Condition category
Infections and Infestations
Date applied
14/04/2011
Date assigned
18/04/2011
Last edited
17/05/2011
Prospective/Retrospective
Retrospectively 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 Philip McCall

ORCID ID

Contact details

Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3132
mccall@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomised controlled trial of household-based insecticide-treated indoor curtains for control of the dengue vector Aedes aegypti and prevention of transmission of dengue in the community

Acronym

Study hypothesis

We investigated whether window curtains made from long-lasting insecticide-treated netting and deployed inside houses, could reduce dengue virus transmission, as measured by seroconversion rates in humans, following reductions in dengue vector populations, as measured by a series of standard indices for Aedes aegypti intra-domiciliary and peri-domestic abundance, in intervention groups compared to control groups.

Ethics approval

1. Research Ethics Committee of the Liverpool School of Tropical Medicine approved on 8th June 2009 (ref: 09/59)
2. Loreto Regional Health (Direccion Regional de Salud de Loreto), Peru approved on 3rd July 2009 (ref 586-2009-GRL-DRS/30.09.01)
3. US Naval Medical Research Center Detachment (NAMRID) Lima approved on 8th September 2009 (project no. 6000 RAD1.S.B0302; Approval ref. NAVMEDRSCHCENDETACHMENTINST 3900.6H)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 (including Dengue Haemorrhagic Fever [DHF] and Dengue Shock Syndrome [DSS])

Intervention

Insecticide-treated curtains deployed inside human habitations. The curtains are made from PermaNet® deltamethrin-coated polyester netting, a long-lasting impregnated material (Vestergaard-Frandsen, Lausanne, Switzerland), that has been approved for indoor use (World Health Organisation Pesticide Evaluation Scheme [WHOPES]), with proven efficacy against dengue vectors.

Householders in treated clusters are permitted to dictate the quantity and location of their insecticide-treated materials (ITMs), with a minimum of one ITM required for the household to be classified as receiving treatment.

Control households received no treatment, but will be offered ITMs at the end of the study.

Efficacy of the intervention (Insecticide-treated curtains as described in E51) fell to an unacceptably low level (as determined by standard WHO recommended bioassays and other methods), when monitored over a period of months during 2010. Consequently, in October and November 2010, the existing curtains were treated again with a different product ("K-O Tab 1 2 3"; Bayer Environmental Science, Germany) designed to deliver a long-lasting formulation of the same insecticide.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effect of ITMs on dengue transmission - measured by detection of dengue specific antibodies in human blood, taken from householders within the study area, using the Plaque Reduction Neutralizing Antibody test (PRNT). PRNT is specific to dengue virus serotype, and is the gold standard against which all other dengue virus (DV) serological assays are validated.

Blood samples will be collected from the study population at baseline and at three 9-month intervals thereafter (9, 18, 24 months post intervention) in householders that were not positive for all four circulating serotypes during the immediate preceding survey.

Secondary outcome measures

1. The effect of ITMs on household vector infestation and breeding – primarily measured by:
1.1 The adult index (proportion of houses positive for adult Ae. aegypti)
1.2. The Breteau index (number of containers with immature vector stages/100 houses)
Secondarily by the other Stegomyia indices:
1.3. Pupae per person index (number of pupae per number of people)
1.4. House index (percentage of houses found with immature stages of Ae. aegypti)
1.5. Container index (percentage of water-holding containers found with immature stages of Ae. aegypti).
Six surveys will be conducted: Baseline and 1, 6, 12, 18 and 24 months post intervention.
2. Quantification of spill-over effects from treated clusters on nearby control clusters, a potential confounding effect on analyses as well as an indicator of potential community-level impact
3. Determining factors associated with adoption and continued use of ITMs, including the most effective diffusion mechanism (channel of communication) for ITM promotion, by household questionnaires and focus group discussions. Surveys will coincide with the serological surveys.

Overall trial start date

01/11/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. All occupied households
1.1. Persons aged 3 years or older with parental permission
1.2. Adults consenting to participate in the study living in the study area
1.3. Assent to participation for 8-17 year old persons

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Estimated 9,200 participants from 1,400 households (based on 20 clusters of 70 houses/460 individual participants per cluster, 10 clusters per treatment arm)

Participant exclusion criteria

1. Persons younger than 3 years old
2. Temporary visitors to the study areas
3. Adults who do not consent to participate
4. 8-17 year old persons who do not assent or who do not have parental permission to participate in the study

Recruitment start date

01/11/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Peru

Trial participating centre

Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor type

University/education

Website

http://www.lstmliverpool.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 085714)

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

Publication citations

Additional files

Editorial Notes