Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The Mentor Initiative
- Enrollment
- 18,404
- Locations
- 1
- Primary Endpoint
- Entomological outcome: phlebotomine sandfly density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Intervention feasibility, acceptability and uptake(11 months)
Investigators
Richard Allan
Principal Investigator
The Mentor Initiative