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

摘要 以临床为基础的宫颈癌筛查大大降低了这种疾病在美国和美国的发病率 其他拥有广泛筛查计划的国家。然而，近20%的美国女性仍处于高危状态 对于未参与和未充分参与筛查的宫颈癌。自体宫颈阴道镜检查 高危人乳头瘤病毒(HR-HPV)样本是已知的有效应对策略 在全球环境下进行基于临床的筛查的障碍。然而，关于其有效性和有效性的数据有限 在美国卫生系统中实施，特别是在服务于社会经济的安全网卫生系统中 弱势少数群体是宫颈癌负担最重的群体。在安全网的背景下 卫生系统，将邮寄的自我样本HPV检测与患者导航配对，以证据为基础的外联 干预措施可能会对增加筛查不足妇女的筛查参与率产生协同作用。 自我测试增加筛查的前瞻性评估(PRESTIS)试验是第一个进行评估的试验 邮寄美国安全网健康设置中的自我样本HPV检测。安全网健康的患者群体 嵌入PRESTIS试验的系统主要是西班牙裔和非西班牙裔黑人。反映了这一点 实施试验的人口构成和后勤限制，目前资格仅限于 会说英语或西班牙语的病人。会说英语的亚裔/亚裔美国女性目前包括 受试者比例较小(4%)。此外，会说语言的亚裔/亚裔美国女性 除英语(特别是越南语，68%的亚洲患者的主要语言)外，目前 没有资格参加试验。试验中的少数亚裔/亚裔美国患者是有问题的，因为它排除了 它们包含在分组分析中，并限制了试验结果的推广。包括亚洲/亚洲 鉴于宫颈癌筛查参与率较低，自我抽样试验中的美国女性至关重要 亚裔/亚裔美国女性和某些亚裔群体，特别是越南女性，有更高的 宫颈癌发病率与其他种族/民族妇女的比较。使用建议的管理 作为补充，我们将通过调整患者教育材料和导航策略来扩大PRESTIS试验 扩大试验人群并招募不了解宫颈疾病的亚裔/亚裔美国女性 癌症筛查。在这样做的过程中，我们将确保PRESTIS试验有权严格评估和比较 对包括亚裔/亚裔美国人在内的种族/民族和语言亚群的参与进行筛查 女人。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 在亚裔/亚裔美国女性中进行临床随访的女性以及障碍和促进者 HR-HPV阳性。

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.