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.

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.

Behavioral Activation for Comorbid Depression in People With Noncommunicable Disease in India: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: The increasing burden of depression and noncommunicable disease (NCD) is a global challenge, especially in low- and middle-income countries, considering the resource constraints and lack of trained human resources in these settings. Effective treatment of depression in people with NCDs has the potential to enhance both the mental and physical well-being of this population. It will also result in the effective use of the available health care resources. Brief psychological therapies, such as behavioral activation (BA), are effective for the treatment of depression. BA has not been adapted in the community health care services of India, and the feasibility of using BA as an intervention for depression in NCD and its effectiveness in these settings have not been systematically evaluated. OBJECTIVE: Our objective is to adapt BA for the Indian NCD context and test the acceptability, feasibility, and implementation of the adapted BA intervention (BEACON intervention package [BIP]). Additionally, we aim to test the feasibility of a randomized controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care. METHODS: Following well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural, and resource context) for delivery in India. The intervention was also adapted for potential remote delivery by telephone. In a randomized controlled trial, we will be testing the acceptability, feasibility, and implementation of the adapted BA intervention (BIP). We shall also test if a randomized controlled feasibility trial can be delivered effectively and estimate important parameters (eg, recruitment and retention rates and completeness of follow-up) needed to design a future definitive trial. RESULTS: Following the receipt of approval from all the relevant agencies, the development of the BIP was started on November 28, 2020, and completed on August 18, 2021, and the quantitative data collection was started on August 23, 2021, and completed on December 10, 2021. Process evaluation (qualitative data) collection is ongoing. Both the qualitative and quantitative data analyses are ongoing. CONCLUSIONS: This study may offer insights that could help in closing the gap in the treatment of common mental illness, particularly in nations with limited resources, infrastructure, and systems such as India. To close this gap, BEACON tries to provide BA for depression in NCDs through qualified NCD (BA) counselors integrated within the state-run NCD clinics. The results of this study may aid in understanding whether BA as an intervention is acceptable for the population and how feasible it will be to deliver such interventions for depression in NCD in South Asian countries such as India. The BIP may also be used in the future by Indian community clinics as a brief intervention program. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2020/05/025048; https://tinyurl.com/mpt33jv5. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41127.

Exploring support, experiences and needs of older women and health professionals to inform a self-management package for urinary incontinence: a qualitative study.

OBJECTIVES: Many women attempt to manage urinary incontinence (UI) independently with variable success while health professionals may be unaware of their needs. This study aimed to (1) understand older women's experiences of UI, their self-management strategies and support needs; (2) explore health professionals' experiences of supporting women and providing relevant services and (3) combine their experiences contribute to development of a theory-based and evidence-based self-management package for UI. DESIGN: Qualitative semi-structured interviews were conducted with 11 older women with UI and 11 specialist health professionals. Data were analysed independently using the framework approach, then synthesised in a triangulation matrix to identify implications for content and delivery of the self-management package. SETTING: Community centres, community continence clinic and urogynaecology centre of a local teaching hospital in northern England. PARTICIPANTS: Women aged 55 years and over who self-reported symptoms of UI and health professionals delivering UI services. RESULTS: Three overarching themes emerged. Older women see UI as a 'fact of life' but many struggle with it: women typically considered UI as part of ageing yet expressed annoyance, distress, embarrassment and had made significant lifestyle changes. Access to information and limited high-quality professional support: health professionals provided specialist UI care and information. Yet less than half of women accessed specialist services, those who had, highly valued these services. 'Trial and error' with different self-management strategies: women had tried or were using different strategies (continence pads, pelvic floor exercises, bladder management and training, fluid management and medication), with mixed success. Health professionals provided evidence-based, personalised support and motivation. CONCLUSIONS: Findings informed the content of the self-management package that focused on providing facts, acknowledging challenges of living with/self-managing UI, sharing others' experiences, using motivational strategies and self-management tools. Delivery preferences were independent use by women or working through the package with a health professional.

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.

Being pregnant and becoming a parent during the COVID-19 pandemic: a longitudinal qualitative study with women in the Born in Bradford COVID-19 research study.

