Mailing At-Home HPV Tests May Boost Cervical Cancer Screening Rates in Underscreened Women

Mailing at-home human papillomavirus (HPV) self-collection tests and providing booking assistance for in-clinic screening visits nearly doubled the rate of cervical cancer screenings among underscreened women from low-income backgrounds vs scheduling assistance alone in a phase 3 study whose findings were published in Lancet Public Health.¹

Researchers at the University of North Carolina (UNC) Gillings School of Global Public Health and UNC Lineberger Comprehensive Cancer Center conducted the My Body, My Test-3 study to determine whether mailing at-home tests to underscreened women would increase uptake of cervical cancer screenings. Most cervical cancer cases in the United States occur in women who are underscreened, the authors noted.

“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 2-fold increase in screening uptake,” said study author Jennifer S. Smith, PhD, MPH, professor of epidemiology at the UNC Gillings School of Global Public Health, in a statement.² “Many hadn’t engaged in the screening system for a while and getting the kit to their homes helped break down a fundamental barrier.”

The open-label, 2-arm, randomized trial recruited women from 22 counties in North Carolina. Eligible patients were aged 25 to 64 years, had an intact cervix, were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less of the federal poverty level, lived within the catchment area of a participating clinic, and were overdue for cervical cancer screening at the time of the study.

The study’s primary outcome was screening uptake within 6 months of enrollment in the intention-to-treat population, whether an individual attended an in-person appointment or tested negative for high-risk HPV with a self-collected sample.

Participants were randomized 2:1 to either an intervention group that received a mailed HPV self-collection kit in addition to scheduling assistance or a control group that received scheduling assistance alone. For the self-collection test, participants collected a cervical-vaginal sample at home and returned it by mail to be tested, then received results via phone call.

Scheduling assistance primarily included help booking appointments for in-person visits and was offered whether or not an at-home test was offered or returned and regardless of the HPV testing results. Staff at participating trial locations made up to 3 attempts to provide scheduling assistance via phone call.

A total of 697 women were eligible for inclusion and returned consent forms for participation. After 32 women were determined to be ineligible after randomization, 665 were included in the final analysis. Of these women, 438 were assigned to the intervention group and 227 were assigned to the control group. Most participants with available data were Black non-Latina and non-Hispanic (n = 311; 47%). Further, 78% (n = 518) were uninsured.

In the intervention group, 72% of participants (n = 317) underwent cervical cancer screening, compared with 37% (n = 85) in the control group. In the intervention cohort, 78% of women (n = 341) returned self-collection kits in the mail. Of the returned kits, 11 had invalid results and 1 was damaged. Among the evaluable samples, 52 women (16%) tested positive for high-risk HPV. Only 3 participants reported experiencing hurt or injury during self-collection.

Overall, the study demonstrated dramatically increased cervical cancer screening uptake among underscreened women with low-income backgrounds who were mailed at-home self-collection HPV testing kits. The results suggest there is a benefit to mailed HPV tests in this patient population.

“We believe our results are applicable to low-income, underscreened women across the United States,” Smith said. “We’re now working with clinical partners to identify women who might be overdue for screening through electronic medical records. We hope to provide the option of either mailing them a self-collection kit to use at-home to mail back to us or hand a kit directly to them when they come into clinics for other services with the vision to eventually make self-collection a regular clinical provision.”

References

1. Pretsch PK, Spees LP, Brewer NT, et al. Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label randomised controlled trial. Lancet Public Health. Published online May 11, 2023. 10.1016/S2468-2667(23)00076-2

2. Cervical cancer screening doubles when under-screened women are mailed testing kits. News release. UNC Lineberger Comprehensive Cancer Center. May 11, 2023. Accessed May 11, 2023. https://sph.unc.edu/sph-news/cervical-cancer-screening-doubles-when-under-screened-women-are-mailed-testing-kits/