Clinical trial NCT03799237: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dengue
Keywords: Dengue
Adult Aedes
GOS trap
Dengue NS1 antigen test
Early dengue detection and surveillance
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Petaling Jaya City Council, Malaysia
name: Selangor State Health Department, Malaysia
First posted: 2019-01-10
Enrollment: 7979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Trial
Primary purpose: PREVENTION

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

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.

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.

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

Primary outcomes:
measure: Change in number of weekly notified dengue cases in intervention arm
timeFrame: Assess weekly, through study completion, 1 and a half years
measure: Change in the duration of dengue outbreaks in intervention arm
timeFrame: Through study completion, an average of 1 and a half years
Secondary outcomes:
measure: Change in adult Aedes density in the intervention arm
timeFrame: Assess weekly, through study completion, within 1 and half years.
measure: Change in level of dengue Knowledge, Attitude and Practice in the intervention arm
timeFrame: 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
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Petaling Jaya City Council
state: Selangor
Study officials:
affiliation: University of Malaya
name: Jonathan WK Liew, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Indra Vythilingam, PhD
role: STUDY_DIRECTOR
References:
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