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.

The Lifetime Health and Economic Burden of Smokeless Tobacco use in Bangladesh, India, and Pakistan: Results From ASTRAMOD.

INTRODUCTION: Under the current policy landscapes, the lifetime health and economic burden of smokeless tobacco (ST) products, consumed by over 297 million ST users in South Asia, is unknown. The aim of this study was to estimate the lifetime health effects and costs attributable to current and future ST use in Bangladesh, India, and Pakistan where the majority of ST users live. AIMS AND METHODS: We developed a Markov-based state-transition model (ASTRAMOD) to predict the lifetime costs of treatment of four diseases (oral, pharyngeal, esophageal cancers, and stroke) and disability-adjusted life years (DALYs), attributable to the current and future use of ST under existing ST policy scenario. Country-specific Global Adult Tobacco Surveys, life tables, and meta-analyses of South Asian and South East Asian studies were used to populate the model. A probabilistic sensitivity analysis evaluated the uncertainty in model predictions. RESULTS: If there were no change in the current ST policies, the lifetime ST-attributable treatment costs would be over US$19 billion in India, over US$1.5 billion in Bangladesh, and over US$3 billion in Pakistan. For all countries, the attributable costs are higher for younger cohorts with costs declining with increasing age for those over 50. The model predicted that a typical 15-year-old male adoloscent would gain 0.07-0.18 life years, avert 0.07-0.19 DALYs, and generate a cost-savings of US$7-21 on healthcare spending if ST policies were changed to eliminate ST use. CONCLUSIONS: Policy interventions aimed at decreasing the uptake of ST and increasing quitting success have the potential to substantially decrease the economic and health burden of ST. IMPLICATIONS: This study provides the most comprehensive estimates of the lifetime health and economic burden of ST by 5-year age and sex cohorts. This is also the first study that highlights the scale of health and economic burden of ST in Bangladesh, India, and Pakistan if there were no changes in the current ST policies. Policymakers and practitioners can use the reported data to justify their decisions to improve current ST policies and practices in their country. Researchers can use the ASTRAMOD methodology to estimate the impact of future ST policy changes.

Is smokeless tobacco use associated with lower health-related quality of life? A cross-sectional survey among women in Bangladesh.

INTRODUCTION: Bangladesh has 22 million adult users of smokeless tobacco (ST). The prevalence among women is higher (24.8%). Health-related quality of life outcome (HRQoL) for ST use is little known. We investigated the association between HRQoL and daily ST use among adult women in Bangladesh. METHODS: Using multi-stage design, a cross-sectional survey was conducted. Adult women (randomly selected) were surveyed from 4 purposively selected divisions (Dhaka, Chittagong, Khulna and Rangpur). Female ST users and non-users were compared using HRQoL scores. Self-perceived Visual Analogue Scale (EQ-VAS) values and HRQoL scores were modelled to examine their association with ST use. RESULTS: A total of 2610 women (1149 users and 1461 non-users) were surveyed. The proportion reported any type of problem in all health dimensions was significantly higher among female ST users than non-users (mobility: 43.3% vs 19.5%, self-care: 29.6% vs 11.9%, usual activities: 48.7% vs 21.8%, pain or discomfort: 69.8% vs 40.6%, and anxiety or depression: 61.3% vs 37.5%). The average HRQoL scores were 0.79 (95% CI: 0.78-0.81) and 0.90 (95% CI: 0.89-0.90) for users and non-users, respectively. Moreover, EQ-VAS average values were significantly higher for non-users [80.7 (95% CI: 79.9-81.6) vs 70.27 (95% CI: 69.2-71.2)]. Controlling the sociodemographics, ST use significantly reduced the HRQoL score by an average of 0.15 points. The EQ-VAS values on average decreased by 0.04 points for ST use. CONCLUSIONS: ST use is significantly associated with the HRQoL of females in Bangladesh. Considering the higher prevalence of ST, especially among women, HRQoL hazards need to be communicated for awareness building.

Multicomponent Behavioural Intervention during Pregnancy to Reduce Home Exposure to Second-Hand Smoke: A Pilot Randomised Controlled Trial in Bangladesh and India.

