- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02448745
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
April 27, 2018 updated by: The Mentor Initiative
A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia.
Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria control.
In Bomi County Liberia, LLINs have been distributed but malaria prevalence in children under 5 remains high, with prevalence in study villages found to be 42% in April 2014.
The major malaria vector species are resistant to pyrethroid insecticides approved for use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the population.
Study Type
Interventional
Enrollment (Actual)
6317
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bomi County
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Tubmanburg, Bomi County, Liberia
- Bomi County Health Team
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child resides in village
- Child presents with parent or guardian
Exclusion Criteria:
- Child or guardian has history of Ebola exposure
- Child has 3 symptoms of Ebola
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
21 clusters composed of one or more villages with a total number of 30 to 70 children under 5 years old.
Routine distribution of long-lasting insecticidal nets is the only malaria control intervention.
|
|
Experimental: Intervention
21 clusters composed of one or more villages with a total of 30 to 70 children under 5 years old.
Routine distribution of long-lasting insecticidal nets is available and in addition insecticide treated wall lining is installed in all sleeping areas with homeowner consent.
All 4 walls and the ceiling are covered with lining.
|
Polypropylene non-woven fabric.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malaria Prevalence
Time Frame: 6 months
|
Tested by mRDT and PCR
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin
Time Frame: 6 months
|
Hemoglobin measured by Hemocue 301
|
6 months
|
Fever
Time Frame: 6 months
|
Number of participants with Fever, defined as tympanic temperature above 37.5C
|
6 months
|
Mosquito biting rate.
Time Frame: 2 months
|
Mosquitoes trapped indoors and outdoors using light traps and exit traps.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David J Giesbrecht, MSc, study coordinator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
May 15, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (Estimate)
May 19, 2015
Study Record Updates
Last Update Posted (Actual)
May 1, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LiberiaDL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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