Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (SCALE)

项目摘要/摘要 2018年，世界卫生组织(世卫组织)呼吁采取行动，实现全球消除 宫颈癌。成员国于2020年8月批准了实现这一目标的战略。世界卫生组织 该计划呼吁对人类乳头瘤病毒采取积极的疫苗接种、筛查和治疗方法。 (HPV)，宫颈癌的唯一原因。在低收入和中等收入国家(LMIC)，它们承担着90%的 全球宫颈癌的发病率和死亡率，据估计，这些目标要到 2120--一个世纪后的今天。显著缩短这一时间线的一种方法是通过HPV自我采样和 对筛查呈阳性的患者立即进行治疗。为了扩大HPV，必须有一种低成本、 易于现场使用的有效测试。最佳的现场测试将允许女性收集她们自己的 在不影响疗效的情况下提供样品。世界卫生组织唯一专门为LOW开发的资格预审测试 资源设置为CareHPV，临床医生采集样本时灵敏度较好，但 其在自采样时表现不佳。迫切需要评估一种低成本的自我 抽样测试是有效的，并且易于在LMIC中实现。AmpFire®(加利福尼亚州阿提拉生物系统公司)、 一种新的低成本HPV检测方法，在自我采集的样本中表现出高灵敏度，可能会表现得更好 而不是提供者收集的CareHPV。此外，目前针对CareHPV的方案需要两天的访问，因为 这些机器位于中心位置，需要3-4个小时进行处理。AmpFire®可从本地运行 使用电池供电的聚合酶链式反应机器。由于这些测试过程大约需要1个小时，单个- 探视方式是可行的，它对卫生系统更有效率，对患者更方便。这个 本研究的目的是比较AmpFire®和CareHPV在检测高级别HPV方面的疗效 癌前病变(宫颈上皮内瘤变，2级或以上，或CIN2+)，并比较其疗效和 通过以下目标进行每项测试的可行性：目标1：将自行收集的AmpFire®与标准进行比较 提供者收集的用于检测高级别宫颈癌前病变的CareHPV。目标2：演示 使用自行收集的AmpFire®的单次访问方法将导致比 目前使用提供者收集的护理HPV的传统两次访问方法。目标3：执行成本- 自我抽样的有效性分析比较疗效、失访和泛化 AmpFire®HPV与提供商收集的护理HPV。

PROJECT SUMMARY/ABSTRACT In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of cervical cancer. A strategy for achieving this goal was ratified by member states in August 2020. The WHO plan calls for an aggressive approach of vaccination, screening, and treatment of the human papillomavirus (HPV), the single cause of cervical cancer. In low- and middle-income countries (LMIC), which bear 90% of the incidence and mortality of cervical cancer globally, it is estimated that these goals will not be reached until 2120 – a century from now. One way to markedly shorten this timeline is through HPV self-sampling and immediate treatment for those who screen positive. In order to scale-up HPV there must be a low-cost, effective test that is easy to use in the field. An optimal field test would allow women to collect their own samples without compromising efficacy. The only WHO prequalified test specifically developed for low resource settings is careHPV, which has relatively good sensitivity when a sample is taken by a clinician, but which performs poorly when self-sampled. There is an urgent need for evaluation of a low-cost self- sampling test that is effective and can be easily implemented in LMIC. AmpFire® (Atila Biosystems, CA), a new low-cost HPV test, has demonstrated high sensitivity in self-collected samples and may perform better than provider-collected careHPV. Furthermore, the current protocol for careHPV requires a 2-day visit because the machines are in a central location and require 3-4 hours for processing. AmpFire® can be run from local locations using a battery-operated PCR machine. Since these tests process in approximately 1 hour, a single- visit approach is feasible, which is more efficient for the health system and more convenient for patients. The purpose of this study is to compare the efficacy of AmpFire® versus careHPV for the detection of high grade precancer (cervical intraepithelial neoplasia, grade 2 or higher, or CIN2+) and to compare the efficacy and feasibility of each test through the following aims: Aim 1: To compare self-collected AmpFire® to standard provider-collected careHPV for the detection of high grade cervical precancer. Aim 2: Demonstrate that a single-visit approach using self-collected AmpFire® will result in lower loss to follow-up than the current conventional two-visit approach using provider-collected careHPV. Aim 3: Perform a cost- effectiveness analysis to compare efficacy, loss to follow-up and generalizability of self-sampled AmpFire® HPV versus provider-collected careHPV.