Clinical Trial: Study to Test Whether Shoes Protect Children Against Hookworm Infection on Pemba Island, Zanzibar

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 C

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.

Detailed Summary:

Aim: To carry out a cluster randomised controlled trial (non-blinded) to test under field conditions whether the provision of shoes to school-aged children on Pemba Island, Zanzibar, an area of high hookworm prevalence and anaemia, could reduce the transmission, incidence and disease burden of hookworm infection among this susceptible population.

Methods:

Setting: Pemba Island is the northern of the two main islands that make up the Zanzibar archipelago, situated in the Indian Ocean and close to the coast of East Africa, just below the equator. The climate is tropical and humid and the island has two rainy seasons, from March-June (Masika) and October-December (Vuli). Humidity is high, up to 1000mm during the Masika rains. Economic activities are mainly agriculture and fishing and considerable improvements to infrastructure - roads and electricity - have been made in recent years. The island's population totalled 460,196 in 2008, of whom 50 percent were children aged <15 years. Zanzibar is an autonomous part of the United Republic of Tanzania and on the mainland, the under 5 mortality rate (U5MR) is 81 per 1,000 live births but is substantially higher on Zanzibar at 116 per 1,000 live births. The area is highly endemic for soil transmitted helminths - a recent study on neighbouring Unguja Island found three-quarters of rural inhabitants and half of urban inhabitants to be infected with parasitic worms, despite 15 years of mass drug treatment. Other risk factors for concomitant anaemia are poor nutrition, focal areas of Schistosoma haematobium transmission and malaria, although recent control efforts have made impressive reductions in malaria transmission (reduced to 0.8% prevalence in 2007).

Study schools (clusters): 12 government primary schools from across the entire i
Sponsor: Bird, Christopher

Current Primary Outcome: Reduction in hookworm prevalence and intensity of infection in intervention arm [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Bird, Christopher

Dates:
Date Received: April 1, 2013
Date Started: July 2011
Date Completion:
Last Updated: June 1, 2013
Last Verified: June 2013