Clinical trial NCT01697852: The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
Official title: Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Keywords: vector control
LLIN
IRS
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: Kilimanjaro Christian Medical Centre, Tanzania
First posted: 2012-10-02
Enrollment: 22300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.

Findings from this study are expected to inform decision making so that resource utilization can be optimised.


Eligibility criteria: Inclusion Criteria:

* resident in selected cluster (village)

Exclusion Criteria:

* Not resident in selected cluster (village)

Primary outcomes:
measure: Prevalence of malarial infection in children 6 months to 10 years
timeFrame: 9 months post randomisation
Secondary outcomes:
measure: Moderate to severe anaemia in children under 5 years
timeFrame: 9 months post randomisation
measure: Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
timeFrame: 6 months post randomisation
Other outcomes:
measure: Entomological Innoculation Rate
timeFrame: Malaria season post randomisation(Average value during 6 months after randomisation)
measure: Relative abundance of adult Anopheles mosquitoes by species
timeFrame: Malaria season post randomisation (Average value during 6 months after randomisation)
measure: genotypic markers of insecticide resistance in malaria vector mosquitoes
timeFrame: Malaria season post randomisation (Average value during 6 months after randomisation)
Locations:
city: Muleba
country: Tanzania
facility: PAMVERC office
state: Kagera
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Mark Rowland, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Immo Kleinschmidt, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
citation: West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
citation: West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
citation: West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.