Interventions for tobacco use cessation in people living with HIV.

BACKGROUND: The prevalence of tobacco use among people living with HIV (PLWH) is up to four times higher than in the general population. Unfortunately, tobacco use increases the risk of progression to AIDS and death. Individual- and group-level interventions, and system-change interventions that are effective in helping PLWH stop using tobacco can markedly improve the health and quality of life of this population. However, clear evidence to guide policy and practice is lacking, which hinders the integration of tobacco use cessation interventions into routine HIV care. This is an update of a review that was published in 2016. We include 11 new studies. OBJECTIVES: To assess the benefits, harms and tolerability of interventions for tobacco use cessation among people living with HIV. To compare the benefits, harms and tolerability of interventions for tobacco use cessation that are tailored to the needs of people living with HIV with that of non-tailored cessation interventions. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, Embase, and PsycINFO in December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of individual-/group-level behavioural or pharmacological interventions, or both, for tobacco use cessation, delivered directly to PLWH aged 18 years and over, who use tobacco. We also included RCTs, quasi-RCTs, other non-randomised controlled studies (e.g. controlled before and after studies), and interrupted time series studies of system-change interventions for tobacco use cessation among PLWH. For system-change interventions, participants could be PLWH receiving care, or staff working in healthcare settings and providing care to PLWH; but studies where intervention delivery was by research personnel were excluded. For both individual-/group-level interventions, and system-change interventions, any comparator was eligible. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods, and used GRADE to assess certainty of the evidence. The primary measure of benefit was tobacco use cessation at a minimum of six months. Primary measures for harm were adverse events (AEs) and serious adverse events (SAEs). We also measured quit attempts or quit episodes, the receipt of a tobacco use cessation intervention, quality of life, HIV viral load, CD4 count, and the incidence of opportunistic infections. MAIN RESULTS: We identified 17 studies (16 RCTs and one non-randomised study) with a total of 9959 participants; 11 studies are new to this update. Nine studies contributed to meta-analyses (2741 participants). Fifteen studies evaluated individual-/group-level interventions, and two evaluated system-change interventions. Twelve studies were from the USA, two from Switzerland, and there were single studies for France, Russia and South Africa. All studies focused on cigarette smoking cessation. All studies received funding from independent national- or institutional-level funding. Three studies received study medication free of charge from a pharmaceutical company. Of the 16 RCTs, three were at low risk of bias overall, five were at high risk, and eight were at unclear risk. Behavioural support or system-change interventions versus no or less intensive behavioural support Low-certainty evidence (7 studies, 2314 participants) did not demonstrate a clear benefit for tobacco use cessation rates in PLWH randomised to receive behavioural support compared with brief advice or no intervention: risk ratio (RR) 1.11, 95% confidence interval (CI) 0.87 to 1.42, with no evidence of heterogeneity. Abstinence at six months or more was 10% (n = 108/1121) in the control group and 11% (n = 127/1193) in the intervention group. There was no evidence of an effect on tobacco use cessation on system-change interventions: calling the quitline and transferring the call to the patient whilst they are still in hospital ('warm handoff') versus fax referral (RR 3.18, 95% CI 0.76 to 13.99; 1 study, 25 participants; very low-certainty evidence). None of the studies in this comparison assessed SAE. Pharmacological interventions versus placebo, no intervention, or another pharmacotherapy Moderate-certainty evidence (2 studies, 427 participants) suggested that varenicline may help more PLWH to quit smoking than placebo (RR 1.95, 95% CI 1.05 to 3.62) with no evidence of heterogeneity. Abstinence at six months or more was 7% (n = 14/215) in the placebo control group and 13% (n = 27/212) in the varenicline group. There was no evidence of intervention effects from individual studies on behavioural support plus nicotine replacement therapy (NRT) versus brief advice (RR 8.00, 95% CI 0.51 to 126.67; 15 participants; very low-certainty evidence), behavioural support plus NRT versus behavioural support alone (RR 1.47, 95% CI 0.92 to 2.36; 560 participants; low-certainty evidence), varenicline versus NRT (RR 0.93, 95% CI 0.48 to 1.83; 200 participants; very low-certainty evidence), and cytisine versus NRT (RR 1.18, 95% CI 0.66 to 2.11; 200 participants; very low-certainty evidence). Low-certainty evidence (2 studies, 427 participants) did not detect a difference between varenicline and placebo in the proportion of participants experiencing SAEs (8% (n = 17/212) versus 7% (n = 15/215), respectively; RR 1.14, 95% CI 0.58 to 2.22) with no evidence of heterogeneity. Low-certainty evidence from one study indicated similar SAE rates between behavioural support plus NRT and behavioural support only (1.8% (n = 5/279) versus 1.4% (n = 4/281), respectively; RR 1.26, 95% CI 0.34 to 4.64). No studies assessed SAEs for the following: behavioural support plus NRT versus brief advice; varenicline versus NRT and cytisine versus NRT. AUTHORS' CONCLUSIONS: There is no clear evidence to support or refute the use of behavioural support over brief advice, one type of behavioural support over another, behavioural support plus NRT over behavioural support alone or brief advice, varenicline over NRT, or cytisine over NRT for tobacco use cessation for six months or more among PLWH. Nor is there clear evidence to support or refute the use of system-change interventions such as warm handoff over fax referral, to increase tobacco use cessation or receipt of cessation interventions among PLWH who use tobacco. However, the results must be considered in the context of the small number of studies included. Varenicline likely helps PLWH to quit smoking for six months or more compared to control. We did not find evidence of difference in SAE rates between varenicline and placebo, although the certainty of the evidence is low.

Children Learning About Second-hand Smoke (CLASS II): a mixed methods process evaluation of a school-based intervention.

BACKGROUND: Children are vulnerable to the effects of second-hand smoke exposure. Creating smoke-free homes is an effective strategy to limit exposure. We developed a smoke-free intervention (SFI) using children as a catalyst for change and teaching skills to negotiate a smoke-free home. In this paper, we present the process evaluation conducted within a pilot trial. METHODS: This was a mixed-methods study comprising qualitative interviews and quantitative fidelity assessment of SFI delivery. Interviews in the six intervention schools were conducted with six headteachers and 12 teachers. These explored experiences of delivering the SFI, perceived impact, barriers and facilitators to success, and ideas for improvement and for scaling up. The data were analysed using framework analysis. Delivery of the SFI was observed and fidelity scores calculated. RESULTS: The SFI was acceptable to headteachers and teachers. Fidelity scores ranged from 27/40 to 37/40. Didactic components were more fully implemented than interactive components. Time to complete the sessions, timing in the school day and school calendar were key challenges. Embedding the SFI into the curriculum was a potential solution. CONCLUSIONS: These findings provide useful information to finalise the content and delivery and inform the scale-up of the SFI for our definitive trial, which is now underway. TRIAL REGISTRATION: ISRCTN68690577.

Evaluation of tobacco dependence measures in South Asian smokeless tobacco users.

BACKGROUND: Despite the high prevalence of smokeless tobacco (ST) use in South Asia, ST dependence in this population has not been studied. Therefore, it is of interest to explore if ST dependence measures developed and validated in the western countries are of similar relevance to ST users who are culturally different and use distinct ST products. The aim of this study is to assess ST dependence among its users in Bangladesh by employing ST dependence scales based on three different approaches to measure tobacco dependence. METHODS: Data collected from a community-based sample of exclusive ST users living in Dhaka, Bangladesh (n = 200) were used for this study. Three ST dependence measures, Tobacco Dependence Screener (TDS), Fagerström Test for Nicotine Dependence for ST users (FTND-ST), and Oklahoma Scale for Smokeless Tobacco Dependence (OSSTD), were translated in Bangla and administered to the study participants. Saliva samples were collected for cotinine measurement. Reliability and concurrent and construct validity of FTND-ST and OSSTD were examined. RESULTS: Median cotinine concentration of the study participants was 440.2 (min = 2.9, max = 1874) ng/ml and 47% of them had TDS-based dependence diagnosis. Women had higher mean OSSTD, FTND-ST, and TDS scores as compared to men (p < 0.001). OSSTD demonstrated better reliability (α = 0.93) than FTND-ST, and TDS (α = 0.64 and 0.86, respectively). Concurrent validity of FTND-ST as evaluated by TDS, OSSTD, and cotinine concentration was affirmative. CONCLUSION: The FTND-ST is a valid and reliable tool to measure physical dependence among ST users in Bangladesh. The study was unable to replicate the structure of OSSTD.

Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial.

BACKGROUND: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas. OBJECTIVES: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. METHODS/DESIGN: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. DISCUSSION: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.

Frailty, inequality and resilience.

Frailty is a common condition in later life in which minor stressors may result in major changes in health. While the biological mechanisms of frailty are increasingly understood, relationships with the wider determinants of health, health inequalities and the concept of resilience are less well-established and the role of the clinician in their modification is less well understood.The wider determinants are the modifiable conditions in which people are born, grow, work and live, and the wider set of systems shaping the conditions of daily life. They interact across the life course, driving a well-recognised social gradient in health. The wider determinants are closely linked to the concept of resilience, which is the process of effectively negotiating, adapting to or managing significant sources of stress or trauma. Better recognition of the relationship between frailty, the wider determinants, inequalities and resilience can enable a framework around which policy responses may be developed to build resilience in people living with frailty at an individual and community level as well as enabling clinicians to better identify how they may support their patients.

Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.

INTRODUCTION: Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children. METHODS: In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children's salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577. RESULTS: Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm-a mean difference of -1.31 ng/ml (95% CI = -2.86 to 0.24). CONCLUSION: It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials. IMPLICATIONS: In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children's exposure to SHS-an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.

Secondhand Smoke Exposure in Primary School Children: A Survey in Dhaka, Bangladesh.

INTRODUCTION: We report on second-hand smoke (SHS) exposure based on saliva cotinine levels among children in Bangladesh-a country with laws against smoking in public places. METHODS: A survey of primary school children from two areas of the Dhaka district was conducted in 2015. Participants completed a questionnaire and provided saliva samples for cotinine measurement to assess SHS exposure with a cut-off range of ≥0.1ng/mL. RESULTS: Four hundred and eighty-one children studying in year-5 were recruited from 12 primary schools. Of these, 479 saliva samples were found sufficient for cotinine testing, of which 95% (453/479) were positive for recent SHS exposure. Geometric mean cotinine was 0.36 (95% CI = 0.32 to 0.40); 43% (208/479) of children lived with at least one smoker in the household. Only 21% (100/479) reported complete smoking restrictions for residents and visitors; 87% (419/479) also reported being recently exposed to SHS in public spaces. Living with a smoker and number of tobacco selling shops in the neighborhood had positive associations with recent SHS exposure. CONCLUSIONS: Despite having a ban on smoking in public places, recent SHS exposure among children in Bangladesh remains very high. There is an urgent need to reduce exposure to SHS in Bangladeshi children. IMPLICATIONS: Children bear the biggest burden of disease due to SHS exposure than any other age group. However, children living in many high-income countries have had a sharp decline in their exposure to SHS in recent years. What remains unknown is if children living in low-income countries are still exposed to SHS. Our study suggests that despite having a ban on smoking in public places, most primary school children in Dhaka, Bangladesh are still likely to be exposed to SHS.

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.

BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

Tobacco use among people living with HIV: analysis of data from Demographic and Health Surveys from 28 low-income and middle-income countries.

