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 range30 Years – 80 Years

SexFEMALE

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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)

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