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

April 1, 2025 updated by: Richard Allan, The Mentor Initiative
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
2 clusters received: 1.The study intervention was Mosquito ShieldTM. The active ingredient releases on a controlled basis over a 1-month period (1 emanator in rooms up to 18 m 2 / 2 emanator per 9 m). The households in the intervention arm were provided with Mosquito ShieldTM for 9 months (April-December 2021). This was distributed directly to households every month with pictogram instructions in the local language describing the correct intervention usage: how to open Mosquito ShieldTM, the number to be installed per room, how to attach and position Mosquito ShieldTM and the duration of Mosquito ShieldTM usage (30 days) prior to replacement. 2. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 3. Free of charge access to diagnostic and treatment services
Device: Spatial repellant emanator
Spatial emanator with an active ingredient Transfluthrin (C15H12Cl2F4O2, 110mg, EPA registered number 432-1588).
No Intervention: Control
4 clusters received: 1. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 2. Free of charge access to diagnostic and treatment services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological outcome: cutaneous leishmaniasis incidence
Time Frame: 11 or 9 months
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).
11 or 9 months
Entomological outcome: phlebotomine sandfly density
Time Frame: 9 months
Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention feasibility, acceptability and uptake
Time Frame: 11 months
To measure community and household intervention acceptability and uptake, a questionnaire will be conducted post-intervention.
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mentor Initiative

Collaborators

Hacettepe University
University of Nevada, Las Vegas

Investigators

  • Principal Investigator: Richard J Allan, PhD, The Mentor Initiative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Estimated)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGCSR-Syria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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