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ISRCTN
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ISRCTN27581154
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ClinicalTrials.gov identifier
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Public title
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Camino Verde: sustainable dengue control
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Scientific title
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Camino Verde: a randomised controlled cluster trial to reduce dengue risk in Nicaragua and Mexico though evidence-based community mobilisation
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Acronym
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Camino Verde
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Serial number at source
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IDX-2009
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Study hypothesis
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Evidence-based community mobilisation is no less effective in controlling dengue than temephos in drinking water. Informed community mobilisation adds value through other health-related advantages and increased social capital.
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Lay summary
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Ethics approval
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The pilot project in Nicaragua received human subjects research approval from the University of California, Berkeley (ref: UCB 2004-6-179); this was renewed each year from 2004 - 2009. The IRB in the Nicaragua Ministry of Health also approved the project in 2004. Approvals are pending for the current phase from UCB, the Universidad Autónoma de Guerrero, Mexico, and CIETcanada.
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Study design
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Randomised controlled cluster trial
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Countries of recruitment
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Mexico, Nicaragua
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Disease/condition/study domain
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Dengue infection
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Participants - inclusion criteria
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All residents of 100 - 120 households in the 170 census enumeration areas, in each country selected as a random sample of the most recent population census.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/11/2009
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Anticipated end date
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30/10/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50,000 individuals in 9,000 households in 170 clusters in two countries
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Interventions
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Feedback of for dengue immunological status and entomological indicators informs community-led pesticide-free interventions (for example, cleaning and sealing water tanks). Gender stratified focus groups and then community meetings will discuss possible interventions, based on this evidence. A small community action research team (CART) in Mexico and local brigadistas in Nicaragua (three to five people in each community) will receive training in pesticide free vector control and provide the continuity from season to season.
The duration is two dengue seasons - two years.
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Primary outcome measure(s)
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Measured after the first dengue season (year 2) and in the third year, at the end of this phase of the trial:
1. Childhood recent dengue infection (age 4 - 9 years) as estimated by saliva IgG (two samples with 4-fold increase in titre)
2. Entomological index (pupal density)
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Secondary outcome measure(s)
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Measured after the first dengue season (year 2) and in the third year, at the end of this phase of the trial:
"CASCADA" of intermediate outcomes:
1. Conscious knowledge regarding dengue, its prevention and control
2. Attitudes (in relation to different options for dengue control; is it worth doing this or that action)
3. Subjective norms (what neighbours do) and positive deviations from a negative norm
4. Intention to change behaviour in the future and to implement preventive action
5. Agency (collective and individual self-efficacy - feel capable of carrying out the actions in a sustained manner and with one's own resources)
6. Socialisation (discussions about dengue, its prevention, control and consequences)
7. Action (interventions, practices)
8. Health literacy, resilience, social capital
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Sources of funding
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A Swiss Private Foundation (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Neil
Andersson
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Address
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CIET
Calle Pino, El Roble
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City/town
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Acapulco
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Zip/Postcode
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CP39640
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Country
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Mexico
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Sponsor
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CIET Tropical Disease Research Centre (Mexico)
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Address
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c/o Dr Neil Andersson
Universidad Autónoma de Guerrero
Calle Pino, El Roble
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City/town
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Acapulco
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Zip/Postcode
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CP39640
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Country
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Mexico
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Sponsor website:
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http://www.ciet.org
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Date applied
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15/10/2009
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Last edited
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22/10/2009
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Date ISRCTN assigned
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22/10/2009
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