Self-Collection Kits for HPV Screening
What You Need to Know Before You Apply
What is the purpose of this trial?
Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a cohort of 20 patients.
Phase II: Evaluate the feasibility and acceptability of the CHW4CervicalHealth: Use of a self-collection kit to improve cervical health screening intervention aimed to promote HPV self-collection uptake among screening-eligible and under-screened ethnic minority women in the community.
Who Is on the Research Team?
Sandra Dayaratna, MD, MBA
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I: Validation
In-person accrual, enrollment, and study implementation to validate self-collection kit by comparing results with clinical Pap smear results
Phase II: Community Implementation
Conduct educational workshops and distribute self-collection kits to evaluate feasibility and acceptability of HPV self-collection
Follow-up
Participants are monitored for safety and effectiveness after self-collection kit use
What Are the Treatments Tested in This Trial?
Interventions
- CHW4CervicalHealth
- Copan Floqswab
- Evalyn® Brush
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will be assigned to use the Copan FLOQSwab device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
Participants will be assigned to use the Evalyn Brush device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
Participants will be provided the Evalyn Brush self-sample kit at their scheduled Pap smear; a self-collected HPV test will also be collected as part of validation purposes for the study. Results will be shared from both their regularly scheduled appointment and the HPV self sample kit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Roche Pharma AG
Industry Sponsor
Dr. Thomas Schinecker
Roche Pharma AG
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Dr. Levi Garraway
Roche Pharma AG
Chief Medical Officer since 2019
MD from University of California, San Francisco
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