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临床试验/NCT03799237
NCT03799237Unknown不适用

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

Jonathan Liew Wee Kent1 个研究点 分布在 1 个国家目标入组 7,979 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7,979
试验地点
1
主要终点
Change in number of weekly notified dengue cases in intervention arm

研究概览

简要总结

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.

详细描述

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

  1. Intervention arm: Harmoni Apartment, Impian Apartment, Park Avenue Condominium, and Suria Shop Apartment
  2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in number of weekly notified dengue cases in intervention arm

时间窗: Assess weekly, through study completion, 1 and a half years

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

时间窗: Through study completion, an average of 1 and a half years

The duration of dengue outbreaks in the study sites will be obtained from the District Health Office.

次要结局

  • Change in adult Aedes density in the intervention arm(Assess weekly, through study completion, within 1 and half years.)
  • Change in level of dengue Knowledge, Attitude and Practice in the intervention arm(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)

研究者

发起方
Jonathan Liew Wee Kent
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jonathan Liew Wee Kent

Postdoctoral Research Fellow

University of Malaya

研究点 (1)

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