Malaria
Conditions
Keywords
EaveTubes, Housing, Malaria control, LLINs, Cost-effectiveness, Malaria, Vector-borne diseases, Mosquito vectors, Incidence
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.
Interventions
DEVICEIn2Care 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.
Sponsors
Institut Pierre Richet
In2Care
University of Notre Dame
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of malaria infection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical malaria incidence | 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. |
| Malaria parasitemia | 24 months | 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) | 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. |
| Malaria parasite sporozoite rate | 24 months | Assessed in 10% of all anophelines captured by CDC light trap. |
| Entomological Inoculation Rates | 24 months | Measured in each study arm as the product of the anopheline vector density and sporozoite rate. |
| Mean numbers of female malaria mosquitoes (An. gambiae s.l., An funestus s.l.) captured in study houses | 24 months | Measured by CDC light traps in 20 clusters, 10 houses per cluster on a monthly basis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of EaveTubes compared to the previously applies Screening + EaveTubes intervention, and compared to other vector control interventions such as LLINs and IRS. | 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. |
| User acceptance of EaveTubes | 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. |
Countries
Côte d’Ivoire
Outcome results
None listed