ToQuit: Development and preliminary evaluation of a technology assisted tobacco cessation intervention in India

Context: India is the second largest consumer and third largest producer of tobacco in the world; and has one of the highest mortality rates related to tobacco. Although there is good evidence for the effectiveness of tobacco cessation interventions they are not completely suitable for the Indian context because they focus on smoked tobacco (whereas the most commonly used tobacco in India is smokeless tobacco) and are designed to be delivered by healthcare workers (a limited resource in India). Hence, despite the growing public health impact of tobacco use, only a very small proportion of those who want to discontinue tobacco use receive any help to quit. One way of increasing access to tobacco cessation interventions in low resource settings is to develop and scale up an effective and contextually appropriate but non-resource-intensive intervention. Our proposal is to develop and then preliminarily evaluate, a contextually appropriate intervention, that can be delivered using mobile text messaging (a cheap and easily available technological platform in India). Thus we will overcome the human resource barriers by using mobile phone technology to deliver tobacco cessation interventions to large numbers of tobacco users, quickly and at low cost. Furthermore, we will follow a systematic methodology to culturally adapt the intervention to increase acceptability by tobacco users and the feasibility of delivery using a technology platform.

Aims/Objectives: The overall objective of ToQuit is to use evidence-based treatment development processes to develop a contextually appropriate tobacco cessation intervention that can be delivered using mobile phone technology in order to overcome barriers to access in low resource settings. The specific aims of ToQuit are to 1) Develop a tobacco cessation intervention package, to be delivered in India using mobile phone technology; 2) Examine if it is acceptable and feasible to deliver such an intervention in an Indian setting; 3) Conduct preliminary testing to see if the intervention helps in increasing tobacco quit rates; and 4) Fine-tune procedures for the definitive testing of the effectiveness of the intervention within a feasibility RCT. These aims will be achieved through a range of processes including development of the intervention and adapting it utilising feedback from a range of individuals and groups, including tobacco users; refinement of the intervention; and testing of its preliminary impact. The output of this treatment development process would be a contextually acceptable and feasible tobacco cessation intervention package that can be delivered through mobile phone technology; and which is ready to be tested in a larger trial.

Potential applications and benefits: Tobacco use is a big and growing problem, because it leads to high levels of health problems (e.g. cancers) and deaths. We want to help tobacco users to reduce levels of harm caused to them, by transforming a way of helping which has in the past been delivered face-to-face, only by highly trained and expensive healthcare workers, into a much more accessible and widely available form, by using mobile phones (widely owned across India and other low and middle income countries [LMIC]). If successfully developed and found to be cost-effective, our intervention can reach millions of people across LMICs and could be a real game-changer in the field of public health.

Despite the high public health burden of tobacco use in India, a very small proportion of tobacco users wanting to quit, get any help to do so. Despite extensive evidence demonstrating the effectiveness of tobacco cessation interventions, in India, the major barriers to making such evidence-based treatments accessible are the lack and inequitable distribution of trained healthcare professionals and the focus of the interventions on smoked tobacco (in India, predominant use is of smokeless tobacco). ToQuit aims to overcome these barriers and to increase access to care for large numbers of tobacco users, quickly and at a low cost, by developing a tobacco cessation intervention, not restricted to smoked tobacco, that can be delivered using cheap and easily accessible SMS text messaging. More specifically the aims of ToQuit include: 1) Develop and refine a tobacco cessation intervention package delivered using mobile phone technology; 2) Examine contextual acceptability/feasibility of the intervention; 3) Conduct preliminary evaluation of its impact on tobacco quit rates; and 4) Fine-tune procedures for a RCT to test the effectiveness of the intervention compared to usual care. These aims will be achieved through a mixed methods study that will develop the intervention package through participatory methods involving multiple stakeholders; iteratively refine the intervention package and delivery platforms through data obtained from a treatment cohort with a before and after design; and preliminarily test the impact of the intervention and procedures for a definitive RCT through a feasibility RCT. The output of this treatment development process would be a contextually acceptable and feasible tobacco cessation intervention package, suitable for delivery through SMS; and ready for testing in a definitive RCT.

There are several key groups that will benefit from this research. First, people who use tobacco. This project has the potential to significantly improve health outcomes amongst tobacco users. Tobacco users have many short and long term health problems as a result of their tobacco use, and utilise disproportionate levels of health care. ToQuit will demonstrate whether a contextually adapted intervention for tobacco cessation is feasible to deliver through text messaging; and acceptable to the target group. Research has shown that behavioural interventions are effective in increasing tobacco quit rates. Our treatment development and feasibility study will attempt to demonstrate that such interventions can be delivered through inexpensive text messaging, a delivery platform, that is potentially scalable throughout India and other low and middle income countries (LMICs).

Tobacco users recruited in our study will benefit in many ways; primarily by reduction in morbidity and mortality secondary to tobacco use. The intervention will be underpinned by an empirically supported model, suggesting that tobacco cessation will occur due to enhancement of motivation and acquisition of skills to deal with risk factors for relapse. Besides the positive impact of tobacco cessation on the health of the tobacco user, their family members too will benefit from reduced exposure to the adverse effects of tobacco use (e.g. passive smoking, diversion of funds from essential household expenses).

Our study will be an important advance in the field of tobacco cessation research in low resource settings as this will be the first time in India that a potentially scalable and contextually relevant tobacco cessation intervention will be developed using a scientifically rigorous methodology. This intervention, although developed in India, would potentially be useful in similar low resource settings across the world. Although there is a growing interest in tobacco cessation activities from policy makers and other stakeholders in India, the absence of scalable solutions hinders the development of programmes that will realistically increase access to care for tobacco users. ToQuit, if proven to be effective in a definitive randomised controlled trial (RCT), would be an appropriate innovation that overcomes the barriers to scalability (primarily the shortage of trained formal healthcare professionals) in low resource settings.

Evidence about the acceptability and feasibility of ToQuit will be relevant for health care providers who come into contact with tobacco users. In the longer term, if our contextually appropriate ToQuit is found to be cost-effective then it has the potential of being integrated into routine care through modifying clinical guidelines for tobacco cessation activities in India. However, in the shorter term, the biggest impact of ToQuit would be in providing a contextualised scalable tobacco cessation intervention and data on processes to successfully test the effectiveness of the intervention in a definitive RCT. This would be a critical first step of a systematic research process, and meets the key aims of this grant call.

To achieve the impact described above we will disseminate our findings to these various groups, as described in our 'communications plan', and also use our findings to apply for a grant to conduct a definitive RCT of ToQuit.