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

Launched by ANNE'S DAY LTD · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of diagnostic tampon, called the DAYE Diagnostic Tampon (DDT), to see how well it can detect infections like Chlamydia, Gonorrhea, Bacterial Vaginosis, and Human Papilloma Virus (HPV). The goal is to compare how accurate this tampon method is compared to traditional ways of collecting samples, such as vaginal swabs taken by a doctor or self-collected swabs. The trial is currently recruiting participants who are female, between the ages of 25 and 65, and who are sexually active.

To participate, individuals must also have had a confirmed diagnosis of HPV within the last four weeks, particularly in the UK, where they will need to provide evidence of this diagnosis. Participants will need to provide informed consent and follow the trial procedures. It's important to note that those who have had a hysterectomy, are pregnant or breastfeeding, or have certain medical conditions may not be eligible to participate. If chosen, participants can expect to help researchers learn more about how to improve testing methods for these infections, potentially leading to better healthcare options in the future.

Gender

FEMALE

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. -