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ACTIVE NOT RECRUITING

NCT05736679

EaveTubes for Vector Control

Sponsor: University of Notre Dame

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

6 Months - 10 Years

Study Type

INTERVENTIONAL

Enrollment

1870

Start Date

2023-03-23

Completion Date

2025-12

Last Updated

2025-05-23

Healthy Volunteers

Yes

Conditions

Malaria

Interventions

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.

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.

Locations (1)

Institut Pierre Richet

Bouaké, Côte d’Ivoire