SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1
NCT ID: NCT02371109
Last Updated: 2019-08-20
Study Results
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Basic Information
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COMPLETED
1786 participants
OBSERVATIONAL
2014-12-09
2017-07-14
Brief Summary
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However, they are expensive, and taking samples from extragenital sites would treble the costs. We propose that swabs from the three sites per person are pooled and analysed together rather than tested separately. This method would identify whether the person had the infection but not the anatomical site; this would not alter the management of the individual. Swabs from the rectum and throat have historically been taken by clinicians (doctors or nurses). The main attraction of community screening is that it is client led using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the costeffectiveness of this approach has not been investigated. Our aim is to establish whether in MSM and females selftaken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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selftaken vs clinical taken swabs
selftaken versus clinically taken swabs
Interventions
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selftaken versus clinically taken swabs
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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The Leeds Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Countries
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References
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Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3183-e3193. doi: 10.1093/cid/ciaa1546.
Wilson JD, Wallace HE, Loftus-Keeling M, Ward H, Davies B, Vargas-Palacios A, Hulme C, Wilcox MH. Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia. Clin Infect Dis. 2021 Nov 2;73(9):e3172-e3180. doi: 10.1093/cid/ciaa1266.
Other Identifiers
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GU12/10329
Identifier Type: -
Identifier Source: org_study_id
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