Accelerating Tobacco Cessation within Healthcare Systems of European LMICs: A Multi-Country Implementation-Effectiveness Trial

The countries of Georgia, Armenia, Serbia, and Albania suffer from a public health crisis where high smoking rates drive a devastating burden of non-communicable diseases (NCDs). This crisis is compounded by a critical implementation gap: proven cessation services, standard in many HICs, are not systematically integrated into routine healthcare.The Accelerating Tobacco Cessation in Healthcare Systems (ACTS) project is an implementation science study designed to close this evidence-to-practice gap. Using a pragmatic Hybrid Type 2 design, a large-scale, multi-country cluster randomized trial will be conducted, recruiting 1,700 patients across 34 primary and specialist care sites. The trial will simultaneously evaluate clinical effectiveness (smoking abstinence) and, importantly, a comprehensive set of implementation outcomes guided by the RE-AIM framework (e.g., reach, adoption, fidelity, cost). The Consolidated Framework for Implementation Research (CFIR) will guide the systematic, co-creative adaptation of a multi-component intervention package (behavioural support, pharmacotherapy, digital tools) to each unique national context, with a strong focus on health equity.A foundational principle is our equitable HIC-LMIC partnership with joint scientific leadership and co-creation embedded in all activities to ensure local ownership.The primary outputs will be a validated, scalable model for integrated care, delivered through a practical ‘Implementation Playbook’ and ‘Policy Toolkit’. These tools provide policymakers with an evidence-based roadmap for sustainable, national scale-up. By generating robust, real-world implementation knowledge, ACTS will strengthen health systems, reduce the NCD burden, and provide a replicable model for other low- and middle-income countries.