(2015) Interrupting transmission of soil-transmitted helminths : a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya. BMJ Open, 5 (10). pp. 1-27. e008950 . doi:10.1136/bmjopen-2015-008950

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Abstract

Introduction:
In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most costeffective treatment strategy and delivery system to achieve this goal?

Methods and analysis:
Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision—termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.

Ethics and dissemination:
Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a dedicated web site.

Trial registration number: NCT02397772

Item Type:	Journal Article
Alternative Title:
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Science > Life Sciences (2010- ) Faculty of Science > Mathematics
Library of Congress Subject Headings (LCSH):	Helminths, Soilborne infection, Tropical medicine, Clinical trials
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	19 October 2015
Dates:	Date Event 19 October 2015 Published 30 July 2015 Accepted 1 June 2015 Submitted
Date of first compliant deposit:	30 December 2015
Volume:	5
Number:	10
Number of Pages:	27
Page Range:	pp. 1-27
Article Number:	e008950
DOI:	10.1136/bmjopen-2015-008950
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Bill & Melinda Gates Foundation, Great Britain. Department for International Development, Medical Research Council (Great Britain) (MRC), Wellcome Trust (London, England), Children’s Investment Fund Foundation (CIFF), GlaxoSmithKline
Grant number:	OPP1033751 (B&MGF), MR/M021289/1 (MRC), 098045 (WT)

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