Clinical trial NCT06154239: Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Official title: Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chlamydia
Gonorrhea
Bacterial Vaginosis
Human Papilloma Virus
Lead sponsor: Anne's Day Ltd
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2023-12-04
Enrollment: 550
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV
timeFrame: Within 4 weeks of the samples being received at the lab.
Secondary outcomes:
measure: Assess the usability of the DDT (via After-Scenario Questionnaire - ASQ)
timeFrame: Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
measure: Explore participants views of the usability and acceptability of the DDT
timeFrame: Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
measure: Explore participants views of the usability and acceptability of the DDT
timeFrame: Through study completion, an average of 4-6 weeks
measure: Assess whether the DDT is a preferred sampling method for participants
timeFrame: Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
measure: Assess if the order of sample collection (self-swab vs DDT) impacts diagnostic accuracy as assessed by assays
timeFrame: Post sample analysis - 4 weeks after the last samples are received at the lab
measure: willingness to pay
timeFrame: Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
measure: Understand the health economic consequences of using the DDT for STI, BV and HPV testing - time taken
timeFrame: Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
measure: Explore stakeholder attitudes to tampons as a means of sample collection for microbial testing.
timeFrame: Throughout the trial (and once stakeholders with a role in the trial have engaged with the tampon)
measure: Assess the occurrence of AEs/SAEs as a result of tampon sampling.
timeFrame: 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 outcomes:
measure: Explore the relationship between duration of wear and diagnostic accuracy.
timeFrame: Post sample analysis - 4 weeks after the last samples are received at the lab
measure: 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.
timeFrame: Samples will be analysed around 2 weeks after collection. The outcome will be assessed as soon as 21 positive samples have been obtained.
Locations:
city: London
country: United Kingdom
facility: Lindus Health
Study officials:
affiliation: Lindus Health
name: Luke Twelves
role: PRINCIPAL_INVESTIGATOR
References: