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: 10543925
• 负责人: Elizabeth Renata Brown
• 金额: $ 68.89万
• 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/10543925
• 关键词: AIDS/HIV problem; 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; Epidemiology; Fostering; Geography; Goals; Gynecologic Oncology; HIV; HIV-1; 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; NCI Scholars Program; Nurses; Preparation; Procedures; Protocols documentation; Public Health; Recurrence; Research; Research Personnel; Resource-limited setting; Risk; Sampling; 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; cost outcomes; effectiveness outcome; 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 trial; preventive intervention; programs; quality assurance; racial and ethnic disparities; randomized trial; 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 的总体目标（艾滋病毒感染者的宫颈癌预防 (WLWH)） 研究动员基地）的目的是生成关键证据，为优化、实施和规模提供信息 - 针对 WLWH 制定有效的宫颈癌预防干预措施。发挥科学中心的作用 CASCADE Network、CLIMB 将通过熟练和创新的科学推动网络的科学议程 和统计领导力、严格和强有力的业务监督以及培训和能力建设 促进宫颈癌预防干预措施研究、实施和扩大的机会 预期用途设置。我们高素质的研究团队具有互补性和综合性 HPV/宫颈癌预防和控制、妇科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、统计学和方法学方面的专业知识 实施科学；以及在整个连续体中领先的临床试验和研究的良好记录 美国和中低收入国家 (LMIC) 实施研究的有效性。这 具体目标是： 1) 制定并开展严格务实的多中心临床试验，以解决未满足的问题 WLWH 在宫颈癌预防方面的需求，以及 2) 在资源有限的领域培养新兴研究人员 通过提供指导、能力建设机会以及所需技能和学科的培训来改善环境 领导宫颈癌预防的未来研究。我们将制定试验概念和方案并领导 三项试验的实施、操作监督、统计分析和手稿准备。我们 提出实用性试验来评估美国重要的临床有效性和实施结果 在中低收入国家，目标如下： 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病变检测的影响； 2) 比较分子分类 （例如，p16/ki-67 双染色、甲基化）与 HPV 阳性随访率结果后立即消融对比 HPV/癌前病变检测； 3) 将任务转移策略与具有电子质量保证的护士进行比较 当日宫颈癌筛查和治疗与需要转诊进行随访的常规护理程序 筛查和治疗率； 4) 比较热消融与 LEEP 治疗癌症前期的效果 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健康系的治疗、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，包括研究基础同步在线课程、虚拟和现场培训构建 宫颈癌预防的研究能力和现场临床培训。我们将推动发展 通过 CASCADE 学者计划培养早期职业调查人员，包括流行病学和 手稿准备的统计和指导。