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

邮寄自盖 HPV 检测的随机对照试验，以提高综合安全网医疗保健系统中少数族裔/服务不足的妇女的宫颈癌筛查参与率

• 批准号: 10320732
• 负责人: Jane R Montealegre
• 金额: $ 63.67万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-16 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10320732
• 关键词: Age; Attitude; Australia; Behavior Therapy; Canada; Caring; Cervical; Cervical Cancer Screening; Cessation of life; Characteristics; Client; Clinic; Clinical; Country; Data; Detection; Development; Diagnostic Reagent Kits; Disease; Etiology; Europe; Funding; Future; Generations; Guidelines; HPV-High Risk; Health system; Healthcare Systems; Home; Human Papillomavirus; Incidence; Individual; Infection prevention; Integrated Health Care Systems; Intervention; Low Prevalence; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Minority Groups; Minority Women; Pap smear; Participant; Patient Education; Patients; Pattern; Privatization; Publishing; Randomized; Randomized Controlled Trials; Reporting; Research; Sampling; Telephone; Testing; Vaccines; Virus; Woman; World Health; arm; base; cancer diagnosis; cancer health disparity; cancer risk; cervicovaginal; compare effectiveness; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; disadvantaged population; ethnic minority; ethnic minority population; evidence base; experience; follow-up; high risk; improved; outcome prediction; outreach; patient population; population based; primary outcome; programs; racial and ethnic; routine screening; safety net; screening; screening participation; screening program; secondary outcome; socioeconomic disadvantage; three-arm study; underserved minority; vaccine acceptance

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.

项目总结 实施以临床为基础的巴氏(Pap)试验筛查宫颈癌的工作取得了显著进展 通过广泛的筛查计划，减少了这种疾病在美国和其他国家的发病率。 然而，许多妇女由于不能或不愿意周期性地患宫颈癌，仍然处于高风险状态。 参加基于诊所的筛查。目前，以证据为基础、以客户为导向的策略，如患者 提醒和召回、患者教育和患者导航是许多行为干预的基础 增加筛查参与度。然而，仅靠这些战略往往无法解决许多 筛选不出席者面临的障碍。使用邮寄的自我抽样试剂盒检测高危人群 乳头瘤病毒(HPV)，这种导致宫颈癌的病毒，可能会克服多种障碍，使临床 放映。然而，这种邮寄的自我抽样尚未在美国的安全网卫生系统中进行评估 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，将邮寄的自我样本HPV检测与患者导航配对，外展 在服务不足的少数群体中有强有力证据的干预措施，将对 增加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来比较三种外展干预措施的效果。 增加30-65岁筛查不足妇女的初次筛查参与率和临床随访 在一个安全的医疗系统中生活了数年。试验的背景是哈里斯健康系统，这是第三大公共资助的 国家的安全网卫生系统，主要服务于种族/民族少数群体和 社会经济上处于不利地位的人群。这三个学习臂是：1)电话回忆(控制)；2) 通过邮寄的自我样本HPV检测试剂盒进行电话召回(干预)；以及3)通过邮寄的自我检测试剂盒进行电话召回 HPV样本检测试剂盒和患者导航(干预加)。主要结果是初步筛查 参与。二次结果是临床随访筛查和就诊的预测因素 银幕阳性的女性。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试剂盒的妇女和对检测为阳性的妇女进行临床随访的妇女 高危人乳头瘤病毒。最后，我们的研究将单独评估邮寄自我样本HPV检测的成本效益 并与患者导航相结合，增加筛查参与率，降低宫颈癌风险 安全网卫生系统。总而言之，这些数据将定义自我采样HPV检测在真实- 世界卫生系统环境，这是开发可扩展、成本效益高的方案的关键一步 消除未得到充分服务的种族/少数民族妇女患宫颈癌的差距。