Abstract
In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation. To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening. Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018. The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit. Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome. A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60). Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+. ClinicalTrials.gov identifier: NCT02005510.
Highlights
IntroductionIn the United States, 25% of women delay or forego recommended cervical cancer screening
In the United States, 25% of women delay or forego recommended cervical cancer screening.1-3 Welldocumented barriers include lack of time or transportation, difficulties finding childcare or taking time off work, fear of pelvic examinations, and prior negative experiences with screening.4-9 Reducing underscreening is a key prevention priority,10 as more than 50% of the 12 000 cervical cancers diagnosed annually are in underscreened women.9,11-13In 2018, the US Preventive Services Task Force released updated cervical cancer screening guidelines14 that include 3 recommended options for women aged 30 to 65 years: Papanicolaou testing alone, Papanicolaou and human papillomavirus (HPV) cotesting, and primary HPV-only screening
Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment
Summary
In the United States, 25% of women delay or forego recommended cervical cancer screening.. In 2018, the US Preventive Services Task Force released updated cervical cancer screening guidelines that include 3 recommended options for women aged 30 to 65 years: Papanicolaou testing alone, Papanicolaou and human papillomavirus (HPV) cotesting, and primary HPV-only screening (a new strategy). Population-based randomized clinical trials in countries with organized screening programs (ie, centrally designed and managed, with standardized screening invitations and follow-up for a specific target population) demonstrated that mailing HPV self-sampling kits to underscreened women increased participation compared with invitations for clinic-based screening and diagnostic follow-up compliance after HPV-positive selfsampling results was high, yielding increased detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).. Australia and the Netherlands—the first countries to implement primary HPV screening—have included HPV self-sampling options for underscreened women. With primary HPV screening, home-based screening is an emerging option because HPV tests (unlike Papanicolaou tests) can be performed on clinician- or self-collected samples with comparable sensitivity. population-based randomized clinical trials in countries with organized screening programs (ie, centrally designed and managed, with standardized screening invitations and follow-up for a specific target population) demonstrated that mailing HPV self-sampling kits to underscreened women increased participation compared with invitations for clinic-based screening and diagnostic follow-up compliance after HPV-positive selfsampling results was high, yielding increased detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). Australia and the Netherlands—the first countries to implement primary HPV screening—have included HPV self-sampling options for underscreened women.
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