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

Not Applicable

Completed

• Conditions: Smoking Cessation; Tuberculosis

• Registration Number: NCT02238405
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Study Start: 2015-05-25
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Smoking cessation rate	6 months post-TB treatment

Secondary Outcome Measures

Name	Time	Method
negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy	6 months post-TB treatment	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.

Trial Locations

Locations (1)

Indus Hospital; 🇵🇰 Karachi, Pakistan