ProtocolInternational Journal of Clinical Trials
Publication: Scaling up tobacco control in India: a protocol for a hybrid III cluster randomized trial comparing smartphone to in-person training to implement a tobacco control program for school teachers
Int J Clin Trials. 2026;13(2):222-231.DOI10.18203/2349-3259.ijct20261388
Abstract
Background Low-and middle-income countries (LMICs) face increasing tobacco-related deaths. India is second in global tobacco use, with 29% adult users. Logistical challenges with in-person training in LMICs limit scale-up of tobacco control evidence-based interventions (EBIs). The Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program was previously shown to help teachers quit tobacco and schools adopt tobacco control policies. We are comparing smartphone-based training to in-person training to scale up the TFT-TFS program.
Methods Hybrid III cluster-randomized comparative effectiveness trial, involving 200 high schools and high secondary schools in Madhya Pradesh, India. To implement the TFT-TFS program, researchers randomly assigned schools to either smartphone-based (n=110 schools) or in-person (n=90 schools) training arms. Trained teachers from both arms implement the program in their respective schools. We will examine differences in program implementation, reach, and effectiveness between schools from the two arms. Post-implementation mixed-methods will employ the consolidated framework for implementation research (CFIR) to identify contextual factors influencing implementation.
Conclusions This study will scientifically and economically evaluate smartphone-based training to expand the use of EBIs for tobacco control in LMICs. Analyzing the contextual influences on TFT-TFS use in each training program will allow this work to create actionable guidance for education departments and groups involved in implementing smartphone-based training. These findings will help the CFIR strengthen its evidence on how to implement tobacco control EBIs successfully in low-resource environments. Trial Registration: This study is registered at ClinicalTrials.gov ID: NCT05500235.
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Affiliations
- Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India
- Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA
- Public Health Editor, Boston, MA, USA
- Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA
- Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA
