我们对临床试验的支持如何减少新的艾滋病毒感染并改善对年轻人的护理?

Challenge

Concerned about the growing numbers of U.S. adolescents and young adults (AYA) with HIV, 尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所(NICHD)妇幼传染病处(MPIDB)于2000年建立了艾滋病毒/艾滋病干预措施青少年药物试验网络(ATN). 该计划旨在支持研究网络的研究人员测试各种治疗和行为干预措施，以减少AYA感染艾滋病毒的风险因素，改善AYA艾滋病毒感染者(LWHIV)的健康结果，并预防艾滋病毒传播. NICHD has advanced its initiative to identify at-risk populations, engage them in care, 并通过支持目前的ATN项目，让他们参与研究，以加强艾滋病毒预防项目，并改善获得护理和治疗的机会.

After serving as the ATN Data and Operations Center from 2001-17, 趣赢平台被选为当前ATN迭代的操作和协作中心(OCC). This iteration aims to develop and conduct innovative interventional studies, collaboratively and independently, 致力于减少高危青年中的新发艾滋病毒感染，并改善亚州lwhhiv中艾滋病毒护理连续体的数量，重点是将未成年人纳入其中. 它还建立了科学领导中心(SLC)， 趣赢平台将与之合作. The work demands operational efficiency, protocol development and implementation skills, technological innovativeness, regulatory oversight dexterity, and experience conducting on-site clinical site monitoring.

Solution

趣赢平台独特地塑造了其运营方法，以增强ATN开发和管理多种创新行为的能力, community-based, translational, therapeutic, microbicide, and vaccine trials. 随着我们的协议发展战略的到位和建立我们强大的, flexible, and responsive regulatory infrastructure, we are ensuring efficient timelines, streamlined communication, clinical site consortium assistance for enrollment and high-quality research, 在多个研究项目和机构之间以及与其他网络之间顺利协调科学合作.

Training all clinical site personnel on quality control, quality assurance procedures, 协议要求是支持学习收益和保留成功的关键. So is maximizing our operational efficiencies, 我们正在通过引进一些创新技术来做到这一点, 包括社区参与和招聘结果数据库(CERO DB). CERO数据库是一个中心机制，它将获得社区外展工作的系统指标，以参与和维持社区伙伴关系，并在每个参与站点联盟(sc)中招募和保留HIV或LWHIV风险的AYA。. SC可以使用CERO数据库的输出来评估是否需要修改或额外的方法和创新来实现预期的结果，并确定SC社区活动的最佳实践.

趣赢平台 also developed an automated, user-friendly web-based Query & 通知系统(QNS)，以方便安全专员与协议小组之间的沟通, and address, track, and archive questions, notifications (e.g., deviations), and responses that arise as SCs conduct ATN clinical studies. 该系统可以根据主题向指定的个人发送通信.e., safety, regulatory) and help ensure that responses are consistent, timely, and documented methodically. The SCs and protocol teams will be able to access the QNS on the ATN website, which we have built and will continue to maintain.

Over the course of this work, 我们期望协调ATN参与其他研究网络和制药公司支持的研究.

Further, we will actively support various ATN operational components, such as develop protocol-specific procedures manuals, provide regulatory support and oversight, identify and manage the ATN single Institutional Review Board (IRB), oversee performance of selected SCs, and monitor SC community engagement activities, including coordinate the ATN National Community Advisory Board.

趣赢平台’s staff members will also serve on the leadership units of the ATN, including the Executive Committee and SC Performance Committee.

Results

ATN研究的结果将用于为国家科学议程提供信息，以改善在有风险的亚中亚地区预防艾滋病毒感染和亚中亚低艾滋病毒感染者的健康结果. 本研究的结果旨在实质性地促进美国的健康.S. 美国卫生与公众服务部(HHS)通过减少美国新增艾滋病毒感染来结束艾滋病毒流行(EHE)的目标.S. by 90% by 2030 by scaling up key HIV prevention and treatment strategies.