Screening with Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
- Conditions
- ChlamydiaGonorrheaHuman Papilloma VirusBacterial Vaginosis
- Interventions
- Device: DAYE Diagnostic TamponDiagnostic Test: Vaginal self-swabDiagnostic Test: Clinician vaginal swab
- Registration Number
- NCT06154239
- Lead Sponsor
- Anne's Day Ltd
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 550
-
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.
- 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. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: DDT then self-swab DAYE Diagnostic Tampon 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. Arm B: DDT then self-swab Vaginal 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. Arm A: Self-swab then DDT DAYE Diagnostic Tampon 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. Arm A: Self-swab then DDT Vaginal self-swab 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. Arm A: Self-swab then DDT Clinician vaginal swab 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. Arm B: DDT then self-swab Clinician vaginal 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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)
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 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
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 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.
Trial Locations
- Locations (1)
Lindus Health
🇬🇧London, United Kingdom