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

Simon J Brooker, Charles S Mwandawiro, Katherine E Halliday, Sammy M Njenga, Carlos Mcharo, Paul M Gichuki, Beatrice Wasunna, Jimmy H Kihara, Doris Njomo, Dorcas Alusala, Athuman Chiguzo, Hugo C Turner, Caroline Teti, Claire Gwayi-Chore, Birgit Nikolay, James E Truscott, T Déirdre Hollingsworth, Dina Balabanova, Ulla K Griffiths, Matthew C Freeman, Elizabeth Allen, Rachel L Pullan, Roy M Anderson, Simon J Brooker, Charles S Mwandawiro, Katherine E Halliday, Sammy M Njenga, Carlos Mcharo, Paul M Gichuki, Beatrice Wasunna, Jimmy H Kihara, Doris Njomo, Dorcas Alusala, Athuman Chiguzo, Hugo C Turner, Caroline Teti, Claire Gwayi-Chore, Birgit Nikolay, James E Truscott, T Déirdre Hollingsworth, Dina Balabanova, Ulla K Griffiths, Matthew C Freeman, Elizabeth Allen, Rachel L Pullan, Roy M Anderson

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.

Keywords: EPIDEMIOLOGY; PARASITOLOGY; PUBLIC HEALTH.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Summary of study design.
Figure 2
Figure 2
Map showing location of study sites and community units.
Figure 3
Figure 3
The relationship between baseline prevalence of hookworm infection (proportion of all community members found to be infected) and predicted impact following 2 years of treatment for each proposed treatment strategy. Based on a mathematical model of transmission dynamics, assuming 80% treatment coverage of school-based deworming and 70% of community-based treatment. Biannual school-based treatment did not differ significantly from annual school-based treatment and therefore is not shown. Sensitivity of diagnosis is assumed to be 63%.

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