UnknownNot Applicable

Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection

1,306 participantsStarted 2024-07-25

Plain-language summary

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.

Who can participate

Age range

30 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site: * Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy) * Able to understand scope of study * Able to provide written informed consent * Willing to provide all necessary samples Exclusion Criteria: * Vaccinated for HPV * Pregnancy * Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard.

Timeframe: 6 Months

Trial details

NCT IDNCT06213051

SponsorFoundation for Innovative New Diagnostics, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

Contact for this trial

Rita Szekely

+41 22 749 29 32 rita.szekely@finddx.org

View on ClinicalTrials.gov More Human Papillomavirus Infection trials