CAMPO Administrative and Coordinating Core

CAMPO 行政和协调核心

• 批准号: 10496180
• 负责人: JOEL Michael PALEFSKY
• 金额: $ 25.27万
• 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: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10496180
• 关键词: CAMPO; Administrative; Coordinating; Core

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.

摘要的行政和协调核心核心加利福尼亚 - 墨西哥 - 帕尔托里科（Campo）财团将进行三项临床研究，重点介绍墨西哥和波多黎各的HIV阳性妇女的预防宫颈癌。研究1将检查研究2中4000名HIV阳性女性的宫颈高级别鳞状上皮内病变（HSIL）的新筛查算法，将评估肛门和宫颈菌群谱对肛门和宫颈菌群概况的肛门生物使用对600 Hs和宫颈HSRESSISTION在600 HSIL妇女中的关系的影响。没有病变。研究3将评估基于腺病毒的多价复制缺陷型HPV疫苗的安全性和有效性，以治疗300名HIV阳性女性和男性的宫颈和肛门HSIL，并鉴定HSIL回归的免疫反应相关性。坎波联盟将由行政和协调核心（ACC）监督。与数据管理和统计核心，中央实验室核心和临床试验计划合作，ACC具有以下目的：（1）促进财团成员和财团活动之间有效，定期和可持续的沟通方式； （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）支持早期职业研究人员的职业发展和研究基础设施，该研究人员在拉丁美洲具有HIV和HPV相关的恶性肿瘤研究兴趣； （4）监视和评估财团的影响； （5）确保NIH官员，外部科学咨询小组（ESAG）和社区顾问委员会（CAB）（CAB）以及政策制定者在财团的活动中的识别，持续参与和双向整合。 ACC将由UCSF领导，请联系MPI MPI Joel Palefsky博士，并由UPR的MPIS Ana Ortiz Martinez博士和Insp的Jorge Salmeron博士主持。 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，临床试验计划的负责人，社区顾问委员会主席以及Emmes Corporation的代表。 ACC将每两周开会，讨论财团活动，监控进度，并确保财团的所有组成部分有效地合作。 ACC将为执行委员会提供指导，该委员会由三名主要研究人员组成，并将作为财团的决策机构。