Hepatitis C Point-of-Care Testing

Establishing the Framework for Decentralized Hepatitis C Point-of-Care Testing and Treatment in Canada: An Implementation Science-based Approach

What are our goals?

Building on studies supported by the CIHR-funded Canadian Network on Hepatitis C (CanHepC), our overall goal is to generate evidence to inform the scale-up point-of-care HCV testing and treatment in key settings across three Canadian provinces. Our specific objectives are to:

Why?

Hepatitis C virus (HCV) infection poses a significant public health challenge in Canada, where achieving the World Health Organization’s goal of eliminating HCV by 2030 requires a dramatic increase in diagnoses and treatment. While current treatments boast cure rates over 95%, the diagnostic process remains cumbersome and inefficient, often leading to treatment delays and loss to follow-up, particularly among high-risk groups such as people who inject drugs and incarcerated individuals. These groups face unique obstacles, including stigma, discrimination, and limited access to healthcare services. Innovative finger-stick point-of-care tests, which can detect HCV antibodies and RNA within an hour, offer a promising solution by enabling single-visit diagnosis and treatment, thereby increasing testing acceptability and reducing loss to follow-up.

how?

By recruiting 12 sites across British Columbia, Ontario, and Quebec, including needle and syringe programs, drug treatment clinics, prisons, and outreach settings, the research employs an implementation science approach to drive the adoption of these point-of-care tests. Using process mapping, semi-structured interviews, and user-centered design, the study seeks to design implementation strategies and protocols, aiming to transform HCV testing and treatment in high-prevalence settings and accelerate progress toward HCV elimination in Canada.

Point-of-Care Testing Reviews

Effectiveness, cost-effectiveness, implementation strategies, and barriers and facilitators of point-of-care testing for HIV, viral hepatitis, and sexually transmissible infections: A comprehensive series of systematic reviews and meta-analyses

What are our goals?

Why?

The 2022–30 Global Health Sector Strategies on HIV, viral hepatitis, and sexually transmitted infections (STIs) emphasize the importance of cross-disease learning and leveraging innovations to enhance healthcare responses. Point-of-care testing (POCT) for infectious diseases such as HIV, viral hepatitis, and STIs is crucial for improving patient outcomes and reducing transmission rates. Unlike centralized, laboratory-based testing, which can delay diagnosis and treatment, POCT allows healthcare professionals and community organization workers to quickly identify patients’ conditions, provide rapid results, and administer appropriate care immediately. The World Health Organization (WHO) recommends POCT assays for various applications, including HIV viral load monitoring, early infant diagnosis of HIV, hepatitis C virus RNA viral load testing, and human papillomavirus (HPV) DNA testing.

how?

To achieve these objectives, a systematic review is underway, focusing on outcomes such as testing uptake, time to testing, receipt of test results, linkage to care, and treatment initiation for HIV, viral hepatitis, and STIs. Implementation strategies will be coded using the Expert Recommendations for Implementing Change (ERIC) Implementation Strategy Taxonomy, and barriers and facilitators will be analyzed using the Consolidated Framework for Implementation Research (CFIR). NVivo qualitative data analysis software will support data extraction, with all studies coded by two coders to ensure consistency, followed by content and theme analysis.

OPTIMIZE-IPC

Optimizing infection prevention and control practices: an evidence synthesis and matrixed multiple case study using implementation science and integrated knowledge translation

What are our goals?

Why?

Globally, healthcare-associated infections (HAI) are a significant cause of morbidity, mortality, extended hospital stays, and increased healthcare costs. In Canada, 7.9% of patients contracted at least one infectious disease in a healthcare setting in 2017. Improving compliance with infection prevention and control (IPC) practices, including hand hygiene, remains a complex and pervasive challenge in healthcare. Implementation science offers innovative methods to synthesize evidence on effective interventions, identify barriers and facilitators, and co-design tailored strategies for the adoption and sustained use of IPC practices.

how?

This evidence synthesis and matrixed multiple case study employs an integrated Knowledge Translation (iKT) approach co-designed with key Knowledge Users (KUs) at CHU Sainte-Justine, the largest pediatric health center in Canada. For Objective 1, we are updating the Cochrane systematic review and meta-analysis on interventions to improve hand hygiene compliance, utilizing the Expert Recommendations for Implementing Change Taxonomy (ERIC) to identify strategies within these complex interventions. For Objective 2, we will use a matrixed multiple case study design to investigate multilevel factors influencing compliance with IPC practices across three care units at CHU Sainte-Justine with the lowest compliance rates. This will involve semi-structured interviews with healthcare workers and focus groups with stakeholders. For Objective 3, we will employ user-centered design methods to conduct three workshops with stakeholders to co-design tailored implementation strategies.

Theory2Practice

From theory to practice: unveiling the theoretical basis and components of effective implementation strategies for improving nursing practice and patient outcomes

What are our goals?

Why?

Many current implementation strategies aimed at promoting practice change among healthcare professionals lack a systematic, theory-driven approach in their development and evaluation. The early incorporation of theory into the implementation strategy development phase can provide a structured framework to better address the complex factors influencing healthcare professionals’ behavior change. Our recent systematic review and meta-analysis on the effects of implementation strategies on nursing practice and patient outcomes (N = 204 studies) highlighted the need to further investigate the key factors and components that affect the effectiveness of different implementation strategies.

how?

This study is a secondary analysis of implementation strategies identified from a prior systematic review. It will employ both qualitative and quantitative methods, including content analysis and meta-regression. Content analysis will be used to systematically analyze and interpret the qualitative data, aiming to identify patterns, themes, and categories within the dataset. The analysis will focus on coding and interpreting the content of the included studies related to implementation strategies, allowing for a comprehensive understanding of how these strategies are developed and evaluated.

PROMs/PREMs

Development and validation of an implementation blueprint for the implementation of patient-reported outcome and experience measures (PROMs/PREMs) in oncology

What are our goals?

Why?

Patient-reported outcome and experience measures (PROMs/PREMs) have been a focus of healthcare research for over 40 years, providing valuable insights into patients’ health, functioning, quality of life, and experiences while receiving care. These standardized, validated questionnaires have been shown to improve patient-clinician communication, enhance symptom management, reduce healthcare utilization, and even increase survival rates. Despite significant investments in PROM/PREM implementation worldwide, including efforts led by the Canadian Partnership Against Cancer, implementation in oncology remains in its early stages, particularly in Quebec. Challenges include barriers at the patient level (e.g., low health literacy), clinician level (e.g., obtaining results from external digital platforms), and service level (e.g., workflow integration). There is a lack of clear guidance on selecting and tailoring implementation strategies to address these barriers effectively.

how?

The study uses implementation mapping and the Consolidated Framework for Implementation Research (CFIR) to explore barriers and enablers across five domains: Innovation, Outer Setting, Inner Setting, Individuals, and Implementation Process. An umbrella review of systematic and scoping reviews on PROM/PREM implementation in oncology will generate an initial list of barriers and enablers, complemented by qualitative data from the e-IMPAQc project. Using the Expert Recommendations for Implementing Change (ERIC) Taxonomy, the project will develop an implementation blueprint that links these barriers and enablers to specific strategies. Each strategy will be assessed using APEASE criteria and tailored based on Proctor’s dimensions. Validation will involve focus groups with knowledge users to refine and finalize the blueprint, ensuring practical applicability in oncology settings.

IS-Theory

Identifying desirable attributes and selection criteria for implementation science theories, models, and frameworks (TMFs) and mapping TMFs: a scoping review and an umbrella review

What are our goals?

Why?

Implementation strategies are essential methods for facilitating the adoption of evidence-based interventions in healthcare. They must be context-specific, addressing the unique challenges faced by healthcare providers, organizations, and systems. However, many strategies are developed using informal theories, which can lead to inconsistent language, lack of standardization, and potential biases. To overcome these limitations, implementation scientists are increasingly turning to formal theories, models, and frameworks (TMFs) to guide the design of implementation strategies. These TMFs help ensure a rigorous and systematic approach, providing a structured pathway to behavior change. Given the vast array of TMFs available, each with different purposes, levels, and constructs, there is a critical need to understand the desirable attributes of TMFs and establish clear criteria for selecting the most appropriate ones for specific contexts.

how?

This study is a dual-review approach to identify desirable attributes and selection criteria for theories, models, and frameworks (TMFs) used in designing implementation strategies within healthcare settings. The project consists of two complementary reviews: a scoping review and an umbrella review. The scoping review will explore existing literature to define and categorize the attributes considered essential for TMFs when designing implementation strategies. It aims to map key characteristics, identify gaps in current knowledge, and provide a comprehensive overview of the factors influencing TMF selection in practice. Concurrently, an umbrella review will synthesize findings from existing reviews of TMFs, providing a meta-perspective on their application and effectiveness across various healthcare contexts. By combining insights from both reviews, the project seeks to develop a refined set of criteria to guide the selection and utilization of TMFs, ultimately enhancing the design and implementation of effective healthcare strategies.

HCV POCT Logic Model

Describing the theory underlying the National Australian HCV Point-of-Care Testing Program: A program impact theory-driven evaluation study

What are our goals?

Why?

The National Australian HCV Point-of-Care Testing (POCT) Program is one of the first global initiatives to scale up point-of-care testing and treatment for hepatitis C virus (HCV) across diverse settings, with the goal of reducing HCV prevalence and achieving the World Health Organization’s objective of eliminating HCV as a public health threat by 2030. Despite initial successes, such as partnerships with over 150 community, practice, and policy stakeholders and implementation at 90 sites, there remain challenges, including low median testing and treatment uptake, particularly in community settings.

Understanding the underlying processes and influences on implementation is crucial for improving the uptake and effectiveness of the program. By describing the program’s theory of change and impact, the study aims to identify the conditions and mechanisms necessary for successful implementation and integration into policy and practice.

how?

This study employs a program impact theory-driven evaluation approach, utilizing both qualitative and quantitative methods to analyze and validate the processes behind the outcomes of the National HCV POCT Program. Guided by the Implementation Research Logic Model, the study aims to enhance the rigor and transparency of implementing evidence-based interventions. Aim 1 involves developing an initial version of the program impact theory through a comprehensive review of program documentation, such as job descriptions, strategic plans, guidelines, and operating procedures, focusing on clinical intervention components, implementation determinants, strategies, mechanisms, and outcomes. Aim 2 entails collecting new data via semi-structured interviews with up to 25 key stakeholders, including program leaders and healthcare professionals, to gain insights into program components, processes, and intended impacts, and conducting virtual observations to capture roles, responsibilities, and contextual factors influencing the program. The collected data will be analyzed using framework analysis to refine the program impact theory. Aim 3 focuses on validating the refined program impact theory through 2-3 focus groups with diverse stakeholders to ensure alignment with real-world experiences and identify potential improvements. The feedback from these focus groups will be analyzed to finalize the program impact theory and update the Implementation Research Logic Model.

Métropoles Sans Hep C Evaluation

Evaluating the Métropoles Sans Hep C Initiative: An implementation science-informed mixed-methods study on effectiveness, adoption, and sustainability

What are our goals?

Why?

Hepatitis C remains a significant public health challenge, with substantial morbidity and mortality rates worldwide. The Métropoles Sans Hep C Initiative aims to address this challenge by implementing strategies to eliminate hepatitis C in urban populations through comprehensive testing, treatment, and prevention efforts. Understanding the effectiveness, adoption, and sustainability of such initiatives is crucial for informing future public health strategies and policies. Evaluating these aspects can help identify best practices, barriers, and facilitators, ultimately contributing to more efficient and effective hepatitis C elimination efforts.

how?

