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

NCT ID: NCT06179732

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Malaria Childhood ALL Vector Borne Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Mesh

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

Group Type EXPERIMENTAL

Mesh - spatial repellent impregnated with transfluthrin (2500mg)

Intervention Type 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)

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

University of Maiduguri

OTHER

Sponsor Role collaborator

US government

UNKNOWN

Sponsor Role collaborator

SCJohnson

UNKNOWN

Sponsor Role collaborator

The Mentor Initiative

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Allan

Role: PRINCIPAL_INVESTIGATOR

The Mentor Initiative

Locations

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Sara Estecha Querol

Haywards Heath, West Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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USDA01YEM - Nigeria

Identifier Type: -

Identifier Source: org_study_id

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