Smoking cessation in people with tuberculosis Other
Conditions
Interventions
Current interventions as of 19/03/2025:
This trial is a clustered RCT where health facilities will be randomly allocated to the different trial arms. The health facilities (clusters) would be random
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
All
Age
15 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Less than 15 years of age 2. Retreatment TB, multidrug-resistant (MDR) TB, miliary or extrapulmonary TB 3. Currently using any pharmacotherapy for tobacco dependence 4. Unwilling or unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Bangladesh, Pakistan
Outcome results
None listed