Researchers have found that mailing human papillomavirus (HPV) self-collection kits in addition to offering scheduling assistance to underscreened, underserved patients may increase the rate of cervical cancer screenings compared with scheduling assistance alone, according to a new study published by Pretsch et al in The Lancet Public Health.
Background
HPV is the most common sexually transmitted infection. In most cases, HPV resolves on its own in a few years and does not cause health problems. However, for some individuals, the infection can spur precancerous lesions in the cervix. If physicians are aware that a patient has HPV-associated cervical lesions, they can remove the lesions early to decrease the risk of developing cervical cancer. The biggest risk factor for cervical cancer is often forgoing cervical cancer screenings, which is more common among those without medical insurance or the financial stability to cover the costs of tests or in-person clinical visits.
“Many of the cervical cancer cases in the United States are occurring among [patients] who haven’t been screened regularly, or at all, because of [a] lack of insurance, barriers to transportation, or a lack of knowledge about statewide screening programs that offer screenings free of charge or at a sliding scale,” explained senior study author Jennifer S. Smith, PhD, Associate Professor of Epidemiology at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and Director of the Cervical Cancer-Free Coalition.
In 2018, the World Health Organization announced a global call to eliminate cervical cancer. Because nearly all cervical cancers are caused by an initial infection with oncogenic types of HPV, screening for the virus is critical to preventing and treating the disease. However, providing HPV screenings only within clinical settings could limit access for many underserved patients across the United States.
“We showed that underscreened [patients] were able to take the time to complete an HPV self-collection kit, return it successfully, found the process acceptable, and it actually led to their reengagement in cervical cancer screenings,” highlighted Dr. Smith. “Our study was particularly unique because we used two levels of intervention to increase screening uptake,” she added.
Study Methods and Results
In the new open-label, two-arm, randomized controlled My Body, My Test-3 phase III trial, the researchers contacted and helped book screening appointments at nearby clinics for 665 patients. The patients participating in the trial were further broken down into two groups—one comprising individuals offered HPV self-collection kits and scheduling assistance and a second comprising individuals only offered scheduling assistance—to help the researchers determine whether the intervention was successful on its own.
The HPV self-collection kits included illustrated instructions, a self-collection brush to obtain cervicovaginal cell samples to test for HPV infection, and a prestamped envelope to send back their samples for laboratory testing. The HPV tests have been found to be comparable in performance to physician-collected tests regarding the detection of high-grade cervical precancerous lesions or cancer.
One of the advantages of self-collection kits is that it eliminates the need for an initial in-clinic pelvic examination and can be performed at home or at another location that is convenient for the patient. Those with positive HPV results are then referred to follow-up care at the clinic. The researchers emphasized that the mailing of self-collection kits may help reduce access barriers to care.
Conclusions
The researchers found that the trial served as a challenging learning experience about the strategies physicians can use to reach patients overdue for cervical cancer screenings. They used a variety of community-outreach methods to recruit patients for the screening trial—including social media, radio, and flyers on local buses. The researchers stressed the importance for physicians, researchers, and programs to find interventions and screening strategies that cater to the patients who need to be screened.
“We won’t make an impact on reducing cervical cancer in North Carolina, or globally, until we are able to find the [patients] who aren’t being screened and ensure that they get screenings. We need to work together with them. Our results showed that mailing HPV self-collection kits to [patients] who had not been screened regularly doubled cervical cancer screening uptake,” Dr. Smith underscored.
The researchers noted that the idea of self-collection techniques is not a new concept globally; however, the technique is still under review by the U.S. Food and Drug Administration (FDA). They hope their new findings will help provide some extra momentum for the FDA’s approval of HPV self-collection kits. If the kits are approved by national screening bodies; programs; and community organizations such as Medicaid, Federally Qualified Health Centers, or the Breast and Cervical Cancer Control Program, they could implemented by mail or within the clinical setting.
The researchers underlined that as more programs consider integrated self-collection techniques as part of patient care, it is critical to consider the entire cervical cancer cascade—from increasing screening access to providing the needed follow-up care if a self-test result is positive.
“It is important to ensure that [patients] can have access to providers if they have questions about the self-collection process or their results. If they have a positive self-test result, they need to be ensured the appropriate follow-up care for good patient care,” Dr. Smith concluded.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