BACKGROUND: Uncertainty around the risk of COVID-19 to pregnant women and their babies prompted precautionary restrictions on their health and care during the pandemic. Maternity services had to adapt to changing Government guidance. Coupled with the imposition of national lockdowns in England and restrictions on daily activities, women's experiences of pregnancy, childbirth and the postpartum period, and their access to services, changed rapidly. This study was designed to understand women's experiences of pregnancy, labour and childbirth and caring for a baby during this time. METHODS: This was an inductive longitudinal qualitative study, using in-depth interviews by telephone with women in Bradford, UK, at three timepoints during their maternity journey (18 women at timepoint one, 13 at timepoint two and 14 at timepoint three). Key topics explored were physical and mental wellbeing, experience of healthcare services, relationships with partners and general impact of the pandemic. Data were analysed using the Framework approach. A longitudinal synthesis identified over-arching themes. RESULTS: Three longitudinal themes captured what was important to women: (1) women feared being alone at critical points in their maternity journey, (2) the pandemic created new norms for maternity services and women's care, and (3) finding ways to navigate the COVID-19 pandemic in pregnancy and with a baby. CONCLUSIONS: Modifications to maternity services impacted significantly on women's experiences. The findings have informed national and local decisions about how best to direct resources to reduce the impact of COVID-19 restrictions and the longer-term psychological impact on women during pregnancy and postnatally.

IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S): A protocol for a randomised controlled feasibility trial of a combined behavioural and pharmacological support intervention.

INTRODUCTION: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. METHODS: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation. RESULTS: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries. CONCLUSIONS: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums. TRIAL REGISTRATION: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.

Design and implementation of tailored intervention to increase vaccine acceptance in a Somali community in Stockholm, Sweden - based on the Tailoring Immunization Programmes approach.

Objectives: Sweden has had a high and stable vaccination coverage for measles-mumps-rubella (MMR) vaccine (>96%) through the national immunization program (NIP), but coverage rates highlight local pockets of lower vaccination coverage. This project addressed low MMR vaccine acceptance among parents in a Somali community, in Stockholm. The objective of the intervention was to increase vaccine confidence and MMR-vaccine uptake and also to inform practices addressing vaccine acceptance. Study design: This paper describes the design and implementation of a multi-component intervention based on the Tailoring Immunization Programmes (TIP) approach, developed by the WHO European Regional Office. Methods: The theoretical underpinning of TIP is the Capability, Opportunity, and Motivation Model (COM-B model) and Behaviour Change Wheel framework (BCW), adapted for vaccination. The COM-model was used to identify barriers and drivers to vaccination and intervention types. The TIP-phases described in this paper are: pre-TIP (planning), three succeeding TIP phases (situational analysis, formative research, intervention design) and the post-TIP phase (implementation). Results: The situation analysis and formative research revealed that parents feared the MMR vaccine due to autism or that their child would stop talking following vaccination, despite lack of scientific evidence for an association between autism and MMR vaccines. Barriers were linked to their associated COM-B factors and mapped to appropriate intervention types for two target groups: Somali parents and nurses at the Child Health Centres (CHC). Selected intervention types targeting parents were education, persuasion and modelling whereas education and training were selected for CHC nurses. The intervention activities included community engagement for parents, while the activities for nurses focused on improving encounters and dialogue with parents having low vaccine acceptance. Following the intervention design the activities were developed, pilot tested and implemented. Conclusion: This study confirm that the TIP approach is valuable for guiding a stepwise working process for a thorough understanding of barriers and drivers for MMR vaccination among parents in this Somali community. It facilitated the design of a theory and evidence-informed intervention targeting parents and nurses.

"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.

Medical specialists' attitudes and practices towards childhood vaccination: a qualitative study in Armenia.

