Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
IDX-2009
Study information
Scientific title
Camino Verde: a randomised controlled cluster trial to reduce dengue risk in Nicaragua and Mexico though evidence-based community mobilisation
Acronym
Camino Verde
Study hypothesis
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.
Ethics approval(s)
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.
Study design
Randomised controlled cluster trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dengue infection
Intervention
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.
Intervention type
Other
Primary outcome measure
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)
Secondary outcome measures
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
Overall study start date
01/11/2009
Overall study end date
30/10/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type(s)
All
Age group
All
Sex
Both
Target number of participants
50,000 individuals in 9,000 households in 170 clusters in two countries
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/11/2009
Recruitment end date
30/10/2012
Locations
Countries of recruitment
Mexico, Nicaragua
Study participating centre
CIET
Acapulco
CP39640
Mexico
Sponsor information
Organisation
CIET Tropical Disease Research Centre (Mexico)
Sponsor details
c/o Dr Neil Andersson
Universidad Autónoma de Guerrero
Calle Pino
El Roble
Acapulco
CP39640
Mexico
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Other
Funder name
A Swiss Private Foundation (Switzerland)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/07/2015 | Yes | No | |
| Other publications | ethical issues | 30/05/2017 | Yes | No | |
| Other publications | secondary analysis | 30/05/2017 | Yes | No | |
| Results article | results | 30/05/2017 | Yes | No | |
| Results article | results | 30/05/2017 | Yes | No |