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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06179732
Enrollment
2400
Registered
2023-12-22
Start date
2023-06-05
Completion date
2023-12-31
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood ALL, Malaria, Vector Borne Diseases

Keywords

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

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.

Interventions

COMBINATION_PRODUCTMesh - 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.

BEHAVIORALInformation 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_TESTtest 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.

Sponsors

Liverpool School of Tropical Medicine
CollaboratorOTHER
University of Maiduguri
CollaboratorOTHER
US government
CollaboratorUNKNOWN
SCJohnson
CollaboratorUNKNOWN
The Mentor Initiative
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
entomological outcome: vector density7 monthsthe relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies
epidemiological outcome: malaria incidence7 monthsMalaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.

Secondary

MeasureTime frameDescription
feasibility, acceptance and uptake of Mesh7 monthsTo measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026