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

• Sponsor: The Mentor Initiative (Other)
• Overall Status: Completed
• CT.gov ID: NCT02448745
• Collaborator: Ministry of Health, Liberia (Other)
• Enrollment: 6,317
• Location: 1
• Arms: 2
• Actual Duration (Months): 37
• Patients Per Site Per Month: 170.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria, Falciparum; Anemia	Device: Insecticide treated wall lining	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6317 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

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.	Device: Insecticide treated wall lining; Polypropylene non-woven fabric.; Other Names: Durable wall lining PermaNet Lining

Outcome Measures

Primary Outcome Measures

1. Malaria Prevalence [6 months]

   Tested by mRDT and PCR

Secondary Outcome Measures

1. Hemoglobin [6 months]

   Hemoglobin measured by Hemocue 301

2. Fever [6 months]

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

3. Mosquito biting rate. [2 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bomi County Health Team	Tubmanburg	Bomi County	Liberia

Sponsors and Collaborators

• The Mentor Initiative
• Ministry of Health, Liberia

Investigators

• Principal Investigator: David J Giesbrecht, MSc, Study Coordinator

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The MENTOR Initiative

Publications

None provided.

• Responsible Party: The Mentor Initiative
• ClinicalTrials.gov Identifier: NCT02448745
• Other Study ID Numbers: LiberiaDL
• First Posted: May 19, 2015
• Last Update Posted: May 1, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Malaria, Falciparum

Study Results

No Results Posted as of May 1, 2018