04055nas a2200697 4500000000100000008004100001653001600042653003100058653000900089653001200098653003000110653002000140653001800160653001600178653000900194653002500203653001000228653001100238653002400249653001100273653002800284653002600312653003300338653002100371653001000392653001800402653001600420653002200436653000900458653001000467653001500477100001400492700001700506700001500523700001300538700001300551700001400564700001400578700001300592700001200605700001400617700001500631700001300646700001100659700001800670700001400688700001500702700002100717700001700738700001600755700001500771700001200786700001300798700001500811245018300826856008501009300001201094490000601106520223101112022001403343 2015 d10aYoung Adult10aSurveys and Questionnaires10aSoil10aSchools10aResidence Characteristics10aResearch Design10aPublic health10aMiddle Aged10aMale10aLongitudinal studies10aKenya10aHumans10aHookworm Infections10aFemale10aCross-Sectional Studies10aCost-Benefit Analysis10aCommunicable Disease Control10aChild, Preschool10aChild10aAnthelmintics10aAlbendazole10aAged, 80 and over10aAged10aAdult10aAdolescent1 aBrooker S1 aMwandawiro C1 aHalliday K1 aNjenga S1 aMcharo C1 aGichuki P1 aWasunna B1 aKihara J1 aNjomo D1 aAlusala D1 aChiguzo AN1 aTurner H1 aTeti C1 aGwayi-Chore C1 aNikolay B1 aTruscott J1 aHollingsworth DT1 aBalabanova D1 aGriffiths U1 aFreeman MC1 aAllen E1 aPullan R1 aAnderson R00aInterrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya. uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4611208/pdf/bmjopen-2015-008950.pdf ae0089500 v53 a

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.

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