UZ-UCSF CTU

乌兹别克斯坦大学旧金山分校 CTU

基本信息

批准号：
10306357
负责人：
ZVAVAHERA MIKE CHIRENJE
金额：
$ 531.27万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-03-01 至 2027-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10306357
关键词：
AIDS clinical trial group AIDS prevention AIDS/HIV problem Adherence Adolescent Adult Anti-Retroviral Agents Award Breast Feeding California Caring Child Clinical Trials Clinical Trials Unit Collaborations Communities Complex Drug Delivery Systems Economics Effectiveness Enrollment Ensure Environment Epidemiology Evaluation Female Adolescents Funding Goals HIV HIV Vaccine Trials Network HIV prevention trials network HIV/TB Health Policy International International Maternal Pediatric Adolescent AIDS Clinical Trials Intervention Investments Laboratories Lead Mentors Mentorship Methodology Methods Microbicide Trials Network Mission Outcome Participant Pathogenesis Performance Pharmacy facility Phase Policies Politics Population Prevention Prevention Research Prevention approach Prevention strategy Preventive vaccine Research Research Infrastructure Research Priority Role San Francisco Social Behavior Technology Therapeutic Therapeutic Human Experimentation Training Treatment outcome United States National Institutes of Health Universities Woman Work Zimbabwe antiretroviral therapy base cis-female clinical research site community engagement comorbidity design effectiveness evaluation experience female sex worker high risk high risk population innovation investigator training knowledge hub men who have sex with men multidisciplinary neutralizing antibody next generation novel novel strategies pandemic disease pre-exposure prophylaxis pregnant social therapeutic vaccine treatment optimization uptake vaccine candidate young woman

项目摘要

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.

项目概要/摘要二十多年来，津巴布韦大学-加州大学旧金山分校临床试验中心 (UZ- UCSF CTU）利用经验丰富的团队，持续进行高质量的 I-IV 期临床试验 CTU 是一个跨多个网络的多学科、经过交叉培训的调查员和研究人员。预防和控制艾滋病毒/艾滋病的卓越中心，并为全球认识做出了贡献 HIV 流行病学和发病机制、政策和护理标准在当前的资助周期中，CTU 负责研究艾滋病毒流行病学和发病机制、政策和护理标准。在 NIH 资助的所有 5 个网络（ACTG、IMPAACT、 HPTN、HVTN、MTN）在 7 个临床研究中心 (CRS)，生成 138 篇科学文章并提供信息津巴布韦的卫生政策进行了创新，以克服因疫情带来的运营挑战。 CTU 建议继续科学发展津巴布韦的政治和经济环境。严格且管理良好的 CTU 支持 4 个拟议网络（ACTG、 IMPAACT、HPTN、HVTN），培训津巴布韦下一代研究领导者，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. 主导对 ACTG、IMPAACT、HPTN、HVTN 网络的研究议程做出积极贡献 a) 继续评估新颖且持久的系统性先进的基于 ARV 的治疗和预防策略：(i) 在没有抗逆转录病毒治疗的情况下控制艾滋病毒复制；(ii) 控制传染性和非传染性合并症；(iii) 预防重点人群的艾滋病毒，包括少女和年轻女性、男性通过评估新型 PrEP 药物输送系统，与男性和女性性工作者发生性关系 b) 继续；评估新型预防性和治疗性疫苗候选物以及广泛中和抗体儿童、青少年和成人的艾滋病毒/结核病控制； c) 实施综合战略来评估社会影响在高危重点人群中预防艾滋病毒的行为、生物医学和结构干预措施，同时优化感染艾滋病毒的儿童、青少年和成人的治疗结果 d) 调查新的情况；使用混合方法评估新产品的有效性的产品可接受性、吸收率和依从性方法，包括多用途预防技术；具体目标 2. 强化社区参与研究的各个阶段并发展社区咨询委员会成员以代表，动员并增强关键人群的权能，支持艾滋病规划署 95-95-95 目标。维持具体目标 3；并调整我们的 CTU 在 CRS 和实验室、药房、社区、监管、质量管理、行政和财务各部门推动合规并确保试验的有效执行；具体目标 4. 强化 CTU 的能力作为地方、区域和全球知识中心的角色，投资于未来的培训和指导一代科学和社区领袖。