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

NCT06213051 | Unknown

• 1 other identifier: WH001
• Study Type: observational
• Target: 1,306
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 Months

Secondary Outcomes (5)

• 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

• 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

• 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

• Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.

  6 Months

• 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

Study Arms (1)

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

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

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

Interventions

• COPAN Self-collection FLOQSwabs® (COPAN, Italy) DEVICE

COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Also known as: COPAN Self-collection FLOQSwabs® (COPAN, Italy) with 5ml PreservCyt Solution (Hologic)

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Adult Females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants are eligible to be included in the study only if all of the inclusion criteria and none of the exclusion criteria indicated below apply. Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Kenya Medical Research Institute: collaborator
• Frere Hospital, East London, South Africa: collaborator
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Muriuki

  Foundation for Innovative New Diagnostics (FIND)

  STUDY DIRECTOR

Central Study Contacts

Rita Szekely

CONTACT

+41 22 749 29 32; rita.szekely@finddx.org

Debashish Das

CONTACT

+447708561187; debashish.das@finddx.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: January 19, 2024
• Study Start: July 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 29, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share