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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 3 - TB and Tobacco (Tobacco cessation within TB programmes: A â€˜real worldâ€™ solution for countries with dual burden of disease)

Teaser

Summary

Introduction and Objectives
TB and Tobacco is coordinated by the University of York (Department of Health Sciences). It involves eight other partners: ARK Foundation, Bangladesh; HERD International Pvt. Ltd., Nepal; National TB Programme, Pakistan; The Initiative, Pakistan; Heinrich-Heine University, DÃ¼sseldorf, Germany; the University of Edinburgh, UK; the University of Leeds, UK and the General University Hospital, Prague, Czech Republic.
The overall objective of TB and Tobacco is to reduce the burden of lung disease in low- and middle-income countries (LMIC). We aim to do this by helping people with TB to stop smoking, using inexpensive strategies that have already been shown to work elsewhere. The strategies are aimed at patients who have been newly diagnosed with TB, and will be integrated into TB control programmes in our target countries. The research is focussed on three countries that have high incidence of tobacco use and high prevalence of TB; namely Bangladesh, Pakistan and Nepal.
Our study is centred round a clinical trial of a drug called cytisine, which has been evaluated in combination with behavioural support for tobacco cessation, and compared with behavioural support alone. Cytisine has been shown to be effective as a tobacco cessation medication in Eastern Europe, but until TB & Tobacco, no clinical trials had been conducted with it in LMIC.
We have assessed the effectiveness and cost-effectiveness of tobacco cessation strategies in helping TB patients to quit smoking and to improve their clinical outcomes â€“ the effectiveness goal. We have explored how best to implement these strategies, scale them up and sustain them over the long term â€“ the implementation goal.
By studying the â€˜real worldâ€™ influences on the implementation and success of stopping smoking in these contexts, we are determined to translate the findings of the study into real benefits for patients and society.

Work performed

The research involved in TB and Tobacco is assigned to 7 different Work Packages (WPs). WP1 is concerned with Development and Feasibility of the Behavioural Support (BS) Package. WP2 (Effect Evaluation) concerns the cytisine trial. WP3 (Economic Evaluation) examines the cost-effectiveness of the tobacco cessation strategies studied. WP4 (Process Evaluation) involves assessing the design and delivery of the smoking cessation programmes. WP5 (Context Evaluation) aims to identify the contextual factors that influence the delivery of the tobacco cessation strategies. WP6 (Scale-up and Sustainability) investigates the costs and effects of scaling-up tobacco cessation strategies in TB control and the obstacles and opportunities for scale-up. WP7 (Co-ordination and Management) is concerned with project management across all work packages.
During Periods 1 and 2, BS materials were developed (WP1), for a behavioural intervention aimed at encouraging smoking cessation in TB patients. These materials have been adapted for use in Nepal, Pakistan and Bangladesh, and Health Workers have been trained to deliver the intervention.
Recruitment to the TB & Tobacco trial began in June 2017 and closed on 30th April 2018. In total, 2472 patients were enrolled; 1527 in Bangladesh and 945 in Pakistan. Smoking cessation at Month 6 was the primary outcome.
Following statistical analysis, a detailed report on the trial has been written up as a scientific paper and was submitted for publication in December 2019.
Economic Analysis (WP3) of the trial has been completed. A paper will be submitted in early 2020.
Data collection and analysis for the Process Evaluation (WP4) were completed in this reporting period. The Process Evaluation protocol was published in 2018, and the Scientific Report was published in npj Primary Care Respiratory Medicine in 2019.
The Context Evaluation (WP5) was completed, with the third of 3 waves of COM-B and COACH data collected and analysed. Qualitative data from an observation survey of Research Assistants were collected from all three countries, and analysed.
As planned, WP6 has been very active during period 3. The BS intervention was revised as appropriate. Implementation for future scale-up was evaluated in all 3 countries. Cost analysis of implementation was conducted. Strategic needs for training Health Workers were identified. Substantial progress was made with revising routine TB reporting forms, so that tobacco status and cessation advice are recorded. Work with NTPs (National TB Programmes) has been on-going (including at WHO in Geneva in November 2018), to strengthen supervision and policy, so that tobacco cessation is prioritised within TB control programmes. â€˜Way Forwardâ€™ stakeholdersâ€™ workshops have been held in all 3 countries. A new survey â€“ STOP (Studying Tobacco Users of Pakistan) â€“ has been carried out, researching tobacco use and quitting behaviours in Pakistan.
WP7 was active throughout the period, with continuous project management and monitoring of progress.

Final results

The Behavioural Intervention developed in WP1 of TB and Tobacco represents a new way to educate TB patients about the dangers of smoking and encourages them to quit, with concomitant substantial public health benefits. The BS materials are available at TB clinics in Pakistan, Bangladesh and Nepal, to provide on-going education about the risks of smoking. It is expected that this will have a long-term beneficial public health impact.
Other specific impacts include:
-roll-out of TB & Tobacco materials and training to every TB clinic in Khyber Pakhtunkhwa Province, Pakistan.
-influence on Pakistanâ€™s national TB control guidelines, through inclusion of tobacco cessation within Pakistan Chest Societyâ€™s TB clinical advice, following suggestions from our TB & Tobacco consortium.
-integrating tobacco in routine TB recording in Pakistan. In response to the findings of the TB & Tobacco study, the national body responsible for TB control in Pakistan has agreed to include tobacco status on the TB01 form that is completed for every TB patient across Pakistan. This will support integration of cessation within TB programmes.
-influencing training and reporting systems in Bangladesh. TB & Tobacco results were presented at a â€˜Way Forwardâ€™ workshop and the Ministry of Health and Family Welfare (MOHFW) committed to providing tobacco cessation training to TB health workers. The NTP technical committee plan to include tobacco indicators in subsequent print-runs of TB recording cards.
-influencing training in Nepal. Close engagement of our TB & Tobacco consortium members with the NTP has led to the inclusion of our training materials within the national training guide in Nepal. Impacts are being seen beyond TB, with the Ministry of Health planning to include the TB & Tobacco materials and training videos within guidelines on non-communicable diseases, which are soon to be rolled out in seven districts in Nepal.
-Global Influence. TB & Tobacco consortium members contributed to the International Union against TB and Lung Disease white paper on the integration of Tobacco with TB programmes.
Kamran Siddiqi was commissioned to work with two other colleagues to develop a WHO TB-Tobacco mHealth guide, which contained an inventory of text messages, many of which were adopted directly from the TB & Tobacco intervention. This guide was approved in 2018 and is being used in Egypt and India for a roll out of TB-Tobacco mHealth packages.