Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria

The Mentor Initiative18,404 enrolled

Overview

The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

18,404

Conditions

Leishmaniasis, Cutaneous Vector Borne Diseases

Interventions

Spatial repellant emanatorDEVICE

Spatial emanator with an active ingredient Transfluthrin (C15H12Cl2F4O2, 110mg, EPA registered number 432-1588).

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Known history of cutaneous leishmaniasis in camp Sleeping under same shelter type (all UNHCR tents / plastic sheets) Camp easily accessible by road Camps a minimum of 5km apart Adequate security levels Exclusion Criteria: Camps closer than 5km from a camp included in the study Camps with no previously recorded cases of cutaneous leishmaniasis Displaced communities living outside of defined camp settings

Locations (1)

The MENTOR Initiative, North East Syria

Ar-Raqqa, Syria

Outcomes

Primary Outcomes

Epidemiological outcome: cutaneous leishmaniasis incidence

Cutaneous leishmaniasis incidence per 1,000 will be estimated as the total number of cutaneous leishmaniasis episodes per 1,000 persons over the course of the trial. Two different incubation times or diagnostic cut-offs will be used: at 2 months post-intervention (from August 2021 to April 2022) and at 4 months post-intervention (from August 2021 to April 2022).

Time frame: 11 or 9 months

Entomological outcome: phlebotomine sandfly density

Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.

Time frame: 9 months

Secondary Outcomes

Intervention feasibility, acceptability and uptake

To measure community and household intervention acceptability and uptake, a questionnaire will be conducted post-intervention.

Time frame: 11 months

Data from ClinicalTrials.gov

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