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

ScreenFire（一种低成本 HPV 检测）的单次临床验证：功效和成本效益 (SCALE)

• 批准号: 10340927
• 负责人: Miriam Cremer
• 金额: $ 57.88万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10340927
• 关键词: Ablation; Age; Area; Biomedical Engineering; Biopsy; Caring; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Clinical; Clinical Trials; Collection; Colposcopy; Cost Effectiveness Analysis; Cost Measures; Country; Data; Detection; Disease; El Salvador; Electricity; Environment; Epidemiology; Evaluation; Female Adolescents; Financial cost; Goals; Guidelines; Health; Health Planning Organizations; Health system; Hour; Human Papillomavirus; Human papilloma virus infection; Incidence; Lesion; Location; Malignant neoplasm of cervix uteri; Measures; Methods; Pathology; Patients; Prevalence; Process; Protocols documentation; Provider; Public Health; Research; Resource-limited setting; Running; Sampling; Screening Result; Sensitivity and Specificity; Specimen; Technology; Testing; TimeLine; Treatment Cost; Ursidae Family; Vaccinated; Vaccination; Vagina; Validation; Visit; Woman; Work; World Health Organization; comparative efficacy; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; disability-adjusted life years; economic cost; efficacy testing; field study; follow-up; health economics; industry partner; low and middle-income countries; member; mortality; portability; premalignant; programs; scale up; screening; statistics; treatment strategy

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.

项目总结/摘要 2018年，世界卫生组织（世卫组织）呼吁采取行动，实现全球消除疟疾。 宫颈癌成员国于2020年8月批准了实现这一目标的战略。世卫组织 该计划要求对人乳头瘤病毒进行积极的疫苗接种、筛查和治疗 (HPV)宫颈癌的病因有哪些？低收入和中等收入国家（LMIC）承担了90%的 宫颈癌的发病率和死亡率，估计这些目标将无法实现，直到 2120 -一个世纪从现在开始。显著缩短这一时间轴的一种方法是通过HPV自我采样， 对筛查呈阳性者立即进行治疗。为了扩大HPV的规模，必须有一个低成本， 这是一种易于在现场使用的有效测试。一个最佳的现场测试将允许妇女收集自己的 样品而不影响功效。世卫组织专门为低血糖患者开发的唯一资格预审检测 资源设置是careHPV，当临床医生采集样本时，其具有相对较好的灵敏度，但 其在自采样时表现不佳。目前迫切需要对一种低成本的自我评估方法进行评估， 抽样测试是有效的，可以很容易地在LMIC实施。AmpFire®（Atila Biosystems，CA）， 一种新的低成本HPV检测，在自我收集的样本中表现出高灵敏度， 而不是提供者收集的careHPV。此外，目前的careHPV方案需要2天的访视，因为 机器位于中心位置，需要3-4小时进行处理。AmpFire®可以从本地 使用电池操作的PCR机器。由于这些测试过程在大约1小时内，一个单一的- 访视方式是可行的，对卫生系统更有效率，对患者更方便。的 本研究的目的是比较AmpFire®与careHPV检测高级别HPV的有效性。 癌前病变（宫颈上皮内瘤变，2级或更高，或CIN 2+），并比较疗效和 通过以下目的，每个测试的可行性：目的1：比较自我收集的AmpFire®与标准 提供者收集的careHPV用于检测高级别宫颈癌前病变。目标2：展示 使用自我收集的AmpFire®的单次访视方法将导致随访损失低于 目前使用提供者收集的careHPV的常规两次访视方法。目标3：执行成本- 有效性分析，以比较自我抽样的有效性、失访率和普遍性 AmpFire® HPV与提供者收集的careHPV。