Implementing HIV/Cervical Cancer Prevention CASCADE Clinical Trials in Zimbabwe (ZIM-CASCADE)

在津巴布韦实施艾滋病毒/宫颈癌预防 CASCADE 临床试验 (ZIM-CASCADE)

基本信息

批准号：
10758129
负责人：
ZVAVAHERA MIKE CHIRENJE
金额：
$ 27.59万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-04 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10758129
关键词：
Acetic Acids Advocacy Algorithms Area California Cancer Prevention Intervention Cancer Prevention Trial Caring Cervical Cervical Cancer Screening Clinical Clinical Research Clinical Trials Clinical Trials Network Clinical Trials Unit Cold Therapy Collaborations Communities Country Cytology DNA Data Dedications Development Diagnosis Eligibility Determination Enrollment Ensure Equity Funding Genotype Guidelines Gynecologic Oncologist HIV HIV/AIDS HPV-High Risk Health Health Policy High Prevalence Human Papillomavirus Human papilloma virus infection Incidence Infrastructure Intervention Laboratories Leadership Lesion Life Cycle Stages Malignant Neoplasms Malignant neoplasm of cervix uteri Mentors Mission Multi-Institutional Clinical Trial Outcome Participant Pathogenesis Performance Persons Phase Policies Population Density Population Heterogeneity Pragmatic clinical trial Prevalence Prevention Procedures Protocols documentation Public Health Publications Regulation Research Research Activity Research Infrastructure Research Personnel Resource-limited setting Resources Risk San Francisco Scientist Screening for cancer Seminal Site System Testing Thermal Ablation Therapy Training Training and Education Treatment Efficacy United States National Institutes of Health Universities Virus Diseases Visual Woman World Health Organization Zimbabwe advanced disease aged antiretroviral therapy base cancer epidemiology cancer prevention cancer therapy cervical cancer prevention clinical infrastructure clinical research site clinically significant eligible participant experience innovation insight investigator training low and middle-income countries migration multimodality next generation point of care premalignant preventive intervention primary care clinic primary health center programs public health intervention recruit retention rate scale up screening therapeutic HPV vaccine treatment duration treatment optimization trial planning

项目摘要

Project Summary/Abstract Zimbabwe is a resource-constrained country with a high burden of HIV and cervical cancer (CXCA). Zimbabwean women with CXCA present with advanced disease and two-thirds die within a year of diagnosis. CXCA screening has low coverage (13%), and is conducted largely through visual inspection with acetic acid (VIA), with plans to migrate to human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing. Precancer treatment is mostly cryotherapy or thermal ablation but is only accessed by 53% of women screen positive. To meet the WHO 2030 target of eliminating CXCA by 2120, Zimbabwe needs new interventions that are acceptable, affordable, point-of-care, scalable, and clinically proven. To optimize CXCA screening and the pre- cancer treatment cascade for women living with HIV (WLWH), University of California, San Francisco (UCSF) and the University of Zimbabwe–Clinical Trials Research Centre (CTRC), in collaboration with local PEPFAR- funded implementation partners Organization for Public Health Interventions and Development (OPHID) and the Zimbabwe Technical Assistance, Training and Education Center for Health (Zim-TTECH) (collectively, ZIM-CASCADE) propose to serve as a LMIC CASCADE UG1 Clinical Site. ZIM-CASCADE draws on extensive experience in conducting clinical research and CXCA screening and treatment among WLWH, with access to 95,000 WLWH, of whom >44,000 are currently receiving comprehensive CXCA screening and treatment through the OPHID and Zim-TTECH programs located in Zimbabwe’s high-density population centers of Harare and Chitungwiza. ZIM-CASCADE will be led by 2 gynecological oncologists with globally recognized expertise in CXCA screening and treatment and will utilize research personnel and infrastructure from dedicated clinical research sites and community-based primary care clinics, whose experience has been developed over nearly 3 decades of continuous research activities. ZIM-CASCADE will participate in all 4 scientific focus areas of the CASCADE Network, and will complete the following Specific Aims: (1) Provide insight as to clinical significance and feasibility of planned trials by drawing on extensive clinical expertise in CXCA prevention among WLWH; (2) Utilize the expansive pluripotent infrastructure and research management systems developed over 28 years to conduct high quality pragmatic clinical trials; (3) Accrue and retain eligible WLWH through effective and equitable engagement with community partners; and (4) Ensure compliance with all protocol procedures and applicable research regulations. Completion of the Aims will contribute critical evidence to inform optimization, implementation, and scale-up of effective cervical cancer prevention interventions for WLWH in resource-limited settings, and the multi-modal CASCADE data will inform public health policy in Zimbabwe and globally.

项目概要/摘要津巴布韦是一个资源有限的国家，艾滋病毒和宫颈癌（CXCA）负担较高。患有 CXCA 的津巴布韦妇女已处于晚期疾病，三分之二的妇女在诊断后一年内死亡。 CXCA 筛查覆盖率低（13%），主要通过醋酸目视检查进行 (VIA)，计划迁移到人乳头瘤病毒 (HPV) 脱氧核糖核酸 (DNA) 癌前检测。治疗方法主要是冷冻疗法或热消融，但只有 53% 的筛查呈阳性的女性接受治疗。为了实现世界卫生组织 2030 年到 2120 年消除 CXCA 的目标，津巴布韦需要新的干预措施：可接受的、负担得起的、即时护理、可扩展且经过临床验证的。针对女性艾滋病毒感染者的癌症治疗级联 (WLWH)，加州大学旧金山分校 (UCSF) 和津巴布韦大学临床试验研究中心 (CTRC) 与当地 PEPFAR 合作资助的实施伙伴公共卫生干预与发展组织 (OPHID) 和津巴布韦卫生技术援助、培训和教育中心 (Zim-TTECH)（统称为 ZIM-CASCADE）提议作为 LMIC CASCADE UG1 临床站点。在 WLWH 中进行临床研究以及 CXCA 筛查和治疗方面拥有丰富的经验，接触 95,000 名 WLWH，其中超过 44,000 人目前正在接受全面的 CXCA 筛查和通过位于津巴布韦高密度人口的 OPHID 和 Zim-TTECH 项目进行治疗哈拉雷和奇通维萨中心将由 2 名全球妇科肿瘤学家领导。 CXCA 筛查和治疗方面公认的专业知识，并将利用研究人员和基础设施来自专门的临床研究场所和社区初级保健诊所，其经验 ZIM-CASCADE 将参与全部 4 项研究活动。 CASCADE 网络的科学重点领域，并将完成以下具体目标： (1) 提供通过利用广泛的临床专业知识，了解计划试验的临床意义和可行性 WLWH 中的 CXCA 预防；(2) 利用广泛的多能基础设施和研究管理 28 年来开发的系统，用于进行高质量的实用临床试验 (3) 积累并保留合格的临床试验；通过与社区合作伙伴有效和公平的参与实现 WLWH；以及 (4) 确保遵守所有协议程序和适用的研究法规将有助于实现目标。为优化、实施和扩大有效宫颈癌预防提供信息的证据在资源有限的环境中对 WLWH 进行干预，多模式 CASCADE 数据将告知公众津巴布韦和全球的卫生政策。