BACKGROUND: Childhood vaccination rates in Armenia are high. However, anecdotal evidence suggests that some health workers may advise against vaccination. The extent and reasons behind this are unknown. This study used the World Health Organization Tailoring Immunization Programmes approach to investigate medical specialists' vaccination practices. METHODS: Face-to-face interviews were conducted with 30 medical specialists (paediatricians, immunologists, neonatologists, neurologists, gynaecologists). Interviews explored their vaccination practices (recommending/administering), knowledge, attitudes and confidence. Data were analysed using the Framework approach and COM (Capability, Opportunity, Motivation) factors. FINDINGS: Medical specialists were routinely consulted by parents about vaccination. They engaged in conversations, even if they did not administer vaccinations and lacked expertise. Vaccination recommendation was "selective", influenced by their own vaccine hesitancy. Doctors administering vaccination used false contraindications to postpone vaccination. Multiple barriers and drivers to positive vaccination practices were evident, with differences between specialists administering/not administering vaccinations. Capability Drivers were knowledge of vaccination, vaccines, and vaccine-preventable diseases; with awareness and use of protocols for adverse events and contraindications (those with a vaccination role). Barriers were a lack of a detailed understanding of vaccination, vaccines, and vaccine-preventable diseases, especially amongst neonatologists and gynaecologists, and for HPV. Poor knowledge of adverse events and mixed knowledge of contraindications was evident, as was low confidence about conversations with parents declining vaccination. Opportunity Drivers were using "official" guidance and professional information and feeling protected by the Government of Armenia should an adverse event occur. Conversely, barriers were a reliance on media/social media without considering credibility, peers not recommending vaccination, increasing parent demands and not feeling protected by the Government. Motivation Drivers were seeing vaccination as their responsibility (those who administer vaccinations); and generally supporting vaccination. Barriers were vaccine hesitancy, some anti-vaccination sentiments amongst neonatologists and gynaecologists and not seeing vaccination as their role (those who do not administer vaccinations). CONCLUSIONS: Applying a theory-informed approach allowed us to identify critical issues and possible solutions. High vaccination coverage may disguise underlying issues, e.g. false contraindications. We addressed gaps in the literature, with our geographical focus and study of medical specialists advising parents on vaccination, a widely used practice in this sub-region.

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.

Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): a combined evidence and theory-based plus partnership intervention development approach.

INTRODUCTION: Deaths from second-hand smoke (SHS) exposure are increasing, but there is not sufficient evidence to recommend a particular SHS intervention or intervention development approach. Despite the available guidance on intervention reporting, and on the role and nature of pilot and feasibility studies, partial reporting of SHS interventions is common. The decision-making whilst developing such interventions is often under-reported. This paper describes the processes and decisions employed during transitioning from the aim of adapting an existing mosque-based intervention focused on public health messages, to the development of the content of novel community-based Smoke-Free Home (SFH) intervention. The intervention aims to promote smoke-free homes to reduce non-smokers' exposure to SHS in the home via faith-based messages. METHODS: The development of the SFH intervention had four sequential phases: in-depth interviews with adults in households in Dhaka, identification of an intervention programme theory and content with Islamic scholars from the Bangladesh Islamic Foundation (BIF), user testing of candidate intervention content with adults, and iterative intervention development workshops with Imams and khatibs who trained at the BIF. RESULTS: It was judged inappropriately to take an intervention adaptation approach. Following the identification of an intervention programme theory and collaborating with stakeholders in an iterative and collaborative process to identify barriers, six potentially modifiable constructs were identified. These were targeted with a series of behaviour change techniques operationalised as Quranic verses with associated health messages to be used as the basis for Khutbahs. Following iterative user testing, acceptable intervention content was generated. CONCLUSION: The potential of this community-based intervention to reduce SHS exposure at home and improve lung health among non-smokers in Bangladesh is the result of an iterative and collaborative process. It is the result of the integration of behaviour change evidence and theory and community stakeholder contributions to the production of the intervention content. This novel combination of intervention development frameworks demonstrates a flexible approach that could provide insights for intervention development in related contexts.

Understanding vaccination communication between health workers and parents: a Tailoring Immunization Programmes (TIP) qualitative study in Serbia.

Vaccine communication between health workers and parents affects parental acceptance, so understanding this is particularly important when vaccination rates drop. This paper presents the findings of a qualitative research study conducted in Serbia as part of a Tailoring Immunization Programmes (TIP) project. The aims were to explore the process of vaccination communication between health workers and parents (accepting, indecisive, delaying, refusing), and identify barriers and drivers to effective communication. In-depth interviews with 14 health workers were supplemented and qualified by observations of 40 consultations, using thematic analysis. Study sites were two community health centers in two Belgrade municipalities where a significant drop in childhood vaccination rates had occurred. Key findings were: (1) communication mainly took place between pediatricians and parents, while nurses focused on administering vaccines. (2) Health workers were confident in their skills to communicate and address concerns of accepting and indecisive parents, successfully applying specific strategies. (3) When interacting with delaying and refusing parents, they sometimes agreed to delay vaccination to maintain relationships, confident that most parents would vaccinate in due course. (4) Some refusing parents asked questions grounded in a socio-political agenda regarding vaccines or vaccination. Such questions exceeded the domain of health workers' expertise, which affected the communication between them. (5) Health workers' behavior in consultations was sometimes affected by parents' (dis) trust in their recommendations about vaccination. The study revealed that health workers in Serbia require additional skills and techniques to respond to parents who refuse and wish to delay vaccination, to secure timely vaccination.

