STAMP: Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Study Details
Study Description
Brief Summary
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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Group 1: 50 participants with a recent confirmed HPV diagnosis (UK and Italy)
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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:
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Group A: Approximately half the participants will perform the self-swab followed by the DDT.
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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.
Study Design
Arms and Interventions
| 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.
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV [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
Secondary Outcome Measures
- 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]
After scenario questionnaire scores - higher scores = more usable
- 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]
Quantitative and qualitative feedback from pre- and post-sampling questionnaires
- Explore participants views of the usability and acceptability of the DDT [Through study completion, an average of 4-6 weeks]
Qualitative feedback from focus groups
- 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]
User preferences (self-report)
- 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]
Comparison between the detection accuracy of infections between sample order (Group A and Group B) using assays
- willingness to pay [Post-sampling (once all samples are collected) - at study completion usually after 4 weeks]
Willingness to pay for the DDT via questions in post-sampling questionnaire
- Understand the health economic consequences of using the DDT for STI, BV and HPV testing - time taken [Post-sampling (once all samples are collected) - at study completion usually after 4 weeks]
Comparison of time taken for DDT vs clinician swab
- Explore stakeholder attitudes to tampons as a means of sample collection for microbial testing. [Throughout the trial (and once stakeholders with a role in the trial have engaged with the tampon)]
Qualitative feedback from stakeholder questionnaires
- Assess the occurrence of AEs/SAEs as a result of tampon sampling. [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]
AE/SAE occurrence.
Other Outcome Measures
- Explore the relationship between duration of wear and diagnostic accuracy. [Post sample analysis - 4 weeks after the last samples are received at the lab]
Duration of DDT wear and diagnostic accuracy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals aged 25-65 years.
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People assigned female at birth (AFAB).
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Sexually active individuals. In this case, "sexually active" is defined as having penetrative vaginal sex.
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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.
Exclusion Criteria:
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Previous hysterectomy or total hysterectomy with removal of cervix
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Known allergy or sensitivity to tampons
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History of TSS (both tampon-associated and non-tampon associated)
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Individuals who are pregnant or breastfeeding.
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Participation in another interventional clinical trial or use of investigational drugs in the last 30 days.
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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. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lindus Health | London | United Kingdom |
Sponsors and Collaborators
- Anne's Day Ltd
- Lindus Health
- Careggi Hospital
Investigators
- Principal Investigator: Luke Twelves, Lindus Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LH-DA-01