Expanding a pragmatic randomized trial to assess mailed self-sample HPV testing to increase cervical cancer screening participation among Asian immigrant women in a safety net health system

扩大一项务实的随机试验，以评估邮寄的自我样本 HPV 检测，以提高安全网卫生系统中亚洲移民妇女的宫颈癌筛查参与度

• 批准号: 10675374
• 负责人: Jane R Montealegre
• 金额: $ 38.31万
• 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/10675374
• 关键词: Address; Administrative Supplement; Asian; Asian Americans; Attitude; Black race; Caring; Cervical; Cervical Cancer Screening; Clinic; Clinical; Country; Data; Development; Disease; Economically Deprived Population; Effectiveness; Eligibility Determination; Ensure; Ethnic Origin; Etiology; Future; Generations; HPV-High Risk; Health; Health system; Hispanic; Human Papillomavirus; Immigrant; Incidence; Individual; Infection prevention; Intervention; Language; Linguistics; Literature; Logistics; Low income; Malignant neoplasm of cervix uteri; Minority Groups; Minority Women; Neighborhoods; Not Hispanic or Latino; Outcome; Participant; Patient Education; Patients; Population; Race; Safety; Sampling; Self-Examination; Subgroup; System; Testing; Vaccines; Woman; base; cancer health disparity; cancer risk; cervicovaginal; comparative effectiveness; compare effectiveness; cost effective; evidence base; experience; follow-up; high risk; improved; innovation; medically underserved; outreach; patient population; primary outcome; programs; prospective; racial and ethnic; randomized trial; recruit; safety net; screening; screening participation; screening program; segregation; self testing; social health determinants; socioeconomic disadvantage; treatment as usual; uptake; vaccine acceptance

SUMMARY Clinic-based screening for cervical cancer has dramatically reduced the incidence of this disease in the U.S. and other countries with widespread screening programs. However, almost 20% of U.S. women remain at high risk for cervical cancer due to non- and under-participation in screening. Testing self-collected cervicovaginal samples for high-risk human papillomavirus (HR-HPV) is known to be an effective strategy for addressing barriers to clinic-based screening in global settings. However, there are limited data on its effectiveness and implementation in U.S. health systems, particularly in safety net health systems that serve socioeconomically disadvantaged minority populations who carry the highest burden of cervical cancer. In the context of safety net health systems, pairing mailed self-sample HPV testing with patient navigation, an evidence-based outreach intervention, may have a synergistic effect for increasing screening participation among underscreened women. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is the first trial to evaluate mailed self-sample HPV testing in U.S. safety net health settings. The patient population of the safety net health system where the PRESTIS trial is embedded is predominantly Hispanic and non-Hispanic Black. Reflecting this demographic composition and logistical constraints of implementing the trial, eligibility is currently limited to patients who speak English or Spanish. Asian/Asian American women who speak English currently comprise a small proportion of trial participants (4%). Furthermore, Asian/Asian American women who speak languages other than English (particularly Vietnamese, the primary language of 68% of Asian patients) are currently ineligible for the trial. The small number of Asian/Asian American patients in the trial is problematic as it precludes their inclusion in subgroup analyses and limits the generalizeability of trial findings. The inclusion of Asian/Asian American women in self-sampling trials is critical given that cervical cancer screening participation is low among Asian/Asian American women and certain Asian subpopulations, notably Vietnamese women, have higher cervical cancer incidence compared to women of other race/ethnicities. With the proposed Administrative Supplement, we will expand the PRESTIS trial by adapting patient education materials and navigation strategies to broaden the trial’s population and recruit Asian/Asian American women who are not up-to-date with cervical cancer screening. In doing so, we will ensure that the PRESTIS trial is powered to rigorously assess and compare screening participation across racial/ethnic and linguistic subpopulations inclusive of Asian/Asian American women. We will also assess acceptability and experiences with self-sampling among Asian/Asian American women, as well as barriers and facilitators to clinical follow-up among Asian/Asian American women who test positive for HR-HPV.

总结 基于诊所的宫颈癌筛查大大降低了美国这种疾病的发病率， 其他有广泛筛查计划的国家。然而，近20%的美国妇女仍然处于高风险之中。 由于没有或没有充分参与筛查，检测自己采集的宫颈阴道 高危型人乳头瘤病毒（HR-HPV）的样本是一种有效的策略， 在全球范围内进行临床筛查的障碍。然而，关于其有效性的数据有限， 在美国卫生系统中实施，特别是在社会经济服务的安全网卫生系统中 宫颈癌的发病率是最高的。在安全网方面 卫生系统，将邮寄的自我样本HPV检测与患者导航配对， 干预，可能有协同效应，增加筛查不足的妇女的筛查参与。 自我检测增加筛查的前瞻性评估（PRESTIS）试验是第一个评估 在美国安全网健康环境中进行邮寄自我样本HPV检测。健康安全网的患者人群 PRESTIS试验所嵌入的系统主要是西班牙裔和非西班牙裔黑人。反映这一 由于实施试验的人口组成和后勤限制，目前资格仅限于 会说英语或西班牙语的病人目前，讲英语的亚裔/亚裔美国妇女占 试验参与者比例较小（4%）。此外，讲各种语言的亚裔/亚裔美国妇女 除了英语（特别是越南语，68%的亚洲患者的主要语言）， 没有资格参加试验。试验中亚洲/亚裔美国人患者的数量较少是有问题的，因为它排除了 它们被纳入亚组分析，并限制了试验结果的普遍性。包括亚洲/亚洲 美国妇女在自我抽样试验是至关重要的，因为宫颈癌筛查的参与率很低， 亚裔/亚裔美国妇女和某些亚裔亚群，特别是越南妇女， 与其他种族/族裔妇女相比的宫颈癌发病率。拟议的行政 作为补充，我们将通过调整患者教育材料和导航策略来扩展PRESTIS试验 扩大试验人群，招募宫颈癌最新信息不全的亚裔/亚裔美国女性， 癌症筛查在这样做的过程中，我们将确保PRESTIS试验能够严格评估和比较 跨人种/种族和语言亚群（包括亚裔/亚裔美国人）的筛选参与 妇女我们还将评估亚裔/亚裔美国人自我抽样的可接受性和经验 女性，以及亚裔/亚裔美国女性临床随访的障碍和促进因素， HR-HPV阳性