Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

描述（由申请人提供）：在美国，超过一半的宫颈癌是在未接受筛查或筛查不足的女性中诊断出来的。新的国家指南将提高筛查率确定为降低宫颈癌相关发病率和死亡率的首要任务。创新的筛查策略，消除了基于诊所的筛查的需要，可以非常有效地提高筛查依从性，同时保持高质量的护理。越来越多的人对使用高危（hr） HPV筛查，然后对hrHPV患者进行细胞学分类作为主要筛查策略感兴趣，研究表明，这种策略对于检测宫颈肿瘤既具有成本效益，又敏感。如果样品

DESCRIPTION (provided by applicant): Over half of all cervical cancers in the U.S. are diagnosed in unscreened or under screened women. New national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. Innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. There is growing interest in using high-risk (hr) HPV screening followed by cytology-based triage of women with hrHPV as a primary screening strategy, with studies suggesting that such a strategy could be both cost- effective and sensitive for detecting cervical neoplasia. If samples for hrHPV screening could be self-collected at home (with in-clinic follow-up of hrHPV-positive women), the need for in-clinic screening could be eliminated for a majority of women. We propose a large, pragmatic randomized controlled trial within Group Health (a large integrated health care delivery system in Washington State) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women aged 30-65 years. The first approach (control arm) is usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home hrHPV screening kit. Primary outcomes are early detection and treatment of cervical neoplasia and secondary outcomes are cervical cancer screening uptake, predictors of screening, and patient experiences and attitudes towards in-home hrHPV testing and follow-up of hrHPV+ results (measured through surveys and interviews). We will identify all 30 to 65 year old female enrollees who are overdue for routine Pap screening (no Pap test within the last 3.4 years). We will randomize 7,200 to in-home hrHPV screening and the remainder (~10,400) to usual care. Compared to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. The trial will provide definitive evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting.