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/文摘