A Randomized Controlled Trial of Mail-Self Stamped HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System

项目摘要 宫颈癌的临床巴氏（Pap）检测筛查的实施， 降低了美国和其他国家广泛筛查项目的发病率。 然而，许多妇女仍然处于宫颈癌的高风险之中，因为她们不能或不愿意定期检查。 参加基于诊所的筛查。目前，以证据为基础，以客户为导向的战略，如病人 提醒和回忆、患者教育和患者导航是许多行为干预的基础 提高筛查参与率。然而，单靠这些策略往往无法解决许多问题。 筛选非与会者所面临的障碍。使用邮寄自采样试剂盒检测高危人群 乳头状瘤病毒（HPV），导致宫颈癌的病毒，可以克服多种障碍，以临床为基础， 筛选然而，这种邮寄的自我采样尚未在美国的安全网卫生系统中进行评估 这些机构为很大一部分社会经济上处于不利地位的个人提供照顾。我们假设在 安全网卫生系统的背景下，配对邮寄自我样本HPV检测与患者导航， 在得不到充分服务的少数群体中进行有力证据的干预，将产生协同效应， 提高筛查不足妇女的筛查参与率。 我们建议进行一项随机对照试验，比较三种外展干预措施的有效性 增加30-65岁筛查不足妇女的初级筛查参与和临床随访 在安全网医疗系统中的时间。该试验的背景是哈里斯卫生系统，第三大公共资助的 国家的安全网卫生系统，主要为少数种族/族裔服务， 社会经济弱势群体。三个研究组是：1）电话回忆（对照）; 2） 电话召回邮寄的自我样本HPV检测试剂盒（干预）;和3）电话召回邮寄的自我样本HPV检测试剂盒（干预）。 样本HPV检测试剂盒和患者导航（干预加）。主要结果是初步筛查 参与的次要结果是筛查和临床随访的预测因素， 筛查呈阳性的女性我们的研究还将确定对自我抽样的态度和经验， 接受邮寄的自我采样工具包的妇女和对检测呈阳性的妇女进行临床随访的妇女 高危型HPV最后，我们的研究将评估邮寄自我样本HPV检测的成本效益，单独 结合患者导航，以增加筛查参与并降低宫颈癌风险， 安全网卫生系统。总的来说，这些数据将定义自我样本HPV检测在真实的- 世界卫生系统的设置，朝着发展可扩展的，具有成本效益的计划， 消除得不到充分服务的少数种族/族裔妇女患宫颈癌的差异。

PROJECT SUMMARY The implementation of clinic-based Papanicolaou (Pap) test screening for cervical cancer has dramatically reduced the incidence of this disease in the US and other countries with widespread screening programs. However, many women remain at high risk for cervical cancer due to their inability or unwillingness to periodically attend for clinic-based screening. At present, evidence-based, client-directed strategies such as patient reminders and recalls, patient education, and patient navigation are the basis for many behavioral interventions to increase screening participation. However, these strategies alone are often unable to resolve many of the barriers faced by screening non-attendees. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. However, this mailed self-sampling has not been evaluated in safety net health systems in the US that provide care for a large portion of socioeconomically disadvantaged individuals. We hypothesize that in the context of a safety net health system, pairing mailed self-sample HPV testing with patient navigation, an outreach intervention with strong evidence among underserved minority populations, will have a synergistic effect for increasing screening participation among underscreened women. We propose to conduct a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women ages 30-65 years in a safety net health system. The trial setting is Harris Health System, the third largest publicly-funded safety net health system in the nation, which serves a predominantly racially/ethnically minority and socioeconomically disadvantaged population. The three study arms are: 1) telephone recall (control); 2) telephone recall with mailed self-sample HPV testing kits (intervention); and 3) telephone recall with mailed self- sample HPV testing kits and patient navigation (intervention plus). The primary outcome is primary screening participation. Secondary outcomes are predictors of screening and attendance for clinical follow-up among screen-positive women. Our study will also identify attitudes and experiences toward self-sampling among women who receive a mailed self-sampling kit and toward clinical follow-up among women who test positive for high-risk HPV. Finally, our study will evaluate the cost-effectiveness of mailed self-sample HPV testing, alone and in combination with patient navigation, to increase screening participation and reduce cervical cancer risk in safety net health systems. Collectively, these data will define the impact of self-sample HPV testing in a real- world health system setting, a critical step toward the development of scalable, cost-effective programs to eliminate cervical cancer disparities among underserved racial/ethnic minority women.