NCT06179732

Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities

Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,400 (actual)
• Sponsor: The Mentor Initiative · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Malaria
• Childhood ALL
• Vector Borne Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mesh - spatial repellent impregnated with transfluthrin (2500mg)	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.
BEHAVIORAL	Information and Education Campaigns (IEC)	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.
DIAGNOSTIC_TEST	test and treat malaria cases	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.

Timeline

• Start date: 2023-06-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-12-22
• Last updated: 2024-04-23

Locations

1 site across 1 country: United Kingdom