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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

级联攀爬的总体目标（艾滋病毒（WLWH）女性的宫颈癌预防研究动员基础）是为了产生关键证据，以告知优化，实施和规模 - 对WLWH有效预防宫颈癌的干预措施。充当科学枢纽级联网络，攀登将通过熟练和创新的科学来推动网络的科学议程以及统计领导力，严格且强大的运营监督以及培训和能力建设促进宫颈癌预防干预措施的研究，实施和扩大的机会预期使用的设置。我们能干的调查人员团队拥有免费的整合 HPV/宫颈癌预防和控制的多学科研究和临床专业知识，妇科肿瘤学，妇女健康和艾滋病毒/艾滋病；流行病学，统计学和实施科学；以及在整个连续体中进行领先的临床试验和研究的强有力记录在美国和低收入国家（LMIC）的实施研究的有效性。这具体目的是：1）开发和进行严格的务实的多站点临床试验 WLWH的宫颈癌预防需求，以及2）在资源限制中培养新兴研究者通过提供指导，能力建设机会以及所需技能和学科的培训来设置领导预防宫颈癌的未来研究。我们将制定试验概念和协议，并领导三个试验的实施，操作监督，统计分析和手稿准备。我们提出务实的试验，以评估美国重要的临床有效性和实施结果在LMIC中，具有以下目的：1）比较提供HPV自我采样与当地标准的策略筛查率和预测率检测率的护理筛查方法； 2）比较分子分类（例如，p16/ki-67双染色，甲基化）与随访速率的HPV阳性后与立即消融 HPV/预科检测； 3）将任务转换策略与具有电子质量保证的护士进行比较同一天的宫颈癌筛查和治疗与常规护理程序，需要推荐进行随访筛查和治疗率； 4）比较热消融与用于治疗预科生的LEEP WLWH具有2型转换区域的WLWH，对治疗后HPV检测/预科疗法复发的速率。我们将利用华盛顿大学全球卫生治疗，研究和专家教育和电子学习计划，以提供培训和能力建设活动以级联临床网站，包括研究基础知识的同步在线课程，虚拟和现场培训以构建研究能力和宫颈癌预防的现场临床培训。我们将促进发展通过级联学者计划，包括流行病学培训和手稿准备的统计和指导。