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

Bacterial Vaginosis Clinical Trial

— STAMP  

Official title:

Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06154239
• Other study ID #: LH-DA-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Anne's Day Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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: - 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 437
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Chlamydia
• Gonorrhea
• Human Papilloma Virus
• Papilloma
• Vaginosis, Bacterial

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Lindus Health	London

Sponsors (3)

Lead Sponsor	Collaborator
Anne's Day Ltd	Careggi Hospital, Lindus Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the relationship between duration of wear and diagnostic accuracy.	Duration of DDT wear and diagnostic accuracy	Post sample analysis - 4 weeks after the last samples are received at the lab
Primary	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	Assess the usability of the DDT (via After-Scenario Questionnaire - ASQ)	After scenario questionnaire scores - higher scores = more usable	Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
Secondary	Explore participants views of the usability and acceptability of the DDT	Quantitative and qualitative feedback from pre- and post-sampling questionnaires	Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
Secondary	Explore participants views of the usability and acceptability of the DDT	Qualitative feedback from focus groups	Through study completion, an average of 4-6 weeks
Secondary	Assess whether the DDT is a preferred sampling method for participants	User preferences (self-report)	Pre-sampling (baseline) and Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
Secondary	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	Post sample analysis - 4 weeks after the last samples are received at the lab
Secondary	willingness to pay	Willingness to pay for the DDT via questions in post-sampling questionnaire	Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
Secondary	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	Post-sampling (once all samples are collected) - at study completion usually after 4 weeks
Secondary	Explore stakeholder attitudes to tampons as a means of sample collection for microbial testing.	Qualitative feedback from stakeholder questionnaires	Throughout the trial (and once stakeholders with a role in the trial have engaged with the tampon)
Secondary	Assess the occurrence of AEs/SAEs as a result of tampon sampling.	AE/SAE occurrence.	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