MalariaNCT00355225
Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso
A study testing ITN distribution channel in people with Malaria, run by Heidelberg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- ITN distribution channel
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Who cannot join
- Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
About this study
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- ITN distribution channel
- Keywords
- insecticide-treated bednets, malaria, africa, social marketing, ante-natal care, ITN coverage, ITn use
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITN distribution channelProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ITN coverage in households 12 and 24 months after the start of the interventions
ITN use during pregnancy and infancy
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Olaf Mueller, MD, MPH, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355225
- Sponsor's protocol ID
- SFB544D4
- Status last verified
- Jul 2006
- First submitted
- 19 Jul 2006
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso
- ClinicalTrials.gov ID
- NCT00355225
- Acronym / sponsor ID
- SFB544D4
- Conditions
- Malaria
- Keywords
- insecticide-treated bednets, malaria, africa, social marketing, ante-natal care, ITN coverage, ITn use
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- First posted
- 21 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Key exclusion criteria (1 listed)
- Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITN distribution channel | Procedure or surgery | – |
Primary outcome
ITN coverage in households 12 and 24 months after the start of the interventions
ITN use during pregnancy and infancy
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Mueller, MD, MPH principal investigator
Heidelberg University
Questions about this trial
What is this clinical trial studying?
A study testing ITN distribution channel in people with Malaria, run by Heidelberg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITN coverage in households 12 and 24 months after the start of the interventions. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2006.