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Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes

Primary Purpose

Dengue

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
GOS trap and dengue NS1 antigen kit
Sponsored by
Jonathan Liew Wee Kent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue focused on measuring Dengue, Adult Aedes, GOS trap, Dengue NS1 antigen test, Early dengue detection and surveillance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years and above, including pregnant women and healthy individuals
  • Reside in the study sites
  • Work at the study sites for at least 40 hours per week
  • Able to give consent
  • Willing to participate in blood taking

Exclusion Criteria:

  • Age below 18 years
  • Unable to give consent
  • Not willing to undergo venepuncture or finger-prick

Sites / Locations

  • Petaling Jaya City CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GOS trap and dengue NS1 antigen kit

Control

Arm Description

Gravid Oviposition Sticky (GOS) traps will be placed to trap adult Aedes mosquitoes and changed weekly. NS1 will be used to detect dengue in trapped Aedes mosquitoes. When dengue NS1 positive mosquitoes are found, community will be alerted via flyers, banners and other means. Routine Aedes/dengue control and surveillance will be carried out as usual as per the current Ministry of Health guidelines.

The GOS traps will be placed randomly in the control arm once per month for entomological survey. Routine Aedes control and surveillance will be carried out as per the current Ministry of Health guidelines. Dengue control measure will be initiated by the health authorities when human cases are reported from this arm.

Outcomes

Primary Outcome Measures

Change in number of weekly notified dengue cases in intervention arm
The number of notified dengue cases in the study sites will be obtained from the District Health Office
Change in the duration of dengue outbreaks in intervention arm
The duration of dengue outbreaks in the study sites will be obtained from the District Health Office.

Secondary Outcome Measures

Change in adult Aedes density in the intervention arm
Based on the weekly trap index
Change in level of dengue Knowledge, Attitude and Practice in the intervention arm
The mean of the percentage score of the population for each domain (knowledge & attitude/practises) will be determined for the pre- and post-test. Then, paired t-test will be performed to determine the presence of significant changes in both means (An increase in score percentage indicate a better outcome). Additionally, an individual percentage score of 80% and above indicates indicates good knowledge/attitude/practice.

Full Information

First Posted
January 2, 2019
Last Updated
January 8, 2019
Sponsor
Jonathan Liew Wee Kent
Collaborators
Petaling Jaya City Council, Malaysia, Selangor State Health Department, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03799237
Brief Title
Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes
Official Title
Cluster Randomized Controlled Trial: Efficacy of Gravid Oviposition Sticky Trap (GOS) and Dengue NS1 Antigen Rapid Diagnostic Test for Early Surveillance of Dengue Among Adult Aedes Mosquitoes to Reduce Dengue Outbreaks in PJU10, Damansara Damai, Selangor, Malaysia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Liew Wee Kent
Collaborators
Petaling Jaya City Council, Malaysia, Selangor State Health Department, Malaysia

