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Tracking Information | |||||||||
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First Received Date † | June 28, 2007 | ||||||||
Last Updated Date | June 28, 2007 | ||||||||
Start Date † | July 2007 | ||||||||
Current Primary Outcome Measures † |
The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis [ Time Frame: Two years ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Trial of Rapid Diagnostic Tests in Rural Ghana | ||||||||
Official Title † | An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana | ||||||||
Brief Summary | 1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis). |
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Detailed Description | BACKGROUND There is good evidence from multiple sites, including in Ghana, that malaria is massively over-diagnosed. It could be argued that where microscopy is not available it can be introduced, and elsewhere it can be improved, but high-quality microscopy is not easy to sustain. If substantial over-diagnosis continues in Ghana in an era where an ACT is now the first-line treatment, it will lead to the intervention being substantially more expensive due to over-prescription than it should be, potentially rendering it unsustainable. The introduction of rapid diagnostic tests (RDTs) has the potential to provide a way of more accurately directing ACTs to those that need them and may also encourage clinicians to consider alternative diagnoses in test-negative cases, reducing the risk of missing treatable, and potentially fatal, alternative causes of febrile illness. RDTs to direct ACT use also have the possibility to be cost-effective, but only if clinicians prescribe logically on the basis of test results. Initial data from Tanzania suggests that providing RDTs in the context of formal healthcare settings may have little impact on clinician behaviour, but the health system in Ghana is very different, and both clinician and patient beliefs about malaria are likely to be different. Additionally, this has not been properly tested in areas with little or no access to microscopy, nor where ACTs are currently available, which may influence clinician behaviour. Many believe this is the most useful setting for RDTs, and may limit over-prescription of anti-malarials but there are no data to support this belief, nor are there data on the cost-effectiveness of this approach. This trial aims to test the impact of RDT use on clinician behaviour directly by means of a randomised trial. OBJECTIVES Principal Objective To determine by means of a randomized trial the impact of the introduction of Rapid Diagnostic Tests (RDTs) on the appropriate prescription of anti-malarials in the two public healthcare settings found in Ghana. Specifically,
In both cases RDT is being compared to the standard of care in the health centre. METHODS The study will be carried out in the Dangme West District in the southern part of Ghana. It will be an individually randomized controlled trial
There will be at least two focus group discussions comprising 8-12 discussants each from each health facility. These discussions will be carried out by means of interview guides. The discussions will be conducted in the local language and recorded on a tape recorder. In both settings data will be collected for the cost-effectiveness studies. |
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † |
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Intervention † | Device: Rapid diagnostic test | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Not yet recruiting | ||||||||
Enrollment † | 6500 | ||||||||
Estimated Completion Date | June 2009 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | |||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Ghana | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00493922 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Gates Malaria Partnership | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | Gates Malaria Partnership | ||||||||
Verification Date | June 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |