Combined use of several vector control tools for the control of dengue in Malaysia

INTERVENTION: The sample size determination was based on an adapted version of the bootstrap approach proposed by Kleinman K and Huang SS [Kleinman 2016] for cluster randomized trials. Localities in the catchment area that fulfilled the eligibility criteria are the sampling frames for the intervention and control arms and were randomly allocated between the arms. The random allocation of the localities to the control or the intervention arm (1:1 ratio) was carried out using the plan procedure of SAS software, version 9.4 (Copyright (c) 2002‐2012 by SAS Institute Inc., Cary, NC, USA) by a statistician of the Service of Biostatistics of Hospices Civils de Lyon, France. The code written by a first statistician was double‐checked by a second statistician in regard to the conformity to the randomization protocol. The random allocation was stratified on the level of the localities (low or medium) because the dengue incidence rate is different between the two strata. In each stratum, the localities were randomly numbered and block randomization was carried out with block sizes of 10 and 16 in order to allocate the localities to the arm 1 (intervention) or 2 (control). Then the list of localities in each arm was saved in a text file and transmitted to the investigators. Randomization has been carried out following the approval of the protocol by the IMR research committee and district/ state health office. The study population include all household members living in high‐rise buildings in both intervention and control areas. Overall, 280 clusters will be randomly allocated in a 1:1 ratio, in an unblinded manner, to receive either the proactive IVM approach or the standard vector control activities. The sample size determination is based on CONDITION: Dengue ; Infections and Infestations ; Dengue PRIMARY OUTCOME: Dengue incidence rate estimates obtained from the national eDengue system at the end of the intervention, year 2 SECONDARY OUTCOME: ; 1. Ovitrap index estimated as the percentage of the number of positive ovitraps to the number of ovitraps recovered at the end of baseline data collection (08/02/2020) and at the end of the intervention, year 2; 2. Larval count per trap estimated as the total number of larvae recovered in positive ovitraps at the end of baseline data collection (08/02/2020) and at the end of the intervention, year 2; INCLUSION CRITERIA: This is a cluster randomized trial that does not involve the direct participation of individuals. Low and medium level localities in the Federal Territory of Kuala Lumpur and Putrajaya, Malaysia with 800 to 8000 inhabitants and with recurrent dengue outbreaks reported from 2015 to 2018 were eligible to be included in the trial.