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

Human Papillomavirus Infection Clinical Trial

— HPV  

Official title:

Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA to Screen for CIN2+ Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213051
• Other study ID #: WH001
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: Rita Szekely
• Phone: +41 22 749 29 32
• Email: rita.szekely[@]finddx.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 to screen for CIN2+ lesions using LBC as the reference standard.

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 to screen for CIN2+ lesions using LBC as the reference standard.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1306
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Device:
• • COPAN Self-collection FLOQSwabs® (COPAN, Italy)
COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Frere Hospital, East London, South Africa, Kenya Medical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Compare 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.	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 to screen for CIN2+ lesions using LBC as the reference standard.	6 Months
Primary	To Compare 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.	Negative, positive, overall percent agreement and Cohen's Kappa Coefficient between self-collected vaginal dry and wet swab results for each index test.	6 Months