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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02238405 |
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Date of registration:
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22/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes
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Scientific title:
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A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes |
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Date of first enrolment:
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May 25, 2015 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02238405 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Jonathan E Golub, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Smoking Cessation
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Intervention(s)
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Other: Intensive anti-smoking counseling
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Primary Outcome(s)
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Smoking cessation rate
[Time Frame: 1-6 months]
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Smoking cessation rate
[Time Frame: 6 months post-TB treatment]
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Secondary Outcome(s)
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negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy
[Time Frame: 6 months post-TB treatment]
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Secondary ID(s)
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IRB00037636
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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