NCT01869127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,056

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

April 1, 2013

Last Update Submit

June 1, 2013

Conditions

Hookworm

Keywords

hookwormnecator americanusancyclostoma duodenaleshoesanaemiachildren

Outcome Measures

Primary Outcomes (1)

  • Reduction in hookworm prevalence and intensity of infection in intervention arm

    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).

    6 months

Secondary Outcomes (1)

  • Use of shoes by children in intervention arm

    6 months

Study Arms (2)

Control

NO INTERVENTION

Standard care

Shoes

EXPERIMENTAL

Shoes

Device: Shoes

Interventions

ShoesDEVICE

A unisex canvas slip-on with a sturdy sole.

Also known as: 'Giving Shoe' produced by TOMS Shoes, Los Angeles, California, USA
Shoes

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • lack of consent from family
  • allergy to Albendazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Laboratory

Chake Chake, Pemba Island, Zanzibar, Tanzania

Location

Related Publications (1)

  • Bird C, Ame S, Albonico M, Bickle Q. Do shoes reduce hookworm infection in school-aged children on Pemba Island, Zanzibar? A pragmatic trial. Trans R Soc Trop Med Hyg. 2014 May;108(5):297-304. doi: 10.1093/trstmh/tru037. Epub 2014 Mar 5.

    PMID: 24603321DERIVED

MeSH Terms

Conditions

AncylostomiasisAnemia

Condition Hierarchy (Ancestors)

Hookworm InfectionsStrongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Christopher K Bird, MBBS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

June 5, 2013

Study Start

July 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

TA(1)