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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179732
• Other study ID #: USDA01YEM - Nigeria
• Status: Completed
• Phase: Phase 3
• Start date: June 5, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: The Mentor Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood ALL
• Malaria
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Vector Borne Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Sara Estecha Querol	Haywards Heath	West Sussex

Sponsors (5)

Lead Sponsor	Collaborator
The Mentor Initiative	Liverpool School of Tropical Medicine, SCJohnson, University of Maiduguri, US government

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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