Condition category
Infections and Infestations
Date applied
17/03/2010
Date assigned
18/03/2010
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip McCall

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

075930

Study information

Scientific title

A cluster randomised controlled trial of household-based insecticide treated window curtains and water jar covers for control of the dengue vector Aedes aegypti in the community

Acronym

DENCO Venezuela

Study hypothesis

We investigated whether window curtains and covers for domestic water storage containers, both made from long-lasting insecticide-treated netting and deployed either separately or in combination, could reduce populations of Aedes aegypti, the mosquito vector of dengue, to levels that could reduce dengue virus transmission in treated communities.

Ethics approval

1. Research Ethics Committee of the Liverpool School of Tropical Medicine approved on the 2nd February 2006 (ref: 06/12)
2. Bio-ethical committee of the Jose Witremundo Torrealba Research Institute, Trujillo, Venezuela, approved on the 18th June 2006

Study design

Cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dengue (including Dengue Haemorrhagic Fever [DHF] and Dengue Shock Syndrome [DSS])

Intervention

Curtains made from deltamethrin-coated polyester netting (Long Lasting Impregnated netting; PermaNetĀ® Vestergaard-Frandsen, Lausanne, Switzerland), hung in all outer windows regardless of the presence or absence of other window coverings (World Health Organization Pesticide Evaluation Scheme [WHOPES], approved material for indoor use).

Insecticide-treated water storage container covers are provided as ready-to-use products (a pre-packaged standard size with elasticated border, to close round the water container rim). Treated households provided with enough covers for all large household receptacles that hold water for longer than 1 week (it is from these containers that most Aedes aegypti emerge).

Control households received no treatment.

Following introduction of ITMs, the total duration of both intervention and follow-up was 26 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Entomological outcomes, the standard larval indices for the Aedes aegypti mosquito vector of dengue:
1. Breteau index: number of containers with immature stages per 100 houses
2. House index: number of houses containing immature stages per 100 houses
3. Container index: number of containers with immature stages per 100 containers with water
4. Pupal surveys were also undertaken to calculate the number of pupae per person index (number of pupae collected/human population in a sector)

Follow up surveys made to all houses at 1, 18, 24, 26 months post-intervention. Analyses to measure impact of the intervention on dengue vector populations will be undertaken according to intention to treat and per protocol (based on extent of coverage as determined in follow-up surveys).

Secondary outcome measures

1. Seroconversion rates (as measured by IgM ELISA) in households in the treated and control sectors compared at baseline and at the trial's end. Members of each household between 2 - 8 years of age specifically selected for the study.
2. Interview surveys used to determine:
2.1. Household characteristics
2.2. Previous vector control intervention
2.3. Better understanding of the local population's knowledge, attitudes and practice about previous methods of dengue prevention and control, and about ITMs for the same purpose
3. Insecticide-susceptibility assays undertaken before, at follow-up surveys and after intervention

Each house was also georeferenced with a handheld global positioning system receiver to permit subsequent overspill effects between adjacent treated and control clusters to be quantified.

Overall trial start date

01/07/2006

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All occupied households

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

7,500 households

Participant exclusion criteria

1. Business-only premises
2. Multi-storey buildings

Recruitment start date

01/07/2006

Recruitment end date

31/10/2008

Locations

Countries of recruitment

Venezuela

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor type

Research organisation

Website

http://www.lstmliverpool.ac.uk

Funders

Funder type

Government

Funder name

European Union (EU) (Belgium) - Sixth Framework Programme (FP6): INCO-DEV-2 (ref: PL 517708)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 075930)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes