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OpenTrials
Completed

NCT Number: NCT06917040

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 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The MENTOR Initiative, North East Syria

Ar-Raqqa, Syria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spatial repellant emanator

Device

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Mentor Initiative

Other

Collaborators

  • Hacettepe University
  • University of Nevada, Las Vegas

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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