Camino Verde: sustainable dengue control

ISRCTN	ISRCTN27581154
DOI	https://doi.org/10.1186/ISRCTN27581154
Protocol serial number	IDX-2009
Sponsor	CIET Tropical Disease Research Centre (Mexico)
Funder	A Swiss Private Foundation (Switzerland)

Submission date: 15/10/2009
Registration date: 22/10/2009
Last edited: 17/07/2017

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

Dr Neil Andersson
Scientific

CIET
Calle Pino, El Roble
Acapulco
CP39640
Mexico

Study information

Primary study design	Interventional
Study design	Randomised controlled cluster trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Camino Verde: a randomised controlled cluster trial to reduce dengue risk in Nicaragua and Mexico though evidence-based community mobilisation
Study acronym	Camino Verde
Study objectives	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.
Health condition(s) or problem(s) studied	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(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/10/2012

Eligibility

Participant type(s)	All
Age group	All
Sex	All
Target sample size at registration	50000
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/11/2009
Date of final enrolment	30/10/2012

Locations

Countries of recruitment

Mexico
Nicaragua

Study participating centre

CIET

Acapulco
CP39640
Mexico

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	08/07/2015		Yes	No
Results article	results	30/05/2017		Yes	No
Results article	results	30/05/2017		Yes	No
Other publications	ethical issues	30/05/2017		Yes	No
Other publications	secondary analysis	30/05/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2017: Publication references added.