Mailing human papillomavirus (HPV) self-collection tests and offering assistance in booking appointments to under-screened, low-income women improved cervical cancer screening by nearly two-fold compared to scheduling assistance alone.
The findings, published Thursday in Lancet Public Health, were obtained via a phase III, open-label, randomized, controlled trial.
HPV is a common virus that can cause various cancers — including cervical cancer — later in life. An estimated 14,000 women are diagnosed with cervical cancer in the U.S. annually, and the cancer leads to more than 4,300 annual deaths. Cervical cancer disproportionately affects Black and Hispanic women, with Hispanic women having the highest incidence rates, and Black women having the highest mortality rates for the disease. Most cervical cancers occur among under-screened women. An estimated 22% of eligible adults in the U.S. are overdue for screening.
The “My Body, My Test-3” study recruited 665 women, ages 25 to 64, from 22 counties across North Carolina; most lived in urban areas. The women had low incomes and were either uninsured or enrolled in Medicaid or Medicare. All were overdue for screening, having had neither a Pap test in four years nor a high-risk HPV test in six years.
Two-thirds of the women received mailed HPV self-collection kits, followed by scheduling assistance. The other third received scheduling assistance alone, which primarily consisted of helping to book an appointment for in-person screening at a clinic, regardless of whether an at-home test was offered or returned, or whether the HPV test was positive.
Screening uptake was 72% among women who received mailed HPV kits, compared to 37% for the other women. The effect of self-collection outreach upon screening uptake did not vary with age, race, ethnicity, time since last screening, Medicaid or Medicare insurance, or education. The researchers note that at-home kits enable women without access to transportation, and/or those reluctant to undergo cervical exams, to still be screened. They believe their results are applicable to low-income, under-screened women across the U.S.
The researchers are now working to identify women who might be overdue for screening through electronic medical records. They hope to provide the option of either mailing these women at-home self-collection kits to mail back, or offering kits directly to women who come to clinics for other services. They envision eventually making self-collection kits a regular clinical provision, and hope their findings will spur the U.S. Food and Drug Administration (FDA) to approve HPV self-collection as a primary screening test for cervical cancer.
“Many women in our study hadn’t engaged in the screening system for a while and getting the kit to their homes helped break down a fundamental barrier,” Jennifer Smith, corresponding author and epidemiology professor at UNC’s Gillings, said in a statement. “My hope going into this study was that mailing kits for home-based collection might increase cervical cancer screening, but we were thrilled to find a nearly two-fold increase in screening uptake.”
Disclosures: HPV testing reagents, media for self-collected sample preservation, and liquid-based cytology media and cervical sample collection brushes were donated by Hologic. Self-collection brushes were donated by Rovers Medical Devices. Jennifer Smith has received research grants, supply donations, and consultancies from Hologic and Rovers Medical Devices within the past five years.