Tampons for sexually transmitted infection (STI), bacterial vaginosis (BV) and human papillomavirus (HPV) screening
- Conditions
- Chlamydia, gonorrhea, bacterial vaginosis (BV) and human papillomavirus (HPV)Infections and Infestations
- Registration Number
- ISRCTN14352909
- Lead Sponsor
- Tampon Innovations Ltd (a subsidiary of Daye)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 437
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assays run on each swab:<br>1. Hologic’s APTIMA HPV (for HPV)<br>2. Hologic’s APTIMA AC (for chlamydia and gonorrhoea)<br>3. Cepheid MPV assay (for BV)<br><br>DDT and self-swab are taken at clinic visit minus 24 hours<br>Clinician swab is taken at the clinic visit <br>Assays are run within 4 weeks of receipt of samples at the laboratory
- Secondary Outcome Measures
Name Time Method