Status:
UNKNOWN
Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Kenya Medical Research Institute
Frere Hospital, East London, South Africa
Conditions:
Human Papillomavirus Infection
Eligibility:
FEMALE
30-80 years
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 dete...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
1306 Patients enrolled
Trial Details
Trial ID
NCT06213051
Start Date
July 25 2024
End Date
September 30 2024
Last Update
July 29 2024
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