Back to resultsEaveTubes for Vector Control
Primary Purpose
Malaria
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In2Care EaveTube
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring EaveTubes, Housing, Malaria control, LLINs, Cost-effectiveness, Malaria, Vector-borne diseases, Mosquito vectors, Incidence
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
In2Care EaveTube
Control
Arm Description
EaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets)
Standard of care (standard pyrethroid-only bednets)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Malaria parasitemia
Measured in children between 6 months to 10 years old in the cohorts of 55 children.
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.
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.
Malaria parasite sporozoite rate
Assessed in 10% of all anophelines captured by CDC light trap.
Entomological Inoculation Rates
Measured in each study arm as the product of the anopheline vector density and sporozoite rate.
Full Information
NCT ID
NCT05736679
First Posted
February 10, 2023
Last Updated
February 24, 2023
Sponsor
University of Notre Dame
Collaborators
Institut Pierre Richet, In2Care
1. Study Identification
Unique Protocol Identification Number
NCT05736679
Brief Title
EaveTubes for Vector Control
Official Title
EaveTubes for Control of Vector Borne Diseases in Côte d'Ivoire
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Notre Dame
Collaborators
Institut Pierre Richet, In2Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
EaveTubes, Housing, Malaria control, LLINs, Cost-effectiveness, Malaria, Vector-borne diseases, Mosquito vectors, Incidence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Given the nature of the intervention, it is impossible to conduct this study in a fully blinded manner but those parts of the data collection that can be blinded will be. Observer bias will be reduced where feasible. All laboratory work will be blinded. Mosquito collector bias will be reduced by using standard light traps which do not rely on the ability of the fieldworker to collect specimens. Trap catches will not be examined and analyzed by those who collected them but by different technicians who will not know the trap location. We will use codes to identify any clinical samples. Electronic records will not carry the name of the research participants, only an alphanumeric code. Primary analysis by the project statistician will be conducted on blinded data (e.g. arms designated as treatment A & B or something similar). Datasets will only be unblinded once they have been locked.
Allocation
Randomized
Enrollment
1870 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In2Care EaveTube
Arm Type
Experimental
Arm Description
EaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care (standard pyrethroid-only bednets)
Intervention Type
Device
Intervention Name(s)
In2Care EaveTube
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence rate of malaria infection
Description
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
Secondary Outcome Measure Information:
Title
Clinical malaria incidence
Description
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
Title
Malaria parasitemia
Description
Measured in children between 6 months to 10 years old in the cohorts of 55 children.
Time Frame
24 months
Title
Prevalence of moderate (defined as 7 - 9.9 g/dL hemoglobin) to severe anemia (<7 g/dL hemoglobin)
Description
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
Title
Mean numbers of female malaria mosquitoes (An. gambiae s.l., An funestus s.l.) captured in study houses
Description
Measured by CDC light traps in 20 clusters, 10 houses per cluster on a monthly basis.
Time Frame
24 months
Title
Malaria parasite sporozoite rate
Description
Assessed in 10% of all anophelines captured by CDC light trap.
Time Frame
24 months
Title
Entomological Inoculation Rates
Description
Measured in each study arm as the product of the anopheline vector density and sporozoite rate.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness of EaveTubes compared to the previously applies Screening + EaveTubes intervention, and compared to other vector control interventions such as LLINs and IRS.
Description
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
Title
User acceptance of EaveTubes
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John P Grieco, PhD
Phone
574-631-7572
Email
jgrieco@nd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole L Achee, PhD
Phone
574-631-1561
Email
nachee@nd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Grieco, PhD
Organizational Affiliation
University of Notre Dame
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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URL
https://www.who.int/publications/i/item/WHO-HTM-GMP-2012.5
Description
World Health Organization - Global plan for insecticide resistance management in malaria vectors.
URL
https://www.who.int/publications/i/item/9789240000759
Description
World Health Organization, 2019 - Eleventh meeting of the WHO Vector Control Advisory Group
URL
https://www.up.ac.za/media/shared/236/ZP_Files/VectorWorks/vector-control-landscape-2015_2.zp73113.pdf
Description
MacDonald, M. (2015) Landscape of new vector control products. VectorWorks.
URL
https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=4b41af5f2ae4722759692bee186c91857b91d663
Description
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URL
https://clinicaltrials.gov/ct2/show/NCT04622241?term=eave+tube&draw=2&rank=1
Description
Uganda Housing Modification Study (UHMS)
Learn more about this trial
EaveTubes for Vector Control
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