A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Smoking cessation rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Counseling
Intensive anti-smoking counseling
Intervention: Intensive anti-smoking counseling (Other)
Standard Care
Control group will receive current standard of care.
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)