The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Malaria	Other: Indoor residual spraying with bendiocarb; Other: LLIN by universal coverage campaign	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	22300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	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 Start Date :	January 2011
Estimated Primary Completion Date :	November 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: LLIN plus IRS; LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide	Other: Indoor residual spraying with bendiocarb; 2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart; Other Name: Ficam Other: LLIN by universal coverage campaign; Long lasting Insecticide treated mosquito net; Other Name: Olyset nets
Active Comparator: LLIN only; LLIN by universal coverage campaign	Other: LLIN by universal coverage campaign; Long lasting Insecticide treated mosquito net; Other Name: Olyset nets

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Prevalence of malarial infection in children 6 months to 10 years [ Time Frame: 9 months post randomisation ]

Secondary Outcome Measures :

1. Moderate to severe anaemia in children under 5 years [ Time Frame: 9 months post randomisation ]
2. Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years [ Time Frame: 6 months post randomisation ]

Other Outcome Measures:

1. Entomological Innoculation Rate [ Time Frame: Malaria season post randomisation(Average value during 6 months after randomisation) ]
2. Relative abundance of adult Anopheles mosquitoes by species [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ]
3. genotypic markers of insecticide resistance in malaria vector mosquitoes [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ]

Eligibility Criteria

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Ages Eligible for Study:	6 Months to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• resident in selected cluster (village)

Exclusion Criteria:

• Not resident in selected cluster (village)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Mark Rowland, PHD		Mark.Rowland@lshtm.ac.uk
Contact: Immo Kleinschmidt, PHD		Immo.Kleinschmidt@lshtm.ac.uk

Locations

Tanzania
PAMVERC office	Recruiting
Muleba, Kagera, Tanzania
Contact: Natacha Protopopoff, PHD nprotopopoff@gmail.com
Principal Investigator: Natacha Protopopoff, PHD

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

National Institute for Medical Research, Tanzania

Kilimanjaro Christian Medical Centre, Tanzania

Investigators

Principal Investigator:	Mark Rowland, PHD	London School of Hygiene and Tropical Medicine
Principal Investigator:	Immo Kleinschmidt, PHD	London School of Hygiene and Tropical Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Other Publications:

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT01697852 History of Changes
Other Study ID Numbers:	ITDCVP54
First Posted:	October 2, 2012
Last Update Posted:	October 3, 2012
Last Verified:	October 2012

Keywords provided by London School of Hygiene and Tropical Medicine:

vector control; LLIN; IRS

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases