EaveTubes for Vector Control

May 20, 2025 updated by: John Grieco, University of Notre Dame

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1870

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of malaria infection
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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)
Time Frame: 24 months
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
Time Frame: 24 months
Measured by CDC light traps in 20 clusters, 10 houses per cluster on a monthly basis.
24 months
Malaria parasite sporozoite rate
Time Frame: 24 months
Assessed in 10% of all anophelines captured by CDC light trap.
24 months
Entomological Inoculation Rates
Time Frame: 24 months
Measured in each study arm as the product of the anopheline vector density and sporozoite rate.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
User acceptance of EaveTubes
Time Frame: 24 months
Assessments of willingness to participate and adoption of EaveTubes at the end of the study period through questionnaires and willing to pay surveys.
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.
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Notre Dame

Collaborators

Institut Pierre Richet
In2Care

Investigators

  • Principal Investigator: John P Grieco, PhD, University of Notre Dame

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-10-7454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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