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

Launched by FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS, SWITZERLAND · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different ways of collecting samples from women to test for the human papillomavirus (HPV), a virus that can lead to cervical cancer. The study will look at self-collected vaginal swabs that are either dry (without any liquid) or wet (in a liquid) to see which method is more effective for detecting HPV DNA. The research is aimed at women who are 30 years or older, or 25 years or older if they are HIV positive, and who have received abnormal results from cervical cancer screenings.

If you participate in this trial, you will need to provide three samples: one dry swab, one wet swab, and one swab taken by a healthcare worker. To be eligible, you should be sexually active, able to understand the study, and willing to give your consent and samples. However, if you have been vaccinated for HPV, are pregnant, or are not comfortable providing all three samples, you won't be able to join. The study is not yet recruiting participants, but it aims to help improve how we detect HPV in women.

Gender

FEMALE

Eligibility criteria

• 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)