Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views
Status: Completed
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
United Kingdom
Lindus Health
London
Time Frame
Start Date: 2024-01-15
Completion Date: 2025-07-18
Participants
Target number of participants: 617
Treatments
Other: Arm A: Self-swab then DDT
Participants will take the self-swab sample, followed by the DDT sample at home. They will then have the clinician swab taken in the clinic.
Other: Arm B: DDT then self-swab
Participants will take the DDT sample, followed by the self-swab sample at home. They will then have the clinician swab taken in the clinic.
Other: Sub-study: Arm A: Self-swab then DDT
Participants will take the self-swab sample, followed by the DDT sample at home.
Other: Sub-study: Arm B: DDT then self-swab
Participants will take the DDT sample, followed by the self-swab sample at home.
Related Therapeutic Areas
Sponsors
Leads: Anne's Day Ltd
Collaborators: Lindus Health