Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya

• Type of Material: Article
• Authors: Simon J Brooker, London School of Hygiene & Tropical Medicine; Charles S Mwandawiro, Kenya Medical Research Institute; Katherine E Halliday, London School of Hygiene & Tropical Medicine; Sammy M Njenga, Kenya Medical Research Institute; Carlos Mcharo, Evidence Action; Paul M Gichuki, Kenya Medical Research Institute; Beatrice Wasunna, Kenya Medical Research Institute; Jimmy H Kihara, Kenya Medical Research Institute; Doris Njomo, Kenya Medical Research Institute; Dorcas Alusala, Ministry of Health, Kenya; Athuman Chiguzo, Kwale County Government, Kenya; Hugo C Turner, Imperial College London; Caroline Teti, Evidence Action; Claire Gwayi-Chore, Evidence Action; Birgit Nikolay, London School of Hygiene & Tropical Medicine; James E Truscott, Imperial College London; T Déirdre Hollingsworth, University of Warwick; Dina Balabanova, London School of Hygiene & Tropical Medicine; Ulla K Griffiths, London School of Hygiene & Tropical Medicine; Matthew Freeman, Emory University; Elizabeth Allen, London School of Hygiene & Tropical Medicine; Rachel L Pullan, London School of Hygiene & Tropical Medicineaffiliation; Roy M Anderson, Imperial College London
• Language: English
• Date: 2015-10-19
• Publisher: BMJ Publishing Group: Open Access
• Publication Version: Final Published Version
• Copyright Statement: © 2015, British Medical Journal Publishing Group
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/bmjopen-2015-008950
• Title of Journal or Parent Work: BMJ Open
• ISSN: 2044-6055
• Volume: 5
• Issue: 10
• Start Page: e008950
• End Page: e008950
• Grant/Funding Information: GlaxoSmithKline, the manufacturer of albendazole, has donated, through the Government of Kenya, the drug used in the study.; SJB is supported by a Wellcome Trust Senior Fellowship in Basic Biomedical Science (098045), which also supports RLP and KEH.; The study is supported by the Bill and Melinda Gates Foundation (#OPP1033751) and a grant from the DFID/MRC/Wellcome Trust global health trials scheme (MR/M021289/1), with additional funding provided by the Children's Investment Fund Foundation (CIFF).
• Keywords: Epidemiology; Public health; Parasitology
• Research Categories: Biology, Parasitology; Health Sciences, Epidemiology; Health Sciences, Public Health

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 cost-effective 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.