HPV Self-Collection for Cervical Cancer Screening

Enrolling by invitation at 1 trial location
JM
CT
Overseen ByClinical Trials Referral Office
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether offering an HPV self-collection test at Mayo Clinic Express Care clinics can increase cervical cancer screening rates and improve follow-up care. Regular screening and treatment of early changes can often prevent cervical cancer, yet many people are overdue for screenings. Participants will either receive the usual care, involving an in-office exam, or try the self-collection method. Women overdue for cervical cancer screening by at least a year, without symptoms like pelvic pain or unusual bleeding, might be suitable for this trial.

As an unphased study, this trial provides a unique opportunity to contribute to innovative screening methods that could enhance accessibility and convenience for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using chronic immunosuppressant medication, you would not be eligible to participate.

What prior data suggests that HPV self-collection is safe for cervical cancer screening?

Research has shown that collecting one's own sample for HPV testing is safe and easy to handle. In studies, over 80% of women found this method acceptable, with many stating it was more convenient and less embarrassing than traditional methods. Most women also found it equally or less stressful compared to samples collected by a doctor.

The FDA has approved HPV self-collection, confirming its safety. Many clinics already use this method, so it is not entirely new. Overall, collecting one's own sample for HPV testing appears to be a safe choice for women considering this screening method.12345

Why are researchers excited about this trial?

Researchers are excited about HPV self-collection for cervical cancer screening because it empowers individuals to take charge of their health by collecting samples themselves, potentially increasing screening accessibility and participation. Unlike traditional methods that require a visit to a healthcare provider for a Pap smear or HPV test, this method allows for more privacy and convenience, which can be particularly beneficial for those with limited access to healthcare facilities. By making screening easier and more accessible, HPV self-collection could lead to earlier detection and treatment of cervical cancer, ultimately improving outcomes for more people.

What evidence suggests that HPV self-collection is effective for cervical cancer screening?

This trial will compare HPV self-collection with usual care for cervical cancer screening. Studies have shown that when women collect their own samples for HPV testing, the number of women screened for cervical cancer increases significantly, especially among those overdue for screening. Research indicates that mailing self-collection kits more than doubled participation in cervical cancer screening, particularly among women who had never been screened or were not screened regularly. Most women found self-collection more convenient and less embarrassing than traditional tests conducted by a healthcare provider. This method is also considered cost-effective, making it accessible to many. Overall, HPV self-collection offers a promising way to boost cervical cancer screening rates.56789

Who Is on the Research Team?

KL

Kathy L. Maclaughlin, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals due for cervical cancer screening. It's testing if offering HPV self-collection at clinics with extended hours increases the number of people getting screened and following up on care.

Inclusion Criteria

I am a woman aged 30-63, see a doctor at Mayo in Rochester or Kasson, and feel healthy.
I am overdue for a cervical cancer screening by 1 year or more.
Must have an active Patient Online Services account, approval for research contact status in portal/Epic, documentation of Minnesota research authorization, and health insurance coverage

Exclusion Criteria

I am on long-term medication to suppress my immune system.
I have had a hysterectomy.
I have cervical cancer.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an invitation to schedule and complete cervical cancer screening via HPV self-collection at an Express Care clinic or choose usual care with their primary care team

Up to 6 months

Follow-up

Participants are monitored for follow-up of abnormal results obtained by self-collection or clinician-collection

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • HPV Self-Collection
Trial Overview The study compares usual care, which includes annual reminders to schedule a screening, with an option to use HPV self-collection kits in Express Care clinics. The goal is to see if this improves screening uptake.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (HPV self-collection)Experimental Treatment5 Interventions
Group II: Arm II (usual care)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

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 ...
Cost-Effectiveness of HPV Self-Testing Options for Cervical ...Mailing human papillomavirus (HPV) self-sampling kits to underscreened individuals increases cervical cancer screening and can be cost-effective ...
Mailed 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.
Effect of HPV self-collection kits on cervical cancer ...Mailed HPV self-collected samples have the potential for even greater effects if the US Food and Drug Administration approve them for primary ...
Self-Sampling for Human Papillomavirus TestingMost reported self-sampling as more/equally convenient (89.0%), less/equally embarrassing (99.4%), and less/equally stressful (95.7%) than provider-performed ...
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 ...
New Guidelines for HPV Testing Using Self Collection - NCINew guidelines for clinicians performing cervical cancer screening advise on management of HPV test results from self-collected vaginal samples.
The acceptability, safety, and performance of primary cervical ...The acceptability of self-collection is high with more than 80% of participants indicated positive responses to at least five (out of six) acceptability indices ...
Self-Collection for Primary HPV Testing: Acceptability in a ...In summary, our data suggest that HPV self-collection was well accepted by underscreened women waiting to receive noncritical care at the safety ...
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