Women’s health champions like us cheered in January when the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation for cervical cancer screening for high-risk genotypes of human papillomavirus (HPV), including the use of self-collection tests. The move follows the Food and Drug Administration’s approval of self-collection tests last summer.
The only downside: Both the recent approval and draft recommendations actually limit women to screening themselves in clinics and providers’ offices, limiting this powerful tool’s use. The FDA and the USPSTF must allow women to screen themselves from the comfort of their own homes.
Patients have growing acceptance of and comfort with self-collection tools. Covid taught us about at-home tests; there are self-collection stool samples to predict colorectal cancer, cheek swabs that offer clues to our genetics, sputum samples we mail in to detect HIV. It’s clear people in the U.S., and women in particular, are well-positioned to leverage these tools to promote their own health and increase their access to health care and understand when they’re at risk.
At-home HPV self-collection of samples is simple, efficient, and, for women familiar with using menstrual products, completely comfortable. With a kit in hand — currently distributed through health care providers’ offices, community health workers, or by mail-in research studies — women follow simple instructions. With one foot propped on a toilet seat, much like inserting a tampon, test-takers insert a long collection brush with soft bristles at one end into the vagina until it “stops” at the cervix. Then test-takers twist the brush end five to eight times to ensure a sufficient sample is collected before removing the brush, sealing its collection tip end into the kit’s enclosed vial, and then placing the vial inside a padded, addressed, prepaid envelope, and dropped off at an office or the post office.
There are at-home tests currently approved for use in the home for research purposes only. They are exactly the same as the tests that now allow women to self-collect their own samples in providers’ offices. And women are good at collecting their own samples, too, research has proven. Clinician-collected samples and self-collected samples have similar levels of accuracy.
So why not allow the HPV test to be done by women in their homes? The USPSTF, whose role is to evaluate evidence before making a recommendation, noted there’s evidence that self-collection increases screening engagement when women can complete these tests at home. It’s the FDA that has stymied the test’s approval in the home for now: That organization remains a hurdle in the HPV self-collection test’s approval to being allowed in American women’s homes.
Greenlighting the HPV self-collection test but then confining its use to health care providers’ offices doesn’t make sense. Half of all cervical cancer cases diagnosed in the U.S. are among individuals who have either never been or are infrequently screened. What keeps them away? Lack of awareness, limited income, geography, embarrassment: The list goes on. An HPV self-collection test combined with a way to mail in or drop off specimens will finally give those who are reticent to be screened a path to access, knowledge, and, maybe most importantly, the possibility of a health care home.
It’s unclear precisely how many women don’t get screened for cervical cancer because of the sheer dread of finding themselves splayed on a table, in stirrups, with a speculum uncomfortably inserted into their private parts. What is clear, though, is that HPV self-collection tests are a powerful tool that, if endorsed by the FDA and recommended by the USPSTF for use both in clinics and in private homes, can put us on a clear path to eliminate cervical cancer — and mortality from it — for good.
One of us, Emma, conducted research in rural Nicaragua, where cervical cancer is the leading cause of mortality for women aged 15 to 44. As part of that project, women said that HPV self-collection tests were feasible, acceptable, and easy to use. Ninety-nine percent of the nearly 2,000 women in our study used one. If they tested positive for high-risk genotypes of HPV that cause cervical cancer, we helped them navigate follow up with the local health care system and provided education. Those seemingly small details often meant the difference between battling and surviving cervical cancer — or dying from it.
The National Cancer Institute’s “Last Mile Initiative” is currently investigating broadening the reach of the HPV self-collection test at home. As part of NCI’s SHIP trials, scientists are assessing the test’s usability, acceptability, and the self-collected specimens’ accuracy.
In the U.S., HPV vaccine rates are leveling off, even in states like Virginia, where it’s mandatory. To beat cervical cancer, then, we need ways to reach rarely- and never-screened women. If the FDA/USPSTF approves the HPV self-collection test for use at home, a world of possibility for distributing it opens: When people go to their doctor or even a pharmacy to get a flu or Covid shot, they could take a kit home, popping their sealed specimens in the mail. Electronic health records could enable us to automatically mail HPV self-collection tests to those who are due for screening or haven’t had follow-up visits. This test, and its in-home application can mean we finally, truly, put cervical cancer in our crosshairs.
But without the ability for women to collect their own samples at home, and mail them in, the possibility of eliminating cervical cancer is limited. As someone who has seen what happens when cervical cancer goes untreated, it is ugly. Death from it is painful, horrific, and tragic, and doubly so because cervical cancer, if caught early, is almost entirely treatable.
This is not the end of the Pap, but the beginning of a new era for women’s health and our collective, bold effort to tackle cervical cancer once and for all. The HPV self-collection test’s place is in the home. Approve it for use there and we will be committing to and part of the World Health Organization’s bold plan to eliminate cervical cancer worldwide.
Emma McKim Mitchell, Ph.D., R.N., is an associate professor at the University of Virginia and an NIH-funded nurse scientist who is currently deploying a culturally tailored mHealth approach to screening, follow-up, and treatment of cervical cancer in rural Nicaragua. Christine Phelan Kueter, a former health journalist and public radio reporter, works as a magazine editor at UVA School of Nursing.