A Phase 3 interventional study of Mesh - spatial repellent impregnated with transfluthrin (2500mg) and Information and Education Campaigns (IEC) in Malaria, Childhood ALL and Vector Borne Diseases, sponsored by The Mentor Initiative. Completed at 1 site in United Kingdom. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by The Mentor Initiative · Phase 3, Interventional, and Prevention
The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.
By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 2,400 is above the median of 252 across 937 interventional studies indexed under Malaria.
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Exclusion Criteria:
1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home). 2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home). 2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age 3. Mesh product distributed to households
Combination Product: Mesh - spatial repellent impregnated with transfluthrin (2500mg) · Behavioral: Information and Education Campaigns (IEC) · Diagnostic Test: test and treat malaria cases
Mesh is one of the first spatial repellent tools to provide long-lasting protection to users, with predicted efficacy of 6-months. The active ingredient of Mesh is transfluthrin, a fast-acting volatile pyrethroid with low persistency, which can act either by killing or via sublethal toxicity that causes deviation (repellency) in host attraction, reducing host-contact and risk of infectious bites. The chemical passively releases into the air and interacts with vector odour receptors causing irritation. The design of Mesh is simple with a transfluthrin-infused sheet protected by plastic mesh and encased in a plastic frame. Mesh will be distributed to the intervention arm only.
IEC campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home) using leaflets and word of mouth. IEC will be conducted in both arms.
All children in the cohort (both arms) will be tested by rapid diagnostic testing (RDT) monthly. If any children test positive, they will be treated with a course of 3-day artemisinin combination therapy (ACT) according to standard protocol and local guidelines. All children in the cohort will receive ACT to provide clearance of any malaria parasites during the baseline of the study.
entomological outcome: vector density
the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies
Time frame: 7 months
epidemiological outcome: malaria incidence
Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.
Time frame: 7 months
feasibility, acceptance and uptake of Mesh
To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.
Time frame: 7 months
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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