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).

backgroundAs the result of systemic and structural barriers, hepatitis C virus (HCV) continues to disproportionately affect people who inject drugs, those in prison, Indigenous peoples, immigrants from HCV-endemic countries, and gay, bisexual and other men who have sex with men in Canada. Point-of-care antibody and RNA testing improve access to HCV testing and enable single-visit diagnosis and treatment initiation, yet robust, context-specific strategies are needed to scale these technologies nationally. This protocol describes the SCALE-POCT study, which aims to: (i) map current HCV care pathways and future point-of-care workflows across community and carceral settings; (ii) identify multilevel barriers and facilitators to the adoption and sustainment of point-of-care HCV testing and treatment; (iii) co-design and operationalise theory-informed implementation strategies, protocols, and materials; and (iv) evaluate the acceptability, feasibility, and economic impacts of the co-designed strategies.

methodsGuided by Implementation Mapping and a health equity lens, the study will enroll 20 to 25 sites, including needle and syringe programs, overdose prevention programs, drug treatment clinics, outreach services, community health centers, Indigenous health organizations, and provincial prisons in British Columbia, Ontario, and Québec. Phase 1 will use process mapping focus groups, supplemented by aggregated HCV care cascade indicators, to document site-specific workflows and pinpoint bottlenecks. Phase 2 will employ semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR), Kingdon's Multiple Streams Framework, and the Theoretical Domains Framework to characterize barriers and enablers at the outer setting, inner setting, intervention, individual, and process levels. Triangulated heat-mapping will enable cross-site comparisons. Phase 3 will link these determinants to implementation strategies using the Expert Recommendations for Implementing Change (ERIC) compilation and CFIR-ERIC Matching Tool. User-centered co-design workshops will then refine each strategy's actor, action, target, temporality, and dose, while also developing standard operating procedures, training modules, and quality assurance tools. Phase 4 will apply a mixed-methods evaluation of the implementation strategies developed, using validated instruments to quantify acceptability, appropriateness, and feasibility; feedback sessions to qualitatively assess contextual fit; and time-driven activity-based costing to estimate implementation resource requirements over pre-implementation, implementation, and sustainment periods. DISCUSSION: SCALE-POCT will deliver a rigorously co-designed implementation package, establishing the operational blueprint for large-scale, pragmatic implementation trials of point-of-care testing. It will support national HCV elimination targets while offering a transferable model for other sexually transmitted and blood-borne infections.

trial registrationThis study is registered at ClinicalTrials.gov, NCT07095192.