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

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

Detailed Description
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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.

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

Conditions
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Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus

Intervention / Treatment
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* Device: DAYE Diagnostic Tampon
* Diagnostic Test: Vaginal self-swab
* Diagnostic Test: Clinician vaginal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 25-65 years. People assigned female at birth (AFAB). Sexually active individuals. In this case, sexually active is defined as having penetrative vaginal sex. 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). Willingness to give informed consent and adhere to trial procedures. Exclusion Criteria: Previous hysterectomy or total hysterectomy with removal of cervix Known allergy or sensitivity to tampons History of TSS (both tampon-associated and non-tampon associated) Individuals who are pregnant or breastfeeding. Participation in another interventional clinical trial or use of investigational drugs in the last 30 days. 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. -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A: Self-swab then DDT<br>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. | Device: DAYE Diagnostic Tampon<br>* 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.<br>Diagnostic Test: Vaginal self-swab<br>* 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.<br>Diagnostic Test: Clinician vaginal swab<br>* 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.<br>|
| Other: Arm B: DDT then self-swab<br>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. | Device: DAYE Diagnostic Tampon<br>* 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.<br>Diagnostic Test: Vaginal self-swab<br>* 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.<br>Diagnostic Test: Clinician vaginal swab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV | Accuracy of the STI, BV and HPV detection using menstrual tampons compared to other specimen collection methods (clinician taken and self-swab) via assays | Within 4 weeks of the samples being received at the lab. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the usability of the DDT (via After-Scenario Questionnaire - ASQ) | After scenario questionnaire scores - higher scores = more usable | Post-sampling (once all samples are collected) - at study completion usually after 4 weeks | 
| Explore participants views of the usability and acceptability of the DDT | Quantitative and qualitative feedback from pre- and post-sampling questionnaires | Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks | 
| Explore participants views of the usability and acceptability of the DDT | Qualitative feedback from focus groups | Through study completion, an average of 4-6 weeks | 
| Assess whether the DDT is a preferred sampling method for participants | User preferences (self-report) | Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks | 
| Assess if the order of sample collection (self-swab vs DDT) impacts diagnostic accuracy as assessed by assays | Comparison between the detection accuracy of infections between sample order (Group A and Group B) using assays | Post sample analysis - 4 weeks after the last samples are received at the lab | 
| willingness to pay | Willingness to pay for the DDT via questions in post-sampling questionnaire | Post-sampling (once all samples are collected) - at study completion usually after 4 weeks | 
| Understand the health economic consequences of using the DDT for STI, BV and HPV testing - time taken | Comparison of time taken for DDT vs clinician swab | Post-sampling (once all samples are collected) - at study completion usually after 4 weeks | 
| Explore stakeholder attitudes to tampons as a means of sample collection for microbial testing. | Qualitative feedback from stakeholder questionnaires | Throughout the trial (and once stakeholders with a role in the trial have engaged with the tampon) | 
| Assess the occurrence of AEs/SAEs as a result of tampon sampling. | AE/SAE occurrence. | None expected, but any events will be collected and recorded on an ongoing basis as outlined in the protocol and analysed at study completion usually after 4 weeks |