<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02238405</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00037636</org_study_id>
    <nct_id>NCT02238405</nct_id>
  </id_info>
  <brief_title>A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes</brief_title>
  <official_title>A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Global Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Tuberculosis Control Program, Pakistan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary focus of this intervention trial is to understand the effect of quitting smoking&#xD;
      on TB treatment outcomes. The investigators will compare a cessation strategy based on&#xD;
      guidelines recommended by the World Health Organization (WHO) and the International Union&#xD;
      against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly&#xD;
      observed therapy (DOT) clinics in Pakistan. The investigators study will provide&#xD;
      comprehensive data towards understanding the effectiveness of these strategies for TB&#xD;
      patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB&#xD;
      treatment outcomes. These findings will guide development of effective smoking cessation&#xD;
      strategies in a region with high prevalence of TB and increasing tobacco use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2015</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking cessation rate</measure>
    <time_frame>1-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking cessation rate</measure>
    <time_frame>6 months post-TB treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy</measure>
    <time_frame>6 months post-TB treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive anti-smoking counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will receive current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive anti-smoking counseling</intervention_name>
    <description>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.</description>
    <arm_group_label>Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males, ≥18 years of age&#xD;
&#xD;
          -  diagnosed with pulmonary TB&#xD;
&#xD;
          -  self-reported current smokers, or smoker within 6 months&#xD;
&#xD;
          -  anticipated to be attending the TB treatment clinic for at least 6 months&#xD;
&#xD;
          -  be willing to set a quit date within 2 weeks after baseline assessment&#xD;
&#xD;
          -  agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years of age&#xD;
&#xD;
          -  quit for more than 6 months&#xD;
&#xD;
          -  extra-pulmonary TB&#xD;
&#xD;
          -  unable/unwilling to provide written consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan E Golub, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238405
org study id: IRB00037636
nct id: NCT02238405
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking cessation rate
time frame: 1-6 months
measure: Smoking cessation rate
time frame: 6 months post-TB treatment
measure: negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy
time frame: 6 months post-TB treatment
description: 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.
arm group label: Counseling
arm group type: Experimental
description: Intensive anti-smoking counseling
arm group label: Standard Care
arm group type: No Intervention
description: Control group will receive current standard of care.
intervention type: Other
intervention name: Intensive anti-smoking counseling
description: 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.
arm group label: Counseling
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan E Golub, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Tuberculosis