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筛查或未筛查的妇女中诊断出来的。新的国家指南将增加筛查摄入量确定为减少宫颈癌相关发病率和死亡率的首要任务。创新的筛查战略消除了对以诊所为基础的筛查的需要，在提高筛查依从性方面可能非常有效，同时保持高质量的护理。人们越来越有兴趣使用高危(Hr)HPV筛查，然后对携带hrHPV的妇女进行基于细胞学的分流作为主要筛查策略，研究表明，这种策略对于检测宫颈肿瘤既具有成本效益，又具有敏感性。如果样本 对于hrHPV筛查，可以在家中自行收集(对hrHPV阳性妇女进行门诊随访)，可以消除大多数妇女在诊所进行筛查的需要。我们建议在Group Health(华盛顿州的一个大型综合医疗保健提供系统)内进行一项大型、务实的随机对照试验，以比较两种方案方法在30-65岁逾期妇女中增加宫颈癌筛查的有效性。第一种方法(控制组)是Group Health的常规护理，由患者和提供者层面的服务组成，以促进遵守巴氏筛查；第二种方法(干预组)包括常规护理和邮寄的家庭HrHPV筛查试剂盒。主要结果是早期发现和治疗宫颈肿瘤，次要结果是宫颈癌筛查的摄取率、筛查的预测因素、患者对家庭内hrHPV检测和hrHPV结果的跟踪(通过调查和访谈衡量)的经历和态度。我们将确定所有30至65岁的女性登记者谁是逾期的巴氏筛查(在过去3.4年内没有巴氏试验)。我们将随机选择7,200人进行家庭hrHPV筛查，其余(约10,400人)进行常规护理。与常规护理相比，我们假设家庭hrHPV筛查将提高宫颈肿瘤的早期发现和治疗，并改善筛查的依从性。这项试验将提供关于家庭hrHPV筛查计划在现实世界临床环境中的影响的确凿的循证数据。

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.