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

Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.

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 using LBC and as reference standard.

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)