The study will employ a mixed-methods approach to evaluate the implementation outcomes of the Métropoles Sans Hep C Initiative. Data will be collected on key outcomes, such as the number of people tested, treatment initiation rates, and cure rates, to assess the initiative’s effectiveness. Statistical analyses will be conducted to compare these outcomes before and after the implementation of the initiative. Semi-structured interviews and focus groups will be conducted with healthcare providers, community organization leaders, and patients to gather insights on the adoption and integration of initiative components. These discussions will explore perceived barriers, facilitators, and contextual factors influencing the initiative’s implementation. The study will examine long-term data trends and conduct follow-up interviews to assess the initiative’s sustainability. Factors such as ongoing support, resource allocation, and stakeholder engagement will be evaluated to determine their impact on sustaining outcomes.

MONITOR

Feasibility, acceptability and preliminary effects of multi-condition telemonitoring in individuals living with chronic diseases: the MONITOR pilot study

What are our goals?

Why?

There are significant healthcare challenges posed by the growing prevalence of chronic diseases and multimorbidity. Chronic conditions, such as cardiovascular diseases, diabetes, and chronic respiratory illnesses, contribute to a substantial portion of healthcare costs and are a leading cause of mortality. The aging population, combined with the increase in multimorbidity, places additional pressure on the healthcare system, necessitating innovative solutions to improve patient care and resource utilization. Telemonitoring offers a promising approach to enhance chronic disease management by enabling continuous monitoring, improving patient self-management, and facilitating communication between patients and healthcare providers. Despite its potential, the integration of telemonitoring into routine healthcare is hindered by challenges related to technology adoption, user engagement, and system-level barriers.

how?

The study is designed as a single-center, single-arm pilot to assess the TakeCare telemonitoring platform, involving patients with chronic diseases and healthcare providers from three CIUSSS West-Central Montreal clinics. Participants will receive training on using the platform, and data collection will include quantitative measures like questionnaires and usage data, as well as qualitative interviews to gain insights into user experiences.

BRIDGE-HBV

Promoting Equitable Access to Hepatitis B Screening and Treatment in Canada: An Evidence Synthesis Study Using an Integrated Knowledge Translation Approach

What are our goals?

Why?

Hepatitis B (HBV) remains a significant public health issue globally and in Canada, with an estimated 216,000 Canadians living with chronic HBV infection. Despite having tools such as vaccines, diagnostic tests, and antiviral treatments, significant gaps persist in HBV diagnosis and care. Populations disproportionately affected include immigrants, refugees, people who inject drugs, and those facing socioeconomic challenges. These gaps in care highlight the critical need for effective, evidence-based public health strategies tailored to these vulnerable groups. The Canadian government’s 2024–2030 STBBI Action Plan emphasizes the need to apply implementation science to improve HBV testing and treatment, ensuring no one is left behind in achieving the WHO’s elimination targets for HBV by 2030.

how?

This study uses an integrated Knowledge Translation (iKT) approach and will proceed through three phases:

Phase 1: Conduct a systematic review and meta-analysis to assess the effectiveness of interventions on HBV testing, linkage to care, and treatment uptake, using implementation science to identify key “active components” of these interventions.

Phase 2: Conduct a qualitative evidence synthesis to identify the multilevel barriers and enablers affecting HBV care, using established implementation science frameworks like CFIR and TDF.

Phase 3: Use Qualitative Comparative Analysis (QCA) to explore which configurations of intervention components are most effective in overcoming barriers, followed by an expert review panel to ensure the findings are applicable to real-world HBV care settings.

This project will develop a robust framework to guide the scale-up of HBV interventions, with a focus on equitable access for underserved populations in Canada.