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Evaluation of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Tanzania. (ITENs)

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ClinicalTrials.gov Identifier: NCT05125133
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Ifakara Health Institute

Brief Summary:

This is a household randomized trial of a new tool for house modification, Insecticide-Treated Eave nets (ITENs) in combination with insecticide-treated window screens (ITWS), coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m² and PBO synergist at 10g/kg which corresponds to 480 mg/m², as used in the so-called dual-AI LLIN or "resistance breaking" nets for resistance malaria vector control.

Four hundred and fifty (450) households with intact walls, opened eaves, and those without screens or nets on the windows in Chalinze district, Tanzania will be eligible and only recruited upon written informed consent. The households will be randomly allocated into two arms: one with ITENs and ITWS installed and the other without.

The primary outcome will be malaria parasite detection in household residents aged over 6 months old using a quantitative Polymerase Chain Reaction (qPCR) at approximately 12 months post-installation, coinciding with the long rainy season.


Condition or disease Intervention/treatment Phase
Malaria,Falciparum Other: ITENs + ITWS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Households allocated into Two arms to receive ITENs+ITWS installed or none with a 1:1 ratio at sub-village level.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Household Randomized Control Trial of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Chalinze District, Tanzania.
Actual Study Start Date : July 9, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: ITENs + ITWS
Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m², and PBO synergist at 10g/kg which corresponds to 480 mg/m² are coated in ITENs and ITWS nets that will be installed to cover opened eaves and windows. This was manufactured by Moon Netting FZCO, United Arab Emirates.
Other: ITENs + ITWS
A dual active ingredient (dual AI) Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification.

No Intervention: Negative arm
The houses allocated NOT to receive ITENs and ITWS.



Primary Outcome Measures :
  1. Prevalence of Plasmodium falciparum parasite. [ Time Frame: Approximately 12 months post-installation, coinciding with the long rainy season. ]
    Prevalence of plasmodium falciparum parasite measured by qPCR among residents over 6 months old in houses with ITENs & ITWS compared to houses without.


Secondary Outcome Measures :
  1. Prevalence of Plasmodium falciparum parasite. [ Time Frame: Approximately 6 months post-installation, coinciding with the short rainy season. ]
    Prevalence of plasmodium falciparum parasite in households' residents of over 6 months old with ITENs & ITWS compared to those without using qPCR analysis.

  2. Clinical malaria. [ Time Frame: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons. ]
    The prevalence of clinical malaria cases defined by an axillary temperature of 37.5 degrees (fever) and positive mRDT in houses with ITENs and ITWS compared to the houses without.

  3. The density of malaria vectors and nuisance mosquitoes density. [ Time Frame: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons. ]
    Indoor density of malaria vector and nuisance mosquitoes in houses with ITENs & ITWS compared to houses without measured using Centres for Disease Control (CDC) light traps.

  4. ITENs & ITWS fabric cost [ Time Frame: Baseline (During installation of ITENs & ITWS) ]
    The number of metres of material applied to houses.

  5. ITENS & ITWS time duration [ Time Frame: Baseline (During installation of ITENs & ITWS) ]
    Time in hours to install the intervention.

  6. Adverse effects [ Time Frame: Approximately one month post installation. ]
    The number of participants with perceived adverse effects from ITENs and ITWS.

  7. Attrition [ Time Frame: Appriximately 6 months and 12 months post installation. ]
    Determination of the physical presence of ITENs and ITWS in the field.

  8. Fabric integrity [ Time Frame: Appriximately 6 months and 12 months post installation. ]
    Determination of the number of holes in ITENs and ITWS in the field.

  9. The induced mosquito mortality of ITENs and ITWs on the population of laboratory-reared mosquitoes. [ Time Frame: Approximately 12 months post installation. ]
    The bioefficacy (% induced mosquito mortality) of ITENs and ITWS after field use through WHO bioassays.

  10. Insecticide retainment [ Time Frame: Appriximately 12 months post installation. ]
    The retention of deltamethrin and PBO in grams per kg will be assessed through high performance liquid chromatography.

  11. Use of ITENs and ITWS [ Time Frame: Approximately 6 months and 12 months post installation. ]
    Community opinions of ITENs and ITWS will be sought through questionnaires and Focus Group Discussions.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residents of study households' members.

Exclusion Criteria:

  • None residence.
  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05125133


Contacts
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Contact: Zawadi Mboma, PhD +255 787 428218 zmageni@ihi.or.tz
Contact: Rose Philipo, MSc +255 714583404 rphilipo@ihi.or.tz

Locations
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Tanzania
Vector Control Product Testing Unit Facility Recruiting
Bagamoyo, Tanzania
Contact: Rose Philipo, MSc    +255 714583404    rphilipo@ihi.or.tz   
Principal Investigator: Zawadi Mboma, PhD         
Sub-Investigator: Olukayode Odufuwa, MSc         
Sub-Investigator: Sarah Moore, PhD         
Sponsors and Collaborators
Ifakara Health Institute
London School of Hygiene and Tropical Medicine
Swiss Tropical & Public Health Institute
Investigators
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Study Director: John Bradley, PhD London School of Hygiene and Tropical Medicine
  Study Documents (Full-Text)

Documents provided by Ifakara Health Institute:
Study Protocol and Informed Consent Form  [PDF] November 4, 2021

Publications of Results:
Other Publications:
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Responsible Party: Ifakara Health Institute
ClinicalTrials.gov Identifier: NCT05125133    
Other Study ID Numbers: ITENs
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be disseminated by a report to the sponsor, followed by peer-reviewed publications targeted towards consumers, scientists, and policy-makers. We will publish the results and data sets in open-access, indexed, peer-reviewed journals, making the findings and the data publicly available to all stakeholders. Data obtained from the study will be presented at international conferences and stakeholder meetings including the National Malaria Control Program, with priority given to the young scientists to practice their presentation and collaboration skills. At the end of the project, a meeting will be held to update the local community and the District Medical Officer (DMO), to present findings and answer any questions arising.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available at the end of the trial once it is analysed and published.
Access Criteria: Peer-reviewed open-source journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ifakara Health Institute:
Insecticide-treated nets, Eaves, windows, Malaria, Tanzania.
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases