CAMPO Administrative and Coordinating Core

为管理和协调核心，加州-墨西哥-波多黎各(坎波)联盟将进行三项临床研究，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。研究1将检查墨西哥和波多黎各4000名HIV阳性妇女宫颈高度鳞状上皮内病变(HSIL)的新筛查算法。研究2将评估在600名HIV阳性男女中，使用肛门益生菌对肛门和宫颈微生物区系的影响，与肛门和宫颈HSIL消退的关系，以及在那些没有病变的人中减少高危HPV DNA的持久性。研究3将评估一种基于多价复制缺陷型腺病毒的治疗性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回归的免疫反应相关性。坎波财团将由行政和协调核心(行政协调会)监督。ACC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，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)为临床试验计划提供必要的基础设施、监管和业务支持；(3)支持对拉丁美洲艾滋病毒和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)监测和评估联盟的影响；以及(5)确保NIH官员、外部科学咨询小组(ESAG)、社区咨询委员会(CAB)和政策制定者在联盟活动中的确定、持续参与和双向整合。行政协调委员会将由加州大学旧金山分校的MPI联系人Joel Palefsky博士领导，并由MPIS的UPR的Ana Ortiz Martinez博士和INSP的Jorge Salmeron博士共同领导。ACC的其他成员将包括联盟中的主要利益相关者，包括指导委员会主席、临床试验计划负责人、社区咨询委员会主席和Emmes公司的一名代表。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，并确保联合体的所有组成部分有效合作。行政协调会将向执行委员会提供指导，执行委员会由三名首席调查员组成，并将作为联合体的决策机构。

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.