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

摘要 在尼日利亚，每天估计有28人死于宫颈癌， 是全国女性中最常见的癌症只有少数妇女有资格接受筛查 （筛查合格）在尼日利亚（30-49岁）定期接受HPV筛查-一个重要组成部分 尼日利亚联邦卫生部建议的全面宫颈癌预防计划 卫生和尼日利亚妇产科学会。传统的筛查依赖于 在中央诊所进行巴氏涂片检查和醋酸目视检查，加上当地缺乏 相关的执行战略阻碍了进展。创新战略，分散筛选和 迫切需要增加妇女在这一进程中所有权。在本建议中，我们将采用现有的 结合环介导等温扩增（LAMP）和快速一锅法冻干的HPV检测 协议内的侧向流分析（LFA）的尼日利亚的情况下，然后使用参与式战略 （众包公开呼吁和学习社区），以最终确定以女性为中心的单一HPV的组成部分 自我测试工具包众包公开呼叫具有一组个体（即，筛选合格的妇女）解决全部或部分 然后实施选定的高质量解决方案。学习社区帮助参与者完善 并在尼日利亚符合筛查条件的妇女中进行评估或使用之前优化解决方案。我们的协作 研究小组成功地利用众包公开呼吁和学习社区，以增加艾滋病毒的自我- 在尼日利亚青年中进行测试，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自检原型可以可靠地检测HPV 16和18基因型， 70%的宫颈癌病例。一旦原型符合严格的诊断和试验准备 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）， 该项目将从最初的工程阶段（具体目标1）进入临床阶段（具体目标2 和3）。借鉴设计和参与性行动研究框架，我们提出以下具体建议 目的：（1）使HPV自测测定适合于护理点和同时检测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式学习社区 在符合筛查条件的妇女中，最终确定单一HPV自我检测实施策略（3） 最终修订的HPV自我检测策略是否增加了900名符合筛查条件的妇女的HPV筛查 在18个地方政府地区与常规护理使用阶梯楔形，务实的随机对照试验。 我们的研究将是第一批研究女性自身如何成为优化， 实施和评估HPV自我检测实施策略，该策略结合了他们的独特需求， 预防宫颈癌。我们专注于开放电话和为符合筛查条件的女性定制HPV服务 与NCI，NIH和美国政府的战略优先事项产生共鸣。

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.