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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ClinicalTrials.gov Identifier: NCT00355225 |
Recruitment Status :
Completed
First Posted : July 21, 2006
Last Update Posted : October 9, 2006
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Sponsor:
Heidelberg University
Information provided by:
Heidelberg University
Tracking Information | ||||
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First Submitted Date ICMJE | July 19, 2006 | |||
First Posted Date ICMJE | July 21, 2006 | |||
Last Update Posted Date | October 9, 2006 | |||
Study Start Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | The study aims at assessing which of two distribution channels for insecticide treated bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant women and children under 5. | |||
Detailed Description | The hypothesis that insecticide-treated bed net (ITN) effects may not be long-lasting in young children living in areas of intense malaria transmission due to interactions with the immunologi-cal development has now been refuted in a number of studies including the D4 study. The highly controversial question remains how African programmes can best reach a sustainable high coverage with ITNs in young children and pregnant women. Against this background it is planned to implement a cluster randomised controlled trial in Nouna Health District in Burkina Faso. Twenty-two peripheral health centres and their catchment areas will be 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 primary outcomes are ITN coverage in households and ITN use during pregnancy and infancy. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Educational/Counseling/Training |
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Condition ICMJE | Malaria | |||
Intervention ICMJE | Procedure: ITN distribution channel | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | Not Provided | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00355225 | |||
Other Study ID Numbers ICMJE | SFB544D4 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Heidelberg University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Heidelberg University | |||
Verification Date | July 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |