Screening with Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

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

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 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.

SUB-STUDY DESIGN

A maximum of 210 eligible participants will be recruited and provide 2 samples to a decentralised sub-study to assess the DDTs performance compared to a self-taken vaginal swab. Recruitment will be stopped as soon as 21 positive cases of STI are confirmed by the lab.

* Group 3: 210 participants with suspected or recently confirmed chlamydia or gonorrhoea.

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

Pre-screening, informed consent, screening and eligibility assessments will occur online. Trial team will confirm e-consent and eligibility. Randomisation will be performed at the point of enrolment by a member of the trial team using a re-generated list of treatment allocation blocks. Some demographic information and medical history will be collected at baseline. All eligible participants will be provided with a trial kit containing the DDT and self-swab which they will use at home and send directly to the testing laboratory. Participants will also provide answers to questionnaires at baseline and after all sampling is complete. Participants will enter data directly into the EDC platform. Participation in the sub-study is expected to last approximately 1 week. All samples collected during the trial will be sent to a central accredited laboratory(s) for analysis in the UK.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 25-65 years.
2. People assigned female at birth (AFAB).
3. Sexually active individuals. In this case, "sexually active" is defined as having penetrative vaginal sex.
4. 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).
5. Willingness to give informed consent and adhere to trial procedures.

Exclusion Criteria:

1. Previous hysterectomy or total hysterectomy with removal of cervix
2. Known allergy or sensitivity to tampons
3. History of TSS (both tampon-associated and non-tampon associated)
4. Individuals who are pregnant or breastfeeding.
5. Participation in another interventional clinical trial or use of investigational drugs in the last 30 days.
6. 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. -