Strategies for the prevention of dengue (Estrategias para la prevencion del Dengue)

ISRCTN	ISRCTN88405796
DOI	https://doi.org/10.1186/ISRCTN88405796
Protocol serial number	DGCD-FA2-95900-4
Sponsor	Directorate-General for Development Co-operation (DGDC) (Belgium)
Funders	Directorate-General for Development Co-operation (DGDC) (Belgium) (project ref: 95900) (framework agreement between the Institute of Tropical Medicine of Belgium and of Cuba), Ministry of Health (MINSAP) (Cuba)

Submission date: 08/05/2008
Registration date: 12/06/2008
Last edited: 18/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Patrick Van der Stuyft
Scientific

Institute of Tropical Medicine
Epidemiology and Disease Control Unit, Public Health Department
Nationalestraat 155
Antwerp
2000
Belgium

Email	pvdstuyft@itg.be

Study information

Primary study design	Interventional
Study design	Single-centre cluster randomised controlled trial (blinding not possible).
Secondary study design	Randomised controlled trial
Scientific title	A cluster randomised trial evaluating community involvement in Aedes control and dengue prevention
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Key inclusion criteria	1. Circumscriptions (i.e. neighbourhoods) of central urban Guantanamo 2. Community approval
Key exclusion criteria	1. Circumscriptions without community approval
Date of first enrolment	01/09/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Belgium
Cuba

Study participating centre

Institute of Tropical Medicine

Antwerp
2000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/06/2009		Yes	No