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    Original Investigation
    Obstetrics and Gynecology
    November 6, 2019

    Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Epidemiology, University of Washington, Seattle
    • 2Kaiser Permanente Washington Health Research Institute, Seattle
    • 3Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas
    • 4Division of Biostatistics, Department of Public Health Sciences, University of California, Davis
    • 5Kaiser Permanente Washington, Renton
    JAMA Netw Open. 2019;2(11):e1914729. doi:10.1001/jamanetworkopen.2019.14729
    Key Points español 中文 (chinese)

    Question  Do mailed human papillomavirus self-sampling kits increase detection and treatment of cervical precancers and screening uptake vs usual care (reminders for in-clinic screening)?

    Findings  This randomized clinical trial included 19 851 women; 26% were screened after receiving a human papillomavirus kit vs 17% with usual care, a significant difference. There was no statistically significant difference in the number of cases of precancers detected or treated.

    Meaning  This study indicates that mailing human papillomavirus kits to underscreened women can increase cervical cancer screening, and implementation efforts should strategize how to further increase kit uptake and follow-up of positive results to maximize detection and treatment of precancers in women at high risk.


    Importance  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.

    Objective  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.

    Design, Setting, and Participants  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.

    Interventions  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.

    Main Outcomes and Measures  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.

    Results  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).

    Conclusions and Relevance  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+.

    Trial Registration  ClinicalTrials.gov identifier: NCT02005510