An intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach
1. What is the effect of an intervention, based on the World Health Organization (WHO) 'five steps to quit' model and consisting of training of health professionals, a desk-guide, a desktop patient education tool and leaflet, on patients' point and continuous abstinence from tobacco use? [Effect evaluation]
2. To what extent do the health professionals communicate risks of tobacco use and benefits of its cessation to their patients? What are their experiences and opinions about this strategy? [Process evaluation]
3. How do patients experience the intervention for tobacco addiction? [Ethical evaluation]
4. What is the incremental cost-effectiveness ratio of the intervention for tobacco addiction compared to usual care? [Economic evaluation]
Research Ethics Committees of TB programme and Pakistan Medical Research Council, approval pending as of 05/12/2008.
Cluster randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Tuberculosis and tobacco use
A total of 22 primary care health centres will be selected (11 each for control and intervention arms) and 50 patients recruited with suspected tuberculosis in each of these centres.
In the intervention arm, recruited patients will be given the 'five steps to quit' model. This is based on the evidence-based recommendations for treatment of tobacco addiction published by WHO in 2001. Participants will be:
1. Asked about the status of nicotine use
2. Advised about the benefits of stopping nicotine use
3. Assessed for their motivation to stop its use
4. Assisted in stop attempts through various therapeutic options
5. Provided with an information leaflet
6. Asked to arrange a follow-up
In the control arm, patients will be provided with education leaflets only.
The trial will continue for six months and a review at 1 and 6 months will take place to assess smoking status and clinical outcomes in both arms.
Primary outcome measure
1. Point abstinence at 4 weeks: the proportion of trial participants who have completely given up all forms of nicotine use at four weeks after the completion of NRT, bupropion and/or brief counselling therapy
2. Continuous abstinence up to 6 months: proportion of trial participants who remained abstinent from 4 weeks onwards up to six months
3. We will also measure tobacco use, e.g. number of cigarettes smoked per day to estimate any reduction in tobacco use secondary to the intervention
Secondary outcome measures
1. Incidence of various adverse affects secondary to therapy
2. Economic outcomes assessed in terms of healthcare cost to get one person to stop smoking at four weeks. Healthcare cost will include the treatment cost, the average duration of health professionals' time spent with the patients during assessment, advice and counselling.
3. Process outcomes include:
3.1. The proportion of tobacco users who decide to quit and registered to receive 'five steps to quit' intervention
3.2. The proportion of people registered who continue follow-up for the full period planned
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
In each health centre, we will approach adult patients (greater than or equal to 18 years, either sex), who cough for three or more weeks and are therefore suspected and screened for pulmonary tuberculosis.
Target number of participants
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Nuffield Centre for International Health and Development
International Development Research Centre (IDRC) (Canada)
150 Kent Street
International Development Research Centre (IDRC) (Canada) (ref: 104825-002)
Centre de recherches pour le développement international, Centre de recherches pour le développement international, IDRC
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Siddiqi K, Khan A, Ahmad M, Shafiq-ur-Rehman, An intervention to stop smoking among patients suspected of TB--evaluation of an integrated approach., BMC Public Health, 2010, 10, 160, doi: 10.1186/1471-2458-10-160.
Siddiqi K, Khan A, Ahmad M, Dogar O, Kanaan M, Newell JN, Thomson H, Action to stop smoking in suspected tuberculosis (ASSIST) in Pakistan: a cluster randomized, controlled trial., Ann. Intern. Med., 2013, 158, 9, 667-675, doi: 10.7326/0003-4819-158-9-201305070-00006.