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CompletedNCT02448745Updated May 1, 2018

Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)

An interventional study of Insecticide treated wall lining in Malaria, Falciparum and Anemia, sponsored by The Mentor Initiative. Completed at 1 site in Liberia. Open to participants aged 2 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by The Mentor Initiative · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
6,317
Allocation
Randomized
Ages
2 Months to 59 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malaria, Falciparum
  • Anemia

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03

Who can participate

Ages eligible
2 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Child resides in village
  • Child presents with parent or guardian

Exclusion criteria

Exclusion Criteria:

  • Child or guardian has history of Ebola exposure
  • Child has 3 symptoms of Ebola
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,317 participants (actual)

Study arms

  • 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.

    Device: Insecticide treated wall lining

Interventions

  • DeviceInsecticide treated wall lining

    Polypropylene non-woven fabric.

    Also known as: Durable wall lining, PermaNet Lining

05

What researchers measure

Primary outcomes

  1. Malaria Prevalence

    Tested by mRDT and PCR

    Time frame: 6 months

Secondary outcomes

  1. Hemoglobin

    Hemoglobin measured by Hemocue 301

    Time frame: 6 months

  2. Fever

    Number of participants with Fever, defined as tympanic temperature above 37.5C

    Time frame: 6 months

  3. Mosquito biting rate.

    Mosquitoes trapped indoors and outdoors using light traps and exit traps.

    Time frame: 2 months

06

Study locations

1 site
  • Bomi County Health Team
    Tubmanburg, Bomi County, Liberia
07

References and documents

08

Registry details

Key details

Study ID
NCT02448745
Lead sponsor
The Mentor Initiative
Collaborators
Ministry of Health, Liberia
Responsible party
Sponsor
First posted
May 19, 2015
Start date
Mar 1, 2014
Primary completion
Jun 1, 2016
Completion
Apr 1, 2017
Last update
May 1, 2018

Study contacts

David J Giesbrecht, MSc
principal investigator · Study Coordinator
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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