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Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views — STAMP  

Bacterial Vaginosis Clinical Trial

Official title:
Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views

Clinical Trial Summary

Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).

Clinical Trial Description

A diagnostic trial comparing the diagnostic accuracy, usability and acceptability of the DAYE Diagnostic Tampon (DDT) compared to standard vaginal self-swabs and clinician administration of a vaginal swabs. Diagnostic accuracy will be compared for detection of Chlamydia, Gonorrhoea, BV & HPV. A total of 350 eligible participants will be enrolled into the trial in the UK and Italy. To adequately assess DDT performance on specificity and sensitivity, participants will be recruited from one of two groups: - Group 1: 50 participants with a recent confirmed HPV diagnosis (UK and Italy) - Group 2: 300 participants from the general population (UK only) All participants will be randomised according to sample order for the DDT and self-swab using block randomisation: - Group A: Approximately half the participants will perform the self-swab followed by the DDT. - Group B: Approximately half the participants will perform the DDT followed by the self-swab All eligible participants will be provided with a trial kit containing the DDT and self-swab and attend at least 1 clinic visit as part of their participation in the trial. Participants will also provide answers to questionnaires at baseline and after all sampling is complete. Participation in the trial is expected to last approximately 2-3 weeks (dependent on timing of clinic appointment(s)). All samples collected during the trial will be sent to a central laboratory for analysis, either in the UK or Italy i.e., samples will be analysed in the country they were collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06154239
Study type Interventional
Source Anne's Day Ltd
Contact
Status Active, not recruiting
Phase N/A
Start date January 15, 2024
Completion date July 2024
View Details
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