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

NCT06917040 | Completed Phase 3

• 1 other identifier: CGCSR-Syria
• Study Type: interventional
• Target: 18,404
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leishmaniasis, Cutaneous; Vector Borne Diseases

Keywords

Conflict; Internally displaced people; temporary shelter; spatial repellants

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  9 months

Secondary Outcomes (1)

• Intervention feasibility, acceptability and uptake

  11 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Spatial repellant emanator DEVICE

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Mentor Initiative: lead
• University of Nevada, Las Vegas: collaborator
• Hacettepe University: collaborator

Study Sites (1)

The MENTOR Initiative, North East Syria

Ar-Raqqa, Syria

Location

Related Publications (1)

• Allan R, Scherrer R, Kasap OE, Paris L, Scott T, Sauskojus H, Wetherill O, Estecha-Querol S, Alkhalaf Z, Karakus M, Yilmaz A, Alten B, Messenger LA. Enhancing protection against vector-borne diseases in forcibly displaced communities: evaluating the efficacy of spatial repellents for cutaneous leishmaniasis control in North-East Syria. BMC Med. 2025 Jul 3;23(1):401. doi: 10.1186/s12916-025-04244-2.

  PMID: 40611204 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Vector Borne Diseases

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard J Allan, PhD

  The Mentor Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: February 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

SY (1)