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: 10595668
• 负责人: Miriam Cremer
• 金额: $ 52.21万
• 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/10595668
• 关键词: Ablation; Age; Area; Biomedical Engineering; Biopsy; Caring; Cervical; Cervical Intraepithelial Neoplasia; Clinical; Clinical Trials; Collection; Colposcopy; Cost Analysis; Cost Effectiveness Analysis; Cost Measures; Country; Data; Detection; Disease; El Salvador; Electricity; Eligibility Determination; 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; Treatment Cost; 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; timeline; treatment strategy; Ablation; Age; Area; Biomedical Engineering; Biopsy; Caring; Cervical; Cervical Intraepithelial Neoplasia; Clinical; Clinical Trials; Collection; Colposcopy; Cost Analysis; Cost Effectiveness Analysis; Cost Measures; Country; Data; Detection; Disease; El Salvador; Electricity; Eligibility Determination; 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; Treatment Cost; 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; timeline; 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.

项目摘要/摘要 2018年，世界卫生组织（WHO）呼吁采取行动实现全球消除 宫颈癌。成员国在2020年8月占据了实现这一目标的策略。 计划要求对人乳头瘤病毒的疫苗接种，筛查和治疗进行积极的方法 （HPV），宫颈癌的唯一原因。在低收入和中等收入国家（LMIC）中，占90％的 全球宫颈癌的发病率和死亡率，据估计，直到 2120 - 从现在开始的一个世纪。明显缩短此时间表的一种方法是通过HPV自抽采样和 筛选阳性的人立即治疗。为了扩展HPV，必须有低成本 在现场易于使用的有效测试。最佳现场测试将使女性能够收集自己的 没有损害有效性的样品。唯一专门针对低的预先资格测试的人 资源设置是CareHPV，当临床采集样本时，其灵敏度相对较好，但是 自我采样时的性能很差。迫切需要评估低成本的自我 采样测试是有效的，可以轻松在LMIC中实施。 AMPFIRE®（加利福尼亚州Atila Biosystems）， 一种新的低成本HPV测试，在自收集的样品中表现出很高的灵敏度，并且可能表现更好 比提供者收集的CareHPV。此外，当前的CareHPV协议需要为期2天的访问，因为 这些机器位于中央位置，需要3-4小时进行处理。 Ampfire®可以从本地运行 使用电池操作的PCR机器的位置。由于这些测试在大约1小时内进行过程，因此 访问方法是可行的，这对卫生系统更有效，对患者更方便。 这项研究的目的是比较AMPFire®与CareHPV的效率 前任癌（宫颈上皮内肿瘤，2级或更高级或CIN2+），并比较效率和 每个测试通过以下目的的可行性：目标1：将自我收集的AMPFIRE®与标准进行比较 提供者收集的CAREHPV检测高级宫颈前疗法。目标2：演示 使用自我收集的AMPFIRE®的一次访问方法将导致随访的损失较低 当前使用提供者收集的CareHPV的当前常规两次访问方法。目标3：执行成本 - 有效分析以比较效率，损失对随访的效率和自我采样的概括性 AMPFIRE®HPV与提供商收集的CareHPV。