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)
基本信息
- 批准号:10340927
- 负责人:
- 金额:$ 57.88万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AblationAgeAreaBiomedical EngineeringBiopsyCaringCervicalCervical Cancer ScreeningCervical Intraepithelial NeoplasiaClinicalClinical TrialsCollectionColposcopyCost Effectiveness AnalysisCost MeasuresCountryDataDetectionDiseaseEl SalvadorElectricityEnvironmentEpidemiologyEvaluationFemale AdolescentsFinancial costGoalsGuidelinesHealthHealth Planning OrganizationsHealth systemHourHuman PapillomavirusHuman papilloma virus infectionIncidenceLesionLocationMalignant neoplasm of cervix uteriMeasuresMethodsPathologyPatientsPrevalenceProcessProtocols documentationProviderPublic HealthResearchResource-limited settingRunningSamplingScreening ResultSensitivity and SpecificitySpecimenTechnologyTestingTimeLineTreatment CostUrsidae FamilyVaccinatedVaccinationVaginaValidationVisitWomanWorkWorld Health Organizationcomparative efficacycostcost effectivecost effectivenesscost-effectiveness evaluationdisability-adjusted life yearseconomic costefficacy testingfield studyfollow-uphealth economicsindustry partnerlow and middle-income countriesmembermortalityportabilitypremalignantprogramsscale upscreeningstatisticstreatment strategy
项目摘要
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
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Miriam Cremer其他文献
Miriam Cremer的其他文献
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{{ truncateString('Miriam Cremer', 18)}}的其他基金
Development of an HPV stigma assessment scale and a stigma-reducing intervention to improve cervical cancer prevention in El Salvador
制定 HPV 耻辱评估量表和减少耻辱干预措施,以改善萨尔瓦多的宫颈癌预防
- 批准号:
10844859 - 财政年份:2023
- 资助金额:
$ 57.88万 - 项目类别:
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 - 财政年份:2022
- 资助金额:
$ 57.88万 - 项目类别:
PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling
进展:利用基因分型筛查和当天自我采样预防宫颈癌
- 批准号:
10696230 - 财政年份:2022
- 资助金额:
$ 57.88万 - 项目类别:
PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling
进展:利用基因分型筛查和当天自我采样预防宫颈癌
- 批准号:
10491481 - 财政年份:2022
- 资助金额:
$ 57.88万 - 项目类别:
Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
- 批准号:
10488168 - 财政年份:2018
- 资助金额:
$ 57.88万 - 项目类别:
Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
- 批准号:
10662503 - 财政年份:2018
- 资助金额:
$ 57.88万 - 项目类别:
Development of an LMIC-adapted Thermocoagulation Prototype for the Treatment of Cervical Pre-cancer.
开发适合 LMIC 的热凝原型,用于治疗宫颈癌前病变。
- 批准号:
9903657 - 财政年份:2018
- 资助金额:
$ 57.88万 - 项目类别:
Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
- 批准号:
10411389 - 财政年份:2018
- 资助金额:
$ 57.88万 - 项目类别:
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting
CryoPen:资源匮乏环境下宫颈癌前病变的创新治疗方法
- 批准号:
9355105 - 财政年份:2015
- 资助金额:
$ 57.88万 - 项目类别:
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting
CryoPen:资源匮乏环境下宫颈癌前病变的创新治疗方法
- 批准号:
8930106 - 财政年份:2015
- 资助金额:
$ 57.88万 - 项目类别:
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