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
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
-
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.