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

NCT ID: NCT06213051

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1306 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2024-09-30

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.

Conditions

Human Papillomavirus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: DEVICE

COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Interventions

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

COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Frere Hospital, East London, South Africa

UNKNOWN

Sponsor Role: collaborator

Bangabandhu Sheikh Mujib Medical University, Bangladesh

UNKNOWN

Sponsor Role: collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Muriuki

Role: STUDY_DIRECTOR

Foundation for Innovative New Diagnostics (FIND)

Central Contacts

Rita Szekely

Role: CONTACT

rita.szekely@finddx.org

+41 22 749 29 32

Debashish Das

Role: CONTACT

debashish.das@finddx.org

+447708561187

Other Identifiers

WH001

Identifier Type: -

Identifier Source: org_study_id