HEALing Communities Study Data Coordinating Center

项目摘要/摘要 虽然初步证据表明芬太尼试纸(FTS)的使用可接受性增加， 在理解使用FTS是否会减少吸毒者的危险行为方面仍存在重大差距 (PWUD)。FTS的分布与PWUD对它们的吸收之间的关系也不清楚。 利用现有的治愈社区研究(HCS)基础设施，我们将检查 了解FTS的使用和分发。通过与三个研究地点的观察性研究，我们将 评估与FTS使用和组织级别相关的个人级别过量用药(OD)风险降低 对选定的HCS社区内FTS分发的运营情况进行评估。 RTI现有的数据协调中心(DCC)将协助FTS研究实现其目标。我们的DCC有五个 明确的目标。我们将通过促进统一研究的发展来提高研究的科学性。 应用研究设计和统计方法的最佳原则来解决独特的科学问题的方案 关于FTS的使用、FTS使用的持久性和降低药物过量风险之间的关系的问题 行为(目标1)。我们将提供一个研究基础设施，促进沟通、协调和 通过提供集中的运营、行政和后勤支持建立共识，以促进 跨站点交流，加强协作研究，促进共识(目标2)。我们将最大限度地 通过灵活的数据和研究管理提高效率，促进医疗数据协调和共享， 持续实时监测研究进展、可行性里程碑和数据质量(目标3)。我们会 通过与单一IRB和国家IRB合作并向其报告，保护参与者的安全和学习完整性 药物滥用研究所(NIDA)(目标4)。我们将提供及时的报告、数据分析，并与 所有联合体分析和出版物的调查人员(目标5)。 我们的DCC团队由多名首席调查人员领导-Emmanuel Oga博士、LaShawn Glasgow博士和Gary 扎尔金-他是多站点研究的经验丰富的领导者和药物滥用、数据协调、 项目管理和共识建立；以及联合调查员乔恩·齐贝尔博士。更广泛的团队 核心领导、关键员工和顾问将强大的科学和实施科学技能相互交织在一起 对阿片类药物滥用和成瘾的预防科学有深刻的理解。我们提供经过验证的 计算基础设施和统计专业知识，以支持所有必需的数据管理和分析 这项研究的需要。我们以RTI无与伦比的经验和熟练程度为后盾-诞生于成功 领导其他40多个分会--确保我们支持并实现目标。

Project Summary/Abstract Although preliminary evidence suggests increased acceptability for the use of fentanyl test strips (FTS), significant gaps remain in understanding whether use of FTS reduces risk behaviors of people who use drugs (PWUD). The relationship between the distribution of FTS and their uptake by PWUD also remains unclear. Utilizing the existing HEALing Communities Study (HCS) infrastructure we will examine gaps in our understanding of FTS use and distribution. Through an observational study with three research sites, we will evaluate the individual-level overdose (OD) risk reduction associated with FTS use and an organizational-level assessment of the operations for FTS distribution within select HCS communities. The existing data coordination center (DCC) at RTI will assist the FTS Study in its goals. Our DCC has five specific aims. We will enhance the scientific rigor of the study by facilitating the development of a uniform study protocol that applies the best principles of study design and statistical methods to address the unique scientific questions related to the relationship between the use of FTS, durability of FTS use, and drug OD risk reduction behaviors (Aim 1). We will provide a research infrastructure that facilitates communication, coordination, and consensus-building by providing centralized operational, administrative, and logistical support to facilitate cross-site communication, enhance collaborative research, and foster consensus (Aim 2). We will maximize efficiency with flexible data and study management, promote HEAL data harmonization and sharing, with continuous real time monitoring of study progress, feasibility milestones, and data quality (Aim 3). We will protect participant safety and study integrity by working with and reporting to the single IRB and the National Institute of Drug Abuse (NIDA) (Aim 4). We will provide timely reporting, data analysis, and collaborate with investigators on all consortium analyses and publications (Aim 5). Our DCC team is led by multiple Principal Investigators—Drs. Emmanuel Oga, LaShawn Glasgow, and Gary Zarkin—who are experienced leaders of multisite studies and experts in substance abuse, data harmonization, program management, and consensus building; and Co-Investigator, Dr. Jon Zibbell. The broader team of Core Leaders, key staff, and consultants brings robust scientific and implementation science skills interwoven with a deep understanding of prevention science of opioid misuse and addiction. We offer proven computational infrastructure and statistical expertise to support all the required data management and analysis needs for this study. We are backed by RTI’s unsurpassed experience and proficiency—born from successful leadership of over 40 other DCCs—to ensure that we support and accomplish the aims.