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

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

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

Study Overview

• Status: Completed
• Conditions: Chlamydia; Gonorrhea; Human Papilloma Virus; Bacterial Vaginosis
• Intervention / Treatment: Device: DAYE Diagnostic Tampon; Diagnostic test: Vaginal self-swab; Diagnostic test: Clinician vaginal swab

Detailed Description

MAIN STUDY DESIGN

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.

SUB-STUDY DESIGN

A maximum of 210 eligible participants will be recruited and provide 2 samples to a decentralised sub-study to assess the DDTs performance compared to a self-taken vaginal swab. Recruitment will be stopped as soon as 21 positive cases of STI are confirmed by the lab.

• Group 3: 210 participants with suspected or recently confirmed chlamydia or gonorrhoea.

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

Pre-screening, informed consent, screening and eligibility assessments will occur online. Trial team will confirm e-consent and eligibility. Randomisation will be performed at the point of enrolment by a member of the trial team using a re-generated list of treatment allocation blocks. Some demographic information and medical history will be collected at baseline. All eligible participants will be provided with a trial kit containing the DDT and self-swab which they will use at home and send directly to the testing laboratory. Participants will also provide answers to questionnaires at baseline and after all sampling is complete. Participants will enter data directly into the EDC platform. Participation in the sub-study is expected to last approximately 1 week. All samples collected during the trial will be sent to a central accredited laboratory(s) for analysis in the UK.

• Study Type: Interventional
• Enrollment (Actual): 617
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Lindus Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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. -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm A: Self-swab then DDT; 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; 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.; Diagnostic test: Vaginal self-swab; 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.; Diagnostic test: Clinician vaginal 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. The clinician swab is not taken in sub-study participants.
Other: Arm B: DDT then self-swab; 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; 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.; Diagnostic test: Vaginal self-swab; 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.; Diagnostic test: Clinician vaginal 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. The clinician swab is not taken in sub-study participants.
Other: Sub-study: Arm A: Self-swab then DDT; Participants will take the self-swab sample, followed by the DDT sample at home.	Device: DAYE Diagnostic Tampon; 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.; Diagnostic test: Vaginal self-swab; 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.
Other: Sub-study: Arm B: DDT then self-swab; Participants will take the DDT sample, followed by the self-swab sample at home.	Device: DAYE Diagnostic Tampon; 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.; Diagnostic test: Vaginal self-swab; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the relationship between duration of wear and diagnostic accuracy.	Duration of DDT wear and diagnostic accuracy	Post sample analysis - 4 weeks after the last samples are received at the lab
Sub-study Objective: Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting STIs (Chlamydia, Gonorrhoea) specifically demonstrating a sensitivity of more than 70% for DDT.	Accuracy of the STI detection using menstrual tampons compared to other specimen collection methods (self-swab) via Hologic APTIMA AC assay	Samples will be analysed around 2 weeks after collection. The outcome will be assessed as soon as 21 positive samples have been obtained.

Collaborators and Investigators

• Sponsor: Anne's Day Ltd
• Collaborators: Lindus Health
• Investigators: Principal Investigator: Luke Twelves, Lindus Health

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Neoplasms by Histologic Type; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Communicable Diseases; Sexually Transmitted Diseases; Neoplasms, Squamous Cell; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Vaginitis; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Vaginal Diseases; Papilloma; Vaginosis, Bacterial; Gonorrhea
• Other Study ID Numbers: LH-DA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No