BACKGROUND: Pregnant women exposed to second-hand smoke (SHS) are at increased risk of poor birth outcomes. We piloted multicomponent behavioural intervention and trial methods in Bangalore, India, and Comilla, Bangladesh. METHODS: A pilot individual randomised controlled trial with economic and process evaluation components was conducted. Non-tobacco-using pregnant women exposed to SHS were recruited from clinics and randomly allocated to intervention or control (educational leaflet) arms. The process evaluation captured feedback on the trial methods and intervention components. The economic component piloted a service use questionnaire. The primary outcome was saliva cotinine 3 months post-intervention. RESULTS: Most pregnant women and many husbands engaged with the intervention and rated the components highly, although the cotinine report elicited some anxiety. Forty-eight (Comilla) and fifty-four (Bangalore) women were recruited. The retention at 3 months was 100% (Comilla) and 78% (Bangalore). Primary outcome data were available for 98% (Comilla) and 77% (Bangalore). CONCLUSIONS: The multicomponent behavioural intervention was feasible to deliver and was acceptable to the interventionists, pregnant women, and husbands. With the intervention, it was possible to recruit, randomise, and retain pregnant women in Bangladesh and India. The cotinine data will inform sample size calculations for a future definitive trial.

Perspectives on reforming the tobacco tax administration system in Bangladesh to enhance public health.

BACKGROUND: Taxation is the most cost-effective instrument to regulate the consumption of tobacco products. However, weak tax administration can compromise the effectiveness of taxation. This paper aimed to understand the process of the current tobacco tax administration system in Bangladesh, identify gaps and outline the policy priorities to strengthen the tobacco tax administration process in Bangladesh. METHODS: A sequential qualitative study was conducted in two linked phases: (a) document review and evidence synthesis; and (b) 20 key informant interviews and one workshop with relevant stakeholders to validate the findings generated from both phases. RESULTS: The complex tax system combined with weak tax administration leads to tax evasion in Bangladesh. The processes of procuring and collecting banderoles and tax stamps vary between cigarette and biri companies, and across large and small tax-paying companies. The use of banderoles at the factory level is maintained manually, and there is no system to routinely verify the authenticity of banderoles. Many unregistered small-scale tobacco manufacturing units often reuse the banderoles on new packs. Shortage of staff with inadequate training at the National Board of Revenue restricts adequate tobacco market monitoring. Electronic tax stamps and banderoles combined with a secure digital tracking and tracing system should be introduced to better monitor the supply, distribution and sale of tobacco products. Training needs to be provided to develop capacity of relevant officials. CONCLUSION: The tobacco tax administration needs to be strengthened to increase the government's tobacco tax revenue and protect public health.

Tobacco use in people with severe mental illness: Findings from a multi-country survey of mental health institutions in South Asia.

INTRODUCTION: People with severe mental illness (SMI) tend to die early due to cardiovascular and respiratory diseases, which may be linked to tobacco use. There is limited information on tobacco use in people with SMI in low- and middle-income countries where most tobacco users reside. We present novel data on tobacco use in people with SMI and their access to tobacco cessation advice in South Asia. METHODS: We conducted a multi-country survey of adults with SMI attending mental health facilities in Bangladesh, India, and Pakistan. Using data collected with a standardized WHO STEPS survey tool, we estimated the prevalence and distribution of tobacco use and assessed receipt of tobacco cessation advice. RESULTS: We recruited 3874 participants with SMI; 46.8% and 15.0% of men and women consumed tobacco, respectively. Smoking prevalence in men varied by country (Bangladesh 42.8%, India 20.1% and Pakistan 31.7%); <4% of women reported smoking in each country. Smokeless tobacco use in men also varied by country (Bangladesh 16.2%, India 18.2% and Pakistan 40.8%); for women, it was higher in Bangladesh (19.1%), but similar in India (9.9%) and Pakistan (9.1%). Just over a third of tobacco users (38.4%) had received advice to quit tobacco. Among smokers, 29.1% (n=244) made at least one quit attempt in the past year. There was strong evidence for the association between tobacco use and the severity of depression (OR=1.29; 95% CI: 1.12-1.48) and anxiety (OR=1.29; 95% CI: 1.12-1.49). CONCLUSIONS: As observed in high-income countries, we found higher tobacco use in people with SMI, particularly in men compared with rates reported for the general population in South Asia. Tobacco cessation support within mental health services offers an opportunity to close the gap in life expectancy between SMI and the general population. STUDY REGISTRATION: ISRCTN88485933; https://doi.org/10.1186/ISRCTN88485933 39.

Price elasticity of cigarette smoking in Bangladesh: evidence from the Global Adult Tobacco Surveys (GATS).

INTRODUCTION: The overall prevalence of cigarette smoking has not changed significantly for over a decade in Bangladesh. Raising the price of cigarettes through taxation is an important policy instrument for reducing consumption and achieving public health goals. The price elasticity of cigarette demand is an important parameter for evaluating the effectiveness of raising prices through tax increases in reducing cigarette consumption. The objective of the study was to estimate the price elasticity of cigarette demand in Bangladesh using Global Adult Tobacco Survey 2009 and 2017 data. METHODS: Smoking prevalence and smoking intensity were estimated using a two-part model. Endogeneity of prices was minimised using the average consumption-weighted cigarette price in a cluster, for both smokers and non-smokers residing in a specific cluster. RESULTS: Cigarette demand was found to be price inelastic and ranged between -0.51 and -0.73. It is also price inelastic across wealth groups and areas of residence in Bangladesh. Although the total price elasticity did not differ considerably between rural and urban locations, it is evident that individuals in the lower-wealth group are more than twice as responsive to price increases as their high-wealth counterparts. CONCLUSION: A significant increase in cigarette prices through a tax increase would decrease smoking prevalence and increase tax revenue in Bangladesh. The greater price sensitivity among smokers in lower-wealth groups indicates that a tax-induced cigarette price increase would provide more health benefits to them, thereby contributing to improved health equity.

Children Learning About Secondhand Smoke (CLASS III): a protocol for a cluster randomised controlled trial of a school-based smoke-free intervention in Bangladesh and Pakistan.

INTRODUCTION: Secondhand smoke (SHS) exposure is a major cause of premature death and disease, especially among children. Children in economically developing countries are particularly affected as smoke-free laws are typically only partially implemented and private homes and cars remain a key source of SHS exposure. Currently, firm conclusions cannot be drawn from the available evidence on the effectiveness of non-legislative interventions designed to protect children from SHS exposure. Following the success of two feasibility studies and a pilot trial, we plan to evaluate a school-based approach to protect children from SHS exposure in Bangladesh and Pakistan-countries with a strong commitment to smoke-free environments but with high levels of SHS exposure in children. We will conduct a two-arm cluster randomised controlled trial in Bangladesh and Pakistan to assess the effectiveness and cost effectiveness of a school-based smoke-free intervention (SFI) in reducing children's exposure to SHS and the frequency and severity of respiratory symptoms. METHODS AND ANALYSIS: We plan to recruit 68 randomly selected schools from two cities-Dhaka in Bangladesh and Karachi in Pakistan. From each school, we will recruit approximately 40 students in a year (9-12 years old) with a total of 2720 children. Half of the schools will be randomly allocated to the intervention arm receiving SFI and the other half will receive usual education. Salivary cotinine concentration-a highly sensitive and specific biomarker of SHS exposure-is the primary outcome, which will be measured at month 3 post-randomisation. Secondary outcomes will include frequency and severity of respiratory symptoms, healthcare contacts, school absenteeism, smoking uptake and quality of life. Embedded economic and process evaluations will also be conducted. ETHICS AND DISSEMINATION: The trial has received ethics approval from the Research Governance Committee at the University of York. Approvals have also been obtained from Bangladesh Medical Research Council and Pakistan Health Research Council. If SFI is found effective, we will use a variety of channels to share our findings with both academic and non-academic audiences. We will work with the education departments in Bangladesh and Pakistan and advocate for including SFI within the curriculum. TRIAL REGISTRATION NUMBER: ISRCTN28878365.

The global impact of tobacco control policies on smokeless tobacco use: a systematic review.

