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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Malaria, Falciparum, Anemia

Intervention / Treatment
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* Device: Insecticide treated wall lining


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* Polypropylene non-woven fabric.<br>* Other names: PermaNet Lining;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malaria Prevalence | Tested by mRDT and PCR | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin measured by Hemocue 301 | 6 months | 
| Fever | Number of participants with Fever, defined as tympanic temperature above 37.5C | 6 months | 
| Mosquito biting rate. | Mosquitoes trapped indoors and outdoors using light traps and exit traps. | 2 months |