CAMPO Administrative and Coordinating Core

CAMPO 行政和协调核心

• 批准号: 10469355
• 负责人: JOEL Michael PALEFSKY
• 金额: $ 47.46万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10469355
• 关键词: Adenoviruses; Algorithms; Anus; California; Cervical; Clinical Research; Clinical Trials; Collaborations; Communication; Communities; DNA; Decision Making; Development; Ensure; Environment; Goals; HIV; HIV Seropositivity; HPV-High Risk; Human Papilloma Virus-Related Malignant Neoplasm; Immune response; Infrastructure; Institution; Laboratories; Latin America; Lesion; Mexico; Monitor; Population; Prevention; Principal Investigator; Probiotics; Puerto Rico; Research; Research Infrastructure; Research Personnel; Resources; Safety; Specific qualifier value; Squamous intraepithelial lesion; United States National Institutes of Health; Woman; base; career; career development; cervical cancer prevention; data management; interest; international partnership; member; men; microbiota profiles; programs; research study; screening; statistics; success; therapeutic HPV vaccine

ABSTRACT FOR ADMINISTRATIVE AND COORDINATING CORE The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV- positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. The CAMPO Consortium will be overseen by the Administrative and Coordinating Core (ACC). Working with the Data Management and Statistics Core, Central Laboratory Core and the Clinical Trials Program, the ACC has the following aims: (1) To facilitate effective, regular and sustainable means of communication between Consortium members and Consortium activities; (2) To provide necessary infrastructure, regulatory, and operational support for the Clinical Trials Program; (3) To support career development and research infrastructure for early career investigators with research interests in HIV and HPV-related malignancies in Latin America; (4) To monitor and evaluate the impact of the Consortium; and (5) To ensure the identification, continuous participation, and bi-directional integration of NIH officials, the External Scientific Advisory Group (ESAG) and Community Advisory Board (CAB) and policymakers in the Consortium’s activities. The ACC will be led by UCSF Contact MPI Dr. Joel Palefsky, and co-led by MPIs Dr. Ana Ortiz Martinez of UPR and Dr. Jorge Salmeron of INSP. The other members of the ACC will include the major stakeholders in the Consortium, including the chair of the Steering Committee, the leader of the Clinical Trials Program, the chair of the Community Advisory Board, and a representative of The Emmes Corporation. The ACC will meet biweekly to discuss Consortium activities, monitor progress, and ensure that all components of the Consortium are working together effectively. The ACC will provide guidance to the Executive Committee, which is comprised of the three Principal Investigators and will serve as the decision- making body for the Consortium.

用于管理和协调核心的摘要 加利福尼亚 - 墨西哥 - 普洛托Rico（Campo）财团将进行三项临床研究 专注于预防墨西哥和波多黎各的HIV阳性女性宫颈癌。研究1 将检查4000中宫颈高级鳞状上皮内病变（HSIL）的新筛查算法 墨西哥和波多黎各的艾滋病毒阳性妇女。研究2将评估肛门生物益生菌对 肛门和宫颈微生物元素谱以及与600 HIV的肛门和宫颈HSIL回归的关系 在没有病变的患者中，积极的男女以及降低了高风险的HPV DNA持久性。 研究3将评估基于多价复制缺陷型腺病毒的安全性和效率 治疗性HPV疫苗可在300名HIV阳性男性和男性中治疗宫颈和肛门HSIL并鉴定 HSIL回归的免疫反应相关。坎波联盟将由 行政和协调核心（ACC）。与数据管理和统计核心合作，中央 实验室核心和临床试验计划，ACC具有以下目的：（1）促进有效， 财团成员和财团活动之间的定期和可持续沟通方式； （2） 为临床试验计划提供必要的基础设施，监管和运营支持； （3）到 支持具有研究兴趣的早期职业研究人员的职业发展和研究基础设施 拉丁美洲的HIV和HPV相关的恶性肿瘤； （4）监视和评估财团的影响； （5）确保NIH官员的识别，持续参与和双向整合， 外部科学咨询小组（ESAG）和社区顾问委员会（CAB）以及政策制定者 财团的活动。 ACC将由UCSF与MPI联系MPI Joel Palefsky博士领导，并由MPIS Dr.共同领导。 UPR的Ana Ortiz Martinez和Insp的Jorge Salmeron博士。 ACC的其他成员将包括 财团的主要利益相关者，包括指导委员会主席，临床领导人 试验计划，社区顾问委员会主席和艾米斯公司的代表。 ACC将每两周开会，讨论联盟活动，监控进度并确保所有人 财团的组成部分正在有效合作。 ACC将为 执行委员会，该委员会已完成三位主要调查人员的决定，并将作为决定 - 为财团制作身体。