ASPO Abstracts
Can home-based HPV self-sampling improve cervical cancer screening adherence in underscreened women? Results from the HOME pragmatic randomized trial.
Category: Early Detection & Risk Prediction, Pre-Malignant Conditions
Conference Year: 2018
Abstract Body:
Background: Home-based HPV self-sampling is an innovative cervical cancer screening strategy that could eliminate clinic-based screening for most women and improve screening compliance by removing some barriers to screening. Methods: We conducted a pragmatic randomized controlled trial (the HOME Trial) within Kaiser Permanente Washington to compare two programmatic approaches for increasing screening among women aged 30-64 years who were overdue (3.4 years since last Pap). The control arm included usual care (annual patient reminders and ad hoc outreach by clinics). The intervention arm included usual care plus a mailed HPV self- sampling kit. Women and their healthcare providers were notified of kit results. Providers were responsible for encouraging appropriate follow-up: diagnostic colposcopy if HPV16/18+ and additional in-clinic screening (Pap or co-test) if unsatisfactory or positive for other hrHPV types. If implemented, only HPV-positive women would be triaged to in-clinic screening. In the trial, however, HPV-negative women were still recommended to receive in-clinic screening because home HPV testing is not a guideline-approved screening strategy. Screening uptake was defined as any of the following within 6 months of randomization: 1) in-clinic screening; 2) returning a kit that was HPV-negative or HPV16/18+; or 3) returning a kit that was unsatisfactory or positive for non- HPV16/18 types, followed by in-clinic screening. Results: From 2014-2016, we randomized 16,242 women (8116 control; 8126 intervention) with a median age of 51 years. Screening uptake was higher in the intervention than control arm (28.1% vs. 19.0%; relative risk=1.48, 95%CI:1.40-1.57). Within the intervention arm, 12.5% of women returned a kit and 15.8% attended in-clinic screening without returning a kit. 11.2% of kits were positive (3.0% HPV16/18+; 8.2% other hrHPV types). Conclusions: Mailing HPV kits to under-screened women increased screening compared to usual care alone. Almost half of women who were screened after receiving a mailed HPV kit chose in-clinic screening over self- sampling in a hybrid screening approach. Trial results can inform implementation of primary HPV screening strategies that incorporate home-based self-sampling.
Keywords: pragmatic clinical trial HPV testing cervical cancer screening