HEALing Communities Study Data Coordinating Center

治愈社区研究数据协调中心

• 批准号: 10558270
• 负责人: LaShawn Glasgow
• 金额: $ 24.98万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10558270
• 关键词: Address; Ancillary Study; Area; Back; Biometry; Communication; Communication Board; Communities; Consensus; Consumption; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Drug usage; Drug user; Ensure; Etiology; Fentanyl; Fostering; Goals; Harm Reduction; Human Resources; Individual; Infrastructure; Institutional Review Boards; Intervention; Knowledge; Leadership; Logistics; Methods; National Institute of Drug Abuse; Observational Study; Opiate Addiction; Parents; Pharmaceutical Preparations; Prevention; Principal Investigator; Protocols documentation; Publications; Qualitative Research; Quality Control; Reporting; Research; Research Design; Research Infrastructure; Research Methodology; Research Personnel; Resources; Risk Behaviors; Risk Reduction; Risk Reduction Behavior; Role; Science; Services; Site; Statistical Methods; Structure; Substance abuse problem; Surveys; Time; addiction; behavior change; computer infrastructure; cost; data harmonization; data infrastructure; data management; data modeling; data quality; data sharing; design; economic cost; epidemiology study; experience; flexibility; healing; health economics; implementation science; operation; opioid epidemic; opioid misuse; opioid overdose; overdose risk; parent grant; participant safety; programs; real time monitoring; risk perception; safety study; skills; test strip; tool; uptake

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.

项目总结/摘要 虽然初步证据表明使用芬太尼试纸（FTS）的可接受性增加， 在理解使用FTS是否会减少吸毒者的危险行为方面仍然存在重大差距 （PWUD）。FTS的分布和PWUD的摄取之间的关系也尚不清楚。 利用现有的健康社区研究（HCS）基础设施，我们将研究我们的差距， 了解FTS的使用和分发。通过对三个研究中心的观察性研究，我们将 评价与FTS使用相关的个人水平过量（OD）风险降低和组织水平 在选定的HCS社区内评估FTS分配的操作。 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 具体目标。我们会协助发展一项划一的研究，以提高研究的科学严谨性 研究方案采用研究设计和统计方法的最佳原则，以解决独特的科学 与FTS使用、FTS使用的持久性和药物OD风险降低之间的关系有关的问题 行为（目标1）。我们将提供一个研究基础设施，促进沟通，协调， 通过提供集中的业务、行政和后勤支持， 跨站点沟通，加强合作研究，并促进共识（目标2）。我们将最大限度地 灵活的数据和研究管理，促进HEAL数据的协调和共享， 持续真实的实时监测研究进展、可行性里程碑和数据质量（目标3）。我们将 通过与单个IRB和国家IRB合作并向其报告，保护受试者安全和研究完整性 药物滥用研究所（目标4）。我们将提供及时的报告、数据分析，并与 研究者对所有联合体分析和出版物的研究（目标5）。 我们的DCC团队由多位首席研究员领导-Emmanuel Oga、LaShawn格拉斯哥和加里博士 Zarkin是多地点研究的经验丰富的领导者和药物滥用，数据协调， 项目管理和建立共识;以及共同研究员Jon Zibbell博士。更广泛的团队 核心领导者、主要员工和顾问带来了相互交织的强大的科学和实施科学技能 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，以支持所有必要的数据管理和分析 这项研究的需要。我们以RTI无与伦比的经验和专业知识为后盾， 领导其他40多个地区协调委员会，以确保我们支持和实现目标。