadian Institutes of Health Research (CIHR), Jewish General Hospital, University of British Columbia, British Columbia Centre for Disease Control, University of Toronto, York University, Ottawa Hospital Research Institute, University of Ottawa, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Lady Davis Institute, International Network on Health and Hepatitis in Substance Users, Public Health Agency of Canada (PHAC), Canadian Association of People who Use Drugs, Action Hepatitis Canada, Canadian Liver Foundation, CATIE, Canadian Network on Hepatitis C
- Responsible party
- Principal investigator, Guillaume Fontaine, McGill University
- Investigators
- Guillaume Fontaine, RN, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095192
- Sponsor's protocol ID
- 24-12-038
- Other IDs
- PJT- 517467
- Acronym
- SCALE POCT
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We won't share IPD, we will share aggregated and analyzed data.
Publications
Mooney M, Weight C, Biondi MJ, Grebely J, Kronfli N, Barnett T, Bruneau J, Dunn K, Elakpa DN, Etherington C, Greenaway C, Martel-Laferriere V, Mendlowitz A, Taylor N, Fontaine G. Scaling up point-of-care hepatitis C testing in Canada: protocol for a multilevel implementation science study of clinical processes, barriers, facilitators and implementation strategies (SCALE-POCT study). Implement Sci Commun. 2025 Dec 18;7(1):10. doi: 10.1186/s43058-025-00837-3.
PubMed 41408357
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07095192
- Acronym / sponsor ID
- SCALE POCT / 24-12-038
- Conditions
- HCV, HEPATITIS C VIRUS CHRONIC INFECTION
- Keywords
- HCV, Hepatitis C Virus Chronic Infection, Rapid point-of-care testing, Implementation science, Knowledge translation, Marginalized populations, Infectious diseases, Barriers and facilitators
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- The University of New South Wales, Canadian Institutes of Health Research (CIHR), Jewish General Hospital, University of British Columbia, British Columbia Centre for Disease Control, University of Toronto, York University, Ottawa Hospital Research Institute, University of Ottawa, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Lady Davis Institute, International Network on Health and Hepatitis in Substance Users, Public Health Agency of Canada (PHAC), Canadian Association of People who Use Drugs, Action Hepatitis Canada, Canadian Liver Foundation, CATIE, Canadian Network on Hepatitis C
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Map current hepatitis C care processes and explore how point-of-care testing could fit into these models;
- Identify barriers and facilitators to implementing point-of-care hepatitis C testing across settings and provinces;
- Co-design tools and strategies (such as training guides, standard procedures) to support point-of-care testing;
- Assess feasibility, acceptability, and costs of the co-designed tools and strategies.
Detailed description
Hepatitis C virus (HCV) infection is a major public health threat in Canada (~204,000 people living with HCV in 2019. HCV therapies with cure >95% are one of the greatest medical advances in decades and have led the WHO to set a goal to eliminate HCV by 2030. In Canada, achieving elimination will require significant increases in diagnoses and treatment . A major barrier to increasing uptake of HCV testing/treatment is that the current diagnostic pathway requires multiple visits (an HCV antibody test to confirm exposure, an HCV RNA test to confirm current infection, and one or more assessments to start treatment) leading to loss to follow-up and delays in treatment. This is amplified in populations with the highest HCV burden, including people who inject drugs (85% of new infections; 46.1% prevalence) and those in prison (10.7% prevalence). People who inject drugs face barriers to accessing HCV care including stigma/discrimination (leading to avoidance of healthcare), inadequate health service access, and poor venous access (making blood collection for testing difficult), whereas people in prison are often released prior to their antibody or RNA result (2, 4, 5). There is an urgent need to leverage innovations to streamline the diagnostic pathway and enhance access to testing/treatment.
The introduction of finger-stick tests capable of detecting HCV antibodies (results: 5-20 minutes) and HCV RNA (results: 60 minutes) at the point-of-care has revolutionized the clinical approach to HCV. These point-of-care tests enable diagnosis and treatment in a single visit, increase testing acceptability, and reduce loss to follow-up. Research by our team has demonstrated excellent technical accuracy and clinical utility of these tests, with pilot studies showing high treatment uptake compared to standard diagnostic approaches, informing recommendation in the 2022 WHO Guidelines and their forthcoming approval by Health Canada. Our team has developed a program for the implementation of point-of-care HCV testing in Australia, resulting in rapid national scale-up across 90 sites, with 20,000 tests and >1,500 people treated (79% treatment uptake; 93% in prisons).
