CAMPO Administrative and Coordinating Core

CAMPO 行政和协调核心

• 批准号: 10700198
• 负责人: JOEL Michael PALEFSKY
• 金额: $ 5.54万
• 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/10700198
• 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 加州-墨西哥-波多黎各 (CAMPO) 联盟将进行三项临床研究 研究 1 的重点是预防墨西哥和波多黎各艾滋病毒阳性妇女的宫颈癌。 将在 4000 年检查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女性研究 2 将评估使用肛门生殖器益生菌对健康的影响。 600 例 HIV 感染者的肛门和宫颈微生物群特征及其与肛门和宫颈 HSIL 回归的关系 女性和男性呈阳性，以及无病变人群中高危 HPV DNA 持久性降低。 研究 3 将评估基于多价复制缺陷型腺病毒的安全性和有效性 HPV 疫苗可治疗 300 名 HIV 阳性女性和男性的宫颈和治疗性肛门 HSIL，并确定 与 HSIL 消退相关的免疫反应 CAMPO 联盟将受到 HSIL 的监督。 行政和协调核心 (ACC) 与中央数据管理和统计核心合作。 ACC 实验室核心和临床试验计划的目标如下： (1) 促进有效、 (2) 联合体成员之间和联合体活动之间定期、可持续的沟通方式； (3) 为临床试验计划提供必要的基础设施、监管和运营支持； 支持具有研究兴趣的早期职业研究者的职业发展和研究基础设施 （四）监测和评估联合体的影响； (5) 为确保 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) 以及政策制定者 ACC 联盟的活动将由 UCSF Contact MPI Dr. Joel Palefsky 领导，并由 MPI Dr. Joel Palefsky 共同领导。 ACC 的其他成员包括 UPR 的 Ana Ortiz Martinez 和 INSP 的 Jorge Salmeron 博士。 联盟的主要利益相关者，包括指导委员会主席、临床试验组负责人 Trials Program 社区咨询委员会主席，以及 Emmes Corporation 的代表。 ACC 将每两周举行一次会议，讨论联盟活动、监控进展并确保所有 联盟成员正在有效地合作。 ACC 将为联盟提供指导。 执行委员会由三名首席研究员组成，将作为决策者 为财团打造主体。