EaveTubes for Vector Control

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05736679
• Other study ID #: 22-10-7454
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1870
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Vector Borne Diseases

Intervention

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.

Locations

Country	Name	City	State
Côte D'Ivoire	Institut Pierre Richet	Bouaké

Sponsors (3)

Lead Sponsor	Collaborator
University of Notre Dame	In2Care, Institut Pierre Richet

Country where clinical trial is conducted

Côte D'Ivoire, 

References & Publications (25)

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Barreaux AMG, Brou N, Koffi AA, N'Guessan R, Oumbouke WA, Tia IZ, Thomas MB. Semi-field studies to better understand the impact of eave tubes on mosquito mortality and behaviour. Malar J. 2018 Aug 22;17(1):306. doi: 10.1186/s12936-018-2457-4. — View Citation

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Oumbouke WA, Pignatelli P, Barreaux AMG, Tia IZ, Koffi AA, Ahoua Alou LP, Sternberg ED, Thomas MB, Weetman D, N'Guessan R. Fine scale spatial investigation of multiple insecticide resistance and underlying target-site and metabolic mechanisms in Anopheles gambiae in central Cote d'Ivoire. Sci Rep. 2020 Sep 15;10(1):15066. doi: 10.1038/s41598-020-71933-8. — View Citation

Oumbouke WA, Tia IZ, Barreaux AMG, Koffi AA, Sternberg ED, Thomas MB, N'Guessan R. Screening and field performance of powder-formulated insecticides on eave tube inserts against pyrethroid resistant Anopheles gambiae s.l.: an investigation into 'actives' prior to a randomized controlled trial in Cote d'Ivoire. Malar J. 2018 Oct 22;17(1):374. doi: 10.1186/s12936-018-2517-9. — View Citation

Pinder M, Conteh L, Jeffries D, Jones C, Knudsen J, Kandeh B, Jawara M, Sicuri E, D'Alessandro U, Lindsay SW. The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies. Trials. 2016 Jun 3;17(1):275. doi: 10.1186/s13063-016-1400-7. — View Citation

Snetselaar J, Njiru BN, Gachie B, Owigo P, Andriessen R, Glunt K, Osinga AJ, Mutunga J, Farenhorst M, Knols BGJ. Eave tubes for malaria control in Africa: prototyping and evaluation against Anopheles gambiae s.s. and Anopheles arabiensis under semi-field conditions in western Kenya. Malar J. 2017 Jul 4;16(1):276. doi: 10.1186/s12936-017-1926-5. — View Citation

Sperling S, Cordel M, Gordon S, Knols BGJ, Rose A. Eave tubes for malaria control in Africa: Videographic observations of mosquito behaviour in Tanzania with a simple and rugged video surveillance system. Malariaworld J. 2017 Jul 1;8:9. eCollection 2017. — View Citation

Sternberg ED, Cook J, Alou LPA, Assi SB, Koffi AA, Doudou DT, Aoura CJ, Wolie RZ, Oumbouke WA, Worrall E, Kleinschmidt I, N'Guessan R, Thomas MB. Impact and cost-effectiveness of a lethal house lure against malaria transmission in central Cote d'Ivoire: a two-arm, cluster-randomised controlled trial. Lancet. 2021 Feb 27;397(10276):805-815. doi: 10.1016/S0140-6736(21)00250-6. — View Citation

Sternberg ED, Ng'habi KR, Lyimo IN, Kessy ST, Farenhorst M, Thomas MB, Knols BG, Mnyone LL. Eave tubes for malaria control in Africa: initial development and semi-field evaluations in Tanzania. Malar J. 2016 Sep 1;15(1):447. doi: 10.1186/s12936-016-1499-8. — View Citation

Tusting LS, Bottomley C, Gibson H, Kleinschmidt I, Tatem AJ, Lindsay SW, Gething PW. Housing Improvements and Malaria Risk in Sub-Saharan Africa: A Multi-Country Analysis of Survey Data. PLoS Med. 2017 Feb 21;14(2):e1002234. doi: 10.1371/journal.pmed.1002234. eCollection 2017 Feb. — View Citation

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Waite JL, Lynch PA, Thomas MB. Eave tubes for malaria control in Africa: a modelling assessment of potential impact on transmission. Malar J. 2016 Sep 2;15(1):449. doi: 10.1186/s12936-016-1505-1. — View Citation

Wanzirah H, Tusting LS, Arinaitwe E, Katureebe A, Maxwell K, Rek J, Bottomley C, Staedke SG, Kamya M, Dorsey G, Lindsay SW. Mind the gap: house structure and the risk of malaria in Uganda. PLoS One. 2015 Jan 30;10(1):e0117396. doi: 10.1371/journal.pone.0117396. eCollection 2015. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness of EaveTubes compared to the previously applies Screening + EaveTubes intervention, and compared to other vector control interventions such as LLINs and IRS.	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
Other	User acceptance of EaveTubes	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
Primary	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.	24 months
Secondary	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.	24 months
Secondary	Malaria parasitemia	Measured in children between 6 months to 10 years old in the cohorts of 55 children.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	Malaria parasite sporozoite rate	Assessed in 10% of all anophelines captured by CDC light trap.	24 months
Secondary	Entomological Inoculation Rates	Measured in each study arm as the product of the anopheline vector density and sporozoite rate.	24 months

External Links

•   Anderson L., Simpson D., Stephens M. (2014) Effective Malaria Control Through Durable Housing Improvements: Can we learn new strategies from past experience? Habitat Humanity International Global Programs Department
•   MacDonald, M. (2015) Landscape of new vector control products. VectorWorks.
•   Uganda Housing Modification Study (UHMS)
•   World Health Organization - Global plan for insecticide resistance management in malaria vectors.
•   World Health Organization, 2019 - Eleventh meeting of the WHO Vector Control Advisory Group