A qualitative interview study with parents to identify barriers and drivers to childhood vaccination and inform public health interventions.

Vaccination coverage in the Federation of Bosnia and Herzegovina, in Bosnia and Herzegovina, has been declining since 2014. This qualitative study aimed to identify barriers and drivers to childhood vaccination for parents. The COM-B (capability-opportunity-motivation-behavior) model was the underpinning theoretical framework. Face-to-face interviews with 22 parents of fully (n = 6), delayed/partially vaccinated (n = 9) and unvaccinated (n = 7) children were conducted. Interviews explored individual factors (capability-knowledge and skills; motivation-attitudes, confidence and trust) and context factors (physical opportunity-information, access, health systems; and social opportunity - social support, norms). Data were analyzed in NVivo using content analysis exploring differences in COM factors by vaccination status and location. Parents of fully vaccinated children typically reported individual and context drivers to vaccination. They accepted vaccination, trusted health workers, and were content with services. Parents of delayed/partially vaccinated children fell into two subgroups: (1) Those who accepted vaccination and attributed delays to their organizational skills or frustration with appointment times. (2) Those fitting the profile of "vaccine hesitant" - generally valuing vaccination and health worker advice, yet with concerns often triggered by media/social media. Parents of unvaccinated children mentioned individual and context barriers to vaccination, notably significant concerns about safety, some distrust of health workers and resentment of mandatory vaccination. Urban/rural differences included urban parents being more likely to report experiences with vaccine shortages and very few had received information leaflets. The study identified complex and inter-related barriers and drivers to parents' childhood vaccination behaviors. These insights have informed the development of tailored interventions to improve coverage.

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.

Efficacy and cost-effectiveness of a community-based smoke-free-home intervention with or without indoor-air-quality feedback in Bangladesh (MCLASS II): a three-arm, cluster-randomised, controlled trial.

BACKGROUND: Exposure to second-hand smoke from tobacco is a major contributor to global morbidity and mortality. We aimed to evaluate the efficacy and cost-effectiveness of a community-based smoke-free-home intervention, with or without indoor-air-quality feedback, in reducing second-hand-smoke exposure in homes in Bangladesh. METHODS: We did a three-arm, cluster-randomised, controlled trial in Dhaka, Bangladesh, and randomly assigned (1:1:1) mosques and consenting households from their congregations to a smoke-free-home intervention plus indoor-air-quality feedback, smoke-free-home intervention only, or usual services. Households were eligible if they had at least one resident attending one of the participating mosques, at least one adult resident (age 18 years or older) who smoked cigarettes or other forms of smoked tobacco (eg, bidi, waterpipe) regularly (on at least 25 days per month), and at least one non-smoking resident of any age. The smoke-free-home intervention consisted of weekly health messages delivered within an Islamic discourse by religious leaders at mosques over 12 weeks. Indoor-air-quality feedback comprised providing households with feedback on their indoor air quality measured over 24 h. Households in the usual services group received no intervention. Masking of participants and mosque leaders was not possible. The primary outcome was the 24-h mean household airborne fine particulate matter (<2·5 microns in diameter [PM2·5]) concentration (a marker of second-hand smoke) at 12 months after randomisation. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). This trial is registered with ISRCTN, 49975452. FINDINGS: Between April 11 and Aug 2, 2018, we enrolled 1801 households from 45 mosques. 640 households (35·5%) were assigned to the smoke-free-home intervention plus indoor-air-quality feedback group, 560 (31·1%) to the smoke-free-home intervention only group, and 601 (33·4%) to the usual services group. At 12 months, the adjusted mean difference in household mean 24-h PM2·5 concentration was -1·0 µg/m3 (95% CI -12·8 to 10·9, p=0·88) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the usual services group, 5·0 µg/m3 (-7·9 to 18·0, p=0·45) for the smoke-free-home intervention only group versus the usual services group, and -6·0 µg/m3 (-18·3 to 6·3, p=0·34) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the smoke-free-home intervention only group. The ICER for the smoke-free-home intervention plus indoor-air-quality feedback versus usual services was US$653 per quality-adjusted life-year (QALY) gained, which was more than the upper limit of the Bangladesh willingness-to-pay threshold of $427 per QALY. INTERPRETATION: The smoke-free-home intervention, with or without indoor-air-quality feedback, was neither effective nor cost-effective in reducing household second-hand-smoke exposure compared with usual services. These interventions are therefore not recommended for Bangladesh. FUNDING: Medical Research Council UK. TRANSLATION: For the Bengali translation of the abstract see Supplementary Materials section.

