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

NCT ID: NCT02238405

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-25
• Study Completion Date: 2018-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Counseling

Intensive anti-smoking counseling

Group Type: EXPERIMENTAL

Intensive anti-smoking counseling

Intervention Type: 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.

Standard Care

Control group will receive current standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intensive anti-smoking counseling

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Global Fund

OTHER

Sponsor Role: collaborator

National Tuberculosis Control Program, Pakistan

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan E Golub, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Indus Hospital

Karachi, , Pakistan

Countries

Pakistan

Other Identifiers

IRB00037636

Identifier Type: -

Identifier Source: org_study_id