Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The Mentor Initiative
- Enrollment
- 2,400
- Locations
- 2
- Primary Endpoint
- epidemiological outcome: malaria incidence
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- feasibility, acceptance and uptake of Mesh(7 months)