Evaluation of the protective efficacy of Olyset®Plus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomized controlled study protocol

Abstract Introduction Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum 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 (LLIN) distribution program, is an urgent task in these areas. One novel vector control candidate is the Olyset®Plus ceiling nets which can overcome the problems of variations in net use behaviors 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 randomized controlled trial is designed to evaluate the impact of Olyset®Plus 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 (Olyset®Plus ceiling nets) and the control group. The assignment will be accomplished through covariate-constrained randomization 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 approval was provided by the Mount Kenya University Institutional Scientific Ethics Review Committee. 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 UMIN000053873 Administrative information Strength and limitations of this study This study is a cluster-randomized controlled trial (CRCT) to evaluate the efficacy of the Olyset®Plus ceiling net as a novel vector control tool and a complement to current malaria control tools in sub-Saharan Africa. This marks the second CRCT of the Olyset®Plus ceiling net intervention in the lake endemic region of Kenya, expanding the evidence base to a different eco-epidemiological setting from the previous CRCT, where promising results were observed on Mfangano Island. Collaboration with local Kenyan institutions such as the Kenya National Bureau of Statistics (KNBS), the National Malaria Control Programme (NMCP), the Kenya Medical Research Institute (KEMRI), and Homa Bay County from the research planning stage is one of the strengths of this trial, allowing for a seamless transition from research implementation in the field to policy development. One of the anticipated limitations is the possible contamination between intervention and control clusters because we will not set a buffer zone due to the geographical proximity of each cluster. We will try to account for such contamination effects by integrating spatial data into our statistical model.