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Completed

NCT Number: NCT02238405

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

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.

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Key information

Conditions

Smoking Cessation Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Gram-Positive Bacterial Infections Health Behavior Infections Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Indus Hospital

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive anti-smoking counseling

Other

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.

Primary outcomes

  1. Smoking cessation rate

    Time frame: 1-6 months

  2. Smoking cessation rate

    Time frame: 6 months post-TB treatment

Secondary outcomes

  1. negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Global Fund
  • National Tuberculosis Control Program, Pakistan

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 12, 2014
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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