UZ-UCSF CTU

项目摘要/摘要 二十多年来，津巴布韦大学-加州大学旧金山临床试验中心(UZ-UZ- UCSF CTU)不断进行高质量的I-IV期临床试验，利用经验丰富的 跨多学科、受过交叉培训的调查人员和多网络CTU的研究人员。CTU是一个 艾滋病毒/艾滋病预防和控制英才中心，并为全球了解做出了贡献 艾滋病毒流行病学和发病机制、政策和护理标准。在当前的筹资周期中，反恐联盟 在所有5个由NIH资助的网络(ACTG，IMPAACT， HPTN、HVTN、MTN)在7个临床研究站点(CRSS)，生成138篇科学文章并提供信息 津巴布韦的医疗政策。反恐联盟已经进行了创新，以克服由 津巴布韦的政治和经济环境。反恐联盟建议继续科学发展其 严谨和管理良好的CTU，以支持4个拟议网络(ACTG， IMPAACT、HPTN、HVTN)，在津巴布韦培训下一代研究领导者，并为 在津巴布韦和全球控制和预防艾滋病毒和结核病，有4个具体目标：具体目标1.领导 对ACTG、IMPAACT、HPTN、HVTN网络的研究议程作出积极贡献；a)继续 新的和持久的基于系统性ARV的治疗和预防策略的预先评估：(I) 在没有抗逆转录病毒疗法的情况下控制艾滋病毒复制；(2)控制传染性和非传染性 (3)在关键人群中预防艾滋病毒，包括少女和年轻妇女、男子 通过评估新的PrEP药物递送系统与男性和女性性工作者发生性关系；b)继续 新型预防和治疗疫苗候选疫苗和广谱中和抗体的评价 在儿童、青少年和成人中控制艾滋病毒/结核病；c)实施综合战略，以评估社会和 在高危重点人群中预防艾滋病毒的行为、生物医学和结构性干预措施，同时 优化儿童、青少年和成人艾滋病毒感染者的治疗结果；d)调查新的 产品可接受性、接受性和依从性使用混合方法评估新的 办法，包括多用途预防技术；具体目标2.强化社区 参与研究的所有阶段，并发展社区咨询委员会成员，以代表、 动员关键人群并赋予其权力，以支持艾滋病规划署95-95-95目标；具体目标3.维持 并使我们CTU高效和复杂的集中式研究基础设施跨越CRSS和 实验室、药房、社区、监管、质量管理、行政和财务 推动合规和确保有效执行审判的部门；以及具体目标4.加强CTU的 作为本地、区域和全球知识中心的角色，投资于下一步的培训和指导 一代以科学和社区为基础的领导者。

Project Summary/Abstract For over 2 decades the University of Zimbabwe-University of California, San Francisco Clinical Trials Unit (UZ- UCSF CTU) has continuously conducted high quality Phase I-IV clinical trials, utilizing experienced teams of multidisciplinary, cross-trained investigators, and research staff across the multi-Network CTU. The CTU is a center of excellence in the prevention and control of HIV/AIDS and has contributed to the global understanding of HIV epidemiology and pathogenesis, policy, and standards of care. In the current funding cycle, the CTU enrolled over 6,700 participants in 48 clinical trials across all 5 NIH-funded Networks (ACTG, IMPAACT, HPTN, HVTN, MTN) at 7 Clinical Research Sites (CRSs), generating 138 scientific articles and informing Zimbabwe’s health policy. The CTU has innovated to overcome operational challenges occasioned by the political and economic environment in Zimbabwe. The CTU proposes to continue to develop its scientifically rigorous and well-managed CTU to support the scientific agendas of the 4 proposed Networks (ACTG, IMPAACT, HPTN, HVTN), train the next generation of research leaders in Zimbabwe, and contribute to the control and prevention of HIV and TB in Zimbabwe and globally, with 4 Specific Aims: Specific Aim 1. Lead robust contributions to the research agendas of the ACTG, IMPAACT, HPTN, HVTN Networks; a) Continue to advance evaluation of novel and durable systemic ARV-based therapeutic and preventive strategies for: (i) control of HIV replication in the absence of ART; (ii) control of communicable and non-communicable comorbidities; and (iii) prevention of HIV in Key Populations, including adolescent girls and young women, men who have sex with men, and female sex workers by evaluating novel PrEP drug delivery systems; b) Continue evaluation of novel preventative and therapeutic vaccine candidates and broadly neutralizing antibodies for HIV/TB control among children, adolescents, and adults; c) Implement integrated strategies to evaluate socio- behavioral, biomedical, and structural interventions for HIV prevention among high-risk Key Populations while optimizing treatment outcomes among children, adolescents, and adults living with HIV; d) Investigate new product acceptability, uptake, and adherence using mixed methods to assess the effectiveness of novel approaches, including Multi-Purpose Prevention Technologies; Specific Aim 2. Intensify community engagement at all stages of research and evolve Community Advisory Board membership to represent, mobilize, and empower Key Populations, in support of the UNAIDS 95-95-95 targets; Specific Aim 3. Maintain and adapt our CTU’s efficient and sophisticated centralized research infrastructures across the CRSs and the Laboratory, Pharmacy, Community, Regulatory, Quality Management, Administration and Finance Departments to drive compliance and ensure efficient execution of trials; and Specific Aim 4. Fortify the CTU’s role as a local, regional, and global knowledge hub with investments in training and mentorship for the next generation of scientific and community-based leaders.