EaveTubes for Vector Control

NCT05736679 | Active Not Recruiting

• 1 other identifier: 22-10-7454
• Study Type: interventional
• Target: 1,870
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

EaveTubes; Housing; Malaria control; LLINs; Cost-effectiveness; Malaria; Vector-borne diseases; Mosquito vectors; Incidence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Clinical malaria incidence

  24 months

• Malaria parasitemia

  24 months

• Prevalence of moderate (defined as 7 - 9.9 g/dL hemoglobin) to severe anemia (<7 g/dL hemoglobin)

  24 months

• Mean numbers of female malaria mosquitoes (An. gambiae s.l., An funestus s.l.) captured in study houses

  24 months

• Malaria parasite sporozoite rate

  24 months

Other Outcomes (2)

• 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

• User acceptance of EaveTubes

  24 months

Study Arms (2)

In2Care EaveTube

EXPERIMENTAL

EaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets)

Device: In2Care EaveTube

Control

NO INTERVENTION

Standard of care (standard pyrethroid-only bednets)

Interventions

In2Care EaveTube DEVICE

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.

In2Care EaveTube

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 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).
• HHs per village.
• ≥2 km apart from another village.

You may not qualify if:

• \< 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.
• HHs must be suitable for ET installation.
• Provision of consent from heads of HH.
• 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.
• 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.
• Children aged \< 6 months or ≥ 8 years old at time of enrollment.

Sponsors & Collaborators

• University of Notre Dame: lead
• Institut Pierre Richet: collaborator
• In2Care: collaborator

Study Sites (1)

Institut Pierre Richet

Bouaké, Côte d’Ivoire

Location

Related Publications (26)

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• Barreaux AMG, Oumbouke WA, Tia IZ, Brou N, Koffi AA, N'guessan R, Thomas MB. Semi-field evaluation of the cumulative effects of a "Lethal House Lure" on malaria mosquito mortality. Malar J. 2019 Aug 30;18(1):298. doi: 10.1186/s12936-019-2936-2.

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• Koffi AA, Ahoua Alou LP, Adja MA, Chandre F, Pennetier C. Insecticide resistance status of Anopheles gambiae s.s population from M'Be: a WHOPES-labelled experimental hut station, 10 years after the political crisis in Cote d'Ivoire. Malar J. 2013 May 4;12:151. doi: 10.1186/1475-2875-12-151.

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• Koffi AA, Ahoua Alou LP, Kabran JP, N'Guessan R, Pennetier C. Re-visiting insecticide resistance status in Anopheles gambiae from Cote d'Ivoire: a nation-wide informative survey. PLoS One. 2013 Dec 16;8(12):e82387. doi: 10.1371/journal.pone.0082387. eCollection 2013.

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• Lindsay SW, Snow RW. The trouble with eaves; house entry by vectors of malaria. Trans R Soc Trop Med Hyg. 1988;82(4):645-6. doi: 10.1016/0035-9203(88)90546-9. No abstract available.

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• Lwetoijera DW, Kiware SS, Mageni ZD, Dongus S, Harris C, Devine GJ, Majambere S. A need for better housing to further reduce indoor malaria transmission in areas with high bed net coverage. Parasit Vectors. 2013 Mar 7;6:57. doi: 10.1186/1756-3305-6-57.

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• 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.

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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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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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.

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• N'Guessan R, Assi SB, Koffi A, Ahoua Alou PL, Mian A, Achee NL, Fustec B, Grieco JP, Liu F, Kumar S, Noffsinger M, Hudson A, Mohlmann TWR, Farenhorst M. EaveTubes for control of vector-borne diseases in Cote d'Ivoire: study protocol for a cluster randomized controlled trial. Trials. 2023 Nov 2;24(1):704. doi: 10.1186/s13063-023-07639-9.

  PMID: 37919815 DERIVED

Related Links

• 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
• MacDonald, M. (2015) Landscape of new vector control products. VectorWorks.
• 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
• Uganda Housing Modification Study (UHMS)

MeSH Terms

Conditions

Malaria; Vector Borne Diseases

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases

Study Officials

• John P Grieco, PhD

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 23, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (1)