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

Phase 3

Completed

• Conditions: Malaria; Childhood ALL; Vector Borne Diseases
• Interventions: Combination Product: Mesh - spatial repellent impregnated with transfluthrin (2500mg); Behavioral: Information and Education Campaigns (IEC); Diagnostic Test: test and treat malaria cases

• Registration Number: NCT06179732
• Lead Sponsor: The Mentor Initiative

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-05
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Shelters with 1 or more children from 6-10 years old
• Shelters with an adult/head of the household

Exclusion Criteria

• Shelters without children from 6-10 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh	Information and Education Campaigns (IEC)	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
Mesh	test and treat malaria cases	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
Mesh	Mesh - spatial repellent impregnated with transfluthrin (2500mg)	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

Primary Outcome Measures

Name	Time	Method
epidemiological outcome: malaria incidence	7 months	Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.
entomological outcome: vector density	7 months	the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies

Secondary Outcome Measures

Name	Time	Method
feasibility, acceptance and uptake of Mesh	7 months	To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.

Trial Locations

Locations (1)

Sara Estecha Querol; 🇬🇧 Haywards Heath, West Sussex, United Kingdom