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ISRCTN
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ISRCTN07985309
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DOI
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10.1186/ISRCTN07985309
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Community-effectiveness of the distribution of insecticide-treated bed nets through social marketing antenatal care services in malaria control in rural Burkina Faso
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Scientific title
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Acronym
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N/A
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Serial number at source
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D4
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Study hypothesis
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There is the highly controversial question how African programmes can best reach a sustainable high coverage with Insecticide-Treated bed Nets (ITNs) in young children and pregnant women. Against this background a cluster randomised controlled trial is implemented in Nouna Health District in Burkina Faso to compare two different forms of distribution of ITNs.
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Lay summary
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Ethics approval
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The protocol has been reviewed and approved by the Ethics Committee of the University of Heidelberg (date: 12 th November 2004, ref: L-357/2004) and the local Ethics Committee in Nouna, Burkina Faso.
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Study design
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Cluster-randomised controlled trial. Evaluation takes place through annual representative household surveys.
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Countries of recruitment
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Burkina Faso
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Disease/condition/study domain
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Malaria
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Participants - inclusion criteria
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Households with children under five years of age.
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Participants - exclusion criteria
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No exclusion criteria.
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Anticipated start date
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01/08/2006
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Anticipated end date
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30/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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sample size: 500 per study arm
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Interventions
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Twenty-four peripheral health centres and their catchment areas were randomised to:
1. ITN provision to the general population through social marketing, and
2. ITN provision to the general population through social marketing plus free provision to all pregnant women through antenatal services
The total duration of the intervention will be three years, and participants will be followed up for a further two years.
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Primary outcome measure(s)
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1. ITN coverage in households 12 and 24 months after the start of the interventions
2. ITN use during pregnancy and infancy
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Secondary outcome measure(s)
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1. Costs per malaria case and per Disability Adjusted Life Years (DALY) prevented
2. Self-reported information on Antenatal Clinic (ANC) visits
3. Insecticide content on ITN and mortality of vector mosquitoes over time
4. Acceptance of health staff and population
Outcomes will be measured at 12 and 24 months after the start of the interventions
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Sources of funding
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German Research Foundation (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - Special Research Area of Control of Tropical Infectious Diseases (Sonderforschungsbereich [SFB] 544)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18784840
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Contact name
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Prof
Olaf
Mueller
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Address
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Im Neuenheimer Feld 324
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Sponsor
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University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
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Address
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Im Neuenheimer Feld 672
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Sponsor website:
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http://www.klinikum.uni-heidelberg.de/
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Date applied
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16/07/2007
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Last edited
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19/09/2008
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Date ISRCTN assigned
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19/07/2007
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