A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes

Study Overview
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Brief Summary
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The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.

Official Title
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A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes

Conditions
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Smoking Cessation, Tuberculosis

Intervention / Treatment
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* Other: Intensive anti-smoking counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, ≥18 years of age diagnosed with pulmonary TB self-reported current smokers, or smoker within 6 months anticipated to be attending the TB treatment clinic for at least 6 months be willing to set a quit date within 2 weeks after baseline assessment agree to participate Exclusion Criteria: less than 18 years of age quit for more than 6 months extra-pulmonary TB unable/unwilling to provide written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling<br>Intensive anti-smoking counseling | Other: Intensive anti-smoking counseling<br>* Study participants randomized to the intervention arm will receive intensive cessation support outside of the TB clinic setting, from a health worker trained in cessation counseling, during the course of their TB treatment. Behavioral elements will consist of follow up using unscheduled drop in or phone sessions, motivational interviewing, and counseling tailored to the needs and circumstances of the patient. Patients who are current smokers and are ready to commit to quit smoking will be supported to stop completely. Recent smokers will supported for having quit, and the counselor will discuss coping strategies to maintain abstinence.<br>|
| No Intervention: Standard Care<br>Control group will receive current standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rate |  | 1-6 months | 
| Smoking cessation rate |  | 6 months post-TB treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy | To assess differences in TB treatment outcomes between smokers and quitters, all patients enrolled in the intervention trial will be included in analyses of a composite negative outcome variable, defined as a composite endpoint of poor clinical response to TB treatment including death, treatment failure, relapse, and/or requirement for prolongation of TB therapy. Risk of a negative treatment outcome will be compared between the following 3 groups: 1) TB patients who were current smokers and quit smoking for 6 months of follow-up; 2) TB patients who were recent smokers and stayed quit for 6 months of follow-up; and, 3) TB patients who are never smokers. | 6 months post-TB treatment |