Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00355225
First received: July 19, 2006
Last updated: October 6, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention
Malaria
Procedure: ITN distribution channel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • ITN coverage in households 12 and 24 months after the start of the interventions
  • ITN use during pregnancy and infancy

Secondary Outcome Measures:
  • Costs per malaria case and per DALY prevented
  • Self-reported information on ANC visits
  • Insecticide content on ITN and mortality of vector mosquitoes over time
  • Acceptance of health staff and population

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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso

Exclusion Criteria:

  • Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355225

Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Olaf Mueller, MD, MPH Heidelberg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00355225     History of Changes
Other Study ID Numbers: SFB544D4
Study First Received: July 19, 2006
Last Updated: October 6, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
insecticide-treated bednets
malaria
africa
social marketing
ante-natal care
ITN coverage
ITn use

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on November 25, 2014