BACKGROUND: Tobacco use among people living with HIV results in excess morbidity and mortality. However, very little is known about the extent of tobacco use among people living with HIV in low-income and middle-income countries (LMICs). We assessed the prevalence of tobacco use among people living with HIV in LMICs. METHODS: We used Demographic and Health Survey data collected between 2003 and 2014 from 28 LMICs where both tobacco use and HIV test data were made publicly available. We estimated the country-specific, regional, and overall prevalence of current tobacco use (smoked, smokeless, and any tobacco use) among 6729 HIV-positive men from 27 LMICs (aged 15-59 years) and 11 495 HIV-positive women from 28 LMICs (aged 15-49 years), and compared them with those in 193 763 HIV-negative men and 222 808 HIV-negative women, respectively. We estimated prevalence separately for males and females as a proportion, and the analysis accounted for sampling weights, clustering, and stratification in the sampling design. We computed pooled regional and overall prevalence estimates through meta-analysis with the application of a random-effects model. We computed country, regional, and overall relative prevalence ratios for tobacco smoking, smokeless tobacco use, and any tobacco use separately for males and females to study differences in prevalence rates between HIV-positive and HIV-negative individuals. FINDINGS: The overall prevalence among HIV-positive men was 24·4% (95% CI 21·1-27·8) for tobacco smoking, 3·4% (1·8-5·6) for smokeless tobacco use, and 27·1% (22·8-31·7) for any tobacco use. We found a higher prevalence in HIV-positive men of any tobacco use (risk ratio [RR] 1·41 [95% CI 1·26-1·57]) and tobacco smoking (1·46 [1·30-1·65]) than in HIV-negative men (both p<0·0001). The difference in smokeless tobacco use prevalence between HIV-positive and HIV-negative men was not significant (1·26 [1·00-1·58]; p=0·050). The overall prevalence among HIV-positive women was 1·3% (95% CI 0·8-1·9) for tobacco smoking, 2·1% (1·1-3·4) for smokeless tobacco use, and 3·6% (95% CI 2·3-5·2) for any tobacco use. We found a higher prevalence in HIV-positive women of any tobacco use (RR 1·36 [95% CI 1·10-1·69]; p=0·0050), tobacco smoking (1·90 [1·38-2·62]; p<0·0001), and smokeless tobacco use (1·32 [1·03-1·69]; p=0·030) than in HIV-negative women. INTERPRETATION: The high prevalence of tobacco use in people living with HIV in LMICs mandates targeted policy, practice, and research action to promote tobacco cessation and to improve the health outcomes in this population. FUNDING: South African Medical Research Council and the UK Medical Research Council.

Determinants of Salivary Cotinine among Smokeless Tobacco Users: A Cross-Sectional Survey in Bangladesh.

INTRODUCTION: More than 80% of all smokeless tobacco (ST) products in the world are consumed in South Asia; yet little is known about their consumption behaviour, addictiveness, and toxic properties. This paper, for the first time, describes associations between salivary cotinine concentrations among ST users in Bangladesh and their socio-demographic characteristics and tobacco use behaviours. METHODS: In a survey of ST users in Dhaka, Bangladesh, we purposively recruited 200 adults who were non-smokers but consumed ST on a regular basis. In-person interviews were conducted to obtain information about socio-demographic and ST use behaviours, and saliva samples were collected to measure cotinine concentration. Simple and multiple linear regression analyses were conducted to test associations between the log transformed salivary cotinine concentration and other study variables. RESULTS: The geometric mean of cotinine concentration among ST users was 380ng/ml (GSD:2). Total duration of daily ST use in months had a statistically significant association with cotinine concentration. Other ST use characteristics including type and quantity of ST use, swallowing of tobacco juice, urges and strength of urges and attempts to cut down on tobacco use were not found to be associated with cotinine concentration in a multivariable model. CONCLUSION: This is the first report from Bangladesh studying cotinine concentration among ST users and it points towards high levels of addiction. This warrants effective tobacco control policies to help ST cessation and prevention.

Global burden of disease due to smokeless tobacco consumption in adults: analysis of data from 113 countries.

