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.

项目摘要 宫颈癌的基于诊所的Papanicolaou（PAP）测试筛查的实施急剧 通过广泛的筛查计划，美国和其他国家的这种疾病的发生率降低了。 但是，许多妇女由于无法定期而无法定期出现宫颈癌的高风险 参加基于诊所的筛查。目前，基于证据的客户指导的策略（例如患者） 提醒和召回，患者教育和患者导航是许多行为干预的基础 增加筛选参与。但是，仅这些策略通常无法解决许多 筛查非参议员面临的障碍。使用邮寄的自助采样套件来测试高风险人类 引起宫颈癌的病毒乳头瘤病毒（HPV）可能会克服基于临床的多个障碍 筛选。但是，该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 这为大部分社会经济处于弱势群体的个人提供了照顾。我们假设在 安全网健康系统的背景，将邮寄的自样本HPV测试与患者导航配对 在服务不足的少数群体中有强有力的干预措施，将对 增加了筛查的妇女的筛查参与。 我们建议进行一项随机对照试验，以比较三项外展干预措施的有效性 增加30-65岁妇女的初级筛查参与和临床随访 在安全网卫生系统中使用年。试验设置是哈里斯卫生系统，第三大公共资助 全国安全网卫生系统，该系统主要在种族/种族上为少数群体提供服务 社会经济处于弱势群体的人口。三个研究臂是：1）电话召回（控制）； 2） 使用邮寄的自样本HPV测试套件的电话召回（干预）； 3）邮寄自行的电话召回 样品HPV测试套件和患者导航（干预加上）。主要结果是主要筛查 参与。次要结果是筛查和出勤的预测指标 屏幕阳性女性。我们的研究还将确定对自我采样的态度和经验 收到邮寄自我采样套件并进行临床随访的妇女在测试阳性的女性中 高风险HPV。最后，我们的研究将评估单独的邮寄自样本HPV测试的成本效益 并结合患者导航，增加筛查参与并降低宫颈癌的风险 安全网卫生系统。总的来说，这些数据将定义自我样本HPV测试的影响 世界卫生系统的设置，迈向开发可扩展，具有成本效益的计划的关键一步 消除服务不足的种族/族裔少数民族妇女的宫颈癌差异。