4. Oversight

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

5. Study Description

Brief Summary
During dengue outbreaks, the Ministry of Health Malaysia employs various methods to control the spread of disease, including killing the larvae of Aedes mosquitoes, fogging, together with educating and disseminating information about the dengue outbreak, to the community. However, this is too late. Research has shown that when an outbreak has occurred, the viral infection has already spread among the community. Therefore, this current trial aims to educate the public (via questionnaire survey and interactions with the residential managements, mainly), detect dengue-infected mosquitoes, inform the communities of the presence of dengue-infected mosquitoes, followed by approaching and educating them to take precautionary measures before the outbreak happens. Trapping (using gravid oviposition sticky (GOS) traps) and detecting dengue virus non-structural 1 (NS1) antigen (using dengue NS1 kit) in the Aedes mosquitoes will be a more reliable way to alert the community before a potential dengue outbreak in their housing area. The community will receive information of presence of infected mosquitoes and probable dengue infections before dengue cases are reported. This will be an ideal time for clean-ups and for search and destroy activities. With this shift in approach and the use of newer techniques, it is hoped that deaths and epidemics due to dengue will be reduced.
Detailed Description
This cluster randomised controlled trial will be conducted to provide evidence on the efficacy of an integrated active vector surveillance and preventive strategy in the community. It aims to demonstrate effectiveness of a new proactive paradigm in reducing dengue epidemics. The main hypotheses are 1) This new paradigm (GOS trap and dengue NS1 kit for detection of dengue in Aedes) will reduce dengue epidemics compared to the usual current vector surveillance/control carried out by the Ministry of Health. 2) Community will be more receptive to this new surveillance activity as they will receive information of dengue transmissions before dengue cases are reported. The study sites at PJU10, Damansara Damai, Petaling Jaya, Selangor, Malaysia are Intervention arm: Harmoni Apartment, Impian Apartment, Park Avenue Condominium, and Suria Shop Apartment Control arm: Permai Apartment, Lestari Apartment, Indah Apartment, and Vista Shop Apartment Activities to be carried out include: A. Questionnaire survey and blood taking for dengue seroprevalence among residents from both arms When people in the community are gathered at an identified, suitable area, the Knowledge, Attitude and Practice (KAP) questionnaires will be distributed for them to answer. After the questionnaire survey, about 3 ml of venous blood would be taken by trained personnel for dengue IgG and IgM serology. B. Placement of the GOS mosquito trap in the intervention arm The GOS mosquito traps will be placed in the intervention arm and serviced weekly. The trapped Aedes mosquitoes would be checked for dengue virus via dengue NS1 rapid diagnostic test kit. The GOS mosquito traps will also be placed randomly in the control arm once per month for entomological survey. C. If a dengue-positive mosquito is found, flyers and banners will be distributed and hung to inform the residents of the presence of dengue transmission in the apartment block/apartment. Alternatively, the residents may also be approached house-to-house or an educational booth set up at strategic locations in the apartment to warn and educate the residents. D. The KAP questionnaire survey will be carried out again 3 months before the completion of the trial in the intervention arm to gauge the communities' perception of this intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Dengue, Adult Aedes, GOS trap, Dengue NS1 antigen test, Early dengue detection and surveillance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7979 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GOS trap and dengue NS1 antigen kit
Arm Type
Experimental
Arm Description
Gravid Oviposition Sticky (GOS) traps will be placed to trap adult Aedes mosquitoes and changed weekly. NS1 will be used to detect dengue in trapped Aedes mosquitoes. When dengue NS1 positive mosquitoes are found, community will be alerted via flyers, banners and other means. Routine Aedes/dengue control and surveillance will be carried out as usual as per the current Ministry of Health guidelines.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The GOS traps will be placed randomly in the control arm once per month for entomological survey. Routine Aedes control and surveillance will be carried out as per the current Ministry of Health guidelines. Dengue control measure will be initiated by the health authorities when human cases are reported from this arm.
Intervention Type
Other
Intervention Name(s)
GOS trap and dengue NS1 antigen kit
Intervention Description
The GOS trap lure and sticky surfaces to trap gravid Aedes mosquitoes. Three GOS traps will be placed on every 3 floors of the residential blocks. The traps will be changed weekly. Trapped Aedes mosquitoes will be identified to species. The mosquitoes will then be dissected, to remove the abdomen from the thorax. Five to seven abdomens of the same mosquito species will be pooled and tested for dengue NS1 antigen using the SD Biosensor Standard Q dengue NS1 antigen test kit. If the pool is tested positive for dengue NS1, the head and thorax of the respective abdomens will be subjected to the same procedure for dengue NS1 antigen test, individually. This may allow us to identify a focus where there could be dengue-infected individuals. Flyers/Posters will be disseminated besides, house-to-house approach to inform the residents of the findings and apartment blocks where these mosquitoes were found. The apartment management will also make use of social media disseminate this information.
Primary Outcome Measure Information:
Title
Change in number of weekly notified dengue cases in intervention arm
Description
The number of notified dengue cases in the study sites will be obtained from the District Health Office
Time Frame
Assess weekly, through study completion, 1 and a half years
Title
Change in the duration of dengue outbreaks in intervention arm
Description
The duration of dengue outbreaks in the study sites will be obtained from the District Health Office.
Time Frame
Through study completion, an average of 1 and a half years
Secondary Outcome Measure Information:
Title
Change in adult Aedes density in the intervention arm
Description
Based on the weekly trap index
Time Frame
Assess weekly, through study completion, within 1 and half years.
Title
Change in level of dengue Knowledge, Attitude and Practice in the intervention arm
Description
The mean of the percentage score of the population for each domain (knowledge & attitude/practises) will be determined for the pre- and post-test. Then, paired t-test will be performed to determine the presence of significant changes in both means (An increase in score percentage indicate a better outcome). Additionally, an individual percentage score of 80% and above indicates indicates good knowledge/attitude/practice.
Time Frame
6 months after recruitment for pre-trial questionnaire survey. 3 months after recruitment for post-trial questionnaire survey, through study completion, 1 and a half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years and above, including pregnant women and healthy individuals Reside in the study sites Work at the study sites for at least 40 hours per week Able to give consent Willing to participate in blood taking Exclusion Criteria: Age below 18 years Unable to give consent Not willing to undergo venepuncture or finger-prick
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan WK Liew, PhD
Phone
+60178858375
Email
jonathanliew@um.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Sivaneswari Selvarajoo, BSc
Phone
+60108968645
Email
sivaneswariselvarajoo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan WK Liew, PhD
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Indra Vythilingam, PhD
Organizational Affiliation
University of Malaya
Official's Role
Study Director
Facility Information:
Facility Name
Petaling Jaya City Council
City
Petaling Jaya
State/Province
Selangor
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poo Soon Ong, Master

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Medical ethics have been obtained with a statement that these information is confidential. These information will be deleted within 1 year after the study is completed
Citations:
PubMed Identifier
28327173
Citation
Lau SM, Chua TH, Sulaiman WY, Joanne S, Lim YA, Sekaran SD, Chinna K, Venugopalan B, Vythilingam I. A new paradigm for Aedes spp. surveillance using gravid ovipositing sticky trap and NS1 antigen test kit. Parasit Vectors. 2017 Mar 21;10(1):151. doi: 10.1186/s13071-017-2091-y.
Results Reference
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PubMed Identifier
25600599
Citation
Klungthong C, Manasatienkij W, Phonpakobsin T, Chinnawirotpisan P, Rodpradit P, Hussem K, Thaisomboonsuk B, Ong-ajchaowlerd P, Nisalak A, Kalayanarooj S, Buddhari D, Gibbons RV, Jarman RG, Yoon IK, Fernandez S. Monitoring and improving the sensitivity of dengue nested RT-PCR used in longitudinal surveillance in Thailand. J Clin Virol. 2015 Feb;63:25-31. doi: 10.1016/j.jcv.2014.12.009. Epub 2014 Dec 12.
Results Reference
background
PubMed Identifier
29125255
Citation
Roslan MA, Ngui R, Vythilingam I, Sulaiman WYW. Evaluation of sticky traps for adult Aedes mosquitoes in Malaysia: a potential monitoring and surveillance tool for the efficacy of control strategies. J Vector Ecol. 2017 Dec;42(2):298-307. doi: 10.1111/jvec.12270.
Results Reference
background
PubMed Identifier
21175947
Citation
Chadee DD, Ritchie SA. Efficacy of sticky and standard ovitraps for Aedes aegypti in Trinidad, West Indies. J Vector Ecol. 2010 Dec;35(2):395-400. doi: 10.1111/j.1948-7134.2010.00098.x.
Results Reference
background
PubMed Identifier
17607465
Citation
Gama RA, Silva EM, Silva IM, Resende MC, Eiras AE. Evaluation of the sticky MosquiTRAP for detecting Aedes (Stegomyia) aegypti (L.) (Diptera: Culicidae) during the dry season in Belo Horizonte, Minas Gerais, Brazil. Neotrop Entomol. 2007 Mar-Apr;36(2):294-302. doi: 10.1590/s1519-566x2007000200018.
Results Reference
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PubMed Identifier
23478581
Citation
Lee C, Vythilingam I, Chong CS, Abdul Razak MA, Tan CH, Liew C, Pok KY, Ng LC. Gravitraps for management of dengue clusters in Singapore. Am J Trop Med Hyg. 2013 May;88(5):888-892. doi: 10.4269/ajtmh.12-0329. Epub 2013 Mar 11.
Results Reference
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PubMed Identifier
26094839
Citation
Lau SM, Vythilingam I, Doss JI, Sekaran SD, Chua TH, Wan Sulaiman WY, Chinna K, Lim YA, Venugopalan B. Surveillance of adult Aedes mosquitoes in Selangor, Malaysia. Trop Med Int Health. 2015 Oct;20(10):1271-80. doi: 10.1111/tmi.12555. Epub 2015 Jul 14.
Results Reference
background
PubMed Identifier
31477185
Citation
Liew JWK, Selvarajoo S, Tan W, Ahmad Zaki R, Vythilingam I. Gravid oviposition sticky trap and dengue non-structural 1 antigen test for early surveillance of dengue in multi-storey dwellings: study protocol of a cluster randomized controlled trial. Infect Dis Poverty. 2019 Sep 3;8(1):71. doi: 10.1186/s40249-019-0584-y.
Results Reference
derived

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Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes

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