Effectiveness and cost-effectiveness of an mHealth intervention (mTB-Tobacco) for smoking cessation in people with tuberculosis

INTERVENTION: This trial is a clustered RCT where health facilities will be randomly allocated to the different trial arms. The health facilities (clusters) would be randomised 2:2:1 to mTB‐Tobacco (intervention A), face‐to‐face (intervention B), or standard care (Control). An independent statistician who will be blinded to centres, will identify and use computer‐generated random‐number lists to generate the allocation sequence. The allocation will be based on using minimisation to ensure balance across the groups on the average number of TB patients seen per month and geographical location (Bangladesh and Pakistan). Using an adaptive design, the researchers will conduct a multi‐centre, cluster randomized, controlled trial consisting of two phases. In Phase 1 (superiority trial), which will last for 12 months (6 months recruitments and 6 months follow‐ups), the researchers will compare mTB‐Tobacco (intervention A) with usual care (control). In Phase 2 (non‐inferiority trial), which will last for another 12 months (6 months recruitment and 6 months follow‐ups), the researchers will compare mTB‐Tobacco (intervention A) with face‐to‐face behavioural support (intervention B). mTB‐TOBACCO (INTERVENTION A) The mTB‐Tobacco programme (intervention A) is designed to send short message service (SMS) content with two distinct areas of intervention. The first tries to instil behaviour change in patients to quit the habit of tobacco use and the second includes a combination of supportive motivational and informative messages through the period of TB treatment. The overall outcome is that a person is able to both successfully quit tobacco consumption and complete TB treatment. FACE‐2‐FACE BEHAVIOURAL SUPPORT (INTERVENTION B) This consists of an adapted version of a pre‐developed and proven CONDITION: Smoking cessation in people with tuberculosis ; Not Applicable PRIMARY OUTCOME: Biochemically verified continuous abstinence at 6 months post‐randomisation. Abstinence is defined as self‐report of not having used more than 5 cigarettes, bidis, or water pipe sessions since the quit date, verified biochemically by a breath carbon monoxide (CO) reading of less than 10 ppm at month 6. INCLUSION CRITERIA: 1. Age at least 15 years (counted as adult TB patients in Bangladesh and Pakistan) 2. Willing and able to provide written informed consent 3. Diagnosed with drug‐sensitive pulmonary TB (smear positive or negative) in the last 4 weeks 4. Currently smokes tobacco on a daily basis or has only stopped or reduced smoking (less than daily) since being diagnosed with TB 5. Willing to quit tobacco use 6. Access to personal mobile phone SECONDARY OUTCOME: 1. Point abstinence, defined as a self‐report of not using tobacco in the previous 7 days, assessed at week 9 and month 6; 2. 2. Adherence to TB treatment: all registered TB patients’ medication logs (for anti‐TB medication) are recorded on the ‘Treatment Support Card’; a copy of this card would be requested from the TB paramedic by the RA at Week 9 and Month 6 and attached with the patient case report form; 3. TB Programme outcomes: the proportion of treatment success (including cured and completed treatment), treatment failure, defaulted and died will be recorded from the TB register (TB03) at month 6. The definitions of these outcomes are as follows:; 3.1. Cured: A patient who was initially smear‐positive and who was smear‐negative in the last month of treatment (at month 6) and on at least one previous occasion; 3.2. Completed treatment: A patient who completed treatment (at month 6) but did not meet the criteria for cure or failure ; 3.3.. Treatment failure: A patient who was initially smear‐positive and who remained smear‐positive at month 6 or later during treatment; 3.4.. Defaulted: A patient whose treatment was interrupted for 2 consecutive months or more ; 3.5. Died: A patient who died from any cause during treatment; 3.6.. Relapse: A patient who was previously treated for TB, was declared cured or treatment completed at the end of his most recent course of treatment, and is now diagnosed with a recurrent episode of TB (either a true relapse or a new episode of TB caused by reinfection)