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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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PACTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
PACTR201211000437277 |
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Date of registration:
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18/10/2012 |
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Primary sponsor: |
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Public title:
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Evaluation of Effect of Stopping Mass Azithromycin Treatment after five years
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Scientific title:
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Evaluation of Effect of Stopping Mass Azithromycin Treatment after five years: a cluster randomized trial |
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Date of first enrolment:
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2012-11-01 |
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Target sample size:
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27 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000437277 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Districts were randomized to one of two study arms using block randomization with a block size of 2,
Allocation of districts to arms will be undertaken by an independent epidemiologist using block randomization to ensure a blanced number of districts across the two trial arms a block size of two was used.,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Stephanie
Palmer |
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Address:
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1149 Ponce de Leon Avenue
30307
Atlanta
United States of America |
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Telephone:
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+1 404-420-3842 |
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Email:
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spalme5@emory.edu |
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Affiliation:
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Program Development Coordinator, Trachoma |
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Name:
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Jeremiah
Ngondi |
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Address:
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University of Cambridge
Cambridge
United Kingdom |
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Telephone:
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+44 11223-763-829 |
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Email:
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jn250@cam.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All districts in West Amhara that have completed five or more annual rounds of MDA with azithromycin and have been surveyed for impact will be eligible for inclusion into the study.
Exclusion criteria: Districts where SAFE has been implemented for less than 5 years or where impact evaluations have showed prevalence of TF in children 1-9 years to be below 10% will not be included into the study. In the excluded districts, the SAFE strategy will be continued as per the WHO standards and national guidelines.
Age minimum:
1 Year
Age maximum:
99 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trachoma
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Primary Outcome(s)
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? Prevalence of ocular Chlamydia infection in children aged 1-9 years
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? Prevalence of TS in people aged 15 years and abov
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Prevalence of TF (trachomatous inflammation-follicular) in children ages 1-9 years
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Secondary Outcome(s)
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? Prevalence of clean faces in children aged 1-9 years
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? Prevalence of TI in children aged 1-9 years
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? Prevalence of TS in people aged below 15 years
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? Uptake of SAFE interventions at the individual and household level
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Secondary ID(s)
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60625
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Emory University IRB #60625
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Source(s) of Monetary Support
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The Carter Center
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The International Trachoma Initiative
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