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

NCT06179732 | Completed Phase 3

• 1 other identifier: USDA01YEM - Nigeria
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Childhood ALL; Vector Borne Diseases

Keywords

malaria; cluster randomised trial; children; vector borne diseases; Nigeria; Internally Displaced People camps

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• feasibility, acceptance and uptake of Mesh

  7 months

Study Arms (2)

Control

NO INTERVENTION

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

Mesh

EXPERIMENTAL

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

Interventions

Mesh - spatial repellent impregnated with transfluthrin (2500mg) COMBINATION_PRODUCT

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.

Mesh

Information and Education Campaigns (IEC) BEHAVIORAL

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.

Mesh

test and treat malaria cases DIAGNOSTIC_TEST

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.

Mesh

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Shelters without children from 6-10 years old

Sponsors & Collaborators

• The Mentor Initiative: lead
• Liverpool School of Tropical Medicine: collaborator
• University of Maiduguri: collaborator
• US government: collaborator
• SCJohnson: collaborator

Study Sites (1)

Sara Estecha Querol

Haywards Heath, West Sussex, RH16 1PG, United Kingdom

Location

Related Publications (1)

• Allan RJ, Scherrer R, Estecha-Querol S, Weetman D, Paris L, Ba'abba Goni U, Idris Abdulhamid F, Nfornuh Alenwi B, Ahmad S, Cross CL, Ashir GM, Waziri M, Ntadom G, Messenger LA. The effectiveness of long-lasting spatial repellent emanators against malaria in humanitarian crisis settings in northern Nigeria: a two-arm pragmatic, open-label, controlled trial. Lancet Infect Dis. 2026 Jan 8:S1473-3099(25)00684-X. doi: 10.1016/S1473-3099(25)00684-X. Online ahead of print.

  PMID: 41520670 DERIVED

MeSH Terms

Conditions

Malaria; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vector Borne Diseases

Interventions

transfluthrin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Richard Allan

  The Mentor Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 22, 2023
• Study Start: June 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)