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

NCT06154239 | Completed

• 1 other identifier: LH-DA-01
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chlamydia; Gonorrhea; Bacterial Vaginosis; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Assess the usability of the DDT (via After-Scenario Questionnaire - ASQ)

  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

  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

  Through study completion, an average of 4-6 weeks

• Assess whether the DDT is a preferred sampling method for participants

  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

  Post sample analysis - 4 weeks after the last samples are received at the lab

Other Outcomes (2)

• Explore the relationship between duration of 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.

  Samples will be analysed around 2 weeks after collection. The outcome will be assessed as soon as 21 positive samples have been obtained.

Study Arms (4)

Arm A: Self-swab then DDT

OTHER

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; Diagnostic Test: Vaginal self-swab; Diagnostic Test: Clinician vaginal swab

Arm B: DDT then self-swab

OTHER

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; Diagnostic Test: Vaginal self-swab; Diagnostic Test: Clinician vaginal swab

Sub-study: Arm A: Self-swab then DDT

OTHER

Participants will take the self-swab sample, followed by the DDT sample at home.

Device: DAYE Diagnostic Tampon; Diagnostic Test: Vaginal self-swab

Sub-study: Arm B: DDT then self-swab

OTHER

Participants will take the DDT sample, followed by the self-swab sample at home.

Device: DAYE Diagnostic Tampon; Diagnostic Test: Vaginal self-swab

Interventions

DAYE Diagnostic Tampon DEVICE

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.

Arm A: Self-swab then DDT; Arm B: DDT then self-swab; Sub-study: Arm A: Self-swab then DDT; Sub-study: Arm B: DDT then self-swab

Vaginal self-swab DIAGNOSTIC_TEST

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.

Arm A: Self-swab then DDT; Arm B: DDT then self-swab; Sub-study: Arm A: Self-swab then DDT; Sub-study: Arm B: DDT then self-swab

Clinician vaginal swab DIAGNOSTIC_TEST

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.

Arm A: Self-swab then DDT; Arm B: DDT then self-swab

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Anne's Day Ltd: lead
• Lindus Health: collaborator

Study Sites (1)

Lindus Health

London, United Kingdom

Location

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea; Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Luke Twelves

  Lindus Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MAIN STUDY: 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. SUB-STUDY In the sub-study will only perform the DDT and self-swab. Participants will be randomised according to sample order for the DDT and self-swab.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 4, 2023
• Study Start: January 15, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)