An interventional study of In2Care EaveTube in Malaria, sponsored by University of Notre Dame. Active, not recruiting at 1 site in Côte D'Ivoire. Open to participants aged 6 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by University of Notre Dame · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to test whether In2Care EaveTubes (ETs) as a stand-alone tool can reduce malaria in an area where transmission is driven by insecticide-resistant Anopheles gambiae. Children who live in homes with ETs will be monitored for malaria infection and compared to children living in homes without ETs in Côte d'Ivoire where there is universal coverage of long lasting insecticide nets and pyrethroid resistance is high.
In2Care EaveTubes (ETs) are an inexpensive, new vector control product under World Health Organization (WHO) evaluation informed by mosquito ecology to efficiently target malaria vectors. By installing ETs in the walls of the house at eave level that funnel the natural airflow, mosquitoes are drawn in by the same heat and odor cues that typically attract them through the eaves. Once inside an ET, mosquitoes come into contact with insecticide-treated netting placed inside the ET.
The aim of this study is to test whether ETs as stand-alone tool have an effect on the epidemiology of malaria in villages where houses have been modified with the ET intervention. This prospective 2-arm cluster randomized control trial based on a WHO Vector Control Advisory Group approved protocol will include 17 intervention clusters and 17 control clusters. Both arms will have pyrethroid-treated bednets. Based on the population census, 55 households per cluster with eligible children will be randomly selected for recruitment into the active detection cohorts. In the intervention arm, we will enroll eligible children who reside in ET-treated houses. In the control arm, we will enroll children residing in villages without ET-treated houses. The intervention and control cohorts will be followed for 4 months for baseline covariate measurements and 24 months of a clinical follow up period. During case detection visits, blood samples will be taken from all febrile children and tested for malaria infection with rapid diagnostic tests. To assess the impact of the ET on mosquito density, entomological measurements will be conducted monthly in 20 clusters (10 ET, 10 Control) in 10 randomly selected households per cluster. To estimate the infectiousness of malaria vectors, sporozoite rates will be measured in subsets of the collected mosquito samples.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 1,870 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →University of Notre Dame is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
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Village Level Inclusion Criteria:
Village Level Exclusion Criteria:
Household Level Inclusion Criteria
Household Level Exclusion Criteria
Individual Level Inclusion Criteria
Individual Level Exclusion Criteria
EaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets)
Device: In2Care EaveTube
Standard of care (standard pyrethroid-only bednets)
In2Care® EaveTubes (ETs) comprise 15 cm diameter, 20 cm long ventilation tubes with removable netting inserts that are placed in the wall under the roof of houses where they attract malaria mosquitoes at night, block them from entering the house, and contaminate them with a lethal dose of insecticide. In2Care® ET netting inserts have an electrostatically charged coating treated with bio-actives in powder form, which kills insecticide-resistant mosquitoes through high active ingredient dose transfer.
Incidence rate of malaria infection
Measured by active infection and clinical malaria case detection in cohorts of 55 children (between 6 months and 10 years old) per cluster, 17 clusters per arm on a biweekly basis in peak transmission season and monthly basis in low transmission season.
Time frame: 24 months
Clinical malaria incidence
Measured in children between 6 months to 10 years old living in the study cohorts using passive case detection via the existing community health workers and health centers.
Time frame: 24 months
Malaria parasitemia
Measured in children between 6 months to 10 years old in the cohorts of 55 children.
Time frame: 24 months
Prevalence of moderate (defined as 7 - 9.9 g/dL hemoglobin) to severe anemia (<7 g/dL hemoglobin)
Measured in children under 5 years of age in the cohorts of 55 children four times: at the start and end of the rainy season (April and November respectively) of Year 1 and Year 2.
Time frame: 24 months
Mean numbers of female malaria mosquitoes (An. gambiae s.l., An funestus s.l.) captured in study houses
Measured by CDC light traps in 20 clusters, 10 houses per cluster on a monthly basis.
Time frame: 24 months
Malaria parasite sporozoite rate
Assessed in 10% of all anophelines captured by CDC light trap.
Time frame: 24 months
Entomological Inoculation Rates
Measured in each study arm as the product of the anopheline vector density and sporozoite rate.
Time frame: 24 months
Cost-effectiveness of EaveTubes compared to the previously applies Screening + EaveTubes intervention, and compared to other vector control interventions such as LLINs and IRS.
Cost modelling will assess cost-effectiveness of EaveTubes compared to the previously applies Screening + EaveTubes intervention, and compared to other vector control interventions such as long lasting insecticide nets and indoor residual spray.
Time frame: 24 months
User acceptance of EaveTubes
Assessments of willingness to participate and adoption of EaveTubes at the end of the study period through questionnaires and willing to pay surveys.
Time frame: 24 months
Plan to share: No
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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