Innovative Rapid Enabling, Affordable, point-of-Care HPV Self-Testing Strategy (I-REACH)

创新的快速、经济、即时护理 HPV 自检策略 (I-REACH)

基本信息

批准号：
10648634
负责人：
YIE-HWA CHANG
金额：
$ 59.33万
依托单位：
SAINT LOUIS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10648634
关键词：
Acceleration Acetic Acids American Area Benchmarking Biological Assay Caring Cervical Cervical Cancer Screening Cervical Intraepithelial Neoplasia Cessation of life Clinic Clinical Clinical Sensitivity Clinical Trials Data Monitoring Committees Community Health Aides Community Healthcare Country Coupled DNA Data Decentralization Detection Development Diagnostic Diagnostic Reagent Kits Discipline of obstetrics Early Diagnosis Eligibility Determination Engineering Equipment Evaluation Foundations Freeze Drying Genotype Geographic Locations Government Gynecology HIV HPV-High Risk Health Health Personnel Human Papillomavirus Human papilloma virus 31 Human papillomavirus 16 Human papillomavirus 18 Individual Institutional Review Boards Instruction Learning Letters Local Government Malignant Neoplasms Malignant neoplasm of cervix uteri Mediating Methods Minority Women Nigeria Nigerian Ownership Pap smear Participant Performance Phase Prevention program Privacy Problem Solving Procedures Process Protocols documentation Randomized Randomized, Controlled Trials Readiness Recommendation Request for Applications Research Resource-limited setting Risk Sampling Screening Result Screening procedure Sensitivity and Specificity Services Societies Specificity Specimen Swab Technology Testing United States National Institutes of Health Validation Visual Woman Youth aged cervical cancer prevention community based participatory research cost crowdsourcing design diagnostic criteria disorder risk experience high risk implementation strategy innovation isothermal amplification lateral flow assay learning community low and middle-income countries middle age multidisciplinary point of care point of care testing prevent primary health center primary outcome prototype public health relevance recruit research study risk variant scale up screening secondary outcome self testing treatment as usual uptake user-friendly

项目摘要

Abstract Each day, there are an estimated 28 cervical cancer deaths in Nigeria, making cervical cancer the second most common cancer among women in the entire country. Only a minority of women eligible for screening (screen-eligible) in Nigeria (30-49 years old) regularly, have received HPV screening - an essential component of comprehensive cervical cancer prevention programs recommended by the Nigerian Federal Ministry of Health and the Society of Obstetrics and Gynecology of Nigeria (SOGON). Conventional screening that relies on Pap smears and visual inspection with acetic acid (VIA) at centralized clinics, coupled with a lack of locally relevant implementation strategies have stalled progress. Innovative strategies to decentralize screening and increase women’s ownership in this process are urgently needed. In this proposal, we will adapt an existing HPV assay that combines loop-mediated isothermal amplification (LAMP) and fast one-pot lyophilization protocol within a lateral flow assay (LFA) for the Nigerian context, and then use participatory strategies (crowdsourcing open calls and learning communities) to finalize components of a single woman-centered HPV self-test kit. Crowdsourcing open calls have a group of individuals (i.e., screen-eligible women) solve all or part of a problem, then implement selected high-quality solutions. Learning communities help participants refine and optimize solutions before evaluation or use among screen-eligible women in Nigeria. Our collaborative research team has successfully used crowdsourcing open calls and learning communities to increase HIV self- testing among Nigerian youth, providing a strong foundation for the proposed research study. Our preliminary data demonstrate that our HPV self-test prototype can reliably detect HPV 16 and 18 genotypes that account for 70% of all cervical cancer cases. Once the prototype meets stringent diagnostic and trial preparedness metrics among Nigerian women, including detection of additional common HPV genotypes (31, 35, and 52), the project will move from the initial engineering phase (Specific Aim 1) to the clinical phase (Specific Aims 2 and 3). Drawing on a design and participatory action research framework, we propose the following specific aims: (1) to adapt an HPV self-test assay for point-of-care and simultaneous detection of HPV genotypes 16, 18, 31, 35, and 52 in Nigeria; (2) to use crowdsourcing open calls and participatory learning communities among screen-eligible women to finalize a single HPV self-testing implementation strategy (3) Determine whether a final revised HPV self-testing strategy increases HPV screening among 900 screen-eligible women in 18 local government areas versus usual care using a stepped-wedge, pragmatic randomized control trial. Our study will be among the first to examine how women themselves can be prime movers in optimizing, implementing and evaluating HPV self-testing implementation strategy that incorporates their unique needs to prevent cervical cancer. Our focus on open calls and tailoring HPV services for screen-eligible women resonates with NCI, NIH, and US government strategic priorities.

抽象的每天，尼日利亚估计有28例宫颈癌死亡，使宫颈癌第二次全国女性中最常见的癌症。只有少数有资格筛查的女性（符合屏幕）在尼日利亚（30-49岁）定期接受HPV筛选 - 必不可少的组成部分尼日利亚联邦部推荐的综合宫颈癌预防计划尼日利亚的健康与妇产科学会（Sogon）。依赖的常规筛选在集中式诊所用乙酸（VIA）视觉检查的子宫颈抹片检查和视觉检查，再加上局部缺乏相关的实施策略阻碍了进步。分散筛查和的创新策略迫切需要在此过程中增加妇女的所有权。在此提案中，我们将适应现有的 HPV分析结合了环路介导的等温扩增（LAMP）和快速的一锅冻干在尼日利亚环境中的横向流量测定法（LFA）中的协议，然后使用参与策略（众包公开电话和学习社区）最终确定以女性为中心的HPV的组件自测套件。众包公开电话有一群人（即符合屏幕符合屏幕的女性）解决所有问题问题，然后实现了选定的高质量解决方案。学习社区帮助参与者完善并在尼日利亚符合屏幕符合屏幕符合筛查的妇女的评估之前优化解决方案。我们的合作研究团队成功使用了众包公开电话和学习社区来增加艾滋病毒自我尼日利亚青年的测试为拟议的研究提供了坚实的基础。我们的初步数据表明，我们的HPV自测原型可以可靠地检测到HPV 16和18的基因型所有宫颈癌病例中有70％。一旦原型符合严格的诊断和试用准备尼日利亚妇女的指标，包括检测其他常见的HPV基因型（31、35和52），该项目将从初始工程阶段（特定目标1）转变为临床阶段（特定目的2 和3）。利用设计和参与行动研究框架，我们提出以下特定的特定目的：（1）适应HPV自测测定法以进行护理点和简单检测HPV基因型16，尼日利亚的18、31、35和52；（2）使用众包公开电话和参与学习社区在符合屏幕的妇女中，在最终确定单个HPV自我测试实施策略（3）确定最终修订的HPV自我测试策略是否会增加900名符合屏幕的女性的HPV筛查在18个地方政府地区，与常规护理相比，使用阶梯式纠缠，务实的随机控制试验。我们的研究将是第一个研究女性自己如何成为优化的主要举措之一。实施和评估HPV自我测试实施策略，该策略纳入了他们的独特需求预防宫颈癌。我们专注于公开通话和为符合屏幕的女性量身定制HPV服务与NCI，NIH和美国政府的战略重点共鸣。