Evaluating a new tampon for diagnosing STIs and HPV

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

This study is testing a new tampon to see if it can accurately detect STIs and HPV better than traditional swabs for people in the UK and Italy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 25 Years to 65 Years
• Sex: Female
• Sponsor: Anne's Day Ltd (industry)
• Locations: 1 site (London)
• Trial ID: NCT06154239 on ClinicalTrials.gov

What this trial studies

This trial compares the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with traditional vaginal swabs for detecting Chlamydia, Gonorrhea, Bacterial Vaginosis, and Human Papilloma Virus (HPV). A total of 350 participants will be enrolled from the UK and Italy, including individuals with a recent HPV diagnosis and those from the general population. Participants will use both the DDT and self-swabs in a randomized order, and their experiences will be assessed through questionnaires. The study aims to determine the usability and acceptability of the DDT compared to standard methods.

Who should consider this trial

Good fit: Ideal candidates are sexually active individuals aged 25-65 who are assigned female at birth.

Not a fit: Patients who have had a hysterectomy or are currently pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and user-friendly method for diagnosing STIs and HPV.

How similar studies have performed: Other studies have shown promise in using self-collection methods for STI diagnosis, suggesting potential success for this novel approach.

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. -

Where this trial is running

London

• Lindus Health — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Luke Twelves — Lindus Health
• Study coordinator: Michelle Gomes

Conditions: Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus