Tobacco cessation is also included in WHO’s MPOWER approach, which is a set of six high impact policy measures for reducing tobacco use. The need for evidence-based guidelines and treatment for tobacco dependence is supported by Article 14 of the World Health Organization’s Framework Convention for Tobacco Control (WHO-FCTC). This group is conducting a range of studies (focusing on cessation, youth, policy and economics) to understand and address ST use in South Asian settings. In an effort to reduce the impact of ST use in South Asian populations, the ASTRA Global Health Research group was formed in 2018. ST use in these populations is also linked to ischemic heart disease, as well as preterm delivery, stillbirth and low birth weight deliveries. Their continued use results in oral and oropharyngeal cancers, rates of which are the highest in South Asia. Due to their composition, South and South-East Asian ST products are highly addictive and toxigenic.
VBA PRINT SELECTION TO PDF FREE
On the other hand, their preparation methods induce high levels of free nicotine, Tobacco Specific Nitrosamines (TSNAs) and heavy metals. These South and South-East Asian ST products often contain stimulants and flavourings that enhance flavour and addictiveness. In these low-resource settings where ST is culturally ingrained, it remains cheap, widely available and poorly regulated. While ST is consumed by more than 350 million individuals worldwide, approximately 85% of users are concentrated in South and South-East Asia. Smokeless tobacco (ST) refers to a heterogeneous group of tobacco-containing products that are non-combustible and consumed either orally or by inhalation through the nose.
VBA PRINT SELECTION TO PDF TRIAL
The findings of this pilot trial will inform the development of larger trials for ST cessation among South Asian users, with relevance to wider regions and populations having high rates of ST use. The identification of feasible, effective and cost-effective interventions for ST is necessary to inform national and regional efforts to reduce ST use at the population level.
The widespread and continued use of ST products in South Asia is consistent with a high rate of associated diseases and negative impact on the quality of life. We will also identify potential cessation outcomes to inform the main trial, understand the implementation, context and mechanisms of impact through a process evaluation and, thirdly, establish health resource use and impact on the quality of life through health economic data. The analyses will undertake an assessment of the feasibility of recruitment, randomisation, data collection and participant retention, as well as the feasibility of intervention delivery. Salivary cotinine samples will be collected at baseline and 26 weeks. The participants will provide demographic and ST use related data at baseline, and at 6, 12 and 26 weeks of follow-up. Participants will be individually randomised to receive intervention A (4 or 6 mg NRT chewing gum for 8-weeks), intervention B (BISCA: face-to-face behavioural support for ST cessation), a combination of interventions A and B or usual care (Very Brief Advice - VBA). Daily ST users will be recruited from primary health care settings in Dhaka, Noida and Karachi. We will conduct a factorial design, randomised-controlled pilot trial in Bangladesh, India and Pakistan. This study aims to test the feasibility of conducting a future definitive trial of ST cessation, using a culturally adapted behavioural intervention, and/or nicotine replacement therapy (NRT) in three South Asian countries. Evidence-based interventions to people quit ST use are lacking.
In this region, ST products are cheap and easily accessible. Smokeless tobacco (ST) is consumed globally by more than 350 million people, with approximately 85% of all users based in South and Southeast Asia.
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