Condition category
Infections and Infestations
Date applied
08/03/2011
Date assigned
04/05/2011
Last edited
04/05/2011
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

Prof Patrick Van der Stuyft

ORCID ID

Contact details

Nationale Straat 155
Antwerp
2000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC UZA 8/36/196

Study information

Scientific title

Acceptance and cost effectiveness of insecticide treated curtains in areas with low Aedes infestation levels: a single-centre, cluster, randomised controlled trial

Acronym

Study hypothesis

Acceptance, effectiveness and cost effectiveness of a dengue control intervention implementing insecticide treated curtains, as a single Aedes control strategy will be different than when implementation of curtains is combined with community based environmental management.

Ethics approval

Ethical committee of University Hospital Antwerp approved on 15/09/2008

Study design

Single-centre 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

Effect of intervention on Aedes aegypti infestation levels (vector of dengue fever)

Intervention

1. Insecticide treated curtains: made from long-lasting, insecticide treated (pyrethroid deltamethrin is applied during manufacture) polyester netting that requires no re-impregnation, materials are special ultraviolet (UV) protected and retain their insecticidal properties and efficacy for about 2 years (information from producer).
2. The material has been approved by World Health Organisation Pesticide Evaluation Scheme (WHOPES) for use as bednets.
3. Community based environmental management approach: dengue control activities were identified, designed, planned and executed by the community itself, with the support of newly set up local 'community working groups'
4. Control: routine aedes control programme (entomological surveillance, source reduction, selective adulticiding and health education)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Aedes infestation levels are the primary outcomes
1.1. House Indices (HI) - number of houses positive for at least one container with Aedes aegypti immature stages/100 inspected houses
1.2. Breteau Indices (BI) number of containers positive for Aedes. aegypti immature stages/100 inspected houses
1.3. Pupal Indices (PI) number of Aedes. aegypti pupae/inhabitant
2. In cycles of 11 days, the National Vector Control programme conduct routine entomological surveys in all dwellings of the municipality. This will provide the entomological information for all clusters for the period of study.

Secondary outcome measures

1. Uptake, use and acceptance of Insecticide treated curtains
2. Financial cost of the two interventions in comparison to the control
3. The percentage of blocks repeatedly positive for larvae
4. Level of community participation based on Rifkin criteria

Overall trial start date

30/09/2008

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. No patients, but communities were included
2. Circumscriptions (neighboorhoods) of urban Guantanamo after obtaining community approval

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

12 circumscriptions of 500 households

Participant exclusion criteria

Circumscriptions without community approval

Recruitment start date

30/09/2008

Recruitment end date

01/04/2012

Locations

Countries of recruitment

Cuba

Trial participating centre

Nationale Straat 155
Antwerp
2000
Belgium

Sponsor information

Organisation

Institute of Tropical Medicine (Belgium)

Sponsor details

Epidemiology and Disease Control Unit
Public Health Department
Nationale Straat 155
Antwerp
2000
Belgium

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Directorate General for Development Cooperation (DGDC) (Belgium) (project ref: 95900) (framework agreement between the Institute of Tropical Medicine of Belgium and of Cuba)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Health (MINSAP) (Cuba)

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