Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV
研究概览
简要总结
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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. -
结局指标
主要结局
Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV
时间窗: 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
次要结局
- 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)
- 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)
- 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)
- 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))
- 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)
- willingness to pay(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(Through study completion, an average of 4-6 weeks)
- 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)