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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00939419 |
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Date of registration:
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14/07/2009 |
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Primary sponsor: |
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Public title:
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The Effectiveness of Health Facility-based and Community-based Care for Tuberculosis
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Scientific title:
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A Randomised Control Trial on the Effectiveness of Three Modalities of Tuberculosis Treatment Supervision Under DOTS Strategy in Ethiopia. |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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924 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00939419 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Mengiste M Melese, MD, MPH, 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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Nuffield Centre for International Health and Development, Institute of Health Sciences, University of Leeds |
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Name:
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Madley J Richard, 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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University of Nottingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 15 years or above
- no previous tuberculosis treatment
- sputum exam positive for tuberculosis (PTB+); or negative sputum results but with
consistent clinical and chest x-ray features (PTB-)
Exclusion Criteria:
- age less than 15 years
- previously treated with anti-TB drugs
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Community Health Care
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Quality of Health Care
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Tuberculosis Treatment Effectiveness
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Tuberculosis, Pulmonary
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Volunteer Health Workers
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Intervention(s)
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Other: Community health workers TB care group
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Other: Health workers TB care group
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Other: Self-administered treatment group
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Primary Outcome(s)
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Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases.
[Time Frame: August 2005 to January 2007]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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