Behavioural support and nicotine replacement therapy for smokeless tobacco cessation in Bangladesh, India and Pakistan: A pilot randomized controlled trial.

BACKGROUND AND AIMS: Smokeless tobacco (ST) use in South Asia is high, yet interventions to support its cessation are lacking. We tested the feasibility of delivering interventions for ST cessation in South Asia. DESIGN: We used a 2 × 2 factorial design, pilot randomized controlled trial with a duration of 26 weeks, including baseline and follow-up (6, 12 and 26 weeks) assessments. SETTING: Two primary health-care facilities each in Dhaka (Bangladesh) and Karachi (Pakistan) and a walk-in cancer screening clinic in Noida (India) took part. PARTICIPANTS: Adult daily ST users willing to make a quit attempt within 30 days. Of 392 screened, 264 participants [mean age: 35 years, standard deviation = 12.5, 140 (53%) male] were recruited between December 2020 and December 2021; 132 from Bangladesh, 44 from India and 88 from Pakistan. INTERVENTIONS: Participants were randomized to one of three treatment options [8-week support through nicotine replacement therapy (NRT, n = 66), a behavioural intervention for smokeless tobacco cessation in adults (BISCA, n = 66) or their combination (n = 66)] or the control condition of very brief advice (VBA) to quit (n = 66). MEASUREMENTS: Recruitment and retention, data completeness and feasibility of intervention delivery were evaluated. Biochemically verified abstinence from tobacco, using salivary cotinine, was measured at 26 weeks. FINDINGS: Retention rates were 94.7% at 6 weeks, dropping to 89.4% at 26 weeks. Attendance in BISCA pre-quit (100%) and quit sessions (86.3%) was high, but lower in post-quit sessions (65.9%), with variability among countries. Adherence to NRT also varied (45.5% Bangladesh, 90% India). Data completion for key variables exceeded 93% among time-points, except at 26 weeks for questions on nicotine dependence (90%), urges (89%) and saliva samples (62.7%). Among follow-up time-points, self-reported abstinence was generally higher among participants receiving BISCA and/or NRT. At 26 weeks, biochemically verified abstinence was observed among 16 (12.1%) participants receiving BISCA and 13 (9.8%) participants receiving NRT. CONCLUSIONS: This multi-country pilot randomized controlled trial of tobacco cessation among adult smokeless tobacco users in South Asia demonstrated the ability to recruit and retain participants and report abstinence, suggesting that a future definitive smokeless tobacco cessation trial is viable.

Scaling up tobacco cessation within TB programmes: findings from a multi-country, mixed-methods implementation study.

BACKGROUND: Brief behavioural support can effectively help tuberculosis (TB) patients quit smoking and improve their outcomes. In collaboration with TB programmes in Bangladesh, Nepal and Pakistan, we evaluated the implementation and scale-up of cessation support using four strategies: (1) brief tobacco cessation intervention, (2) integration of tobacco cessation within routine training, (3) inclusion of tobacco indicators in routine records and (4) embedding research within TB programmes. METHODS: We used mixed methods of observation, interviews, questionnaires and routine data. We aimed to understand the extent and facilitators of vertical scale-up (institutionalization) within 59 health facility learning sites in Pakistan, 18 in Nepal and 15 in Bangladesh, and horizontal scale-up (increased coverage beyond learning sites). We observed training and surveyed all 169 TB health workers who were trained, in order to measure changes in their confidence in delivering cessation support. Routine TB data from the learning sites were analysed to assess intervention delivery and use of TB forms revised to report smoking status and cessation support provided. A purposive sample of TB health workers, managers and policy-makers were interviewed (Bangladesh n = 12; Nepal n = 13; Pakistan n = 19). Costs of scale-up were estimated using activity-based cost analysis. RESULTS: Routine data indicated that health workers in learning sites asked all TB patients about tobacco use and offered them cessation support. Qualitative data showed use of intervention materials, often with adaptation and partial implementation in busy clinics. Short (1-2 hours) training integrated within existing programmes increased mean confidence in delivering cessation support by 17% (95% CI: 14-20%). A focus on health system changes (reporting, training, supervision) facilitated vertical scale-up. Dissemination of materials beyond learning sites and changes to national reporting forms and training indicated a degree of horizontal scale-up. Embedding research within TB health systems was crucial for horizontal scale-up and required the dynamic use of tactics including alliance-building, engagement in the wider policy process, use of insider researchers and a deep understanding of health system actors and processes. CONCLUSIONS: System-level changes within TB programmes may facilitate routine delivery of cessation support to TB patients. These strategies are inexpensive, and with concerted efforts from TB programmes and donors, tobacco cessation can be institutionalized at scale.

Smokeless Tobacco Initiation, Use, and Cessation in South Asia: A Qualitative Assessment.

INTRODUCTION: Smokeless tobacco (ST) is a significant South Asian public health problem. This paper reports a qualitative study of a sample of South Asian ST users. METHODS: Interviews, using a piloted topic guide, with 33 consenting, urban dwelling adult ST users explored their ST initiation, continued use, and cessation attempts. Framework data analysis was used to analyze country specific data before a thematic cross-country synthesis was completed. RESULTS: Participants reported long-term ST use and high dependency. All reported strong cessation motivation and multiple failed attempts because of ease of purchasing ST, tobacco dependency, and lack of institutional support. CONCLUSIONS: Interventions to support cessation attempts among consumers of South Asian ST products should address the multiple challenges of developing an integrated ST policy, including cessation services. IMPLICATIONS: This study provides detailed understanding of the barriers and drivers to ST initiation, use, and cessation for users in Bangladesh, India, and Pakistan. It is the first study to directly compare these three countries. The insight was then used to adapt an existing behavioral support intervention for ST cessation for testing in these countries.

Protocol for a feasibility study of longitudinal surveys to assess the impact of policies on tobacco use among school-going adolescents in South Asia.

Background: Smokeless tobacco (ST) use is common among youth in South Asia where 85% of the world's 300 million ST users live and use the most lethal ST forms. Little is known about the impact of tobacco control policies on the youth ST uptake in those countries. We planned to conduct longitudinal surveys among secondary school students to evaluate existing tobacco control policies on ST uptake and use, and a feasibility study for that prospective, observational cohort study. Study objectives: (1) To demonstrate the feasibility of selection, recruitment and retention of schools and of study participants; (2) To assess the feasibility and acceptability of the study procedure and study tool (questionnaire); (3) To assess if the questionnaire can assess tobacco uptake and use, and the potential predictors of tobacco uptake and use of the envisaged main study. Methods and analysis: The feasibility study will be conducted in two administrative areas within each of three South Asian countries: Bangladesh, India and Pakistan. We will use both quantitative and qualitative data collection methods. Eight eligible secondary schools will be randomly selected within purposively selected sub-districts from each country. We plan to conduct one baseline and one follow up survey among secondary school students, one year apart. At each time point, data on tobacco uptake and the potential predictors will be collected from students via self-administered questionnaires. The qualitative component will be embedded into the study with each round of data collection to assess the acceptability of the study instrument (questionnaire) and data collection methods, via focus group discussions with students and semi-structured interviews with schoolteachers. Recruitment and retention rates, completeness of the questionnaires, frequencies and associations of tobacco use and explanatory variables will be reported. Data gathered from the focus group and interviews will be analysed using the framework approach.