Three years ago, the federal government set a series of targets to improve Americans’ overall health. Among the dozens of goals laid out in the plan, called

That, in turn, would enable more people to catch cervical cancer early, .����

New research from the ����Ӱ�Ӵ�ý and the (KPWHRI) found that the simplest solution may also be the most effective: mailing test kits directly to patients’ homes. In a study, researchers report that mailing test kits significantly increased cervical cancer screening rates, both in populations overdue for screening and those who had previously kept up to date. ��

The home test kits detect the presence of the human papillomavirus (HPV), which causes most cervical cancers. And a negative HPV test counts as a negative cervical cancer screening, allowing most people to avoid a clinic visit altogether. Currently, more than half of all cervical cancers diagnosed in the United States are in people who are overdue for screening or have never been screened. The team behind this study believes at-home testing can help close the gap.��

“This is an alternative, patient-centered way to get people screened for cervical cancer, because patients tend to prefer testing at home and not having to come into the clinic,” said , a UW professor of epidemiology who led the research. “This is a strategy that other countries are already using, and there’s overwhelming evidence that an HPV test on a patient-collected sample is to an HPV test on a sample collected by a clinician. So there’s really no reason why this shouldn’t be available in the U.S.” ��

In partnership with Kaiser Permanente Washington, researchers enrolled more than 31,000 female patients between the ages of 30-64 who were either due or overdue for screening, or whose screening history was unknown. Depending on their screening history, patients were randomly sorted into four groups: One group had HPV test kits mailed directly to participants’ homes, another received information on how to request a test kit, and another received an educational brochure on cervical cancer screening. The fourth group received only a standard reminder that participants were due for screening.

Over the next six months, 62% of people who were due for screening and 36% of people who were overdue were screened for cervical cancer after being directly mailed a kit. Those percentages fell to 48% and 19%, respectively, among patients who received only the educational brochure. Sending information on requesting a kit minimally increased screening.����

The results, Winer said, indicate that healthcare systems should prioritize mailing HPV test kits directly to patients to maximize cervical cancer screening participation.����

“We just think this should be an option for all patients,” Winer said. “It’s convenient, preferred by most patients and an accurate way to screen for cervical cancer. So why not have it as an option?”��

This study builds on previous research conducted by Winer and her colleagues, which found that mailing HPV test kits to under–screened patients increased screening rates, though most people remained untested. That study took place before the cervical cancer screening guidelines were updated to include HPV testing alone, so the test kit did not count as a regular screen.������

Self-testing is already an option for other routine screenings, most notably for colorectal cancer. The most recent guidelines encourage home test kits as a primary screening option, suggesting that annual stool samples may be taken in place of a routine colonoscopy, which many patients find uncomfortable. Home test kits are now so commonplace that Saturday Night Live has parodied the ubiquitous TV commercials for one prominent manufacturer.����

Colorectal screening rates have in recent years. ��

There are still significant barriers to overcome before HPV self-sampling can become widely available, Winer said. Chief among them is approval by the Food and Drug Administration, which is expected to come in the next few months.��

Once HPV self-sampling receives FDA approval for use as a cervical cancer screening tool, healthcare systems that want to implement self-screening need to procure test kits, review their policies and educate both patients and providers. Algorithms used to track patients’ care have to be updated. Health centers serving low-income and marginalized communities may not have the staff or financial resources to distribute test kits. Patients without a primary care physician may slip through the cracks

“HPV self-sampling is a tool certainly designed to increase access and reduce disparities,” Winer said. “But sometimes when a new intervention is introduced, it can further widen disparities if there isn’t attention taken to how to best implement it, or how to specifically make sure that it reaches people who need it the most.”��

This research was co-led by , a senior investigator at KPWHRI. Other authors include John Lin, research coordinator in the UW Department of Epidemiology; Melissa Anderson and Kristina Hansen from KPWHRI; Jasmin Tiro and Hongyuan Gao from the University of Chicago; Richard Meenan from the Kaiser Permanente Center for Health Research; Angela Sparks from UnitedHealthcare; and Diana Buist of GRAIL LLC in Menlo Park, Calif. This research was funded by the National Cancer Institute.��

For more information, contact Winer at rlw@uw.edu.����

Signaling a potential major change in cervical cancer screening options for American women, a new study found that mailed self-sampling kits that test for HPV — the virus that can cause cervical cancer — helped significantly more women get screened for the cancer.

