Condition category
Infections and Infestations
Date applied
08/05/2008
Date assigned
12/06/2008
Last edited
18/06/2009
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

Institute of Tropical Medicine
Epidemiology and Disease Control Unit
Public Health Department
Nationalestraat 155
Antwerp
2000
Belgium
pvdstuyft@itg.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DGCD-FA2-95900-4

Study information

Scientific title

A cluster randomised trial evaluating community involvement in Aedes control and dengue prevention

Acronym

Study hypothesis

An integrated community-based environmental management strategy is more effective in terms of reductions in entomological indices in comparison to routine Aedes control.

Ethics approval

Ethics Committee of the Pedro Kouri Institute (Comité de ética y revision del Instituto Pedro Kouri), Havana, Cuba (affiliated to the Ministry of Health [MINSAP]), approved in September 2003 (ref: 0103015)

Study design

Single-centre cluster randomised controlled trial (blinding not possible).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Aedes aegypti infestation/ dengue fever

Intervention

Intervention communities: A community-based environmental management approach combined with the routine national dengue vector control programme. Dengue control activities were identified, designed, planned and executed by the community itself, with the support of newly set-up local Community Working Groups.
Control communities: Routine Aedes aegypti control programme (entomological surveillance, source reduction, selective adulticiding and health education)

Total duration of interventions/ follow-up: 13 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Aedes infestation levels, assessed every 11 days over the total duratin of follow-up (13 months):
1. House Indices (HI): number of houses positive for at least one container with Aedes aegypti immature stages/100 inspected houses
2. Breteau Indices (BI): number of containers positive for Aedes aegypti immature stages/100 inspected houses
3. Pupal Indices (PI): number of Aedes aegypti pupae/inhabitant

In cycles of 11 days, the National Vector Control programme conducted routine entomological surveys in all dwellings of the municipality. This provided the entomological information for all clusters for the period of January 2005-February 2006.

Secondary outcome measures

1. Proportion of breeding sites positive for first and second instar larvae. Data were collected as for the primary outcome measures every 11 days over 13 months.
2. Percentage of blocks (approximately 20-50 houses per block) repeatedly positive for larvae. Data were collected as for the primary outcome measures every 11 days over 13 months.
3. Level of community participation based on the Rifkin criteria, assessed 12 months after the start of interventions

Overall trial start date

01/09/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Circumscriptions (i.e. neighbourhoods) of central urban Guantanamo
2. Community approval

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

32 circumscriptions of each approximately 500 houses

Participant exclusion criteria

1. Circumscriptions without community approval

Recruitment start date

01/09/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Cuba

Trial participating centre

Institute of Tropical Medicine
Antwerp
2000
Belgium

Sponsor information

Organisation

Directorate-General for Development Co-operation (DGDC) (Belgium)

Sponsor details

FOD Buitenlandse Zaken
Buitenlandse Handel en
Ontwikkelingssamenwerking
Karmelietenstraat 15
Brussels
1000
Belgium

Sponsor type

Government

Website

http://www.dgic.be/en/index.html

Funders

Funder type

Government

Funder name

Directorate-General for Development Co-operation (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19509031

Publication citations

  1. Results

    Vanlerberghe V, Toledo ME, Rodríguez M, Gomez D, Baly A, Benitez JR, Van der Stuyft P, Community involvement in dengue vector control: cluster randomised trial., BMJ, 2009, 338, b1959.

Additional files

Editorial Notes