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Clinical Trials/NCT02238405
NCT02238405
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country350 target enrollmentMay 25, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Johns Hopkins University
Enrollment
350
Locations
1
Primary Endpoint
Smoking cessation rate
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2015
End Date
January 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Smoking cessation rate

Time Frame: 6 months post-TB treatment

Secondary Outcomes

  • negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy(6 months post-TB treatment)

Study Sites (1)

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