Is HPV Self-Sampling the New Cologuard?

EBM Focus - Volume 20, Issue 1

Reference: J Med Screen. 2024 Aug 1 early online

Practice Point: Through two degrees of Kevin Bacon, at-home HPV self-collection kits improve cervical cancer survival (see EBM Pearl, next).

EBM Pearl: Screening participation may vary in how well it connects to survival outcomes depending on the condition and population. For cervical cancer screening, the rate of screening participation is thought to be a reliable surrogate.

Cervical cancer is highly preventable through vaccination and screening. While rates of screening are much higher in high-income countries compared to middle- and low-income countries, even in the United States there has been a notable decline in cervical cancer screening in recent years. The high cost of infrastructure needed for screening programs and HPV lab testing is a major barrier in low-income countries, but the physical and emotional vulnerability required for conventional provider-based screening, especially for those with a history of sexual trauma, is an important consideration worldwide. HPV self-screening programs have been studied for at least a decade, but they have not made their way into standard clinical practice yet, in part due to small trial sizes and limited generalizability across populations.

The most recent evidence (that will likely eek us toward an eventual paradigm shift) comes from a large trial recently published comparing the participation rates of three screening programs in Estonia, a country in Europe with relatively low rates of screening and high rates of cervical cancer despite universal access to screening since 2006. Investigators randomized 58,008 patients with valid addresses who were due for screening in 2021 to one of three arms: HPV self-sampling with "opt-out," HPV self-sampling with "opt-in," and a control group who received standard care. In the opt-out arm, patients automatically received a validated HPV self-sampling kit (Qvintip®) in the mail in addition to a screening reminder by email that offered a choice between self-sampling and conventional sampling by a health care provider. Since they already had the HPV self-collection kit in hand, they would have to opt out in order to get screened by a provider or to forgo screening entirely. In the opt-in arm, patients received the email reminder only, which offered the choice of screening and a link to order the (free) self-sampling kit. Patients in the control arm received a standard email reminding them to make an appointment to have conventional screening with their provider.

Overall screening rates (by either self- or provider-sampling) were 41.7% in the opt-out arm, 34.1% in the opt-in arm, and 29% in the control arm; p < 0.001 for comparisons between opt-out or opt-in vs. control group and opt-out vs. opt-in group. Patient acceptance of self-sampling was encouraging, with more patients in both intervention arms choosing self-sampling over provider-sampling, and only 3.5% of respondents who chose self-sampling reporting that they would prefer provider-sampling in the future. And the rate of inadequate samples from self-collection was an impressive 0.2%.

These results seem to make a strong case for HPV self-sampling, and they add to a growing body of evidence suggesting that HPV self-sampling improves participation in cervical cancer screening, especially when the kits are mailed automatically. However, at-home HPV kits are more like Cologuard than at-home COVID tests because you have to send the specimen back to get the results. Improved access to sampling doesn’t mean much in places where processing is still cost-prohibitive. And to step lightly into the realm of the unintended harms of our good intentions, we’d need to make sure that automatically mailing out HPV kits wouldn’t decrease participation in other important screening measures because for some, passing on the Pap may mean skipping the preventive visit altogether. But let’s face it: We live in a world of conveniences, so why would people expect health screenings to be any different? HPV self-sampling has good diagnostic accuracy, probably doesn’t cost more than provider-based testing (all things considered), and cuts out the embarrassment, discomfort, or even trauma from having someone else do it. So the option of HPV self-sampling seems like it should make its way to the table (literally).

For more information, see the topic Cervical Cancer Screening in DynaMed.

DynaMed EBM Focus Editorial Team

This EBM Focus was written by Katharine DeGeorge, MD, MS, Senior Deputy Editor at DynaMed and Associate Professor of Family Medicine at the University of Virginia. Edited by Alan Ehrlich, MD, FAAFP, Executive Editor at DynaMed and Associate Professor in Family Medicine at the University of Massachusetts Medical School; Dan Randall, MD, MPH, FACP, Senior Deputy Editor at DynaMed; Vincent Lemaitre, PhD, Medical Editor at DynaMed; McKenzie Ferguson, PharmD, BCPS, Senior Clinical Writer at DynaMed; Rich Lamkin, MPH, MPAS, PA-C, Clinical Writer at DynaMed; Matthew Lavoie, BA, Senior Medical Copyeditor at DynaMed; Hannah Ekeh, MA, Senior Associate Editor II at DynaMed; and Jennifer Wallace, BA, Senior Associate Editor at DynaMed.