The involving nearly 20,000 women was conducted by researchers from the ����Ӱ�Ӵ�ý and Kaiser Permanente Washington Health Research Institute and was published Nov. 6 in JAMA Network Open.

In the study, women within the Kaiser Permanente Washington system who hadn’t been screened for cervical cancer in more than three years were randomized into two groups: Roughly half were mailed an HPV self-sampling kit that they could complete as an alternative to Pap screening, and the other half received only the standard care reminders to be screened in a clinical setting.

Within the cohort of underscreened women in the self-testing arm of the study, 26% were screened for cervical cancer versus 17% of underscreened women who received the standard reminders. Of those underscreened women who returned the kits, 88% tested negative for the virus, signaling low risk for cervical cancer.

“Many studies have shown that an HPV test on a sample that a woman collects for herself performs as well as an HPV test done on a physician-collected sample,” said lead author , professor of epidemiology at the and affiliate investigator at Kaiser Permanente Washington Health Research Institute. “Randomized trials in other countries have shown that offering home-based HPV testing increases screening participation, but this was the first U.S. trial to study the impact of mailed kits in a real-world health system setting.”

Half of the 12,000 cervical cancers diagnosed annually occur in women who have gone longer than three years without a screening, according to . That makes these women a high-priority population to get screened, the researchers said.

“We found that mailing unsolicited self-collection kits for HPV testing increased cervical cancer screening by 50 percent in women who were underscreened for cervical cancer, and that’s a particularly hard population to reach,” said co-author , senior investigator and director of research and strategic partnerships at .

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“So, it’s a good news story,” Buist said. “And now that HPV-only testing is a recognized screening strategy in the United States, it really opens up the possibility for home testing to be a widespread option for women.”

Researchers also wanted to find out whether this high-priority population of women would perform the self-sampling and then, if the sample tested positive for HPV, go in for a follow-up test to determine the presence of precancerous cervical cells that could be treated to prevent cancer.

Unfortunately, they noted, while the vast majority of women tested negative for the virus, not all of the participants who tested positive followed up.

“It’s great that 88% of women who self-sample at home would not need to come into the clinic,” Winer said, “but there’s a key 12% in our trial that were identified to be at increased risk for cervical cancer — and yet only 70% of those women came in for follow-up testing.”

Consequently, the researchers said, additional implementation efforts need to strategize how to increase use of the kit and in-clinic follow-up for positive results to maximize detection and treatment of pre-cancers in high-risk women.

“The landscape of cervical cancer screening in the U.S. is changing, and there is a real opportunity to expand options and improve the screening process for women,” Winer added. “I’m hopeful that a few years down the line, home-based screening will become routinely available.”

Co-authors include John Lin, research study coordinator at the UW Department of Epidemiology in the School of Public Health; Jasmin Tiro, associate professor at the University of Texas Southwestern Medical Center; Diana Miglioretti, senior investigator at Kaiser Permanente Washington Health Research Institute and professor at University of California, Davis; Tara Beatty, project manager at Kaiser Permanente Washington Health Research Institute; Hongyuan Gao, programmer at Kaiser Permanente Washington Health Research Institute; Kilian Kimbel, research specialist at Kaiser Permanente Washington Health Research Institute; and Chris Thayer, chief medical information officer at Kaiser Permanente Washington.

This research was funded by the National Cancer Institute of the National Institutes of Health.

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Grant: R01CA168598

For more information, contact Winer at rlw@uw.edu or 206-616-5081