BACKGROUND: Smokeless tobacco is consumed in most countries in the world. In view of its widespread use and increasing awareness of the associated risks, there is a need for a detailed assessment of its impact on health. We present the first global estimates of the burden of disease due to consumption of smokeless tobacco by adults. METHODS: The burden attributable to smokeless tobacco use in adults was estimated as a proportion of the disability-adjusted life-years (DALYs) lost and deaths reported in the 2010 Global Burden of Disease study. We used the comparative risk assessment method, which evaluates changes in population health that result from modifying a population's exposure to a risk factor. Population exposure was extrapolated from country-specific prevalence of smokeless tobacco consumption, and changes in population health were estimated using disease-specific risk estimates (relative risks/odds ratios) associated with it. Country-specific prevalence estimates were obtained through systematically searching for all relevant studies. Disease-specific risks were estimated by conducting systematic reviews and meta-analyses based on epidemiological studies. RESULTS: We found adult smokeless tobacco consumption figures for 115 countries and estimated burden of disease figures for 113 of these countries. Our estimates indicate that in 2010, smokeless tobacco use led to 1.7 million DALYs lost and 62,283 deaths due to cancers of mouth, pharynx and oesophagus and, based on data from the benchmark 52 country INTERHEART study, 4.7 million DALYs lost and 204,309 deaths from ischaemic heart disease. Over 85 % of this burden was in South-East Asia. CONCLUSIONS: Smokeless tobacco results in considerable, potentially preventable, global morbidity and mortality from cancer; estimates in relation to ischaemic heart disease need to be interpreted with more caution, but nonetheless suggest that the likely burden of disease is also substantial. The World Health Organization needs to consider incorporating regulation of smokeless tobacco into its Framework Convention for Tobacco Control.

Muslim communities learning about second-hand smoke: a pilot cluster randomised controlled trial and cost-effectiveness analysis.

BACKGROUND: In the United Kingdom, men of Bangladeshi and Pakistani origin have higher smoking rates than the general population. This makes non-smokers in their households more vulnerable to second-hand smoke (SHS) exposure than the general population. AIMS: The aim of this study was to investigate the feasibility of implementing and pilot testing the effectiveness and cost-effectiveness of a 'Smoke-free Homes' (SFH) intervention in Islamic religious settings to encourage families of Bangladeshi and Pakistani origin to apply smoking restrictions in their homes. METHODS: We allocated Islamic religious settings (clusters) to either receive SFH-an educational intervention-or to a control arm. Within each cluster, we recruited households with at least one smoker and one non-smoker. SHS exposure among non-smokers was measured using salivary cotinine. RESULTS: Seven (50%) clusters were randomised to each trial arm. A total of 468 households were assessed for eligibility and 62% (n=289) were eligible, of which 74% (n=213) agreed to participate in the trial. Six of the seven intervention clusters delivered the intervention, and all clusters were retained throughout the trial. In all, 81% (n=172) of households provided data at follow-up. No evidence of a difference in log cotinine level was observed (adjusted mean difference -0.02, 95% confidence interval (CI) -1.28-1.23, P=0.97) between the two trial arms. The direct mean cost of delivering the intervention was £18.18 per household (range £3.55-42.20). CONCLUSIONS: It was possible to recruit, randomise and retain Islamic religious settings and participant households. However, some of the original assumptions, in particular our ability to collect primary outcome data, need to be revisited before a definitive trial.

Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial.

INTRODUCTION: Exposure to secondhand smoke (SHS) increases children's risk of acquiring chest and ear infections, tuberculosis, meningitis and asthma. Smoking bans in public places (where implemented) have significantly reduced adults' exposure to SHS. However, for children, homes remain the most likely place for them to be exposed to SHS. Additional measures are therefore required to protect children from SHS. In a feasibility study in Dhaka, Bangladesh, we have shown that a school-based smoke-free intervention (SFI) was successful in encouraging children to negotiate and implement smoking restrictions in homes. We will now conduct a pilot trial to inform plans to undertake a cluster randomised controlled trial (RCT) investigating the effectiveness and cost-effectiveness of SFI in reducing children's exposure to SHS. METHODS AND ANALYSIS: We plan to recruit 12 primary schools in Dhaka, Bangladesh. From these schools, we will recruit approximately 360 schoolchildren in year 5 (10-12 years old), that is, 30 per school. SFI consists of six interactive educational activities aimed at increasing pupils' knowledge about SHS and related harms, motivating them to act, providing skills to negotiate with adults to persuade them not to smoke inside homes and helping families to 'sign-up' to a voluntary contract to make their homes smoke-free. Children in the control arm will receive the usual education. We will estimate: recruitment and attrition rates, acceptability, fidelity to SFI, effect size, intracluster correlation coefficient, cost of intervention and adverse events. Our primary outcome will consist of SHS exposure in children measured by salivary cotinine. Secondary outcomes will include respiratory symptoms, lung function tests, healthcare contacts, school attendance, smoking uptake, quality of life and academic performance. ETHICS AND DISSEMINATION: The trial has received ethics approval from the Research Governance Committee at the University of York. Findings will help us plan for the definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN68690577.

Smokeless tobacco control policies in South Asia: a gap analysis and recommendations.

INTRODUCTION: Almost a fifth of the world's tobacco is consumed in smokeless form. Its consumption is particularly common in South Asia, where an increasing array of smokeless tobacco (SLT) products is widely available. Mindful of the growing public health threat from SLT, a group of international academics and policy makers recently gathered to identify policy and knowledge gaps and proposed strategies to address these. METHODS: We reviewed key policy documents and interviewed policy makers and representatives of civil society organizations in 4 South Asian countries: Bangladesh, India, Nepal, and Pakistan. We explored if SLT features in existing tobacco control policies and, if so, the extent to which these are implemented and enforced. We also investigated barriers to effective policy formulation and implementation. The findings were presented at an international meeting of experts and were refined in the light of the ensuing discussion in order to inform policy and research recommendations. RESULTS: We found that the existing SLT control policies in these 4 South Asian countries were either inadequate or poorly implemented. Taxes were low and easily evaded; regulatory mechanisms, such as licensing and trading standards, either did not exist or were inadequately enforced to regulate the composition and sales of such products; and there was little or no cessation support for those who wanted to quit. CONCLUSIONS: Limited progress has been made so far to address the emerging public health threat posed by SLT consumption in South Asia. International and regional cooperation is required to advocate for effective policy and to address knowledge gaps.

Effect of cessation interventions on hookah smoking: post-hoc analysis of a cluster-randomized controlled trial.

INTRODUCTION: We explored the differential effect of cessation interventions (behavioral support sessions with [BSS+] and without [BSS] bupropion) between hookah and cigarette smokers. METHODS: We reanalyzed the data from a major cluster-randomized controlled trial, ASSIST (Action to Stop Smoking In Suspected Tuberculosis), which consisted of 3 conditions: (a) behavioral support sessions (BSS), (b) behavioral support sessions plus 7 weeks of bupropion therapy (BSS+), and (c) controls receiving usual care. The trial originally recruited 1,955 adult smokers with suspected tuberculosis from 33 health centers in the Jhang and Sargodha districts of Pakistan between 2010 and 2011. The primary endpoint was continuous 6-month smoking abstinence, which was determined by carbon monoxide levels. Subgroup-specific relative risks (RRs) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression (generalized linear model) between 3 subgroups (cigarette-only: 1,255; mixed: 485; and hookah-only: 215). RESULTS: The test result for homogeneity of intervention effects between the smoking forms was statistically significant (p-value for BSS+: .04 and for BSS: .02). Compared to the control, both interventions appeared to be effective among hookah smokers (RR = 2.5; 95% CI = 1.3-4.7 and RR = 2.2; 95% CI = 1.3-3.8, respectively) but less effective among cigarette smokers (RR = 6.6; 95% CI = 4.6-9.6 and RR = 5.8; 95% CI = 4.0-8.5), respectively. CONCLUSIONS: The differential intervention effects on hookah and cigarette smokers were seen (a) because the behavioral support intervention was designed primarily for cigarette smokers; (b) because of differences in demographic characteristics, behavioral, and sociocultural determinants; or (c) because of differences in nicotine dependency levels between the 2 groups.

TB patients learning about second hand smoke (TBLASS): a pilot individual randomised controlled trial.

BACKGROUND: Living with a smoker is a key determinant of exposure to Second Hand Smoke (SHS) and its exposure mainly occurs at home. Exposure to SHS from tobacco in the household predisposes to the development of tuberculosis (TB) and outcome of the disease gets worse. We aim to develop and evaluate a behavioural intervention 'Smoke Free Homes' (SFH) for TB patients that encourages them to negotiate a smoke free environment within their homes. METHODS AND DESIGN: The pilot individual randomised controlled trial of SFH will inform the design of a future definitive trial. We will first develop SFH intervention using taxonomy of behaviour change techniques aimed at encouraging families of non-smoking TB patients to implement smoking restrictions at home following a logic model of the intervention. This will be followed by conducting a pilot randomised controlled trial of intervention within the context of routine TB control programme. The eligible non-smoking TB patients will be randomised and allocated to one of the two trial arms consisting of "individual based care" and "individual based care" plus "supplementary support". We aim to recruit 150 newly registered pulmonary TB patients from two selected TB centres with 75 cases in each arm. The Primary outcome measure will be SFH of non-smoker TB patient by validating through 'Urine Cotinine' test. We will also determine qualitatively the barriers and key drivers to the creation of smoke free homes followed by developing a definitive trial. DISCUSSION: The male to female distribution of TB cases in Pakistan is almost equal whereas, tobacco use among males is much high as compared to females in Pakistan. This reflects a strong possibility that women health can be affected by men behaviour. Appropriate storage, restricted access and disposal arrangements for participant's personal details will be implemented. All ethical issues will be addressed. There will be no extra burden, financial or otherwise, on the participants. They will not receive any financial incentive to participate in the study. TRIAL REGISTRATION NUMBER: ISRCTN83630841.

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial.

BACKGROUND: In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of 'Smoke Free Homes', an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. METHODS/DESIGN: This is a pilot cluster randomised controlled trial of 'Smoke Free Homes', with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. DISCUSSION: The results of this pilot study will inform the protocol for a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03035510.

Gender disparity in tuberculosis cases in eastern and western provinces of Pakistan.

BACKGROUND: Although globally, the number of notified TB cases is higher for males, a few countries in the Eastern Mediterranean Region (Afghanistan; Lebanon; Iran and Pakistan) of the World Health Organization have a relatively higher number of female cases. Pakistan ranks fifth amongst the highest TB burden countries and poses a rich ground for exploratory research to address the gender differences in TB cases. It is uniquely neighboured by India on the East, having higher number of cases in males than in females, and by Afghanistan and Iran on the West, having higher number of cases in females than in males. The objective is to see whether these gender differences are evenly distributed across the country or vary by geographies, to enable effective targeting of TB control strategies. METHODS: Cross-sectional analysis was carried out on secondary data, obtained from National Tuberculosis Program. Disaggregated at the provincial level, the sex-specific case notification rates (CNR) were calculated and trends over a 10-year span (2001-2010) were examined. Sex-specific differences for the four Pakistani provinces were analyzed using chi-square test and odds ratios with corresponding confidence intervals. Cumulative countrywide sex-specific notification rates were used as the reference group. RESULTS: The trends for 2001-2010 in the western provinces of Pakistan show higher female CNR as compared to those seen in the eastern provinces having slightly higher male CNR. The proportions of female notified TB cases are approximately twice as high in the western provinces when compared to the eastern provinces and Pakistan over all. CONCLUSIONS: These findings suggest that females are particularly affected by TB disease burden in the west parts of Pakistan. This gender disparity requires a coordinated regional and international effort to further explore triggers and moderators of increased acquisition and progression of TB disease among females in the region to guarantee effective TB control.