BACKGROUND: Smokeless tobacco, used by more than 300 million people globally, results in substantial morbidity and mortality. For smokeless tobacco control, many countries have adopted policies beyond the WHO Framework Convention on Tobacco Control, which has been instrumental in reducing smoking prevalence. The impact of these policies (within and outside the Framework Convention on Tobacco Control) on smokeless tobacco use remains unclear. We aimed to systematically review policies that are relevant to smokeless tobacco and its context and investigate their impact on smokeless tobacco use. METHODS: In this systematic review, we searched 11 electronic databases and grey literature between Jan 1, 2005, and Sept 20, 2021, in English and key south Asian languages, to summarise smokeless tobacco policies and their impact. Inclusion criteria were all types of studies on smokeless tobacco users that mentioned any smokeless tobacco relevant policies since 2005, except systematic reviews. Policies issued by organisations or private institutions were excluded as well as studies on e-cigarettes and Electronic Nicotine Delivery System except where harm reduction or switching were evaluated as a tobacco cessation strategy. Two reviewers independently screened articles, and data were extracted after standardisation. Quality of studies was appraised using the Effective Public Health Practice Project's Quality Assessment Tool. Outcomes for impact assessment included smokeless tobacco prevalence, uptake, cessation, and health effects. Due to substantial heterogeneity in the descriptions of policies and outcomes, data were descriptively and narratively synthesised. This systematic review was registered in PROSPERO (CRD42020191946). FINDINGS: 14 317 records were identified, of which 252 eligible studies were included as describing smokeless tobacco policies. 57 countries had policies targeting smokeless tobacco, of which 17 had policies outside the Framework Convention on Tobacco Control for smokeless tobacco (eg, spitting bans). 18 studies evaluated the impact, which were of variable quality (six strong, seven moderate, and five weak) and reported mainly on prevalence of smokeless tobacco use. The body of work evaluating policy initiatives based on the Framework Convention on Tobacco Control found that these initiatives were associated with reductions in smokeless tobacco prevalence of between 4·4% and 30·3% for taxation and 22·2% and 70·9% for multifaceted policies. Two studies evaluating the non-Framework policy of sales bans reported significant reductions in smokeless tobacco sale (6·4%) and use (combined sex 17·6%); one study, however, reported an increased trend in smokeless tobacco use in the youth after a total sales ban, likely due to cross-border smuggling. The one study reporting on cessation found a 13·3% increase in quit attempts in individuals exposed (47·5%) to Framework Convention on Tobacco Control policy: education, communication, training, and public awareness, compared with non-exposed (34·2%). INTERPRETATION: Many countries have implemented smokeless tobacco control policies, including those that extend beyond the Framework Convention on Tobacco Control. The available evidence suggests that taxation and multifaceted policy initiatives are associated with meaningful reductions in smokeless tobacco use. FUNDING: UK National Institute for Health Research.

Prevalence of physical health conditions and health risk behaviours in people with severe mental illness in South Asia: multi-country cross-sectional survey.

BACKGROUND: People with severe mental illness (SMI) die earlier than the general population, primarily because of physical disorders. AIMS: We estimated the prevalence of physical health conditions, health risk behaviours, access to healthcare and health risk modification advice in people with SMI in Bangladesh, India and Pakistan, and compared results with the general population. METHOD: We conducted a cross-sectional survey in adults with SMI attending mental hospitals in Bangladesh, India and Pakistan. Data were collected on non-communicable diseases, their risk factors, health risk behaviours, treatments, health risk modification advice, common mental disorders, health-related quality of life and infectious diseases. We performed a descriptive analysis and compared our findings with the general population in the World Health Organization (WHO) 'STEPwise Approach to Surveillance of NCDs' reports. RESULTS: We recruited 3989 participants with SMI, of which 11% had diabetes, 23.3% had hypertension or high blood pressure and 46.3% had overweight or obesity. We found that 70.8% of participants with diabetes, high blood pressure and hypercholesterolemia were previously undiagnosed; of those diagnosed, only around half were receiving treatment. A total of 47% of men and 14% of women used tobacco; 45.6% and 89.1% of participants did not meet WHO recommendations for physical activity and fruit and vegetable intake, respectively. Compared with the general population, people with SMI were more likely to have diabetes, hypercholesterolemia and overweight or obesity, and less likely to receive tobacco cessation and weight management advice. CONCLUSIONS: We found significant gaps in detection, prevention and treatment of non-communicable diseases and their risk factors in people with SMI.

"Everything the hujur tells is very educative but if I cannot apply those in my own life then there is no meaning": a mixed-methods process evaluation of a smoke-free homes intervention in Bangladesh.

BACKGROUND: Second-hand smoke exposure from tobacco significantly contributes to morbidity and mortality worldwide. A cluster RCT in Bangladesh compared a community-based smoke-free home (SFH) intervention delivered in mosques, with or without indoor air quality (IAQ) feedback to households to no intervention. Neither was effective nor cost-effective compared to no intervention using an objective measure of second-hand smoke. This paper presents the process evaluation embedded within the trial and seeks to understand this. METHODS: A mixed method process evaluation comprising interviews with 30 household leads and six imams (prayer leader in mosque), brief questionnaire completed by 900 household leads (75% response), fidelity assessment of intervention delivery in six (20%) mosques and research team records. Data were triangulated using meta-themes informed by three process evaluation functions: implementation, mechanisms of impact and context. RESULTS: IMPLEMENTATION: Frequency of SFH intervention delivery was judged moderate to good. However there were mixed levels of intervention fidelity and poor reach. Linked Ayahs (verses of the Qur'an) with health messages targeting SHS attitudes were most often fully implemented and had greatest reach (along with those targeting social norms). Frequency and reach of the IAQ feedback were good. MECHANISMS OF IMPACT: Both interventions had good acceptability. However, views on usefulness of the interventions in creating a SFH were mixed. Individual drivers to behaviour change were new SFH knowledge with corresponding positive attitudes, social norms and intentions. Individual barriers were a lack of self-efficacy and plans. CONTEXT: Social context drivers to SFH intervention implementation in mosques were in place and important. No context barriers to implementation were reported. Social context drivers to SHS behaviour change were children's requests. Barriers were women's reluctance to ask men to smoke outside alongside general reluctance to request this of visitors. (Not) having somewhere to smoke outside was a physical context (barrier) and driver. CONCLUSIONS: Despite detailed development and adaption work with relevant stakeholders, the SFH intervention and IAQ feedback became educational interventions that were motivational but insufficient to overcome significant context barriers to reduce objectively measured SHS exposure in the home. Future interventions could usefully incorporate practical support for SFH behaviour change. Moreover, embedding these into community wide strategies that include practical cessation support and enforcement of SFH legislation is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49975452.

Non-compliant packaging and illicit smokeless tobacco in Bangladesh, India and Pakistan: findings of a pack analysis.

INTRODUCTION: Illicit smokeless tobacco (ST) trade has seldom been documented despite ST use in at least 127 countries across the world. Based on non-compliance with packaging regulations, we report the proportion of illicit ST products from samples on sale in Bangladesh, India and Pakistan where 85% of global ST users reside. METHODS: We purchased unique ST products from tobacco sellers in two purposively selected administrative areas (division/district) in each of the three countries. The criteria to determine illicit ST products were based on country-specific legal requirements for ST packaging and labelling. These requirements included: 'market retail price disclosure', 'sale statement disclosure', 'pictorial health warning (PHW) pertinence', 'appropriate textual health warning' and 'using misleading descriptors (MDs)'. Non-compliance with even one of the legal requirements was considered to render the ST product illicit. RESULTS: Almost all ST products bought in Bangladesh and India were non-compliant with the local packaging requirements and hence potentially illicit, all products in Pakistan lacked desirable features. The most common feature missing was health warnings: 84% packs in Bangladesh, 93% in India, and 100% in Pakistan either did not have PHW or their sizes were too small. In Bangladesh, 61% packs carried MDs. In India and Pakistan, the proportions of such packs were 32% and 42%, respectively. CONCLUSIONS: Weak and poorly enforced ST control policies may be slowing the progress of tobacco control in South Asia. Standardised regulations are required for packaging and labelling ST. Improving compliance and reducing sale of cheap illicit products may require business licensing and market surveillance.

Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial.

OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries. DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation. SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan. PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472). INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence. PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping. RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm. CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS. TRIAL REGISTRATION NUMBER: ISRCTN43811467.

Behavioural support and nicotine replacement therapy for smokeless tobacco cessation: protocol for a pilot randomised-controlled multi-country trial.

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 factorial design, randomised-controlled 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), a combination of interventions A and B or usual care (Very Brief Advice - VBA). The participants will provide demographic and ST use related data at baseline, and at 6, 12 and 26 weeks of follow-up. Salivary cotinine samples will be collected at baseline and 26 weeks. 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. 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. 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. 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. TRIAL REGISTRATION: ISRCTN identifier 65109397.

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.

'A contradiction between our state and the tobacco company': conflicts of interest and institutional constraints as barriers to implementing Article 5.3 in Bangladesh.

INTRODUCTION: Bangladesh has not yet adopted measures to implement Article 5.3 of the WHO Framework Convention on Tobacco Control. The National Tobacco Control Cell (NTCC) has drafted a guideline for implementation, but progress has stalled amid high levels of tobacco industry interference in public policy. This paper examines the barriers to minimising industry interference in a context of close relationships between government officials and tobacco companies. METHODS: In-depth interviews were conducted with government officials, representatives from civil society, think tank and media organisations, and academic researchers. The data were analysed using a '3 Is' framework developed within the political sciences, emphasising the interactive role of ideas, interests and institutions in policy change. RESULTS: The findings indicate that policy ideas about protecting public health policy making from tobacco industry interests are largely restricted to the Ministry of Health and Family Welfare, and the NTCC specifically. Both individual and institutional conflicts of interest emerge as key barriers to progress to minimising industry interference and for tobacco control governance more broadly. The data also suggest that development of an Article 5.3 guideline has been shaped by the perceived interests of political actors and institutions, and the institutional position of the NTCC, constrained by limits on its resources, authority and isolation from other ministries. CONCLUSION: NTCC's initiatives towards implementing Article 5.3 constitute an important opportunity to address conflicts of interest that restrict tobacco control in Bangladesh. Progress in minimising industry interference is essential to realising the commitment to being smoke free by 2040.

Effect of quitting smoking on health outcomes during treatment for tuberculosis: secondary analysis of the TB & Tobacco Trial.

BACKGROUND: Despite treatment, patients with tuberculosis (TB) who smoke have poorer outcomes compared with non-smokers. It is unknown, however, if quitting smoking during the 6 months of TB treatment improves TB outcomes. METHODS: The TB & Tobacco Trial was a double-blind, placebo-controlled randomised trial of cytisine for smoking cessation in 2472 patients with pulmonary TB in Bangladesh and Pakistan. In a secondary analysis, we investigated the hypothesis that smoking cessation improves health outcomes in patients during the TB treatment course. The outcomes included an eight-point TB clinical score, sputum conversion rates, chest X-ray grades, quality of life (EQ-5D-5L), TB cure plus treatment completion rates and relapse rates. These were compared between those who stopped smoking and those who did not, using regression analysis. RESULTS: We analysed the data of 2273 (92%) trial participants. Overall, 25% (577/2273) of participants stopped smoking. Compared with non-quitters, those who quit had better TB cure plus treatment completion rates (91% vs 80%, p<0.001) and lower TB relapse rates (6% vs 14%, p<0.001). Among quitters, a higher sputum conversion rate at week 9 (91% vs 87%, p=0.036), lower mean TB clinical scores (-0.20 points, 95% CI -0.31 to -0.08, p=0.001) and slightly better quality of life (mean EQ-5D-5L 0.86 vs 0.85, p=0.015) at 6 months were also observed. These differences, except quality of life, remained statistically significant after adjusting for baseline values, trial arm and TB treatment adherence rates. CONCLUSION: Patients with TB who stop smoking may have better outcomes than those who don't. Health professionals should support patients in stopping smoking.

Demand for tobacco products in Bangladesh.

BACKGROUND: Tobacco tax increase is considered as one of the most effective means to reduce tobacco consumption and its consequences. An increase in taxes, which results in an increase in the price of tobacco products, reduces consumption. Historically, a number of studies estimated the responsiveness of quantity demanded to a change in price-the price elasticity of demand-of tobacco products in Bangladesh. However, the government's stronger commitment to reducing tobacco use, rising standard of living, rapidly changing cultural norms due to globalisation, and the substantial fall in tobacco use seen in GATS 2017 necessitate an updated measure of price elasticity of tobacco use, which will allow for more accurate answers to questions of tobacco tax policy in the country. This study endeavours to fill this gap in the literature on demand for tobacco products in Bangladesh. OBJECTIVE: To estimate the price elasticity of demand for tobacco products, namely cigarettes, biris and smokeless tobacco (SLT) products with the 2016 household income and expenditure survey data in Bangladesh. METHODS: We used the Deaton model (1997) to estimate the price elasticities of demand for tobacco products using the Household Income and Expenditure Survey (HIES) 2016 dataset of the Bangladesh Bureau of Statistics. The HIES 2016 surveyed 46 076 households spread over 2304 primary sampling units across the country. We have calculated own price elasticities of demand for tobacco products by expenditure groups and by regions (rural and urban). RESULTS: The estimates of own-price elasticity of demand for cigarette, biri and SLT products are -1.03, -1.34 and -0.30, respectively. The results show that rural households are more responsive to changes in the prices of cigarettes than urban households. Households with low expenditure are found to be more responsive to changes in the price of cigarettes than the households with high expenditure. This suggests that increases in cigarette prices at the lower end would effectively reduce cigarette consumption among the people having low expenditure and improve health equity. CONCLUSIONS: Our results suggest that the demand for smoking tobacco products is responsive to price changes. Therefore, substantial increase in the prices of tobacco products through taxation will result in significant reduction in tobacco use, particularly among the low expenditure households, while increasing government revenue.

