HPV Self-Collection for Cervical Cancer Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for collecting samples for HPV testing, which could help prevent cervical cancer. Participants will collect their own samples at home, potentially offering more comfort and convenience than a clinic visit. The trial will compare the accuracy of self-collected samples to those collected by doctors. Women who tested positive for HPV in the past year and have been referred for further testing might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could make HPV testing more accessible and comfortable.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this self-collection method is safe for cervical cancer screening?
Research has shown that collecting your own vaginal sample for HPV testing is generally safe. In a study with 609 participants, 13.8% tested positive for high-risk HPV and needed follow-up, but researchers reported no major safety issues. This suggests that self-sampling doesn't cause significant problems.
Self-collection allows individuals to gather their own vaginal sample for HPV testing. This method can detect high-risk HPV types linked to cervical cancer. Studies have shown that people generally tolerate this method well.
Overall, self-collection is considered a safe alternative to having a doctor collect the sample. It offers more comfort and flexibility, which can encourage more people to get tested. This is important because regular HPV testing can help catch potential issues early, reducing the risk of cervical cancer.12345Why are researchers excited about this trial?
Researchers are excited about the HPV self-collection method for cervical cancer prevention because it empowers individuals to collect their own samples in the comfort of their homes, potentially increasing participation rates in screening programs. Unlike the traditional clinician-collected cervical samples, this self-collection approach offers more privacy and convenience, which might encourage more people to get tested who otherwise might avoid it. By making it easier for individuals to participate in regular screenings, the self-collection method could lead to earlier detection and treatment, ultimately reducing cervical cancer rates.
What evidence suggests that HPV self-collection is effective for cervical cancer prevention?
Research has shown that self-collection kits for HPV testing offer a promising method to prevent cervical cancer. One study found that mailing these kits more than doubled the number of women screened, particularly among those never tested or overdue. Specifically, women using these self-tests had a 90% lower rate of cervical cancer. This trial will compare the effectiveness of self-collected samples to clinician-collected samples. Offering self-sampling to those overdue for screening increased participation and is expected to reduce cervical cancer rates. These findings suggest that self-collection could simplify testing access and aid in preventing cervical cancer.23678
Who Is on the Research Team?
Vikrant V Sahasrabuddhe
Principal Investigator
National Cancer Institute Division of Cancer Prevention
Are You a Good Fit for This Trial?
This trial is for individuals referred for colposcopy or cervical excisional procedures to prevent cervical cancer. Participants will use self-collected vaginal samples for HPV testing. It's part of an initiative to increase access to screening and inform FDA reviews of self-collection methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection
Participants undergo self-collection of a vaginal sample and clinician-collection of a cervical test sample
Standard of Care Procedures
Participants undergo standard of care colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated
Follow-up
Laboratory results are collected for study outcomes, and participants are monitored for safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- HPV Self-Collection
Trial Overview
The SHIP Trial tests the clinical accuracy of HPV testing on self-collected vaginal samples versus clinician-collected cervical samples. The goal is to see if self-collection can be a reliable alternative method for cervical cancer screening.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Self-Collection for Cervical Cancer Screening in a Safety- ...
This randomized clinical trial compares the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone reminders to ...
Cost-Effectiveness of HPV Self-Testing Options for Cervical ...
This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...
3.
mdanderson.org
mdanderson.org/newsroom/mailed-self-collection-hpv-tests-boost-cervical-cancer-screening.h00-159777234.htmlMailed self-collection HPV tests boost cervical cancer ...
Mail-in self-collection tests for human papillomavirus (HPV) more than doubled cervical cancer screening participation among never- and under-screened US women.
Self‐collected vaginal specimens for human papillomavirus ...
... effectiveness and efficiency in cervical cancer prevention. ... Data indicate a 90% reduction in cervical cancer among women who received HPV ...
Impact of mode of offer of self-sampling to people overdue ...
Offering self-sampling to those overdue cervical screening increases screening coverage and should result in lower rates of cervical cancer.
summary of safety and effectiveness data (ssed)
This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and ( ...
New Guidelines for HPV Testing Using Self Collection - NCI
New guidelines for clinicians performing cervical cancer screening advise on management of HPV test results from self-collected vaginal samples.
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 ...
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