How does our support for clinical trials reduce new HIV infections and improve care for young people?

挑战

担心越来越多的美国移民.S. 青少年和年轻成人(AYA)感染艾滋病毒, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal and Pediatric Infectious Disease Branch (MPIDB) established the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) in 2000. The initiative was designed to support the research network’s investigators in testing a variety of 治疗 and behavioral interventions to reduce risk factors in AYA for HIV acquisition and to improve health outcomes for AYA living with HIV (LWHIV) and prevent HIV transmission. 联合国儿童发展中心推进了其确定高危人群的倡议, 让他们参与护理, and have them participate in research studies to enhance HIV prevention programs and improve access to care and treatment by supporting the current ATN project.

2001年至2017年担任ATN数据和运营中心, 趣赢平台 was selected to serve as the Operations and Collaboration Center (OCC) for the current ATN iteration. 这一迭代旨在发展和开展创新的介入研究, 协作和独立, toward reducing new HIV infections among at-risk youth and improving numbers across the HIV care continuum among AYA LWHIV with a focus on inclusion of minors. It also establishes the Scientific 领导 Center (SLC) with which 趣赢平台 will collaborate. 这项工作要求操作效率, 协议开发和实施技能, 技术创新, 监管的灵活性, 并具有现场临床现场监测经验.

Solution

趣赢平台 has uniquely shaped its operational approach to amplify ATN’s capacity to develop and manage multiple innovative behavioral, 以社区为基础的, 平移, 治疗, 杀微生物剂, 还有疫苗试验. With our protocol development strategies in place and establishment of our robust, 灵活的, 以及相应的监管基础设施, 我们正在确保有效的时间表, 流线型的沟通, clinical site consortium assistance for enrollment and high-quality research, and smooth coordination of scientific collaboration across multiple research projects and institutions in the ATN and with other networks.

对所有临床现场人员进行质量控制培训, 质量保证程序, and protocol requirements is key to the success of supporting study accrual and retention. 最大化我们的运营效率也是如此, and we are doing this with the introduction of several innovative technologies, including the Community Engagement and Recruitment Outcomes Database (CERO DB). CERO DB is a central mechanism that will obtain systematic metrics on the community outreach efforts for engaging and sustaining community partnerships and recruiting and retaining AYA at-risk for HIV or LWHIV at each of the participating site consortiums (SCs). The output from the CERO DB can be used by the SCs to assess whether modifications or additional methods and innovations are needed to achieve the intended outcomes and for identifying best practices across SC community activities.

趣赢平台还开发了一个自动化的、用户友好的基于web的查询 & Notification System (QNS) to facilitate communications between the SCs and protocol teams, 和地址, track, 存档问题, 通知(e.g.(偏差)，以及SCs进行ATN临床研究时出现的反应. The system can send communications to designated individuals based on subject matter (i.e., safety, 监管)，并帮助确保应对措施的一致性, timely, 并有条理地记录下来. sc和协议小组将能够访问ATN网站上的QNS, 我们已经建立并将继续维护的.

在这个过程中, we anticipate coordinating ATN participation in other research networks and research supported by pharmaceutical companies.

Further, 我们将积极支持ATN的各个业务组件, 例如开发特定于协议的程序手册, 提供监管支持和监督, 识别和管理ATN单一机构审查委员会(IRB), 监督选定的SCs的表现, 监督SC社区参与活动, 包括协调ATN全国社区咨询委员会.

趣赢平台的工作人员也将在ATN的领导单位任职, 包括执行委员会及SC表现委员会.

Results

The results of the ATN studies will be used to inform the nation’s scientific agenda for improving prevention of HIV infection in at-risk AYA and the health outcomes of AYA LWHIV. The effects of this research are intended to substantially contribute to the U.S. Department of Health and Human Services’ (HHS) goal of Ending the HIV Epidemic (EHE) by reducing new HIV infections in the U.S. 通过扩大关键的艾滋病毒预防和治疗战略，到2030年减少90%.