Mailing human papillomavirus (HPV) self-sampling test kits to underscreened women may increase cervical cancer screening uptake in healthcare systems in the United States, according to study results published in JAMA Network Open.
Roughly 25% of women in the US do not adhere to recommended screening for cervical center; reasons include lack of time and transportation, difficulty getting time off work, fear of pelvic exams, and previous negative experience with screening. Several population-based clinical trials in countries with organized, centrally designed screening programs have demonstrated that mailing HPV self-sampling kits to underscreened women resulted in increased participation in screening and in subsequent detection of cervical intraepithelial neoplasia grade 2 or higher. The objective of this randomized clinical trial was to evaluate the efficacy of mailed HPV self-sampling kits for increased detection and treatment of cervical intraepithelial neoplasia grade 2 (CIN2+) and cervical cancer in the United States.
Researchers used electronic medical record data from Kaiser Permanente Washington to identify women between the ages of 30 and 64 years who did not receive a Papanicolaou test within 3 years and 5 months and did not have a hysterectomy. Patients were randomly assigned 1:1 to the intervention or control group between February 2014 and August 2016, with follow-up through February 2018. In totaly, 19,851 patients were included in the intention-to-treat analysis.
Women in the control group (n=9891) received standard-of-care recommendations to undergo Papanicolaou screening, and did not receive the mailed HPV kit from the researchers. Women in the intervention group (n=9960) received usual care plus a mailed HPV kit. If the kit was not returned within 3 weeks, patients received a maximum of 3 reminder calls from researchers to attend screening. Primary outcomes were CIN2+ detection within 6 months of screening and treatment within 6 months of detection. Secondary outcomes were screening uptake within 6 months of randomization and abnormal screening results.
Results revealed that CIN2+ was detected in 12 patients in the intervention group compared with 8 patients in the control group (risk ratio [RR], 1.49; 95% CI, 0.61-3.64). All women in the intervention group received CIN2+ treatment, compared with 7 women in the control group (RR, 1.70; 95% CI, 0.67-4.32). In the intervention group, 2618 women (26.3%) completed screening uptake vs 1719 women (17.4%) in the control group (RR, 1.51; 95% CI, 1.43-1.60). Further, in the intervention group, 225 women (2.3%) had abnormal screening results vs 114 women (1.2%) in the control group (RR, 1.96; 95% CI, 1.57-2.45).
Results also demonstrated that 2646 women (26.6%) in the intervention group initiated screening: 1206 women (12.1%) initiated their screening by returning an HPV kit and 1440 women (14.5%) went directly to in-clinic screening. Among the 1206 women who returned a kit, 1098 attained screening uptake based on their HPV kit results alone, including 1064 (88.2%) with HPV-negative results and 34 (2.8%) with HPV-16– or HPV-18–positive results.
This study had several limitations, including that only Papanicolaou tests that were completed were included in the cervical cancer screening outcome. Further, women with HPV-negative results were encouraged to attend Papanicolaou screening, which may have negatively affected HPV kit uptake. Also, the study results may have been different if HPV kits had not been mailed as part of a research study, and instead, mailed to underscreened women as part of standard care with reassurance that no in-clinic follow-up would be required with negative results. Lastly, kit materials were available in English only, which led to the exclusion of women who did not speak the languange.
The study researchers concluded that healthcare systems in the United States that are considering mailing HPV self-sampling kits to underscreened women should focus on strategies to increase kit uptake and in-clinic follow-up among women who have positive results.
Winer RL, Lin J, Tiro JA, et al. Effect of mailed human papillomavirus test kits vs usual care reminders on cervical cancer screening uptake, precancer detection, and treatment: a randomized clinical trial [published online November 6, 2019]. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2019.14729