EaveTubes for Vector Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EaveTubes for Control of Vector Borne Diseases in Côte d'Ivoire

Conditions
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Malaria

Intervention / Treatment
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* Device: In2Care EaveTube


Participation Criteria
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Eligibility Criteria
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Village Level Inclusion Criteria: ≥ 80% of Households (HHs) must be suitable for EaveTube(ET) installation. ≥70% of HHs willing to have ETs installed. No participation in the previous Screening + ETs cluster randomized control trial (cRCT). Received standard pyrethroid-only long lasting insecticide nets(LLINs) (Permanet 2.0). 100-300 HHs per village. ≥2 km apart from another village. Village Level Exclusion Criteria: < 80% of HHs suitable for ET installation. <70% of HHs willing to have ETs installed. Villages being treated by indoor residual spray (IRS) and/or new generation bed net campaigns. Participation in previous Screening + ET cRCT. <100 and >300 households per village. <2 km from another village. Household Level Inclusion Criteria HHs must be suitable for ET installation. Provision of consent from heads of HH. Household Level Exclusion Criteria HH not suitable for ET installation (e.g. houses with poor quality thatch roofing or very large eaves or wall gaps, houses in substantial disrepair, unfinished houses under construction, poorly constructed houses, ). No provision of consent from heads of HH. Individual Level Inclusion Criteria Children aged ≥ 6 months to < 8 years old at time of enrollment (so all participants are under 10 years old for the duration of clinical follow-up). Provision of written, informed consent by parents/care givers. Children must reside in villages enrolled in the study and in ETs-treated HHs. Hemoglobin at baseline of >7 mg/dL. Individual Level Exclusion Criteria Children aged < 6 months or ≥ 8 years old at time of enrollment. No provision of written, informed consent by parents/care givers for child participation. Expected to be non-resident during a significant part of the transmission season. Hemoglobin at baseline of ≤7 mg/dL, have a known chronic disease, or who have signs of clinical decompensation. Participation in another clinical trial investigating a drug, vaccine, medical device or procedure.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In2Care EaveTube<br>EaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets) | Device: In2Care EaveTube<br>* 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.<br>|
| No Intervention: Control<br>Standard of care (standard pyrethroid-only bednets) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 
| Malaria parasitemia | Measured in children between 6 months to 10 years old in the cohorts of 55 children. | 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. | 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. | 24 months | 
| Malaria parasite sporozoite rate | Assessed in 10% of all anophelines captured by CDC light trap. | 24 months | 
| Entomological Inoculation Rates | Measured in each study arm as the product of the anopheline vector density and sporozoite rate. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EaveTubes, Housing, Malaria control, LLINs, Cost-effectiveness, Malaria, Vector-borne diseases, Mosquito vectors, Incidence