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

NCT02238405 | Completed

• 1 other identifier: IRB00037636
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tuberculosis

Outcome Measures

Primary Outcomes (2)

• Smoking cessation rate

  1-6 months

• Smoking cessation rate

  6 months post-TB treatment

Secondary Outcomes (1)

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

  6 months post-TB treatment

Study Arms (2)

Counseling

EXPERIMENTAL

Intensive anti-smoking counseling

Other: Intensive anti-smoking counseling

Standard Care

NO INTERVENTION

Control group will receive current standard of care.

Interventions

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.

Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• less than 18 years of age
• quit for more than 6 months
• extra-pulmonary TB
• unable/unwilling to provide written consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• Global Fund: collaborator
• National Tuberculosis Control Program, Pakistan: collaborator

Study Sites (1)

Indus Hospital

Karachi, Pakistan

Location

MeSH Terms

Conditions

Smoking Cessation; Tuberculosis

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jonathan E Golub, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: September 12, 2014
• Study Start: May 25, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

PA (1)