ISRCTN ISRCTN27581154
DOI https://doi.org/10.1186/ISRCTN27581154
Secondary identifying numbers IDX-2009
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

Not provided at time of registration

Contact information

Dr Neil Andersson
Scientific

CIET
Calle Pino, El Roble
Acapulco
CP39640
Mexico

Study information

Study designRandomised controlled cluster trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCamino Verde: a randomised controlled cluster trial to reduce dengue risk in Nicaragua and Mexico though evidence-based community mobilisation
Study acronymCamino Verde
Study hypothesisEvidence-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.
ConditionDengue infection
InterventionFeedback 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 typeOther
Primary outcome measureMeasured 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 measuresMeasured 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 date01/11/2009
Overall study end date30/10/2012

Eligibility

Participant type(s)All
Age groupAll
SexBoth
Target number of participants50,000 individuals in 9,000 households in 170 clusters in two countries
Participant inclusion criteriaAll 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 exclusion criteriaDoes not meet inclusion criteria
Recruitment start date01/11/2009
Recruitment end date30/10/2012

Locations

Countries of recruitment

  • Mexico
  • Nicaragua

Study participating centre

CIET
Acapulco
CP39640
Mexico

Sponsor information

CIET Tropical Disease Research Centre (Mexico)
Research organisation

c/o Dr Neil Andersson
Universidad Autónoma de Guerrero
Calle Pino, El Roble
Acapulco
CP39640
Mexico

Website http://www.ciet.org
ROR logo "ROR" https://ror.org/054tbkd46

Funders

Funder type

Other

A Swiss Private Foundation (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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

Editorial Notes

17/07/2017: Publication references added.

Springer Nature