About this trial
This randomized controlled trial aims to evaluate the efficacy of Wolbachia-infected male mosquitoes combined with sterile insect technique (IIT-SIT) to mitigate active dengue transmission in Singapore.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Biological (Male Wolbachia-infected Aedes aegypti)
Biological/VaccineReleases of male Wolbachia-infected Aedes aegypti mosquitoes
Treatment groups
Trial outcomes
Primary outcomes
Impact of male Wolbachia-Aedes deployments on the time to cluster extinction
In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Cox proportional hazards models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the hazards ratio, which compares the probability of cluster extinction between arms from following up clusters from enrolment to cluster extinction.
Impact of male Wolbachia-Aedes deployments on final cluster size, as measured by the difference in final cluster size between arms
In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Negative binomial models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the average treatment effect of the intervention on the final number of dengue cases in intervention versus control clusters.
Secondary outcomes
Impact of male Wolbachia-Aedes deployments on the prevalence of Ae. aegypti/Ae. albopictus mosquitoes
The study will test whether male Wolbachia-Aedes deployments will effectively suppress Ae. aegypti mosquito populations as well as whether they have an off-target impact on Ae. albopictus mosquito populations in intervention vs. control clusters.
Impact of male Wolbachia-Aedes deployments on dengue risk in clusters, measured by odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls
In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether a patient's residence is in an dengue cluster receiving intervention or a control cluster, where residence is defined as the primary place where the patient resided at reporting date.
Impact of male Wolbachia-Aedes deployments on the individual level reproduction number
In this analysis, the researchers will use notified and individually geolocated dengue cases to calculate the spatially adjusted time-varying reproduction number, which estimates the number of forward infections caused by an individual.
Sponsors and contacts
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National Environment Agency, Singapore
Lead sponsor
Ministry of Health, Singapore
Collaborator