Background: Smokeless Tobacco (ST) is consumed globally by more than 350 million people, with approximately 85% of all users based in South and Southeast Asia. In this region, ST products are cheap and easily accessible. Evidence-based interventions to people quit ST use are lacking. 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.
Methods: We will conduct a randomised, factorial design pilot trial in Bangladesh, India and Pakistan. Daily ST users will be recruited from primary health care settings in Dhaka, Noida and Karachi. 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), combination of Interventions A and B, or Usual Care (Very Brief Advice - VBA). Participants will provide demographic and ST use related data at baseline, and at 6, 12 and 26 weeks follow-up. The primary trial outcome will be validated abstinence to all forms of tobacco at 26 weeks, using a carbon monoxide breath test and salivary cotinine level. Secondary outcomes will be self-reported point prevalence of tobacco use at 6, 12 and 26 weeks. An embedded process evaluation (at 6 weeks) and data collection on health resource use and quality of life (at baseline and 26 weeks) will also be conducted. We will report on the feasibility of intervention delivery, recruitment, randomisation and retention.
Discussion: 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. 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. 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.
Trial registration: ISRCTN identifier 65109397
Trial funding: NIHR (programme reference 17/63/76/ Global Health Research Groups)
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)