A Phase 3 interventional study of Spatial repellant emanator in Leishmaniasis, Cutaneous and Vector Borne Diseases, sponsored by The Mentor Initiative. Completed at 1 site in Syria. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by The Mentor Initiative · Phase 3, Interventional, and Prevention
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.
110 studies on the registry are indexed under Leishmaniasis, Cutaneous; 17 are open to participants now.
This study's enrollment of 18,404 is above the median of 63 across 83 interventional studies indexed under Leishmaniasis, Cutaneous.
Browse Leishmaniasis, Cutaneous studies →The Mentor Initiative is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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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
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
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
Spatial emanator with an active ingredient Transfluthrin (C15H12Cl2F4O2, 110mg, EPA registered number 432-1588).
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
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
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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The Mentor Initiative