Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association 2023-11, Vol.330 (20), p.1971-1981
• Main Authors: Winer, Rachel L, Lin, John, Anderson, Melissa L, Tiro, Jasmin A, Green, Beverly B, Gao, Hongyuan, Meenan, Richard T, Hansen, Kristina, Sparks, Angela, Buist, Diana S. M
• Format: Article
• Language: English
• Subjects: Adult; Cancer; Cancer screening; Cervical cancer; Clinical trials; Diagnostic Self Evaluation; Early Detection of Cancer - methods; Education; Educational materials; Educational Status; Electronic health records; Electronic medical records; Female; Health care; Human papillomavirus; Human Papillomavirus Viruses - isolation & purification; Humans; Hysterectomy; Mail; Medical screening; Middle Aged; Original Investigation; Papillomavirus Infections - complications; Papillomavirus Infections - diagnosis; Patients; Postal Service; Primary care; Randomization; Sampling; United States - epidemiology; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - etiology
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2023.21471

IMPORTANCE: Optimal strategies for increasing cervical cancer screening may differ by patient screening history and health care setting. Mailing human papillomavirus (HPV) self-sampling kits to individuals who are overdue for screening increases adherence; however, offering self-sampling kits to screening-adherent individuals has not been evaluated in the US. OBJECTIVE: To evaluate the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (screening-adherent and currently due, overdue, or unknown). DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Individuals aged 30 to 64 years with female sex, a primary care clinician, and no hysterectomy were identified through electronic health records (EHRs) and enrolled between November 20, 2020, and January 28, 2022, with follow-up through July 29, 2022. INTERVENTIONS: Individuals stratified as due (eg, at the time of randomization, these individuals have been previously screened and are due for their next screening in ≤3 months) were randomized to receive usual care (patient reminders and clinician EHR alerts [n = 3671]), education (usual care plus educational materials about screening [n = 3960]), direct mail (usual care plus educational materials and a mailed self-sampling kit [n = 1482]), or to opt in (usual care plus educational materials and the option to request a kit [n = 3956]). Individuals who were overdue for screening were randomized to receive usual care (n = 5488), education (n = 1408), or direct mail (n = 1415). Individuals with unknown history for screening were randomized to receive usual care (n = 2983), education (n = 3486), or to opt in (n = 3506). MAIN OUTCOMES AND MEASURES: The primary outcome was screening completion within 6 months. Primary analyses compared direct-mail or opt-in participants with individuals randomized to the education group. RESULTS: The intention-to-treat analyses included 31 355 randomized individuals (mean [SD] age, 45.9 [10.4] years). Among those who were due for screening, compared with receiving education alone (1885 [47.6%]), screening completion was 14.1% (95% CI, 11.2%-16.9%) higher in the direct-mail group (914 [61.7%]) and 3.5% (95% CI, 1.2%-5.7%) higher in the opt-in group (2020 [51.1%]). Among individuals who were overdue, screening completion was 16.9% (95% CI, 13.8%-20.0%) highe