Should HPV self-testing be usual care in the US?
Self-sampling for HPV infection to screen for cervical cancer prevention would be a useful option for many at-risk individuals as an alternative to provider-collected HPV and cervical cytology.
The COVID-19 pandemic highlights the need for remote testing as a potential option for our most vulnerable and potentially high-risk patients who have been delaying routine well-woman preventive care.
More than 50% of women who are diagnosed with cervical cancer in the U.S. have been unscreened or underscreened within the 5 years prior to their diagnosis. Reasons behind this troubling statistic include limited access to providers due to child care, work or other competing priorities; no insurance or limited coverage due to high deductible plans; limited use of the health care system for prevention, which has been shown to be higher in minority populations; fear of the health care system; or fear of knowing the results of the testing.
The USPSTF, and even more recently, the American Cancer Society, recommended primary HPV testing for cervical cancer prevention based on large prospective U.S. and non-U.S.-based cohort studies suggesting comparable performance with potentially less harm, mainly defined as less colposcopies. This is a major change to prior recommendations that included cytology and cotesting with a Pap and an HPV test. The algorithm starts with the more sensitive HPV test. A standard Pap test, which is more specific, is recommended for those who have high-risk HPV infection that is not HPV type 16 or 18.
Providers, laboratories and patients in some U.S. communities have been transitioning to primary HPV testing for cervical cancer prevention, but it is not a commonly used screening method in the United States. The FDA, in collaboration with the NCI, has been considering self-sampling as an alternative to provider-collected HPV testing, particularly for the hard-to-reach individuals at risk.
Self-sampling with culturally and literacy-level specific guidance has been shown to have similar performance to provider-based testing. For instance, Chen and colleagues reported a 97.5% agreement between the two methods, with high-risk HPV detected in 45.5% of women using self-collected cervicovaginal specimens and 46% using physician-collected cervical specimens. In a noninferiority trial, Polman and colleagues showed the sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling for CIN2+ (relative sensitivity, 0.96; 95% CI, 0.9-1.03; relative specificity, 1; 95% CI, 0.99-1.01) and for CIN3+ (relative sensitivity, 0.99; 95% CI, 0.91-1.08; relative specificity, 1; 95% CI, 0.99-1.01).
In these times of social distancing and limited attention to preventive care due to legitimate concerns of our patients, having the option for self-sampling for highly sensitive HPV testing could overcome some of the challenges of reaching the unreachable and lower the bar for individuals to access safe and reliable cervical cancer screening. With the inclusion of such testing, along with primary prevention with vaccination against HPV, we can come closer to eliminating cervical cancer.
Chen K, et al. J Obstet Gynaecol Res. 2016;doi:10.1111/jog.13132.
Polman NJ, et al. Lancet Oncol. 2019;doi:10.1016/S1470-2045(18)30763-0.
Yeh PT, et al. BMJ Glob Health. 2019;doi:10.1136/bmjgh-2018-001351.
Mark H. Einstein, MD, MS, FACS, FACOG, is professor and chair in the department of obstetrics, gynecology and reproductive health at Rutgers New Jersey Medical School. He can be reached at email@example.com.
I feel strongly that HPV self-sampling should not be standard of care at this time for a multitude of reasons.
First, the quality of the HPV test determines the likelihood that this method is as good as current provider-based screening. Although some HPV tests are able to meet this standard, many are not and a drop in sensitivity could decrease detection rates on a population scale.
Further, self-sampling alone may not alter current screening practices for many women because presentation for screening choices are multifactorial, including access and insurance coverage. Reaching disenfranchised women for screening will require coordination with state free-screening programs, large-scale navigation and coordination of follow-up, as well as counseling about the importance of screening. The most successful self-screening programs went door-to-door.
Lastly, the greatest concern lies in disruption of the current screening model. Currently, more than 80% of women present for screening for cervical cancer and in the process may receive testing and counseling for breast cancer, colon cancer, STDs, birth control, weight management, hypertension, smoking cessation, domestic violence, immunizations and evaluation for symptoms that might indicate other issues. Widespread self-sampling programs that decrease the number of women who present to their provider’s office will have significant negative consequences unrelated to cervical cancer screening. These visits serve many roles in the health of women.
According to a study by Rozemeijer and colleagues, self-sampling will only achieve health effects if the relative sensitivity for CIN2+ is 0.95 or greater, previously unscreened women are recruited to participate and the total attendance increases by at least 6 percentage points.
If we are to have a self-screening program, it needs to include the use of an FDA-approved HPV test for self-sampling that is free and connected to state cervical cancer screening programs that also pay for follow-up testing and treatment. It also must be specifically targeted to women who have not presented for screening within the last 5 years. All women entered in the program will need navigation and counseling to ensure that participation also results in a health care provider visit for other disease prevention and appropriate follow-up of abnormal screening results. Until we have these pieces in place, we are not ready for widespread self-sampling.
Rozemeijer K, et al. Cancer Epidemiol Biomark Prev. 2015;doi:10.1158/1055-9965.EPI-14-0998.
Jennifer Young Pierce, MD, MPH, FACOG, is residency program director of obstetrics and gynecology and professor of interdisciplinary clinical oncology specialty at University of South Alabama. She can be reached at firstname.lastname@example.org.