Long-acting Spatial Emanators / Repellents (LASER)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorLiverpool School of Tropical Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Guardian

    Device

    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 - methyl

    Device

    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.

Treatment groups

22,815 Participants
are divided into 3 treatment groups
Group A: LASERExperimental treatment 1 intervention
Group B: IRSExperimental treatment 1 intervention
Group C: Standard controlNo intervention 0 interventions

Trial outcomes

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

Time frame
Measured one time in randomly selected participants at baseline and 6, 12, 18 and 24 months post intervention deployment.

Secondary outcomes

1

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.
2

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.
3

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.
4

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

Other outcomes

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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