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: 10542670
• 负责人: Jane R Montealegre
• 金额: $ 58.66万
• 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 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10542670
• 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; Economically Deprived Population; Etiology; Europe; Funding; Future; Generations; Guidelines; HPV-High Risk; Health system; Healthcare Systems; Home; Human Papillomavirus; Incidence; Infection prevention; Integrated Health Care Systems; Intervention; Licensing; Low Prevalence; Malignant neoplasm of cervix uteri; Minority; 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; cancer diagnosis; cancer health disparity; cancer risk; cervicovaginal; compare effectiveness; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; ethnic minority; ethnic minority population; evidence base; experience; follow-up; high risk; improved; outcome prediction; outreach; patient navigation; patient population; population based; premalignant; primary outcome; programs; racial minority; racial minority population; 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.

项目概要 基于临床的巴氏 (Pap) 试验筛查宫颈癌的实施显着 通过广泛的筛查计划，在美国和其他国家降低了这种疾病的发病率。 然而，许多女性由于无法或不愿意定期进行宫颈癌筛查，仍然面临着患宫颈癌的高风险。 参加临床筛查。目前，基于证据的、以客户为导向的策略，例如患者 提醒和回忆、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，仅靠这些策略往往无法解决许多问题 筛选未出席者面临的障碍。使用邮寄的自我采样套件来检测高危人群 乳头瘤病毒（HPV）是导致宫颈癌的病毒，可能会克服临床治疗的多重障碍 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 为大部分社会经济弱势群体提供护理。我们假设在 在安全网卫生系统的背景下，将邮寄的自我样本 HPV 检测与患者导航、外展相结合 对服务不足的少数群体进行有确凿证据的干预，将对以下方面产生协同效应： 提高筛查不足的女性的筛查参与度。 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有效性 提高 30-65 岁筛查不足的女性的初级筛查参与度和临床随访率 安全网卫生系统中的年数。试验地点是哈里斯医疗系统，第三大公共资助的医疗系统 国家的安全网卫生系统，主要服务于少数族裔/族裔和 社会经济弱势群体。三个研究组是：1）电话回忆（对照）； 2） 电话召回并邮寄自检 HPV 检测试剂盒样本（干预）； 3) 电话召回并邮寄自我报告 HPV 检测试剂盒样本和患者导航（干预加）。主要结果是初步筛查 参与。次要结果是筛查和参加临床随访的预测因素 屏幕呈阳性的女性。我们的研究还将确定人们对自我抽样的态度和经验 收到邮寄的自我采样套件的女性以及对检测呈阳性的女性进行临床随访 高危型HPV。最后，我们的研究将单独评估邮寄自检样本 HPV 检测的成本效益 并与患者导航相结合，提高筛查参与度并降低宫颈癌风险 安全网卫生系统。总的来说，这些数据将定义自我采样 HPV 检测在实际情况中的影响。 世界卫生系统的设置是制定可扩展的、具有成本效益的计划的关键一步 消除服务不足的少数族裔妇女中宫颈癌的差异。