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.

摘要在墨西哥和波多黎各Rico中，在高级鳞状上的上皮内病变（HSIL）中，在高级鳞状上皮内病变（HSIL）的HIV阳性女性中，对HIV阳性妇女的宫颈癌癌症进行了研究研究摘要。益生菌在肛门和宫颈微生物群中使用，以及与600个HIV阳性男性和男性的肛门和宫颈HSIL遗迹的关系，也要求HPV DNA持久性在没有多重病变的患者中。宫颈肛门HSIL在300个艾滋病毒阳性的女性和男性中，并识别出HSIL遗迹的免疫相关性（ACC）。 ）促进有效的，定期和可持续的交流手段（2），以提供必要的基础设施，并为临床试验计划提供支持HIB及其相关的拉丁语（4）监测和评估财团的影响； C. OnSortium活动中的COMUNITY顾问委员会（CAB）和政策制定者将由UCSF与MPI联系MPI Joel Palefsky博士，并由MPIS由MPIS主持。临床试验计划的负责人，社区顾问委员会主席和Emmes Corporation的代表。首席研究人员并将涉足财团的决策机构。