Implementation research for taking tobacco control policies to scale in India: a realist evaluation study protocol.

introductionThere are ongoing policies and programs to reduce tobacco use and minimise the associated health burden in India. However, there are several challenges in practice leading to different outcomes across Indian states. Inadequate understanding of how national tobacco control policies achieve their results under varied circumstances obstruct the implementation and scaling up of effective strategies. This study is a realist evaluation using largely qualitative methods to understand the implementation process of India's tobacco control policies. It will do so by evaluating India's Cigarettes and Other Tobacco Products Act (COTPA) and the National Tobacco Control Program (NTCP). The study aims to examine how, why, for whom and under which circumstances COTPA and NTCP are implemented in India. METHODS AND ANALYSIS: A realist synthesis on implementation of tobacco control policies in low-income and middle-income countries is conducted. This is followed by qualitative data collection and analysis in three Indian states selected based on data from two rounds of the Global Adult Tobacco Survey. The study comprises of three steps (1): development of initial programme theories, (2) testing and refinement of initial programme theories and (3) testing and validation of refined programme theories. We will interview policy-makers, programme managers and implementers to identify facilitators and barriers of implementation. The purpose is to identify context-specific evidence-based strategies to gain insights into the implementation process of COTPA and NTCP. Further we aim to contribute to tobacco control research by establishing communities of practice to engage with cross-cutting issues. ETHICS AND DISSEMINATION: The Institutional Ethics Committee, at the Institute of Public Health (Bengaluru), has approved the protocol. Written informed consent forms will be obtained from all the participants. Dissemination has been planned for researchers, policy-makers and implementers as well as the public through peer-reviewed publications, conference presentation, webinars and social media updates. PROSPERO REGISTRATION NUMBER: CRD42020191541.