Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol.

INTRODUCTION

Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of with partial artemisinin resistance in East Africa and beyond is a great concern. The establishment of more effective vector control, in addition to the current long-lasting insecticide-treated net distribution programme, is an urgent task in these areas. One novel vector control candidate is the pyrethroid-PBO ceiling nets (OlysetPlus ceiling nets) which can overcome the problems of variations in net use behaviours and metabolic resistance to insecticide in vectors. Our preliminary study suggests the protective efficacy and high acceptability of this tool. With this proposed second trial, we aim to evaluate the impact of this tool in a different eco-epidemiological setting in the lake endemic region of Kenya.

METHODS

A cluster-randomised controlled trial is designed to evaluate the impact of pyrethroid-PBO ceiling nets in Ndhiwa Sub-County, Homa Bay County, Kenya. A total of 44 clusters will be randomly assigned in a 1:1 ratio to the intervention group (pyrethroid-PBO ceiling nets) and the control group. The assignment will be accomplished through covariate-constrained randomisation of clusters. For the primary outcome of clinical malaria incidence, 38 children from each cluster will be enrolled in a cohort and followed for 18 months. We will also evaluate the effects of the intervention on entomological indicators as well as its acceptance by communities and cost-effectiveness.

ETHICS AND DISSEMINATION

Ethics approvals were provided by the Mount Kenya University Institutional Scientific Ethics Review Committee and the Ethics Committee Osaka Metropolitan University. Study results will be shared with study participants and communities, the Homa Bay County government and the Kenya National Malaria Control Programme. Results will also be disseminated through publications, conferences and workshops to help the development of novel malaria control strategies in other malaria-endemic countries.

TRIAL REGISTRATION NUMBER

UMIN000053873.