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Impact of Project Wolbachia - Singapore on Dengue Incidence

Primary Purpose

Dengue

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Biological (Male Wolbachia-infected Aedes aegypti)
Sponsored by
National Environment Agency, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Dengue-suspected patients living in the intervention and non-intervention clusters whose blood samples are collected by a national network of diagnostic laboratories that support private clinics, public polyclinics, or public/private hospitals.
  • Test positive cases: Patients with virologically confirmed DENV infection through RT-qPCR, testing positive for NS1 antigen or IgM. A positive test for any of the three assays would classify the patient as a dengue case.
  • Test negative controls: Patients with negative test results for DENV through RT-qPCR, NS1 antigen ELISA, or DENV IgM.

Sites / Locations

  • National Environment AgencyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention clusters

Non-intervention clusters

Arm Description

Residential areas that receive releases of male Wolbachia-infected Aedes aegypti

Residential areas that do not receive releases of male Wolbachia-infected Aedes aegypti

Outcomes

Primary Outcome Measures

Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls
Dengue cases and dengue test-negative controls data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.
Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters
Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

Secondary Outcome Measures

Prevalence of Ae. aegypti/Ae. albopictus mosquitoes
Data will be obtained from the national gravitrap surveillance system
Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions
Sentiment surveys pre-trial and during the course of the trial, using true/false and Likert-type scales. Higher scores mean better outcomes.

Full Information

First Posted
July 19, 2022
Last Updated
August 16, 2022
Sponsor
National Environment Agency, Singapore
Collaborators
Ministry of Health, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05505682
Brief Title
Impact of Project Wolbachia - Singapore on Dengue Incidence
Official Title
Assessing the Efficacy of Male Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Singapore: a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Environment Agency, Singapore
Collaborators
Ministry of Health, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is a cluster-randomised controlled trial set in Singapore, to assess if the deployment of male Wolbachia-infected Aedes aegypti mosquitoes can reduce dengue incidence in intervention clusters.
Detailed Description
The study is designed as a parallel, two-arm, non-blinded cluster-randomised controlled trial to be conducted in high-rise public housing estates in Singapore. The aim is to determine whether large-scale deployment of male Wolbachia-infected Ae. aegypti mosquitoes can significantly reduce dengue incidence in intervention clusters. The investigators will use the cluster-randomised design, with the study area comprising 15 clusters with a total area of 10.9 km2, covering approximately 722,000 residents in 1,700 apartment blocks. Eight clusters will be randomly selected to receive the intervention, while the other seven will serve as non-intervention clusters. Intervention efficacy will be estimated through two primary endpoints: (1) odds ratio of Wolbachia exposure distribution (i.e. probability of living in an intervention cluster) among laboratory-confirmed reported dengue cases compared to test-negative controls, and (2) laboratory-confirmed reported dengue counts normalized by population size in intervention versus non-intervention clusters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel, two-arm, non-blinded cluster-randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention clusters
Arm Type
Experimental
Arm Description
Residential areas that receive releases of male Wolbachia-infected Aedes aegypti
Arm Title
Non-intervention clusters
Arm Type
No Intervention
Arm Description
Residential areas that do not receive releases of male Wolbachia-infected Aedes aegypti
Intervention Type
Biological
Intervention Name(s)
Biological (Male Wolbachia-infected Aedes aegypti)
Intervention Description
Releases of male Wolbachia-infected Aedes aegypti mosquitoes
Primary Outcome Measure Information:
Title
Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls
Description
Dengue cases and dengue test-negative controls data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.
Time Frame
Up to 3 years
Title
Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters
Description
Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Prevalence of Ae. aegypti/Ae. albopictus mosquitoes
Description
Data will be obtained from the national gravitrap surveillance system
Time Frame
Up to 3 years
Title
Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions
Description
Sentiment surveys pre-trial and during the course of the trial, using true/false and Likert-type scales. Higher scores mean better outcomes.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Dengue-suspected patients living in the intervention and non-intervention clusters whose blood samples are collected by a national network of diagnostic laboratories that support private clinics, public polyclinics, or public/private hospitals. Test positive cases: Patients with virologically confirmed DENV infection through RT-qPCR, testing positive for NS1 antigen or IgM. A positive test for any of the three assays would classify the patient as a dengue case. Test negative controls: Patients with negative test results for DENV through RT-qPCR, NS1 antigen ELISA, or DENV IgM.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Ching Ng, PhD
Phone
+65 67719108
Email
NG_Lee_Ching@nea.gov.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Ching Ng, PhD
Organizational Affiliation
Group Director (Environmental Health Institute)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Environment Agency
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Ching Ng, PhD
Email
NG_Lee_Ching@nea.gov.sg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29855331
Citation
Anders KL, Indriani C, Ahmad RA, Tantowijoyo W, Arguni E, Andari B, Jewell NP, Rances E, O'Neill SL, Simmons CP, Utarini A. The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial. Trials. 2018 May 31;19(1):302. doi: 10.1186/s13063-018-2670-z.
Results Reference
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PubMed Identifier
34107180
Citation
Utarini A, Indriani C, Ahmad RA, Tantowijoyo W, Arguni E, Ansari MR, Supriyati E, Wardana DS, Meitika Y, Ernesia I, Nurhayati I, Prabowo E, Andari B, Green BR, Hodgson L, Cutcher Z, Rances E, Ryan PA, O'Neill SL, Dufault SM, Tanamas SK, Jewell NP, Anders KL, Simmons CP; AWED Study Group. Efficacy of Wolbachia-Infected Mosquito Deployments for the Control of Dengue. N Engl J Med. 2021 Jun 10;384(23):2177-2186. doi: 10.1056/NEJMoa2030243.
Results Reference
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Impact of Project Wolbachia - Singapore on Dengue Incidence

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