NCT05125133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

October 26, 2021

Last Update Submit

November 19, 2021

Conditions

Keywords

Insecticide-treated nets, Eaves, windows, Malaria, Tanzania.

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Plasmodium falciparum parasite.

    Prevalence of plasmodium falciparum parasite measured by qPCR among residents over 6 months old in houses with ITENs \& ITWS compared to houses without.

    Approximately 12 months post-installation, coinciding with the long rainy season.

Secondary Outcomes (11)

  • Prevalence of Plasmodium falciparum parasite.

    Approximately 6 months post-installation, coinciding with the short rainy season.

  • Clinical malaria.

    Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.

  • The density of malaria vectors and nuisance mosquitoes density.

    Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.

  • ITENs & ITWS fabric cost

    Baseline (During installation of ITENs & ITWS)

  • ITENS & ITWS time duration

    Baseline (During installation of ITENs & ITWS)

  • +6 more secondary outcomes

Study Arms (2)

ITENs + ITWS

EXPERIMENTAL

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

Negative arm

NO INTERVENTION

The houses allocated NOT to receive ITENs and ITWS.

Interventions

A dual active ingredient (dual AI) Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification.

ITENs + ITWS

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents of study households' members.

You may not qualify if:

  • None residence.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vector Control Product Testing Unit Facility

Bagamoyo, Tanzania

RECRUITING

Related Publications (6)

  • Gnanguenon V, Azondekon R, Oke-Agbo F, Beach R, Akogbeto M. Durability assessment results suggest a serviceable life of two, rather than three, years for the current long-lasting insecticidal (mosquito) net (LLIN) intervention in Benin. BMC Infect Dis. 2014 Feb 8;14:69. doi: 10.1186/1471-2334-14-69.

    PMID: 24507444BACKGROUND
  • Matiya DJ, Philbert AB, Kidima W, Matowo JJ. Dynamics and monitoring of insecticide resistance in malaria vectors across mainland Tanzania from 1997 to 2017: a systematic review. Malar J. 2019 Mar 26;18(1):102. doi: 10.1186/s12936-019-2738-6.

    PMID: 30914051BACKGROUND
  • Mboera LE, Mweya CN, Rumisha SF, Tungu PK, Stanley G, Makange MR, Misinzo G, De Nardo P, Vairo F, Oriyo NM. The Risk of Dengue Virus Transmission in Dar es Salaam, Tanzania during an Epidemic Period of 2014. PLoS Negl Trop Dis. 2016 Jan 26;10(1):e0004313. doi: 10.1371/journal.pntd.0004313. eCollection 2016 Jan.

    PMID: 26812489BACKGROUND
  • Mboma ZM, Overgaard HJ, Moore S, Bradley J, Moore J, Massue DJ, Kramer K, Lines J, Lorenz LM. Mosquito net coverage in years between mass distributions: a case study of Tanzania, 2013. Malar J. 2018 Mar 1;17(1):100. doi: 10.1186/s12936-018-2247-z.

    PMID: 29490649BACKGROUND
  • Gleave K, Lissenden N, Richardson M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2018 Nov 29;11(11):CD012776. doi: 10.1002/14651858.CD012776.pub2.

  • Odufuwa OG, Moore SJ, Mboma ZM, Mwanga R, Matwewe F, Hofer LM, Matanila I, Abbasi S, Rashid MA, Philipo R, Kihwele F, Moore J, Nguyen H, Bosselmann R, Skovmand O, Stevenson JC, Muganga JB, Bradley J. A household randomized-control trial of insecticide-treated screening for malaria control in unimproved houses in Tanzania. Malar J. 2025 Jun 8;24(1):182. doi: 10.1186/s12936-025-05434-2.

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • John Bradley, PhD

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Central Study Contacts

Zawadi Mboma, PhD

CONTACT

Rose Philipo, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Households allocated into Two arms to receive ITENs+ITWS installed or none with a 1:1 ratio at sub-village level.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 18, 2021

Study Start

July 9, 2021

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations