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NCT05736679
EaveTubes for Vector Control
Conditions: Malaria
Sex: All
Ages: 6 Months – 10 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 1870
Sponsor: University of Notre Dame
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.
Eligibility Criteria
Village Level Inclusion Criteria:≥ 80% of Households (HHs) must be suitable for ET installation.≥70% of HHs willing to have ETs installed.No participation in the previous Screening + ETs cRCT.Received standard pyrethroid-only LLINs (Permanet 2.0).100-300 households 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 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 CriteriaHHs must be suitable for ET installation.Provision of consent from heads of HH.Household Level Exclusion CriteriaHH 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 CriteriaChildren 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 CriteriaChildren 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.
Source: ClinicalTrials.gov (NCT05736679). StuddyBuddy aggregates publicly available trial information.