Long-acting Spatial Emanators / Repellents (LASER) vs Indoor Residual Spraying (IRS) in Western Kenya: a Cluster-randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 22,815
- Locations
- 1
- Primary Endpoint
- Malaria prevalence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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:
- •1. Child not at home after 3 attempts
Exclusion Criteria
- Not provided
Arms & Interventions
LASER
Intervention: Guardian (Device)
IRS
Intervention: IRS with Pirimiphos - methyl (Device)
Standard control
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Proportion of households with at least one LLIN for every two occupants(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(Measured at baseline and 6, 12, 18 and 24 months post intervention deployment)
- LASER intervention coverage(Measured at 6, 12, 18 and 24 months post initial intervention deployment)
- Indoor residual spraying (IRS) coverage(Measured at 6, 12, 18 and 24 months post inital intervention deployment)
- Malaria incidence in patients of all ages from health facility surveillance(Data captured monthly for 24 months post intervention deployment)
- Anopheles spp. vector density(Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment)
- Anopheles mosquitoes species composition(Measured at baseline and 6, 12, 18 and 24 months post intervention deployment)
- Sporozoite rate in Anopheles spp. mosquitoes(Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment)
- Insecticide resistance in Anopheles spp.(Measured at baseline and 6, 12, 18 and 24 months post initial intervention deployment)
- Frequency of insecticide resistance genetic variants in Anopheles mosquitos(Measured at baseline and 6, 12, 18 and 24 months post intervention deployment)
- Acceptability of LASER and preventive measures by participant demographics(Baseline, 12 months post intervention deployment and within 3 months post intervention withdrawal)
- Appropriateness of LASER and other preventive measures in local context(Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.)
- Proportion of participants reporting barriers to LASER use(Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.)
- Reasons for non-adherence to LASER intervention(Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.)
- Contextual factors affecting LASER delivery and transferability(Baseline, 12 months post intervention deployment, and within 3 months post intervention withdrawal.)
- Cost per household protected per year(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(24 months post intervention deployment)
- Incremental cost-effectiveness ratio: Cost per DALY averted(24 months post intervention deployment)
- Mean Household Willingness to Pay(24 months post intervention deployment)
- Budget impact at scale(24 months post intervention deployment)
- Equity of intervention coverage(Measured at baseline and 6, 12, 18 and 24 months post intervention deployment)