CAMPO Administrative and Coordinating Core

CAMPO 行政和协调核心

• 批准号: 10226224
• 负责人: JOEL Michael PALEFSKY
• 金额: $ 41.68万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226224
• 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.

行政和协调核心摘要 加利福尼亚-墨西哥-波多黎各（CAMPO）联盟将进行三项临床研究 重点是在墨西哥和波多黎各预防艾滋病毒阳性妇女的宫颈癌。研究1 将在4000年检查宫颈高度鳞状上皮内病变（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将评估肛门生殖器益生菌使用对 肛门和宫颈微生物群特征以及与600例HIV感染者肛门和宫颈HSIL消退的关系- 阳性的女性和男性以及没有病变的人中高危HPV DNA持续性的降低。 研究3将评估多价复制缺陷型腺病毒为基础的安全性和有效性。 治疗性HPV疫苗治疗300名HIV阳性女性和男性的宫颈和肛门HSIL， 免疫应答与HSIL消退相关。CAMPO财团将由 行政和协调核心。使用数据管理和统计核心，中央 实验室核心和临床试验计划，行政协调会有以下目标：（1）促进有效， 联合会成员和联合会活动之间的定期和可持续的沟通手段;（2） 为临床试验项目提供必要的基础设施、监管和运营支持;（3） 支持职业发展和研究基础设施的早期职业调查员与研究兴趣， （4）监测和评价联合会的影响; （5）为了确保NIH官员的识别、持续参与和双向整合， 外部科学咨询小组和社区咨询委员会以及 财团的活动。ACC将由UCSF Contact MPI博士Joel Palefsky领导，并由MPI博士共同领导。 UPR的Ana Ortiz Martinez和INSP的Jorge Salmeron博士。ACC的其他成员将包括 联盟中的主要利益相关者，包括指导委员会主席、临床 审判计划，社区咨询委员会主席，埃姆斯公司的代表。 ACC将每两周举行一次会议，讨论联合会的活动，监督进展，并确保所有 联合会各组成部分正在有效地合作。行政协调会将为 执行委员会，由三名主要研究者组成，将作为决定- 为财团做准备