Status:
COMPLETED
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Lead Sponsor:
Anne's Day Ltd
Collaborating Sponsors:
Lindus Health
Conditions:
Chlamydia
Gonorrhea
Eligibility:
FEMALE
25-65 years
Phase:
NA
Brief Summary
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
Detailed Description
MAIN STUDY DESIGN A diagnostic trial comparing the diagnostic accuracy, usability and acceptability of the DAYE Diagnostic Tampon (DDT) compared to standard vaginal self-swabs and clinician administr...
Eligibility Criteria
Inclusion
- Individuals aged 25-65 years.
- People assigned female at birth (AFAB).
- Sexually active individuals. In this case, "sexually active" is defined as having penetrative vaginal sex.
- Group 1 only: Confirmed HPV+ diagnosis within the past 4 weeks.
- a. UK only: Ability to upload evidence of this diagnosis to the trial ePRO system (e.g. via a screenshot of the NHS app, or similar to be reviewed by the trial team).
- Willingness to give informed consent and adhere to trial procedures.
Exclusion
- Previous hysterectomy or total hysterectomy with removal of cervix
- Known allergy or sensitivity to tampons
- History of TSS (both tampon-associated and non-tampon associated)
- Individuals who are pregnant or breastfeeding.
- Participation in another interventional clinical trial or use of investigational drugs in the last 30 days.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. -
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
617 Patients enrolled
Trial Details
Trial ID
NCT06154239
Start Date
January 15 2024
End Date
July 18 2025
Last Update
July 31 2025
Active Locations (1)
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1
Lindus Health
London, United Kingdom