Design of a pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake in a U.S. healthcare system: The STEP trial.
Design of a pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake in a U.S. healthcare system: The STEP trial.
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DOI：
10.1016/j.cct.2022.106960
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发表时间：
2022-11
影响因子：
2.2
通讯作者：
Buist, Diana S. M.
中科院分区：
文献类型：
--
作者：
Winer, Rachel L.;Lin, John;Anderson, Melissa L.;Tiro, Jasmin A.;Meenan, Richard T.;Hansen, Kristina;Gao, Hongyuan;Sparks, Angela;Greene, Dina N.;Kilgore-Martin, Sony;Green, Beverly B.;Buist, Diana S. M.
邮寄HPV自我采样试剂盒给逾期的个人增加宫颈癌筛查依从性;提供自我采样到以前的个人还没有在美国进行评估鉴于异质性美国卫生系统和人口，需要数据来优化如何HPV自我采样提供给逾期的个人，由于成功的过去筛选后，或有一个未知的筛选历史。STEP是一项在美国综合医疗保健服务系统内进行的实用随机对照试验，旨在比较不同的外展方法，以在先前筛查行为（先前依从，逾期或未知筛查史）定义的人群中提供HPV自我采样。在14个月内，通过电子病历（EMR）数据确定了符合条件的个体，并根据筛查历史随机分配到家庭护理（UC），教育（UC +有关宫颈癌筛查的教育材料），直邮（UC +教育+邮寄自采样套件）或选择加入（UC +教育+请求套件的选项）。主要目的是通过外展方法和筛选史比较筛选完成情况。次要目标包括评估外展方法的增量成本效益，并确定患者对HPV自我筛查的偏好和满意度，以及异常结果随访的障碍（通过访谈和焦点小组进行测量）。该试验旨在生成美国卫生系统可用于告知主要HPV筛查实施策略的数据，这些策略包括HPV自我采样选项，以改善筛查的可及性、依从性和患者满意度。本报告的目的是描述该实用试验的原理和设计。
Mailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history. STEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups). The trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial.
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