NCT07387341

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,815

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

December 19, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

January 17, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

February 4, 2026

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

December 19, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

spatial repellentsspatial emanatorsIndoor Residual SprayingKenya

Outcome Measures

Primary Outcomes (1)

  • Malaria prevalence

    The primary outcome of the study will be malaria parasite prevalence (any plasmodium species) in participants aged 1-15 years old

    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

    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

    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

    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

    Measured at baseline and 6, 12, 18 and 24 months post intervention deployment

  • Proportion of households that owned at least one LLIN

    Measured at baseline and 6, 12, 18 and 24 months post intervention deployment

  • +21 more secondary outcomes

Study Arms (3)

LASER

EXPERIMENTAL
Device: Guardian

IRS

EXPERIMENTAL
Device: IRS with Pirimiphos - methyl

Standard control

NO INTERVENTION

Interventions

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).

LASER

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.

IRS

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • \. Child not at home after 3 attempts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI Center for Global Health Research

Kisumu, Kenya

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

February 4, 2026

Study Start

January 17, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

February 4, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations