The CASCADE CLIMB: Cervical cancer prevention in women Living with HIV research Mobilization Base

CASCADE CLIMB：女性艾滋病毒感染者宫颈癌预防研究动员基地

• 批准号: 10707161
• 负责人: Elizabeth Renata Brown
• 金额: $ 67.5万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707161
• 关键词: Ablation; Address; Aftercare; Cancer Control; Cancer Prevention Intervention; Cervical Cancer Screening; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical effectiveness; Collaborations; Communication; Decision Making; Detection; Development; Discipline; E-learning; Education; Effectiveness; Electronics; Epidemiology; Fostering; Geography; Goals; Gynecologic Oncology; HIV; HIV-1; HIV/AIDS; Health Policy; Human Papillomavirus; Incidence; Infrastructure; Interdisciplinary Study; Intervention; Lateral; Lead; Leadership; Malignant neoplasm of cervix uteri; Manuscripts; Mentorship; Methodology; Methylation; Modality; Molecular; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nurses; Outcome; Preparation; Procedures; Protocols documentation; Public Health; Recurrence; Research; Research Personnel; Resource-limited setting; Risk; Sampling; Scholars Program; Science; Site; Stains; Statistical Data Interpretation; Structure; Thermal Ablation Therapy; Training; Triage; Universities; Washington; Woman; Women' s Health; Writing; antiretroviral therapy; attributable mortality; base; career; cervical cancer prevention; clinical implementation; clinical research site; clinical training; cost; effectiveness outcome; ethnic disparity; follow-up; fundamental research; global health; health care disparity; implementation outcomes; implementation research; implementation science; improved; innovation; loop electrosurgical excision procedure; low and middle-income countries; mortality; online course; operation; pragmatic randomized trial; pragmatic trial; premalignant; preventive intervention; programs; quality assurance; racial disparity; scale up; scientific hub; screening; screening services; skills; socioeconomic disparity; standard of care; statistics; treatment as usual; treatment services; trial design; virtual

The overall goal of The CASCADE CLIMB (Cervical cancer prevention in women Living with HIV (WLWH) research Mobilization Base) is to generate critical evidence to inform optimization, implementation, and scale- up of effective cervical cancer prevention interventions for WLWH. Functioning as a scientific hub of the CASCADE Network, CLIMB will drive the network's scientific agenda through skilled and innovative scientific and statistical leadership, rigorous and robust operational oversight, and training and capacity-building opportunities to facilitate research, implementation, and scale-up of cervical cancer prevention interventions in intended-use settings. Our highly capable team of investigators has complimentary and integrated multidisciplinary research and clinical expertise in HPV/cervical cancer prevention and control, gynecologic oncology, women's health, and HIV/AIDS; methodological expertise in epidemiology, statistics, and implementation science; and a strong record of leading clinical trials and studies across the continuum of effectiveness to implementation research in both the US and in low- and middle-income countries (LMICs). The specific aims are to: 1) Develop and conduct rigorous pragmatic, multi-site clinical trials that address unmet needs in cervical cancer prevention for WLWH, and 2) Nurture emerging investigators in resource-limited settings by offering mentorship, capacity-building opportunities and training in the skills and disciplines needed to lead future research in cervical cancer prevention. We will develop trial concepts and protocols and lead implementation, operational oversight, statistical analysis, and manuscript preparation for three trials. We propose pragmatic trials to evaluate important clinical effectiveness and implementation outcomes in the US and in LMICs, with the following aims: 1) Compare strategies for offering HPV self-sampling vs. local standard of care screening approaches on rates of screening and precancer detection; 2) Compare molecular triage (e.g., p16/ki-67 dual stain, methylation) vs. immediate ablation after an HPV-positive result on follow-up rates of HPV/precancer detection; 3) Compare a task shifting strategy to nurses with electronic quality assurance for same day cervical cancer screening and treatment vs. usual care procedures that require referral for follow-up on rates of screening and treatment; and 4) Compare thermal ablation vs. LEEP for treating precancers in WLWH with type 2 transformation zones on rates of post-treatment HPV detection/precancer recurrence. We will leverage the University of Washington Department of Global Health's Treatment, Research, and Expert Education and E-Learning Programs to deliver training and capacity-building activities to CASCADE Clinical Sites, including synchronous online courses in research fundamentals, virtual and on-site trainings to build research capacity, and on-site clinical training in cervical cancer prevention. We will promote development of early-career investigators through a CASCADE Scholars program, including training in epidemiology and statistics and mentorship for manuscript preparation.

CASCADE CLIMB（艾滋病毒感染妇女的宫颈癌预防）的总体目标 研究动员基地）是生成关键证据，为优化、实施和规模提供信息- 为WLWH提供有效的宫颈癌预防干预。作为一个科学中心， CASCADE网络，CLIMB将通过熟练和创新的科学议程来推动网络的科学议程。 统计领导、严格有力的业务监督以及培训和能力建设 促进研究、实施和扩大宫颈癌预防干预措施的机会， 预期使用设置。我们的高素质的调查员团队具有互补性和整合性， 在HPV/宫颈癌预防和控制、妇科、生殖健康和生殖健康方面的多学科研究和临床专业知识 肿瘤学，妇女健康和艾滋病毒/艾滋病;流行病学，统计学和 实施科学;以及领先的临床试验和研究的良好记录， 在美国和低收入和中等收入国家（LMICs）的实施研究的有效性。的 具体目标是：1）开发和实施严格务实的多地点临床试验，以解决未满足的 在宫颈癌预防的WLWH的需求，和2）培养新兴的研究人员在资源有限的 通过提供辅导、能力建设机会和所需技能和学科的培训， 引领未来宫颈癌预防的研究。我们将制定试验概念和方案， 三项试验的实施、操作监督、统计分析和手稿准备。我们 建议在美国进行务实的试验，以评估重要的临床有效性和实施结果 在中低收入国家，目的如下：1）比较提供HPV自我采样与当地标准的策略 护理筛查方法对筛查率和癌前检测率的影响; 2）比较分子分类 (e.g., p16/ki-67双重染色，甲基化）与HPV阳性结果后立即消融的随访率 HPV/癌前病变检测; 3）比较任务转移策略与电子质量保证护士， 同一天进行子宫颈癌检查和治疗与需要转介跟进的常规护理程序 对筛查和治疗率的影响;以及4）比较热消融与LEEP治疗 具有2型转化区的WLWH对治疗后HPV检测/癌前复发率的影响。我们 将利用华盛顿大学全球卫生部的治疗、研究和专家 教育和电子学习计划，为CASCADE Clinical提供培训和能力建设活动 网站，包括研究基础的同步在线课程，虚拟和现场培训， 研究能力和预防宫颈癌的现场临床培训。我们将促进发展 通过CASCADE学者计划培养早期职业调查人员，包括流行病学培训， 统计和指导手稿准备。