Increasing Access to Cervical Cancer Screening in Low-Resource Healthcare Settings
Each year in the United States, there are 14,000 cervical cancer cases and over 4,000 deaths due to human papilloma virus (HPV). In May 2024, the US Food and Drug Administration (FDA) approved the self-collection of vaginal specimens for HPV testing in healthcare settings. Screening for HPV can help prevent cervical cancer, and the FDA’s recent approval of HPV self-sampling increases the availability of more accessible cervical cancer screening options that do not require a pelvic exam.
The University of Washington (UW) was recently awarded a grant from the National Cancer Institute to work in partnership with researchers at Kaiser Permanente Washington Health Research Institute (KPWHRI), Kaiser Permanente Center for Health Research, and the University of Chicago, to further research on strategies to implement HPV self-sampling in low-resource healthcare settings. The six-year study called ‘Self-Testing for Cervical Cancer in Priority Populations: the STEP-2 Trial (STEP-2 Trial)’, will evaluate interventions to integrate HPV self-sampling into clinical practice at federally qualified health centers (FQHCs).
“We know that marginalized and underinsured populations experience cervical cancer disparities due to under-screening,” said Rachel Winer, PhD, MPH, a UW professor of epidemiology, who is the STEP-2 Trial Principal Investigator. “This study aims to evaluate strategies to increase cervical cancer screening access for these populations.”
Federally qualified health centers (FQHCs) are federally funded nonprofit healthcare facilities that provide primary care services for medically underserved areas and populations. Currently, the approximately 30 million patients receiving care at FQHCs in the United States have much lower cervical cancer screening rates than national averages. The STEP-2 Trial is a two-phase pilot and pragmatic trial, which will look at interventions to integrate HPV self-sampling into FQHCs. The first phase will use community-engaged research to adapt interventions for distributing HPV self-sampling kits both in FQHC clinics and via mailed self-sampling kits in partnership with Medicaid health plans. Phase two will be a cluster-randomized pragmatic trial in 42 FQHC clinics in Oregon and Washington, to evaluate comparative effectiveness and cost-effectiveness of the interventions.
The STEP-2 Trial builds on previous research from Winer and her colleagues at KPWHRI, which found that mailing HPV test kits significantly increased cervical cancer screening rates, both in populations overdue for screening and those who had previously kept up to date.
“Based on these findings, Kaiser Permanente Washington implemented HPV self-sampling as a standard-of-care cervical cancer screening option for all patients who are due or overdue for screening,” explained Beverly Green, MD, MPH, senior investigator at KPWHRI. “Individuals due or overdue for cervical cancer screening receive HPV self-sampling kits in the mail. They can then complete the screening themselves in the privacy of their home, and have options for either self-sampling or clinician collected cervical cancer screening tests in a clinic.”
“Following the FDA approval for healthcare settings, we expect to see healthcare systems implementing HPV self-sampling options more widely to increase cervical cancer screening,” Winer said. “Our hope with the STEP-2 Trial is to engage FQHCs and the communities they serve to help inform how to effectively integrate self-sampling in these settings and reach patients who may face greater barriers to screening.”