Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Chlamydia Infections

Gonorrhea

Virus Diseases

Papilloma

Vaginosis, Bacterial

Vaginal Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Communicable Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Vaginitis

Gram-Negative Bacterial Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Bacterial

Neisseriaceae Infections

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.

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.

The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion.

DAYE Diagnostic Tampon

A vaginal self-swab typically consists of a long, slender, and flexible stick or handle, often made of plastic or a similar material. At one end, there's a soft, absorbent tip made of cotton or synthetic material. This tip is designed to collect a sample from the vaginal walls or cervix.

Vaginal self-swab

A clinician vaginal swab is a medical tool used by healthcare professionals to collect samples from the vaginal canal for diagnostic purposes. It's typically a long, thin, and flexible instrument. At one end, there's a cotton, rayon, or synthetic tip designed to collect cells, discharge, or other materials from the vaginal walls, cervix, or other areas within the vaginal canal.

Clinician vaginal swab

Luke Twelves

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

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.

All participants will have 3 samples taken: DAYE Diagnostic Tampon (DDT), self-swab and clinician administered swab. Participants will be randomised into 2 groups for sampling order between the DDT and self-swab.

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

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

Duration of DDT wear and diagnostic accuracy

Accuracy of the STI, BV and HPV detection using menstrual tampons compared to other specimen collection methods (clinician taken and self-swab) via assays

After scenario questionnaire scores - higher scores = more usable

Quantitative and qualitative feedback from pre- and post-sampling questionnaires

Comparison between the detection accuracy of infections between sample order (Group A and Group B) using assays

Willingness to pay for the DDT via questions in post-sampling questionnaire

Comparison of time taken for DDT vs clinician swab

Qualitative feedback from stakeholder questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views	NCT06154239	Chlamydia Gonorrhea Bacterial Vagin... Human Papilloma...	DAYE Diagnostic... Vaginal self-sw... Clinician vagin...	25 Years - 65 Years	Anne's Day Ltd
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views	NCT06154239	Chlamydia Gonorrhea Bacterial Vagin... Human Papilloma...	DAYE Diagnostic... Vaginal self-sw... Clinician vagin...	25 Years - 65 Years	Anne's Day Ltd

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