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Completed

NCT Number: NCT06179732

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

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.

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Key information

Conditions

Malaria Childhood ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mosquito-Borne Diseases Neoplasms Neoplasms by Histologic Type Parasitic Diseases Precursor Cell Lymphoblastic Leukemia-Lymphoma Protozoan Infections Vector Borne Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sara Estecha Querol

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. entomological outcome: vector density

    Time frame: 7 months

    the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies

  2. epidemiological outcome: malaria incidence

    Time frame: 7 months

    Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.

Secondary outcomes

  1. feasibility, acceptance and uptake of Mesh

    Time frame: 7 months

    To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.

Sponsors and collaborators

Lead sponsor

The Mentor Initiative

Other

Collaborators

  • Liverpool School of Tropical Medicine
  • SCJohnson
  • US government
  • University of Maiduguri

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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