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.

管理和协调核心的摘要 加州-墨西哥-波多黎各(坎波)联盟将进行三项临床研究 重点关注在墨西哥和波多黎各艾滋病毒阳性妇女中预防宫颈癌。研究1 将在4000年中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将评估使用肛门益生菌对 600例HIV感染者的肛门和宫颈微生物区系及其与肛门和宫颈HSIL消退的关系 阳性的女性和男性，以及那些没有损伤的人中高危HPV DNA持久性的减少。 研究3将评估以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例HIV阳性男女宫颈和肛门HSIL 免疫应答与HSIL回归相关。坎波财团将由 行政和协调核心(行政协调会)。与中环数据管理和统计核心合作 作为实验室核心和临床试验计划，ACC有以下目标：(1)促进有效、 联合体成员与联合体活动之间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、监管和操作支持； 支持具有以下研究兴趣的早期职业调查人员的职业发展和研究基础设施 拉丁美洲艾滋病毒和人乳头瘤病毒相关恶性肿瘤；(4)监测和评估该联盟的影响； 以及(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(ESAG)和社区咨询委员会(CAB)以及 财团的活动。ACC将由加州大学旧金山分校的MPI博士Joel Palefsky领导，并由MPIS博士共同领导。 普遍定期审议的Ana Ortiz Martinez和Insp的Jorge Salmeron博士。行政协调会的其他成员将包括 财团的主要利益攸关方，包括指导委员会主席、临床 试验方案，社区咨询委员会主席，以及Emmes公司的代表。 行政协调会将每两周举行一次会议，讨论联合体的活动，监测进展情况，并确保所有 该联盟的各组成部分正在有效地合作。行政协调委员会将向 执行委员会，由三名首席调查员组成，将作为以下决定- 为财团制作车身。