Study to Test Whether Shoes Protect Children Against Hookworm Infection on Pemba Island, Zanzibar (SKIP)
Small association studies have hypothesised that shoes protect against hookworm infection. The purpose of this pragmatic study was determine, under field conditions, whether school-age children on Pemba Island, Zanzibar, would wear shoes and if shoes protected them against hookworm infection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Shoes for Kids on the Island of Pemba (SKIP): A Pragmatic, Cluster Randomised Controlled Trial to Test if Shoes Reduce Hookworm Infection and Transmission in School-aged Children on Pemba Island, Zanzibar|
- Reduction in hookworm prevalence and intensity of infection in intervention arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]Prevalence of hookworm measured as a percentage in both intervention and control arms; intensity of infection measured as the geometric mean hookworm load in eggs per gram of stool (via Kato-Katz method).
- Use of shoes by children in intervention arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
A unisex canvas slip-on with a sturdy sole.
Other Name: 'Giving Shoe' produced by TOMS Shoes, Los Angeles, California, USA
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01869127
|Public Health Laboratory|
|Chake Chake, Pemba Island, Zanzibar, Tanzania|
|Principal Investigator:||Christopher K Bird, MBBS|