Illicit cigarette trade in the cities of Pakistan: comparing findings between the consumer and waste recycle store surveys.

BACKGROUND: Concerns about the magnitude of illicit cigarette trade have prevented the Government of Pakistan from increasing tobacco taxes. We estimated the proportion of illicit cigarettes sold in Pakistani cities. Moreover, we compared two methods for collecting cigarette packs and investigated if the illicit cigarette trade equates to tax evasion. METHOD: We analysed cigarette packs collected from 10 cities of Pakistan using two methods: consumer survey based on a two-stage random sampling strategy to recruit adult smokers and photograph their cigarette packs and waste recycle store survey to purchase used cigarette packs. Cigarettes were considered illicit if any one of the following was absent from their packs: text and pictorial health warning, underage sale prohibition warning, retail price and manufacturer's name. From the consumer survey, we also estimated the proportion of smokers who purchased loose cigarettes (illegal) and packs below the minimum retail price. Taxation officers (n=4) were consulted to assess their level of confidence in judging tax evasion using the above criteria. RESULTS: Out of 2416 cigarette packs in the consumer survey, 454 (17.8%; 95% CI 15.4% to 20.2%) were illicit. Similarly, out of 6213 packs from waste recycle shops, 1046 (16.8%; 95% CI 15.9% to 17.7%) were illicit; the difference was not statistically significant (p=0.473). Among consumers, 29.5% bought loose cigarettes and 13.8% paid less than the minimum retail price. The taxation officers considered the manufacturer's name and retail price on cigarette packs as the most relevant criteria to detect tax evasion. CONCLUSIONS: One in six cigarette packs consumed in Pakistan could be illicit. These figures are far less than those propagated by the tobacco industry. Collecting packs from waste recycle stores is an efficient and valid method to estimate illicit cigarette trade.

Smoking behaviours and indoor air quality: a comparative analysis of smoking-permitted versus smoke-free homes in Dhaka, Bangladesh.

INTRODUCTION: Exposure to secondhand smoke (SHS) is a health risk to non-smokers. Indoor particulate matter (PM2.5) is associated with SHS exposure and is used as a proxy measure. However, PM2.5 is non-specific and influenced by a number of environmental factors, which are subject to geographical variation. The nature of association between SHS exposure and indoor PM2.5-studied primarily in high-income countries (HICs) context-may not be globally applicable. We set out to explore this association in a low/middle-income country setting, Dhaka, Bangladesh. METHODS: A cross-sectional study was conducted among households with at least one resident smoker. We inquired whether smoking was permitted inside the home (smoking-permitted homes, SPH) or not (smoke-free homes, SFH), and measured indoor PM2.5 concentrations using a low-cost instrument (Dylos DC1700) for at least 22 hours. We describe and compare SPH and SFH and use multiple linear regression to evaluate which variables are associated with PM2.5 level among all households. RESULTS: We surveyed 1746 households between April and August 2018; 967 (55%) were SPH and 779 (45%) were SFH. The difference between PM2.5 values for SFH (median 27 µg/m3, IQR 25) and SPH (median 32 µg/m3, IQR 31) was 5 µg/m3 (p<0.001). Lead participant's education level, being a non-smoker, having outdoor space and smoke-free rule at home and not using kerosene oil for cooking were significantly associated with lower PM2.5. CONCLUSIONS: We found a small but significant difference between PM2.5 concentrations in SPH compared with SFH in Dhaka, Bangladesh-a value much lower than observed in HICs.