An interventional study of Guardian and IRS with Pirimiphos - methyl in Malaria Transmission, Malaria Prevention and Malaria, sponsored by Liverpool School of Tropical Medicine. Not yet recruiting at 1 site in Kenya. Open to participants aged 1 Year to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Liverpool School of Tropical Medicine · Not applicable, Interventional, and Prevention
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 22,815 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are:
The exclusion criterion is:
1. Child not at home after 3 attempts
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Guardian
Device: IRS with Pirimiphos - methyl
The 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).
In 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.
Malaria prevalence
The primary outcome of the study will be malaria parasite prevalence (any plasmodium species) in participants aged 1-15 years old
Time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
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.
Time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
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.
Time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
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.
Time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
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.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Proportion of households that owned at least one LLIN
Proportion of households with at least one long-lasting insecticidal net (LLIN) at the time of community cross-sectional surveys.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Proportion of households with at least one LLIN for every two occupants
Proportion of households with at least one long-lasting insecticidal net (LLIN) per every two household occupants at the time of community cross-sectional surveys.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Proportion of household residents who slept under an LLIN the previous night
Proportion of household residents who report sleeping under a long-lasting insecticidal net (LLIN) the previous night at the time of community cross-sectional surveys.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
LASER intervention coverage
Proportion of sampled households in the LASER intervention arm that have the required number of SCJ Guardian spatial emanators present at the time of community cross-sectional surveys.
Time frame: Measured at 6, 12, 18 and 24 months post initial intervention deployment
Indoor residual spraying (IRS) coverage
Proportion of surveyed households that report received indoor residual spraying (IRS) as part of the study in the IRS arm.
Time frame: Measured at 6, 12, 18 and 24 months post inital intervention deployment
Malaria incidence in patients of all ages from health facility surveillance
Number of cases of malaria diagnosed at participating health facilities among patients of all ages residing in study clusters per unit time, divided by the estimated population of the cluster villages.
Time frame: Data captured monthly for 24 months post intervention deployment
Anopheles spp. vector density
Number of female Anopheles mosquitoes collected by ultra violet light traps per household at the time of entomology surveys in randomly selected households
Time frame: Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment
Anopheles mosquitoes species composition
Proportion of each Anopheles mosquito species identified among collected specimens at the time of entomology surveys by molecular identification.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Sporozoite rate in Anopheles spp. mosquitoes
Proportion of screened Anopheles mosquitoes that test positive for Plasmodium sporozoites.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment
Insecticide resistance in Anopheles spp.
Proportion of Anopheles mosquitoes surviving standard WHO insecticide susceptibility tests at the time of entomology surveys.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment
Frequency of insecticide resistance genetic variants in Anopheles mosquitos
Proportion of screened Anopheles mosquitoes carrying molecular markers associated with insecticide resistance at the time of entomology surveys.
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Acceptability of LASER and preventive measures by participant demographics
Proportion of participants reporting acceptability of spatial repellents (SR) and other preventive measures, assessed using structured questionnaires. Data stratified by gender, age group, and socio-economic activity categories.
Time frame: Baseline, 12 months post intervention deployment and within 3 months post intervention withdrawal
Appropriateness of LASER and other preventive measures in local context
Proportion of participants rating long-acting spatial emanators (LASER) and other preventive measures as appropriate for their local context, assessed using structured questionnaires. Stratified by gender, age group, and socio-economic activity.
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Proportion of participants reporting barriers to LASER use
Proportion of participants in LASER arm identifying specific barriers to LASER intervention use, assessed using semi-structured interviews and focus group discussions. Barriers categorized and quantified by thematic analysis.
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Reasons for non-adherence to LASER intervention
Proportion of non-adherent participants citing specific reasons for non-adherence, assessed using semi-structured interviews. Reasons categorized by thematic analysis and reported as percentage of non-adherent participants per category.
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Contextual factors affecting LASER delivery and transferability
Number and type of contextual factors (social, environmental, health system) affecting LASER delivery identified through key informant interviews and focus group discussions. Factors categorized by thematic analysis to inform transferability to other malaria endemic areas.
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Cost per household protected per year
Annual cost in US dollars (USD) per household protected by the interventions, calculated as total intervention costs divided by the number of households receiving protection. Costs include implementation, distribution, and maintenance costs.
Time frame: Cost data collected monthly throughout 24-month trial period; final calculation at 24 months post intervention deployment
Incremental cost-effectiveness ratio: Cost per malaria case averted
Incremental cost in US dollars (USD) per malaria case averted compared to standard of care.
Time frame: 24 months post intervention deployment
Incremental cost-effectiveness ratio: Cost per DALY averted
Incremental cost in US dollars (USD) per disability-adjusted life year (DALY) averted compared to standard of care
Time frame: 24 months post intervention deployment
Mean Household Willingness to Pay
Mean willingness to pay in US dollars (USD) and local currency units (LCU) per household for the intervention, assessed using contingent valuation methodology with bidding game administered via structured questionnaire.
Time frame: 24 months post intervention deployment
Budget impact at scale
Estimated total cost in US dollars (USD) for scaling up the intervention to a defined target population, calculated using budget impact analysis modeling based on observed unit costs and projected coverage scenarios.
Time frame: 24 months post intervention deployment
Equity of intervention coverage
Proportion of sampled households that have the intervention present at the time of community cross-sectional surveys assessed as coverage by socio-economic status group (quantile).
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Plan to share: Yes
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Liverpool School of Tropical Medicine