HEALing Communities Study Data Coordinating Center

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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.