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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：
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
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/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&apos 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

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.

CASCADE CLIMB项目（预防感染艾滋病毒的妇女宫颈癌）的总体目标