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About the study:

Epidemiological overview:

India is the second largest consumer of tobacco products in the world: 29% of the adult population uses smoked, smokeless, or both forms of tobacco. In the second-largest state of India, Madhya Pradesh (MP), about 34% of all adults (50% males, 17% females) and 21% of school personnel (28% males, 8% females) smoke and/or use smokeless tobacco. There is a dearth of rigorous systematic research testing the use of smartphones as a training-of-trainer approach in health behavior change or tobacco control. Although work has been done to test individual-level interventions using mobile devices (mHealth), research on using smartphones to train program implementers in Low and Middle-Income Countries (LMICs) is still in its infancy.

Context and problem statement:

Our study represents a major departure from the status quo of costly and time-intensive in-person training by testing a low-cost smartphone-based training strategy to scale up the implementation of a tobacco control EBI in a low-resource setting. It will demonstrate the feasibility of smartphone-based training and its effect on EBI implementation in a school setting to improve tobacco control in LMICs. It will present a novel method for collecting and analyzing implementation data via smartphones.

Research Question:

Program In-charges’ implementation of the TFT-TFS program, defined as implementing a minimum standard of core program components within the school, will be as good or superior in the smartphone training arm compared to the in-person training arm.

Study Aims and Objectives:

AIM 1.

Tailor the TFT-TFS program to the MP context and develop a smartphone-based training model centered on the systematic assessment of contextual factors in MP using the Consolidated Framework for Implementation Research (CFIR) framework

Approach:

Step 1: We conducted a three-part formative research study: (1) Key Informant Interviews (KIIs) with Department of Education (DoE) leadership, principals, and Head Masters (HMs); (2) Focus Group Discussions (FGDs) with teachers; and (3) School Observation visits (SOVs).
Step 2: Based on the Technical Working Group consensus, Creative Brief, and iterative feedback from participants, we will tailor the existing in-person TFT-TFS training to ensure content relevance and usability in the MP context.

Methodology:

Step 1: Trained facilitators conducted KIIs and FGDs in Hindi and audio recorded them, with questions guided by four CFIR domains: Intervention characteristics (TFT-TFS program), Inner Setting (schools), Outer Setting (blocks, district), and Individual Characteristics (school teachers).
Step 2: Development of a smartphone-based training model to improve the quality and completion of program implementation and tracking, using ‘gamification’ to improve user engagement. Standard use of this tracking method across the two study arms allowed comparisons between the training models. We conducted formative research in five districts of MP.

Outcomes:

Based on the iterative feedback from the participants, we tailored the existing TFT-TFS program to the MP context for both training models and developed the TFT-TFS Android-based smartphone app for training, implementation, and monitoring.

AIM 2.

Compare the fidelity, effectiveness, and cost of TFT-TFS program implementation for the two training models

Approach:

We conducted a two-arm, cluster randomized control trial, with schools as the unit of randomization, comparing (1) an in-person training model to (2) a smartphone-based training model. We randomly assigned High Schools (HS) and High-Secondary Schools (HSS), which met the eligibility criteria of having eight or more teachers, to one of two conditions.

Methodology:

We conducted a baseline survey in HS and HSS of two selected districts at three data points: i. School Personnel Surveys – to assess tobacco use by type of tobacco; cessation; perceptions and enforcement of school tobacco control policies; and awareness of and participation in the TFT-TFS program. ii. Principals/HMs interviews – to assess tobacco policy implementation and tobacco control efforts iii. School Observation Visits – to record indicators of tobacco policy implementation
We conducted an End line survey in the same schools at the same data points. Being the school’s administrative authority, interviews of the Principals/HMs were conducted during baseline. However, post-implementation of the TFT-TFS program, interviews of the Program In-charge were conducted i as they were the program implementers.

Timeline:

July 2021-June 2025

Program In-charges’ training:

In-person arm, we conducted three bi-monthly face-to-face training for six themes, using the paper-based implementation manual. The training curriculum included demonstrations, group discussions, and opportunities for behavioral rehearsal and feedback through role-plays.
In the Smartphone arm, we conducted only one face-to-face orientation of the TFT-TFS Android app during September-October 2023. Further, to implement the six themes, the program in charge trained themselves using the app.

Expected Outcomes:

We expect to have demonstrated the comparative effectiveness of each training model in implementing the TFT-TFS program and identified any differences in implementation fidelity, cost, and reach.

AIM 3.

Identify factors affecting program implementation after in-person vs. smartphone-based training using a mixed-methods design

Approach:

Based on our prior research experiences, we selected factors within four domains of CFIR as in Aim 1. Analysis of these factors allowed us to (1) examine the relation between quantitative CFIR constructs and implementation data from Aim 2, and (2) explore how these factors influence TFT-TFS implementation, through qualitative interviews with Program In-charges/HMs/principals.

Methodology:

We used an explanatory sequential mixed methods evaluation design, using quantitative survey data from Aim 2 (End-Line survey) and post-implementation qualitative data among the Program In-charges/HMs/Principals/teachers in each arm.
Mixing quantitative and qualitative data: We will present side-by-side comparisons of findings in each arm. Table cells will contain the quantitative/qualitative results for each CFIR construct and the mean number of components implemented, cessation, cost, and reach. With our Technical Working Group, we will synthesize participants’ solutions to challenges and suggestions for future improvements.

Expected Outcomes:

We expect to have identified contextual factors that explain variations in TFT-TFS implementation for each training model.

Type of Study:

Behavioral Mixed-method study using Comparative-effectiveness trial

Study Participants:

Teachers from Government HS and HSS of the state education system of MP

Collaborators:

Dana-Farber Cancer Institute (DFCI) and Harvard T.H. Chan School of Public Health (HSPH) in Boston, USA

Principal Investigators:

Dr. Mangesh S. Pednekar and Dr. Eve M. Nagler

Co-Investigators:

Dr. Prakash C. Gupta and Dr. Glorian Sorensen

Current Status:(July 2021 – December 2024)

AIM 1

We have published an article titled “Smartphones: A Catalyst for Tobacco Control Training in India” in the Proceedings of the 23rd European Conference on e-Learning 2024 on the TFT-TFS smartphone development process

https://papers.academic-conferences.org/index.php/ecel/article/view/3065

AIM 2

We are working on manuscript publications of the baseline data. In addition, we are working on the manuscript publications of cost-and-time data for the training of the Program in-charges, TFT-TFS program implementation, and reach.

AIM 3

We are working on the translations of the KIIs and FGDs conducted as part of the post-implementation qualitative research, and the data cleaning of the end-line surveys.