Self-Testing Options in the era of Primary HPV screening for cervical cancer: the STEP trial

宫颈癌初级 HPV 筛查时代的自我检测选择：STEP 试验

• 批准号: 9796573
• 负责人: DIANA SM BUIST
• 金额: $ 69.37万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9796573
• 关键词: Adherence; Advisory Committees; Affect; Age; Appointment; Australia; Behavior; Cervical Cancer Screening; Clinic; Collection; Cost Analysis; Country; Data; Diabetes Mellitus; Effectiveness; Enrollment; Ensure; Excision; Goals; Guidelines; Health system; Healthcare Systems; Home environment; Human Papillomavirus; Incidence; Influenza vaccination; Instruction; International; Interview; Literature; Malignant neoplasm of cervix uteri; Mental Depression; Netherlands; Outcome; Pap smear; Patient Education; Patients; Population; Preventive service; Provider; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Sampling; Screening Result; Subgroup; Surveys; Target Populations; Testing; Time; Training and Education; Underrepresented Minority; United States; Update; Washington; Woman; adherence rate; aged; arm; base; colorectal cancer screening; comparative; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; design; experience; follow-up; improved; interest; malignant breast neoplasm; mortality; outreach; outreach program; patient oriented; pragmatic trial; preference; prevent; primary outcome; public health relevance; response; satisfaction; screening; screening guidelines; screening participation; secondary outcome; treatment arm; treatment as usual; uptake

The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based human papillomavirus (HPV) kits for improving cervical cancer screening uptake, cost-effectiveness, and patient and provider experience. STEP is timely in response to 2018 US Preventive Services Task Force cervical cancer screening guidelines, which include HPV testing alone (i,e., primary HPV screening) as a newly recommended option for women aged 30-65 years. Because HPV testing can be performed on clinician- or patient-collected samples (unlike Pap tests), primary HPV screening allows home- based screening options–a potential game changer for delivery of cervical cancer screening. US healthcare systems are keenly interested in identifying cost-effective outreach and patient-centered approaches to reverse declining rates of adherence to guideline-recommended cervical cancer screening. Our central hypotheses are that offering home-based HPV self-collection will increase screening participation, be preferred by women, be cost-effective, and not reduce uptake of other preventive services despite removal of in-clinic screening appointments. We propose a pragmatic randomized controlled trial among 19,026 women ages 30-65 years at Kaiser Permanente Washington who are due for routine cervical cancer screening (oversampling underrepresented minorities) that will compare three outreach approaches: Usual Care (standard patient education and reminders for in-clinic screening); Direct Mail (mailed a home HPV testing kit with information on why it is offered and recommended follow-up for different results); or Opt-In (same information as the direct mail arm with instructions on how to request an HPV kit). Randomization allocation will vary among 3 target populations defined by a woman's prior screening behavior: 1) screening adherent (due now or in the next 12 months); 2) overdue (≥6 months past due); and 3) unknown (no recorded screening and recently enrolled). Primary outcomes are screening uptake within 6 months (Aim 1) and cost-effectiveness (Aim 2). Secondary outcomes include: the proportion of women who complete recommended in-clinic follow-up after a positive kit result, uptake of other recommended preventive services (subaim 1), patient and provider preferences about home HPV screening, and facilitators and barriers to follow-up of abnormal results (Aim 3). STEP will be the first US trial to evaluate adherence and cost-effectiveness of different approaches for offering HPV self- sampling for cervical cancer screening. Surveys and in-depth interview data from women and providers will be used with the main trial data to deepen understanding of patient and provider experience with home-based HPV testing. Our trial has tremendous translational potential to improve cervical cancer screening and enable women to receive screening aligned with their preferences. It is timely and directly responsive to calls from US guideline committees to evaluate the effect of HPV self-sampling strategies on screening coverage and follow- up adherence, with the goal of preventing cervical cancer incidence and mortality.

宫颈癌初级HPV筛查时代的自我检测选择（STEP）试验将评估 家用人乳头瘤病毒（HPV）检测试剂盒对提高宫颈癌筛查率的有效性， 成本效益，以及患者和提供者的经验。STEP是及时响应2018年美国预防 服务工作队宫颈癌筛查指南，其中包括HPV检测单独（即，原发性HPV 筛查）作为30-65岁女性的新推荐选择。因为HPV检测可以 在临床医生或患者收集的样本上进行（与巴氏试验不同），初级HPV筛查允许家庭- 基于筛查的选择-一个潜在的游戏规则改变提供宫颈癌筛查。美国医疗保健 系统对确定具有成本效益的外展和以患者为中心的方法非常感兴趣， 对指南建议的宫颈癌筛查的依从率下降。我们的主要假设是 提供以家庭为基础的HPV自我收集将增加筛查的参与，受到女性的青睐， 具有成本效益，尽管取消了门诊筛查，但不会减少其他预防服务的使用 约会.我们建议在19,026名年龄在30-65岁的女性中进行一项实用的随机对照试验， Kaiser Permanente华盛顿的患者，他们将接受常规宫颈癌筛查（过采样 代表性不足的少数民族），将比较三种外展方法： 教育和诊所筛查的提醒）;直接邮件（邮寄家庭HPV检测试剂盒， 关于为什么提供和建议跟进不同的结果）;或选择加入（与直接 邮件手臂上的说明如何要求HPV试剂盒）。随机分配将在3个目标之间变化 由女性先前筛查行为定义的人群：1）筛查依从性（现在或未来12年内 月）; 2）逾期（逾期≥6个月）;和3）未知（未记录筛选和最近入组）。 主要结果是6个月内的筛查摄取（目标1）和成本效益（目标2）。二次 结果包括：在试剂盒呈阳性后完成建议的门诊随访的妇女比例 结果、其他建议的预防服务的接受情况（子目标1）、患者和提供者关于 家庭HPV筛查，以及异常结果随访的促进因素和障碍（目标3）。步骤将是 第一个美国试验，以评估坚持和成本效益的不同方法提供HPV自我- 进行子宫颈癌普查的抽样调查。将对妇女和提供者进行调查和深入访谈， 与主要试验数据一起使用，以加深对患者和提供者家庭护理经验的理解 HPV检测我们的试验具有巨大的转化潜力，可以改善宫颈癌筛查， 妇女接受符合其偏好的筛查。它对来自美国的电话作出及时和直接的反应 指导委员会评估HPV自我采样策略对筛查覆盖率的影响，并遵循- 坚持下去，以预防宫颈癌的发病率和死亡率为目标。