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

Foundation for Innovative New Diagnostics (FIND)

Status: Not yet enrolling

Conditions: Human Papillomavirus Infection

Treatments: Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)

Study type: Observational

Funder types: Other

Identifiers

NCT06213051

WH001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,306 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

1,306 participants in 1 patient group

Cohort of sexually active adult females with an abnormal cervical cancer screening result.

Description:

Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA. Interventions: COPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests

Treatment:

Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)