Condition category
Infections and Infestations
Date applied
15/10/2009
Date assigned
22/10/2009
Last edited
13/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Andersson

ORCID ID

Contact details

CIET
Calle Pino
El Roble
Acapulco
CP39640
Mexico

Additional identifiers

EudraCT 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

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

Trial setting

Community

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2009

Overall trial end date

30/10/2012

Reason abandoned

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

All

Age group

All

Gender

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

Trial 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

http://www.ciet.org

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26156323

Publication citations

Additional files

Editorial Notes