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

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.

Study Overview

• Status: Completed
• Conditions: Vector Borne Diseases; Malaria; Childhood ALL
• Intervention / Treatment: Combination product: Mesh - spatial repellent impregnated with transfluthrin (2500mg); Behavioral: Information and Education Campaigns (IEC); Diagnostic test: test and treat malaria cases

• Study Type: Interventional
• Enrollment (Actual): 2400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • West Sussex
    • Haywards Heath, West Sussex, United Kingdom, RH16 1PG
      • Sara Estecha Querol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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).; Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
Experimental: Mesh; 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).; Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age; Mesh product distributed to households	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
entomological outcome: vector density	the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies	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.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 months

Collaborators and Investigators

• Sponsor: The Mentor Initiative
• Collaborators: Liverpool School of Tropical Medicine; University of Maiduguri; US government; SCJohnson
• Investigators: Principal Investigator: Richard Allan, The Mentor Initiative

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: children; malaria; Nigeria; cluster randomised trial; vector borne diseases; Internally Displaced People camps
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Parasitic Diseases; Protozoan Infections; Leukemia, Lymphoid; Leukemia; Mosquito-Borne Diseases; Malaria; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vector Borne Diseases
• Other Study ID Numbers: USDA01YEM - Nigeria

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No