Malaria TransmissionLASERNCT07387341
Long-acting Spatial Emanators / Repellents (LASER)
A study testing Guardian and IRS with Pirimiphos - methyl in people with Malaria Transmission and Malaria Prevention, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Transmission, Malaria Prevention, Malaria
- What is being tested?
- Guardian and IRS with Pirimiphos - methyl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,815 participants
- Where
- 1 siteKenya
- Study dates
- 17 Jan 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
The inclusion criteria are:
- 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
The exclusion criterion is:
- Child not at home after 3 attempts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalie Tate contact
Kenya1 site
KEMRI Center for Global Health Research
Kisumu
Titus Kwambai, +254722207281, Titus.Kwambai@lstmed.ac.uk
About this study
Official title: Long-acting Spatial Emanators / Repellents (LASER) vs Indoor Residual Spraying (IRS) in Western Kenya: a Cluster-randomised 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.
- Conditions
- Malaria Transmission, Malaria Prevention, Malaria
- Being tested
- Guardian, IRS with Pirimiphos - methyl
- Keywords
- spatial repellents, spatial emanators, Indoor Residual Spraying, Kenya
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuardianDevice
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).
IRS with Pirimiphos - methylDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LASER | Experimental | Not described Receives: Device: Guardian |
| IRS | Experimental | Not described Receives: Device: IRS with Pirimiphos - methyl |
| Standard control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria prevalence
The primary outcome of the study will be malaria parasite prevalence (any plasmodium species) in participants aged 1-15 years old
Measured: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Jan 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two interventions will be evaluated in this trial: (i) LASER (intervention #1) and (ii) IRS with pirimiphos-methyl (intervention #2), as compared to standard of care (control) in a parallel 1:1:1 open label cluster randomised trial . All clusters will receive standard malaria control interventions, including LLINs distributed by the Kenyan NMCP and malaria vaccines (when and where these are deployed).
- Masking
- None (open label)
- Enrolment
- 22,815 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Institute of Tropical Medicine, Belgium, Radboud University Medical Center, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387341
- Sponsor's protocol ID
- 101190818
- Acronym
- LASER
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Spatial Emanators / Repellents (LASER) vs Indoor Residual Spraying (IRS) in Western Kenya: a Cluster-randomised Trial
- ClinicalTrials.gov ID
- NCT07387341
- Acronym / sponsor ID
- LASER / 101190818
- Conditions
- Malaria Transmission, Malaria Prevention, Malaria
- Keywords
- spatial repellents, spatial emanators, Indoor Residual Spraying, Kenya
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22,815 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Institute of Tropical Medicine, Belgium, Radboud University Medical Center, Centers for Disease Control and Prevention
- Study start
- 17 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two interventions will be evaluated in this trial: (i) LASER (intervention #1) and (ii) IRS with pirimiphos-methyl (intervention #2), as compared to standard of care (control) in a parallel 1:1:1 open label cluster randomised trial . All clusters will receive standard malaria control interventions, including LLINs distributed by the Kenyan NMCP and malaria vaccines (when and where these are deployed).
| Arm | Type | Receives |
|---|---|---|
| LASER | Experimental | Device: Guardian |
| IRS | Experimental | Device: IRS with Pirimiphos - methyl |
| Standard control | No intervention | – |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuardianThe 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). | Device | LASER |
| IRS with Pirimiphos - methylIn 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. | Device | IRS |
Primary outcome
Malaria prevalence
Time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.
The primary outcome of the study will be malaria parasite prevalence (any plasmodium species) in participants aged 1-15 years old
26 secondary outcomes
Prevalence of parasitaemia in children aged 1-5 years
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
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
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
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Proportion of households that owned at least one LLIN
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
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
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
LASER intervention coverage
Time frame: Measured at 6, 12, 18 and 24 months post initial intervention deployment
Indoor residual spraying (IRS) coverage
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
Time frame: Data captured monthly for 24 months post intervention deployment
Anopheles spp. vector density
Time frame: Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment
Anopheles mosquitoes species composition
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Sporozoite rate in Anopheles spp. mosquitoes
Time frame: Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment
Insecticide resistance in Anopheles spp.
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
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Acceptability of LASER and preventive measures by participant demographics
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
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Proportion of participants reporting barriers to LASER use
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Reasons for non-adherence to LASER intervention
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Contextual factors affecting LASER delivery and transferability
Time frame: Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.
Cost per household protected per year
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
Time frame: 24 months post intervention deployment
Incremental cost-effectiveness ratio: Cost per DALY averted
Time frame: 24 months post intervention deployment
Mean Household Willingness to Pay
Time frame: 24 months post intervention deployment
Budget impact at scale
Time frame: 24 months post intervention deployment
Equity of intervention coverage
Time frame: Measured at baseline and 6, 12, 18 and 24 months post intervention deployment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Tate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian and IRS with Pirimiphos - methyl in people with Malaria Transmission and Malaria Prevention, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Staedke (+254796667290, sarah.staedke@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria prevalence (time frame: Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.