By Jill Pope, Senior Scientific Editor
Amanda F. Petrik, PhD
A new study at CHR is testing an alternative to the Pap test for cervical cancer screening. CHR Investigator Amanda Petrik’s new study, Self-Testing for Cervical Cancer in Priority Populations—the STEP-2 Trial, funded by the National Cancer Institute, seeks to increase cervical cancer screening rates in safety net clinics. Nearly 30 million people in the U.S. get their health care in clinics like these, which provide care to patients regardless of ability to pay or health insurance. About 90% of patients who get their care in safety net clinics are low-income, and about 64% are members of racial and ethnic minority groups.
Disparities in cervical cancer
Research shows that there are disparities in who gets screened for cervical cancer, and in who gets cervical cancer. About 14,000 cervical cancers are diagnosed each year, and more than half occur among people who were never or rarely screened. Patients who get their health care in safety net clinics have lower rates of cervical cancer screening than national averages. Just over half of eligible patients in these clinics were up to date in 2021. We also know that cervical cancer happens more often among women who are Black or Hispanic (8.3 and 9.3 women per 100,000, respectively) compared to White women (7.4 per 100,000). Black women have the highest rates of death from cervical cancer.
Self-sampling method holds promise
Human papillomavirus (HPV) is the virus that causes nearly all cases of cervical cancer. HPV self-sampling, approved by the Food and Drug Administration (FDA) in May 2024 for cervical cancer screening, allows patients to collect their own vaginal sample privately, when convenient, and without an appointment, instead of having an in-person Pap test. Once their sample is collected, patients can mail it back or drop it off at a clinic for testing. The American Cancer Society has praised the FDA’s approval, saying that “self-collection … has been studied for over two decades and is feasible, acceptable, and comparable to clinician-collected samples.”
Petrik is excited about the role this study may play in making HPV self-sampling kits widely available. “This study hopes to address health disparities before they happen, by testing implementation strategies in high priority populations as the test is being rolled out nationally,” she says. In previous work, Petrik’s team partnered with a media company to create a patient-friendly video that explains why and how to use an HPV self-sampling test.
What the new study will do
In the new study, Petrik and her team at CHR will work with teams at the University of Washington, Kaiser Permanente Washington Health Research Institute, and the University of Chicago to compare two ways to distribute the self-sampling kits to patients. Clinics will be assigned at random to provide either (1) usual care, (2) in-clinic distribution, or (3) in-clinic plus mailed distribution. Clinics will offer the kits to patients ages 30 to 64 who are due or overdue for cervical cancer screening. In addition to looking at kit return rates, the team will assess the cost-effectiveness of the two approaches. Senior Investigator and health economist Richard Meenan will serve as a Co-Investigator on this study, and will lead the cost analysis.
The study team will also work closely with patients and community members to develop effective, culturally tailored messages and reminders about cervical cancer screening. Jamie Thompson, a Senior Research Associate with recognized expertise in this area, will lead this aspect of the work as a study Co-Investigator.
The six-year study will begin with a pilot program at CareOregon, a nonprofit providing health insurance to low-income people, and Virginia Garcia Memorial Health Center, a group of clinics serving Washington and Yamhill counties in Oregon, as well as at two health plans and a clinic in Washington State. As it scales up, the study will partner with five health center organizations representing 66 clinics in urban and rural areas—and nearly 90,000 patients eligible for screening. Anna Edelmann, Project Manager II, will serve as lead project manager for this ambitious study, the first major U.S. clinical trial to test implementation of HPV self-sampling in safety net clinics.
Over the course of this study, Petrik and her fellow researchers hope to learn the most effective ways to offer patients HPV self-sampling tests. If the self-sampling approach improves screening rates among patients at safety net clinics, it could become an effective tool to reduce cervical cancer disparities.