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Study to Test Whether Shoes Protect Children Against Hookworm Infection on Pemba Island, Zanzibar (SKIP)

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ClinicalTrials.gov Identifier: NCT01869127
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : June 5, 2013
London School of Hygiene and Tropical Medicine
Fondazione Ivo de Carneri, Milan, Italy
Information provided by (Responsible Party):
Bird, Christopher

Brief Summary:
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.

Condition or disease Intervention/treatment
Hookworm Device: Shoes

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1056 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Standard care
Experimental: Shoes
Device: Shoes
A unisex canvas slip-on with a sturdy sole.
Other Name: 'Giving Shoe' produced by TOMS Shoes, Los Angeles, California, USA

Primary Outcome Measures :
  1. Reduction in hookworm prevalence and intensity of infection in intervention arm [ Time Frame: 6 months ]
    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).

Secondary Outcome Measures :
  1. Use of shoes by children in intervention arm [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • school-aged children attending one of the 12 schools identified for the study

Exclusion Criteria:

  • lack of consent from family
  • allergy to Albendazole

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869127

Public Health Laboratory
Chake Chake, Pemba Island, Zanzibar, Tanzania
Sponsors and Collaborators
Bird, Christopher
London School of Hygiene and Tropical Medicine
Fondazione Ivo de Carneri, Milan, Italy
Principal Investigator: Christopher K Bird, MBBS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bird, Christopher
ClinicalTrials.gov Identifier: NCT01869127     History of Changes
Other Study ID Numbers: SKIP48039353950
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Bird, Christopher:
necator americanus
ancyclostoma duodenale

Additional relevant MeSH terms:
Hookworm Infections
Strongylida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases