AzTrials
AzTrials

MalariaNCT05736679

EaveTubes for Vector Control

A study testing In2Care EaveTube in people with Malaria, run by University of Notre Dame at 1 site in Côte d’Ivoire.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 6 months to 10 yearsHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
In2Care EaveTube
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,870 participants
Where
1 siteCôte d’Ivoire
Study dates
23 Mar 2023to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country.

Côte d’Ivoire1 site
  • Institut Pierre Richet

    Bouaké

Other trials in Côte d’Ivoire

About this study

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

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.

Read the 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.

Conditions
Malaria
Being tested
In2Care EaveTube
Keywords
EaveTubes, Housing, Malaria control, LLINs, Cost-effectiveness, Malaria, Vector-borne diseases, Mosquito vectors, Incidence
Medical subject headings
Malaria, Vector Borne Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In2Care EaveTubeDevice

    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.

Study groups in NCT05736679
Study groupRoleWhat they receive
In2Care EaveTubeExperimentalEaveTube installation with deltamethrin treated netting; in addition to standard of care (standard pyrethroid-only bednets)
Receives: Device: In2Care EaveTube
ControlNo interventionStandard of care (standard pyrethroid-only bednets)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (6)
  1. 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.

    Measured: 24 months

  2. Malaria parasitemia

    Measured in children between 6 months to 10 years old in the cohorts of 55 children.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. Malaria parasite sporozoite rate

    Assessed in 10% of all anophelines captured by CDC light trap.

    Measured: 24 months

  6. Entomological Inoculation Rates

    Measured in each study arm as the product of the anopheline vector density and sporozoite rate.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start23 Mar 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,870 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05736679
Sponsor's protocol ID
22-10-7454
Status last verified
May 2025
First submitted
10 Feb 2023
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andriessen R, Snetselaar J, Suer RA, Osinga AJ, Deschietere J, Lyimo IN, Mnyone LL, Brooke BD, Ranson H, Knols BG, Farenhorst M. Electrostatic coating enhances bioavailability of insecticides and breaks pyrethroid resistance in mosquitoes. Proc Natl Acad Sci U S A. 2015 Sep 29;112(39):12081-6. doi: 10.1073/pnas.1510801112. Epub 2015 Aug 31.

    PubMed 26324912
  • 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.

    PubMed 30134907
  • 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.

    PubMed 31470873
  • Bhatt S, Weiss DJ, Cameron E, Bisanzio D, Mappin B, Dalrymple U, Battle K, Moyes CL, Henry A, Eckhoff PA, Wenger EA, Briet O, Penny MA, Smith TA, Bennett A, Yukich J, Eisele TP, Griffin JT, Fergus CA, Lynch M, Lindgren F, Cohen JM, Murray CLJ, Smith DL, Hay SI, Cibulskis RE, Gething PW. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015 Oct 8;526(7572):207-211. doi: 10.1038/nature15535. Epub 2015 Sep 16.

    PubMed 26375008
  • Bradley J, Rehman AM, Schwabe C, Vargas D, Monti F, Ela C, Riloha M, Kleinschmidt I. Reduced prevalence of malaria infection in children living in houses with window screening or closed eaves on Bioko Island, equatorial Guinea. PLoS One. 2013 Nov 13;8(11):e80626. doi: 10.1371/journal.pone.0080626. eCollection 2013.

    PubMed 24236191
  • Carey JR, Muller HG, Wang JL, Papadopoulos NT, Diamantidis A, Koulousis NA. Graphical and demographic synopsis of the captive cohort method for estimating population age structure in the wild. Exp Gerontol. 2012 Oct;47(10):787-91. doi: 10.1016/j.exger.2012.06.012. Epub 2012 Jul 7.

    PubMed 22776134
  • Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

    PubMed 10342698
  • Kirby MJ, Ameh D, Bottomley C, Green C, Jawara M, Milligan PJ, Snell PC, Conway DJ, Lindsay SW. Effect of two different house screening interventions on exposure to malaria vectors and on anaemia in children in The Gambia: a randomised controlled trial. Lancet. 2009 Sep 19;374(9694):998-1009. doi: 10.1016/S0140-6736(09)60871-0. Epub 2009 Sep 3.

    PubMed 19732949
  • 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.

    PubMed 23641777
  • 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.

    PubMed 24358177
  • Krajacich BJ, Slade JR, Mulligan RF, LaBrecque B, Alout H, Grubaugh ND, Meyers JI, Fakoli LS 3rd, Bolay FK, Brackney DE, Burton TA, Seaman JA, Diclaro JW 2nd, Dabire RK, Foy BD. Sampling host-seeking anthropophilic mosquito vectors in west Africa: comparisons of an active human-baited tent-trap against gold standard methods. Am J Trop Med Hyg. 2015 Feb;92(2):415-21. doi: 10.4269/ajtmh.14-0303. Epub 2014 Nov 24.

    PubMed 25422393
  • Lengeler C. Insecticide-treated bednets and curtains for preventing malaria. Cochrane Database Syst Rev. 2000;(2):CD000363. doi: 10.1002/14651858.CD000363.

    PubMed 10796535
  • 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.

    PubMed 3256125
  • 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.

    PubMed 23497471
  • 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.

    PubMed 30348154

Questions about this trial

What is this clinical trial studying?

A study testing In2Care EaveTube in people with Malaria, run by University of Notre Dame at 1 site in Côte d’Ivoire.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of malaria infection (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05736679, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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