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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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16 December 2017 |
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Main ID: |
NCT02053129 |
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Date of registration:
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31/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of PTB Screening in ANC in Lusaka, Zambia
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Scientific title:
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Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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5033 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02053129 |
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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: Parallel Assignment. Primary purpose: Diagnostic. 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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Zambia
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Contacts
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Name:
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Annika Kruuner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Infectious Disease Research in Zambia |
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Name:
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Stewart Reid, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Infectious Disease Research in Zambia |
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Name:
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Michael Saag, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor, University of Alabama |
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Name:
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Nzali Kancheya, MMED, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Infectious Disease Research in Zambia |
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Name:
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German Henostroza, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Infectious Disease Research in Zambia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant women
- 18 years or older
- HIV-negative women with any TB symptoms or HIV-infected women regardless of TB
symptoms
- Attending first ANC visit at one of program clinics
Exclusion Criteria:
- HIV negative without any TB symptoms
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pulmonary Tuberculosis
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Intervention(s)
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Other: Sputum smear and culture (only in HIV negative women who are symptomatic)
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Other: TB screening Questionnaire
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Primary Outcome(s)
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number of positive pulmonary tuberculosis (PTB) tests
[Time Frame: 1 day of screening (first antenatal visit)]
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Secondary Outcome(s)
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Sensitivity and specificity of symptom-based TB screening
[Time Frame: 1 day of screening visit]
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Secondary ID(s)
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CIDRZ 1217/IRB12-0417
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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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