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ISRCTN
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ISRCTN88405796
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ClinicalTrials.gov identifier
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Public title
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Strategies for the prevention of dengue (Estrategias para la prevencion del Dengue)
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Scientific title
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A cluster randomised trial evaluating community involvement in Aedes control and dengue prevention
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Acronym
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N/A
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Serial number at source
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DGCD-FA2-95900-4
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Study hypothesis
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An integrated community-based environmental management strategy is more effective in terms of reductions in entomological indices in comparison to routine Aedes control.
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Ethics approval
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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)
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Study design
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Single-centre, cluster randomised controlled trial (blinding not possible).
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Countries of recruitment
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Cuba
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Disease/condition/study domain
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Aedes aegypti infestation/ dengue fever
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Participants - inclusion criteria
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1. Circumscriptions (i.e. neighbourhoods) of central urban Guantanamo
2. Community approval
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Participants - exclusion criteria
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1. Circumscriptions without community approval
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Anticipated start date
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01/09/2004
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Anticipated end date
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31/12/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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32 circumscriptions of each approximately 500 houses
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Directorate-General for Development Co-operation (DGDC) (Belgium) (project ref: 95900) (framework agreement between the Institute of Tropical Medicine of Belgium and of Cuba)
2. Ministry of Health (MINSAP) (Cuba)
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Trial website
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Publications
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Contact name
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Prof
Patrick
Van der Stuyft
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Address
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Institute of Tropical Medicine
Epidemiology and Disease Control Unit, Public Health Department
Nationalestraat 155
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City/town
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Antwerp
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Zip/Postcode
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2000
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Country
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Belgium
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Email
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pvdstuyft@itg.be
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Sponsor
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Directorate-General for Development Co-operation (DGDC) (Belgium)
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Address
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FOD Buitenlandse Zaken
Buitenlandse Handel en
Ontwikkelingssamenwerking
Karmelietenstraat 15
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City/town
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Brussels
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Zip/Postcode
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1000
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Country
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Belgium
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Sponsor website:
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http://www.dgic.be/en/index.html
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Date applied
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08/05/2008
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Last edited
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12/06/2008
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Date ISRCTN assigned
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12/06/2008
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