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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Fondazione Ivo de Carneri, Milan, Italy
Information provided by (Responsible Party):
Bird, Christopher
ClinicalTrials.gov Identifier:
NCT01869127
First received: April 1, 2013
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

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 Intervention
Hookworm
Device: Shoes

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Bird, Christopher:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Use of shoes by children in intervention arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1056
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard care
Experimental: Shoes
Shoes
Device: Shoes
A unisex canvas slip-on with a sturdy sole.
Other Name: 'Giving Shoe' produced by TOMS Shoes, Los Angeles, California, USA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869127

Locations
Tanzania
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
Investigators
Principal Investigator: Christopher K Bird, MBBS
  More Information

No publications provided by Bird, Christopher

Additional 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
Study First Received: April 1, 2013
Last Updated: June 1, 2013
Health Authority: Zanzibar, United Republic of Tanzania: Ministry of Health

Keywords provided by Bird, Christopher:
hookworm
necator americanus
ancyclostoma duodenale
shoes
anaemia
children

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

ClinicalTrials.gov processed this record on September 22, 2014