UZ-UCSF CTU

项目总结/摘要 二十多年来，津巴布韦大学-加州大学旧金山分校弗朗西斯科临床试验部门（UZ- UCSF CTU）一直在利用经验丰富的 跨多网络CTU的多学科、交叉培训的调查员和研究人员。反恐组是一个 预防和控制艾滋病毒/艾滋病的卓越中心，并为全球了解 艾滋病毒的流行病学和发病机制，政策和护理标准。在当前的资金周期中，反恐组 在所有5个NIH资助的网络（ACTG，IMPAACT， HPTN、HVTN、MTN），生成了138篇科学文章， 津巴布韦的卫生政策。反恐组不断创新，克服了 津巴布韦的政治和经济环境。反恐组建议继续发展其科学 严格和管理良好的CTU，以支持4个拟议网络的科学议程（ACTG， IMPAACT，HPTN，HVTN），培训津巴布韦下一代研究领导人，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。铅 为ACTG、IMPAACT、HPTN、HVTN网络的研究议程做出强有力的贡献; a）继续 先进评价新的和持久的基于抗逆转录病毒的系统性治疗和预防战略，以便：㈠ 在没有抗逆转录病毒疗法的情况下控制艾滋病毒的复制;（二）控制传染性和非传染性 合并症;以及（iii）在重点人群中预防艾滋病毒，包括少女和年轻女性，男性 通过评估新型PrEP药物递送系统，与男性发生性关系的女性和女性性工作者; B）继续 新的预防性和治疗性候选疫苗和广泛中和抗体的评价 在儿童、青少年和成年人中控制艾滋病毒/结核病; c）实施综合战略，评估社会影响， 在高危重点人群中进行艾滋病毒预防的行为、生物医学和结构性干预， 优化儿童、青少年和成人艾滋病毒感染者的治疗结果; d）研究新的 产品的可接受性，吸收和坚持使用混合方法来评估新的有效性 方法，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他们权力，以支持艾滋病规划署95-95-95目标;具体目标3。保持 并调整我们的CTU的高效和复杂的集中研究基础设施， 实验室、药房、社区、法规、质量管理、行政和财务 推动合规并确保有效执行试验的部门;以及具体目标4。加强反恐小组的 作为一个地方，区域和全球知识中心的角色，投资于下一个培训和指导 培养科学和社区领导人。

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.