Increasing access to cervical cancer screening in low-resource health care settings

New study builds on findings that home tests improve screening rates

Each year in the United States, there are 14,000 new cases of cervical cancer — almost all caused by the human papilloma virus (HPV) — and over 4,000 people die of this cancer. In May 2024, the Food and Drug Administration (FDA) approved the self-collection of vaginal specimens for HPV testing in health care 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 conduct research on strategies to implement HPV self-sampling in low-resource health care settings. The 6-year study, called “Self-Testing for Cervical Cancer in Priority Populations: the 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 and affiliate investigator at KPWHRI who is the STEP-2 Trial principal investigator. “This study aims to evaluate strategies to increase cervical cancer screening access for these populations.”

FQHCs are federally funded nonprofit health care 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 2-phase pilot and pragmatic trial that 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 2 will be a cluster-randomized pragmatic trial in 42 FQHC clinics in Oregon and Washington that will 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 and a co-investigator on the STEP-2 trial. “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 health care settings, we expect to see health care 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.”  

This has been adapted from a news story by Laura East at the University of Washington Department of Epidemiology.