Malaria,Falciparum Clinical Trial
— ITENsOfficial title:
A Household Randomized Control Trial of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Chalinze District, Tanzania.
NCT number | NCT05125133 |
Other study ID # | ITENs |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2021 |
Est. completion date | September 30, 2022 |
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.
Status | Recruiting |
Enrollment | 1800 |
Est. completion date | September 30, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months and older |
Eligibility | Inclusion Criteria: - Residents of study households' members. Exclusion Criteria: - None residence. - Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Tanzania | Vector Control Product Testing Unit Facility | Bagamoyo |
Lead Sponsor | Collaborator |
---|---|
Ifakara Health Institute | London School of Hygiene and Tropical Medicine, Swiss Tropical & Public Health Institute |
Tanzania,
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:CD012776. doi: 10.1002/14651858.CD012776.pub2. U — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Prevalence of Plasmodium falciparum parasite. | Prevalence of plasmodium falciparum parasite in households' residents of over 6 months old with ITENs & ITWS compared to those without using qPCR analysis. | Approximately 6 months post-installation, coinciding with the short rainy season. | |
Secondary | Clinical malaria. | 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. | Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons. | |
Secondary | The density of malaria vectors and nuisance mosquitoes density. | 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. | Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons. | |
Secondary | ITENs & ITWS fabric cost | The number of metres of material applied to houses. | Baseline (During installation of ITENs & ITWS) | |
Secondary | ITENS & ITWS time duration | Time in hours to install the intervention. | Baseline (During installation of ITENs & ITWS) | |
Secondary | Adverse effects | The number of participants with perceived adverse effects from ITENs and ITWS. | Approximately one month post installation. | |
Secondary | Attrition | Determination of the physical presence of ITENs and ITWS in the field. | Appriximately 6 months and 12 months post installation. | |
Secondary | Fabric integrity | Determination of the number of holes in ITENs and ITWS in the field. | Appriximately 6 months and 12 months post installation. | |
Secondary | The induced mosquito mortality of ITENs and ITWs on the population of laboratory-reared mosquitoes. | The bioefficacy (% induced mosquito mortality) of ITENs and ITWS after field use through WHO bioassays. | Approximately 12 months post installation. | |
Secondary | Insecticide retainment | The retention of deltamethrin and PBO in grams per kg will be assessed through high performance liquid chromatography. | Appriximately 12 months post installation. | |
Secondary | Use of ITENs and ITWS | Community opinions of ITENs and ITWS will be sought through questionnaires and Focus Group Discussions. | Approximately 6 months and 12 months post installation. |
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