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

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
      • 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:
  • Durable wall lining
  • PermaNet Lining

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.

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

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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