protocolSection identificationModule nctId: NCT06268691, orgStudyIdInfo id: ProjectCOLOMBIA-ZMG.U-Freiburg, briefTitle: Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-04, primaryCompletionDateStruct date: 2019-09-02, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Rocio Cardenas Sanchez, class: OTHER, collaborators name: Göteborg University, collaborators name: Instituto Nacional de Salud, Colombia, collaborators name: Instituto Departamental de Salud de Norte de Santander, collaborators name: Universidad Francisco de Paula de Santander, descriptionModule briefSummary: Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.The main questions it aims to answer are:Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined., conditionsModule conditions: Dengue, conditions: Vector Borne Diseases, conditions: Arbovirus Infections, conditions: Zika, conditions: Chikungunya Fever, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35000, type: ACTUAL, armsInterventionsModule interventions name: Insecticide Coating INESFLY, outcomesModule primaryOutcomes measure: Change of dengue incidence for 12 months, secondaryOutcomes measure: Change of vector densities estimated through larval and pupal indices., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Departamental de Salud de Norte de Santander, city: Cúcuta, state: Norte De Santander, zip: 540001, country: Colombia, geoPoint lat: 7.89391, lon: -72.50782, locations facility: Centre for Medicine and Society, city: Freiburg, state: Baden-Württemberg, zip: 79098, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2019-03-11, uploadDate: 2024-02-12T15:19, filename: Prot_000.pdf, size: 2263350, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2019-03-11, uploadDate: 2024-02-12T15:19, filename: SAP_001.pdf, size: 768947, hasResults: False