About this trial
Malaria is a major problem in western Kenya, particularly around Lake Victoria. Whilst current prevention methods like bed nets and vaccines help to reduce malaria burden, additional tools are needed to better protect communities from malaria. The investigators will test a new technology called LASER Guardian™, which are devices that release chemicals to keep mosquitoes away from homes. The investigators will conduct a large study involving 69 villages in western Kenya over two years. Each village will be randomly chosen to receive one of three approaches: the new LASER devices, indoor residual spraying with insecticide (a method already known to work), or the standard prevention methods currently used. All villages will continue to receive the usual malaria prevention tools provided by the Kenyan government, including bed nets and vaccines. In villages receiving LASER, the investigators will install 2-3 small device inside structures once a year for two years. In villages receiving IRS, the investigators will spray the inside walls of homes with insecticide once a year for two years. The investigators want to find out if the LASER devices can reduce malaria better than current methods alone, and whether they work as well as indoor spraying. To do this, the investigators will carry out surveys of the community every six months over two years (four rounds in total), testing about 4,485 children between ages 1 and 15 from approximately 3,450 households in each survey to see how many have malaria. The investigators will also work with local health clinics to track malaria cases, study mosquitoes to understand how the interventions affect them, talk with community members about their experiences, and calculate the costs of these different approaches. This study will help us understand whether LASER tool can effectively protecting against malaria in Kenya and other African countries where malaria is common.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Child aged 1-15 years
Usual resident (a person who has been residing in the survey area for at least the past 4 months) who was present in the sampled household on the night before the survey
Agreement of adult or parent/guardian (of children) to provide informed consent
Agreement of child aged 12 years or older to provide assent
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Guardian
DeviceThe SC Johnson long-acting product (Guardian™) is a vapor releasing product (VP) formed from a polyester (PET) mesh substrate carrier dosed with 2,500 mg of transfluthrin per unit (CAS No. 118721-89-3). Transfluthrin is a type I synthetic pyrethroid that acts through modulation of nerve axon sodium channels, causing neurotoxicity in insects. The product is intended to be used as spatial emanator for the control of mosquitoes. The insecticide emanates from the product and subsequently kills or disrupts the biting behaviour of the surrounding vector population. The LASER product will be procured locally from the SC Johnson factory in Nairobi, Kenya (SC Johnson).
IRS with Pirimiphos - methyl
DeviceIn clusters that are randomised to the IRS arm, IRS will be carried out using pirimiphos-methyl (Actellic®300CS) manufactured by Syngenta, an organophosphate insecticide that is registered for use in Kenya and has demonstrated effectiveness in malaria vector control. The product will be obtained directly from Syngenta to ensure quality and authenticity, with proper documentation and chain of custody maintained throughout the procurement and storage process.
Treatment groups
Trial outcomes
Primary outcomes
Malaria prevalence
The primary outcome of the study will be malaria parasite prevalence (any plasmodium species) in participants aged 1-15 years old
Secondary outcomes
Prevalence of parasitaemia in children aged 1-5 years
Proportion of children aged 1-5 years with blood smears positive for parasites by microscopy at the time of community cross-sectional surveys.
Prevalence of parasitaemia in children aged 6-10 years
Proportion of children aged 6-10 years with blood smears positive for parasites by microscopy at the time of community cross-sectional surveys.
Prevalence of parasitaemia in children aged 11-15 years
Proportion of children aged 11-15 years with blood smears positive for parasites by microscopy at the time of community cross-sectional surveys.
Prevalence of anaemia in children under 5 years
Proportion of children under 5 years of age with haemoglobin \< 11 g/dL at the time of community cross-sectional surveys.
Sponsors and contacts
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Liverpool School of Tropical Medicine
Lead sponsor
Kenya Medical Research Institute
Collaborator
Institute of Tropical Medicine, Belgium
Collaborator
Radboud University Medical Center
Collaborator
Centers for Disease Control and Prevention
Collaborator
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