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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- ITENs & ITWS fabric cost [ Time Frame: Baseline (During installation of ITENs & ITWS) ]The number of metres of material applied to houses.
- ITENS & ITWS time duration [ Time Frame: Baseline (During installation of ITENs & ITWS) ]Time in hours to install the intervention.
- Adverse effects [ Time Frame: Approximately one month post installation. ]The number of participants with perceived adverse effects from ITENs and ITWS.
- Attrition [ Time Frame: Appriximately 6 months and 12 months post installation. ]Determination of the physical presence of ITENs and ITWS in the field.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Zawadi Mboma, PhD||+255 787 firstname.lastname@example.org|
|Contact: Rose Philipo, MSc||+255 email@example.com|
|Vector Control Product Testing Unit Facility||Recruiting|
|Contact: Rose Philipo, MSc +255 714583404 firstname.lastname@example.org|
|Principal Investigator: Zawadi Mboma, PhD|
|Sub-Investigator: Olukayode Odufuwa, MSc|
|Sub-Investigator: Sarah Moore, PhD|
|Study Director:||John Bradley, PhD||London School of Hygiene and Tropical Medicine|