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

Phase 3

Completed

• Conditions: Vector Borne Diseases; Leishmaniasis, Cutaneous

• Registration Number: NCT06917040
• Lead Sponsor: The Mentor Initiative

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18404

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Entomological outcome: phlebotomine sandfly density	9 months	Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.
Epidemiological outcome: cutaneous leishmaniasis incidence	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).

Secondary Outcome Measures

Name	Time	Method
Intervention feasibility, acceptability and uptake	11 months	To measure community and household intervention acceptability and uptake, a questionnaire will be conducted post-intervention.

Trial Locations

Locations (1)

The MENTOR Initiative, North East Syria; 🇸🇾 Ar-Raqqa, Syrian Arab Republic