Point-of-care HCV antibody and RNA testing is a 'game-changing' solution to address a critical gap in care and increase equity in healthcare access, particularly for marginalized groups, as we seek to achieve our national elimination targets. The impact of point-of-care testing will be greatest in high HCV prevalence settings (those caring for people who inject drugs), such as needle and syringe programs, drug treatment, prisons, and outreach settings. However, implementation challenges persist, including quality assurance and integration of point-of-care tests into diverse laboratory/public health surveillance frameworks. A systematic, implementation science-based approach is essential to comprehensively identify factors that will limit or enable point-of-care HCV testing within the Canadian context. This is critical for developing specific implementation strategies that address barriers and amplify facilitators to point-of-care testing, and informing changes to health service delivery, guidelines, and provincial and national strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consumers | – | Other: Preimplementation of HCV Point of care testingIndividuals 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 | – | Other: Preimplementation of HCV Point of care testingParticipants must be currently employed at one of the research sites and involved in or supervising the delivery of HCV-related services. |
| Decision-maker | – | Other: Preimplementation of HCV Point of care testingParticipants 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 | – | Other: Preimplementation of HCV Point of care testingParticipants must hold a role in laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults at risk of HCV (current/past injecting drug use, current/previous incarceration, HIV, having a tattoo/piercing in an unregulated environment). Providers (e.g., physicians, nurses, harm reduction workers, street workers) and managers who work with those at risk of HCV, involved in or supervising the delivery of HCV-related services. Decision-makers: People who 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 stakeholders: People who provide laboratory services, quality assurance, or regulatory oversight of point-of-care testing at the provincial, national, or organizational level.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preimplementation of HCV Point of care testingExploring the pre-implementation of HCV Point of care antibody and RNA tests | Other | Consumers, Decision-maker, Laboratory and quality assurance stakeholder, Provider and manager |
Primary outcome
Measure Barriers and facilitators based on the CFIR Constructs
Time frame: 1 year
Using the ERIC Taxonomy and the CFIR-ERIC Matching Tool, we will link identified barriers and facilitators to evidence-based implementation strategies. The ERIC Taxonomy includes 73 strategies across 9 clusters, such as training stakeholders, supporting clinicians, engaging consumers, and changing infrastructure. This step will produce a matrix that maps each barrier and facilitator to one or more relevant strategies.
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 2)
Time frame: 1 year
The questionnaire adapts the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) to assess acceptability and feasibility. Each strategy is evaluated with 8 Likert-scale questions (1-5). Data will be aggregated as mean scores, with higher scores (minimum score: 8, maximum score: 40) indicating greater perceived acceptability/feasibility.
Acceptability and Feasibility of Point-of-Care Testing Strategies (Provider/Manager Survey, Section 3)
Time frame: 1 year
The questionnaire adapts the Organizational Readiness for Implementing Change (ORIC) tool to assess feasibility by evaluating if the organization has the commitment and confidence in its ability to implement change. Feasability is assessed through with 12 Likert-scale questions (1-5, minimum score: 12, maximum score: 60)
Sustainability of Point-of-Care Testing Strategies using the Time-driven activity-based costing (TDABC)
Time frame: 1 year
Time-driven activity-based costing methodology will guide assessment of costs incurred by health resource use during the patient care cycle to determine the sustainability of the point-of-care testing. This will be done by: 1) determining the frequency, capacity, and average duration of each implementation action by actors, as well as actors' total time spent on each action; 2) determine the price per hour of each actor; 3) determine non-personnel, fixed resources, and their associated expenses; 4) creation and use of a TDABC resource costing matrix to blueprint site-specific implementation processes and calculate total costs;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 41408357Mooney M, Weight C, Biondi MJ, Grebely J, Kronfli N, Barnett T, Bruneau J, Dunn K, Elakpa DN, Etherington C, Greenaway C, Martel-Laferriere V, Mendlowitz A, Taylor N, Fontaine G. Scaling up point-of-care hepatitis C testing in Canada: protocol for a multilevel implementation science study of clinical processes, barriers, facilitators and implementation strategies (SCALE-POCT study). Implement Sci Commun. 2025 Dec 18;7(1):10. doi: 10.1186/s43058-025-00837-3.
- Individual participant dataSharing planned: No. We won't share IPD, we will share aggregated and analyzed data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Fontaine, RN, PhD principal investigator
McGill University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV and HEPATITIS C VIRUS CHRONIC INFECTION, run by McGill University at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meagan Mooney, RN, MA, BSc (514-994-9298, meagan.mooney@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Barriers and facilitators based on the CFIR Constructs (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07095192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.