Self-Collection Kits for HPV Screening
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests self-collection kits for HPV screening, the virus that can lead to cervical cancer. It aims to determine if these kits provide results as reliable as a traditional Pap smear and assess their practicality and acceptability in communities. Participants will use either the Evalyn Brush or Copan FLOQSwab, with bilingual community health workers providing guidance. Women aged 25-65 who haven't had a Pap smear in several years and identify as ethnic minorities, such as Hispanic, Black, or Asian, may be suitable candidates. The goal is to make cervical health screenings more accessible for under-screened groups. As an unphased trial, this study offers a unique opportunity to enhance the accessibility and effectiveness of cervical health screenings for diverse communities.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these self-collection kits are safe for HPV screening?
Research shows that both the Evalyn Brush and Copan FLOQSwab are safe for self-collecting samples to test for high-risk HPV, the virus that can cause cervical cancer.
Studies have found that the Evalyn Brush is easy to use, with no reported safety issues. Women find it acceptable and just as effective for detecting HPV as samples collected by healthcare professionals.
For the Copan FLOQSwab, research indicates it performs as well as samples taken by professionals, with no safety concerns related to the liquid used. However, there is an 18% chance of receiving an invalid test result, meaning the sample might not provide a clear answer.
Overall, both methods are considered safe and effective for self-screening for HPV.12345Why are researchers excited about this trial?
Researchers are excited about the self-collection kits for HPV screening because they offer a convenient and private way for individuals to test for HPV at home. Unlike traditional Pap smears that require a visit to a healthcare provider, the Evalyn Brush and Copan FLOQSwab allow for self-collection, which can increase accessibility for those who might face barriers to in-office testing. These kits are supported by community health workers who provide educational workshops, making the process more approachable and culturally sensitive. This approach may lead to earlier detection and prevention of cervical cancer, especially in communities with limited healthcare access.
What evidence suggests that this trial's self-collection kits could be effective for HPV screening?
Research has shown that both the Evalyn Brush and Copan FLOQSwab effectively collect self-samples for HPV (human papillomavirus) testing. In this trial, participants will join different arms to evaluate these devices. Studies found that 98% of users preferred the Evalyn Brush, and it matches the accuracy of samples taken by doctors. This makes it a safe and reliable method for HPV screening, offering a convenient alternative to clinic visits. The Copan FLOQSwab also provides results similar to those collected by healthcare professionals. Both tools effectively detect high-risk HPV types, making them promising options for increasing access to cervical cancer screening.16789
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?
This trial is for women aged 25-65 who haven't had a Pap smear in the last 3-5 years and self-identify as Hispanic, Black/African or Caribbean, Chinese, Korean, or Vietnamese. They must be able to consent and follow instructions. Women with a history of hysterectomy, cervical cancer, current genital infections, pregnancy or previous HPV study participation are excluded.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
Trial Overview
The trial tests two phases: Phase I validates self-collection kits against clinical Pap smears in patients due for screening; Phase II assesses if the CHW4CervicalHealth intervention can increase HPV self-testing among ethnic minority women who are overdue for screening.
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
Citations
Summary of Safety and Effectiveness Data (SSED)
This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39,. 45, 51, 52, 56, 58, 59, 66, and 68. cobas HPV is indicated for use for routine cervical ...
Performance of BD Onclarity HPV assay on FLOQSwabs ...
No significant difference was observed between self-samples tested with the two platforms and between first- and second-collected swabs.
3.
copanusa.com
copanusa.com/wp-content/uploads/2024/10/Saville_et_al_2020_Analytical_performance_of_HPV_assays_J_Clin_Virol.pdfAnalytical performance of HPV assays on vaginal self ...
Results: HPV16/18 results had high observed agreement between self- and practitioner-collected samples on all assays (range: 0.94-0.99), with good agreement for ...
4.
mediadelivery.copangroup.com
mediadelivery.copangroup.com/wp-content/uploads/2024/05/Copan-Self-Vaginal-FLOQSwabs-Agreement-between-clinician-and-selfcollected-samples-for-HPV-detection-Evidence-from-the-scientific-literature.pdfCopan Self Vaginal FLOQSwabs®: Agreement between ...
Here we present evidence from independent published scientific literature on how vaginal self-collected samples with Copan Self Vaginal FLOQSwabs® provide ...
Large‐Scale Study Comparing Analytical and Diagnostic ...
Analytical and diagnostic performance of samples collected by the three self-sampling devices resulted in similar quality and HPV detection.
6.
mediadelivery.copangroup.com
mediadelivery.copangroup.com/wp-content/uploads/2022/04/Self-Collection_JMKC035R01_DIGITAL.pdfSelf-collection - Copan Group
without any liquid-related safety issues! Dry FLOQSwabs® self-collection performance resulted comparable to professional collection14,15,16 and wet sampling ...
Summary of Safety and Effectiveness Data (SSED)
This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,. 59, 66 and 68. The cobas HPV Test is indicated for use for routine ...
Safety and acceptability of human papillomavirus testing ...
FLOQSwabs™ resulted more often in invalid result on hrHPV testing with all studied HPV assays. Proportion of invalid results on undiluted FLOQSwabs™ was 18% ...
NCT07273383 | Self-sampling for HPV Screening
The specimen will be self-collected using a Copan 552C.80 FLOQ Swab and analyzed with the Cobas HPV test on the Cobas 8800 automated system. All ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.