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.

加利福尼亚-墨西哥-波多黎各（CAMPO）联盟将开展三项临床研究，重点关注墨西哥和波多黎各艾滋病毒阳性妇女宫颈癌的预防。研究1将研究4000名墨西哥和波多黎各hiv阳性妇女宫颈高级别鳞状上皮内病变（HSIL）的新筛查算法。研究2将评估在600名HIV阳性女性和男性中使用肛门生殖器益生菌对肛门和宫颈微生物群的影响，以及与肛门和宫颈HSIL消退的关系，以及无病变人群中高危HPV DNA持久性的降低。研究3将评估基于多价复制缺陷腺病毒的治疗性HPV疫苗治疗300名hiv阳性女性和男性宫颈和肛门HSIL的安全性和有效性，并确定HSIL消退的免疫应答相关因素。CAMPO财团将由行政和协调核心（行政协调会）监督。与数据管理和统计核心、中央实验室核心和临床试验项目合作，ACC有以下目标：(1)促进联盟成员和联盟活动之间有效、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)支持对拉丁美洲HIV和hpv相关恶性肿瘤有研究兴趣的早期职业研究人员的职业发展和研究基础设施；(4)监测和评价联合体的影响；(5)确保NIH官员、外部科学咨询小组（ESAG）和社区咨询委员会（CAB）以及政策制定者在联盟活动中的识别、持续参与和双向整合。ACC将由UCSF联络MPI Joel Palefsky博士领导，MPI UPR的Ana Ortiz Martinez博士和inspo的Jorge Salmeron博士共同领导，ACC的其他成员将包括联盟的主要利益相关者，包括指导委员会主席、临床试验项目负责人、社区咨询委员会主席和Emmes公司的代表。行政协调会将每两周举行一次会议，讨论联盟的活动，监测进展情况，并确保联盟的所有组成部分有效地合作。行政协调会将向执行委员会提供指导，该委员会由三名主要调查员组成，并将作为该联盟的决策机构。