Hongyuan Gao’s research while affiliated with Kaiser Permanente Washington Health Research Institute and other places

Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial.

Background/Aims: Over half of cervical cancers in the United States are diagnosed in unscreened or underscreened women. Innovative strategies that move primary screening out of the clinic could be highly effective in improving screening compliance while maintaining high-quality care. Internationally, there is growing interest in a primary screening strategy of self-collected, in-home high-risk human papillomavirus (hrHPV) screening followed by triage of hrHPV-positive results to clinician-collected cytology or colposcopy. The need for in-clinic screening could be eliminated for a majority of women in organized screening programs if hrHPV screening can be seamlessly integrated with in-clinic follow-up. Methods: In March 2014, we launched a large, pragmatic randomized controlled trial within Group Health to compare effectiveness of two programmatic approaches for increasing cervical cancer screening among 17,000 women aged 30–64 years who are overdue (≥3.4 years since last Pap test or never had a Pap test). The control arm is usual care at Group Health, consisting of an organized program of patient invitation and reminders and electronic medical record (EMR)-based alerts to providers about patients who are not up-to-date with recommended screening. The intervention arm includes usual care plus a mailed in-home hrHPV screening kit. Women mail their screening kits directly to our centralized laboratory, and hrHPV test results are documented in our EMR to notify women’s provider teams of appropriate follow-up care. Primary outcomes are early detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake and screening predictors, and patient experiences and attitudes towards in-home hrHPV testing and follow-up of hrHPV-positive results. We are surveying 100 responders and 100 nonresponders to the in-home hrHPV screening invitation, and interviewing 50 women with hrHPV-positive results (including those with timely versus late completion of clinical follow-up). Results: As of September 2014, 6,194 eligible women were identified and randomized. We will highlight the study design and lessons learned from implementing a pragmatic trial. Discussion: This pragmatic trial will generate evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting. Findings will interest organized programs considering implementing in-home screening and low-resource countries caring for populations with limited access to primary care.