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.

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR).

OBJECTIVE: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service. DESIGN: Randomised controlled, open feasibility trial with embedded economic and process evaluations. SETTING: Audiology departments in two hospitals in two UK cities. PARTICIPANTS: Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid. INTERVENTIONS: Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group). PRIMARY OUTCOME MEASURES: The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery. SECONDARY OUTCOME MEASURES: International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible. RESULTS: Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size. CONCLUSIONS: While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point. TRIAL REGISTRATION NUMBER: ISRCTN28090877.

A behaviour change intervention to reduce home exposure to second hand smoke during pregnancy in India and Bangladesh: a theory and evidence-based approach to development.

BACKGROUND: Home exposure to secondhand smoke (SHS) is highly prevalent amongst pregnant women in low- and middle-income countries like India and Bangladesh. The literature on the efficacy of behaviour change interventions to reduce home exposure to SHS in pregnancy is scarce. METHODS: We employed a theory and evidence-based approach to develop an intervention using pregnant women as agents of change for their husband's smoking behaviours at home. A systematic review of SHS behaviour change interventions led us to focus on developing a multicomponent intervention and informed selection of behaviour change techniques (BCTs) for review in a modified Delphi survey. The modified Delphi survey provided expert consensus on the most effective BCTs in reducing home exposure to SHS. Finally, a qualitative interview study provided context and detailed understanding of knowledge, attitudes and practices around SHS. This insight informed the content and delivery of the proposed intervention components. RESULTS: The final intervention consisted of four components: a report on saliva cotinine levels of the pregnant woman, a picture booklet containing information about SHS and its impact on health as well strategies to negotiate a smoke-free home, a letter from the future baby to their father encouraging him to provide a smoke-free home, and automated voice reminder and motivational messages delivered to husbands on their mobile phone. Intervention delivery was in a single face-to-face session with a research assistant who explained the cotinine report, discussed key strategies for ensuring a smoke-free environment at home and practised with pregnant women how they would share the booklet and letter with their husband and supportive family members. CONCLUSION: A theory and evidence-based approach informed the development of a multicomponent behaviour change intervention, described here. The acceptability and feasibility of the intervention which was subsequently tested in a pilot RCT in India and Bangladesh will be published later.

Smokeless tobacco products, supply chain and retailers' practices in England: a multimethods study to inform policy.

BACKGROUND: In England, many people of South Asian origin consume smokeless tobacco (ST). ST use can lead to oral cancer, which is disproportionately high in South Asians. Our aims were to assess the compliance of ST product retailers with statutory regulations and to explore the supply chain of ST. METHODS: We undertook a multimethods study between August 2017 and July 2019 in five English boroughs with a high proportion of ethnic South Asians. We purchased ST products and conducted field surveys with ST retailers at point of sale. Qualitative interviews were conducted with ST retailers and suppliers. ST packs were assessed for regulatory compliance, while quantitative and qualitative data triangulated information on retailers' practices and the ST supply chain. RESULTS: We collected 41 unique ST products, which included dry snuff, naswar, gutka, chewing tobacco and zarda. ST products were not registered, and demonstrated low compliance with health warning (14.6%) and packaging (56.1%) requirements. ST availability in surveyed boroughs was high (38.2%-69.7%); dry snuff, naswar and zarda were most commonly available. ST retailers demonstrated limited knowledge of regulations, and one-third were found to advertise ST at point of sale. Qualitative insights revealed illicit supply and distribution networks, as well as ST production in discreet locations. CONCLUSION: ST products are widely available in England, yet non-compliant with statutory regulations. In order to safeguard consumers, in particular ethnic South Asians, stronger efforts are needed to regulate the supply chain of ST at both national and international levels.