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

Not yet recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)

• Registration Number: NCT06213051
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-19
• Study Start: 2024-07-25
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1306

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of sexually active adult females with an abnormal cervical cancer screening result.	• COPAN Self-collection FLOQSwabs® (COPAN, Italy)	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

Primary Outcome Measures

Name	Time	Method
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.	6 Months	Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard.

Secondary Outcome Measures

Name	Time	Method
Compare the performance of self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.	6 Months	Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.
Compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.	6 Months	Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected dry swabs to self-collected wet swabs for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.
Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.	6 Months	Assessment of survey responses using descriptive statistics.
Assess the usability of self-collection amongst women and to assess the usability of self-collection using vaginal dry swabs compared to self-collection using vaginal wet swabs and provider collection methods for HPV testing amongst health care workers.	6 Months	Assessment of survey responses using descriptive statistics.
Compare the performance of self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.	6 Months	Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.