HPV Self-Testing Intervention for Cervical Cancer Screening

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byPaul Reiter, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.

Eligibility Criteria

This trial is for women in Appalachia who haven't had a cervical cancer screening (Pap test) in the last 3 years, or a Pap plus HPV test in 5 years. Participants should not be pregnant, have no history of invasive cervical cancer, must have an intact cervix and telephone, live in an Appalachian county, and have visited a participating clinic recently.

Inclusion Criteria

Not currently pregnant

Have a working telephone

Seen in a participating clinic/health system in last 2 years (i.e., active patient)

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Treatment Details

Interventions

HPV Self-Collection (Virus Therapy)
Patient Navigation Program (Behavioral Intervention)

Trial OverviewThe study tests if self-testing for HPV can help more women get screened for cervical cancer. It includes reviewing medical charts, providing information about HPV and screening, guiding patients through the healthcare system (patient navigation), conducting surveys on their experience, and promoting best practices.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (intervention)Experimental Treatment3 Interventions

Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.

Group II: Group II (usual care continued)Active Control4 Interventions

Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

HPV Self-Collection is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as HPV Self-Collection for: