Back to resultsLiberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
Primary Purpose
Malaria, Falciparum, Anemia
Status
Completed
Phase
Not Applicable
Locations
Liberia
Study Type
Interventional
Intervention
Insecticide treated wall lining
Sponsored by
About this trial
This is an interventional prevention trial for Malaria, Falciparum
Eligibility Criteria
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
Sites / Locations
- Bomi County Health Team
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Malaria Prevalence
Tested by mRDT and PCR
Secondary Outcome Measures
Hemoglobin
Hemoglobin measured by Hemocue 301
Fever
Number of participants with Fever, defined as tympanic temperature above 37.5C
Mosquito biting rate.
Mosquitoes trapped indoors and outdoors using light traps and exit traps.
Full Information
NCT ID
NCT02448745
First Posted
May 15, 2015
Last Updated
April 27, 2018
Sponsor
The Mentor Initiative
Collaborators
Ministry of Health, Liberia
1. Study Identification
Unique Protocol Identification Number
NCT02448745
Brief Title
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mentor Initiative
Collaborators
Ministry of Health, Liberia
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum, Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6317 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Insecticide treated wall lining
Other Intervention Name(s)
Durable wall lining, PermaNet Lining
Intervention Description
Polypropylene non-woven fabric.
Primary Outcome Measure Information:
Title
Malaria Prevalence
Description
Tested by mRDT and PCR
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
Hemoglobin measured by Hemocue 301
Time Frame
6 months
Title
Fever
Description
Number of participants with Fever, defined as tympanic temperature above 37.5C
Time Frame
6 months
Title
Mosquito biting rate.
Description
Mosquitoes trapped indoors and outdoors using light traps and exit traps.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Giesbrecht, MSc
Organizational Affiliation
Study Coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bomi County Health Team
City
Tubmanburg
State/Province
Bomi County
Country
Liberia
12. IPD Sharing Statement
Links:
URL
http://www.thementorinitiative.org/
Description
The MENTOR Initiative
Learn more about this trial
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
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