ChlamydiaSTAMPNCT06154239
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
A study testing DAYE Diagnostic Tampon, Vaginal self-swab and Clinician vaginal swab in people with Chlamydia and Gonorrhea, run by Anne's Day Ltd at 1 site in United Kingdom.
Trial summary
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken). Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia, Gonorrhea, Bacterial Vaginosis
- What is being tested?
- DAYE Diagnostic Tampon, Vaginal self-swab and Clinician vaginal swab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus
- Being tested
- DAYE Diagnostic Tampon, Vaginal self-swab, Clinician vaginal swab
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAYE Diagnostic TamponDevice
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.
Vaginal self-swabDiagnostic 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.
Clinician vaginal swabDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: DAYE Diagnostic Tampon; Diagnostic Test: Vaginal self-swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
After scenario questionnaire scores - higher scores = more usable
Measured: 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
Measured: 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
Measured: Through study completion, an average of 4-6 weeks
Assess whether the DDT is a preferred sampling method for participants
User preferences (self-report)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start15 Jan 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne's Day Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Luke Twelves, Principal investigator, Lindus Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154239
- Sponsor's protocol ID
- LH-DA-01
- Acronym
- STAMP
- Status last verified
- Jul 2025
- First submitted
- 8 Nov 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views
- ClinicalTrials.gov ID
- NCT06154239
- Acronym / sponsor ID
- STAMP / LH-DA-01
- Conditions
- Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Anne's Day LtdIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Self-swab then DDT | Other | Device: DAYE Diagnostic Tampon, Diagnostic Test: Vaginal self-swab, Diagnostic Test: Clinician vaginal swabParticipants will take the self-swab sample, followed by the DDT sample at home. They will then have the clinician swab taken in the clinic. |
| Arm B: DDT then self-swab | Other | Device: DAYE Diagnostic Tampon, Diagnostic Test: Vaginal self-swab, Diagnostic Test: Clinician vaginal swabParticipants will take the DDT sample, followed by the self-swab sample at home. They will then have the clinician swab taken in the clinic. |
| Sub-study: Arm A: Self-swab then DDT | Other | Device: DAYE Diagnostic Tampon, Diagnostic Test: Vaginal self-swabParticipants will take the self-swab sample, followed by the DDT sample at home. |
| Sub-study: Arm B: DDT then self-swab | Other | Device: DAYE Diagnostic Tampon, Diagnostic Test: Vaginal self-swabParticipants will take the DDT sample, followed by the self-swab sample at home. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Willingness to give informed consent and adhere to trial procedures.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAYE Diagnostic TamponThe 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. | Device | 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-swabA 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 | 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 swabA 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. | Diagnostic test | Arm A: Self-swab then DDT, Arm B: DDT then self-swab |
Primary outcome
Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV
Time frame: Within 4 weeks of the samples being received at the lab.
Accuracy of the STI, BV and HPV detection using menstrual tampons compared to other specimen collection methods (clinician taken and self-swab) via assays
9 secondary outcomes
Assess the usability of the DDT (via After-Scenario Questionnaire - ASQ)
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 4-6 weeks
Assess whether the DDT is a preferred sampling method for participants
Time frame: 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
Time frame: Post sample analysis - 4 weeks after the last samples are received at the lab
willingness to pay
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Twelves principal investigator
Lindus Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAYE Diagnostic Tampon, Vaginal self-swab and Clinician vaginal swab in people with Chlamydia and Gonorrhea, run by Anne's Day Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV (time frame: Within 4 weeks of the samples being received at the lab.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.