Research Support Core D: Clinical and Behavioral Services

研究支持核心 D：临床和行为服务

• 批准号: 10632099
• 负责人: ANN K AVERY
• 金额: $ 73.19万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10632099
• 关键词: AIDS prevention; Accident and Emergency department; Area; Back; Behavior Therapy; Behavioral; Biological; Biological Specimen Banks; Biopsy; Caring; Cerebrospinal Fluid; Characteristics; Client; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collection; Colon; Communicable Diseases; Community Healthcare; Community Outreach; County; County Hospitals; Data; Data Collection; Databases; Disease; Electronic Health Record; Emergency Department patient; Feces; Funding; Future; HIV; HIV Seronegativity; Health; Health Services Research; Hospitalization; Hospitals; Indigent Care; Individual; Inpatients; Institution; Laboratories; Leadership; Link; Longitudinal cohort; Medical Education; Medical center; Mental Health; Mission; Naloxone; National Institute of Drug Abuse; Needle-Exchange Programs; Nursing Research; Observational Study; Ohio; Opioid; Participant; Patient Care; Patient Outcomes Assessments; Patients; Peripheral Blood Mononuclear Cell; Persons; Plasma; Population; Primary Care; Provider; Psychosocial Assessment and Care; Public Health; RNA purification; Recording of previous events; Recovery Support; Rectum; Registries; Reporting; Research; Research Activity; Research Assistant; Research Personnel; Research Project Grants; Research Subjects; Research Support; Resources; Risk; Rural; Safety; Sampling; Serum; Services; Sexually Transmitted Diseases; Specimen; Suboxone; Substance Use Disorder; Swab; System; Teaching Hospitals; Time Study; Tonsillar Tissue; Training; Translational Research; Universities; Urine; Vagina; Vulnerable Populations; Whole Blood; addiction; behavioral study; biobank; clinical database; cohort; combat; data structure; design; epidemiology study; experience; health organization; implementation science; marginalized population; medical specialties; medication-assisted treatment; mental health organization; motivational enhancement therapy; opioid epidemic; peer support; population health; pre-exposure prophylaxis; programs; recruit; rectal; repository; sample collection; screening; substance use; suburb; success; tool; translational study; trauma centers; virtual; waiver

Project Summary Core D – Clinical and Behavioral Services Core The Clinical and Behavioral Services Core D furthers the scientific mission of the Case Western Reserve University Center for Excellence on the Impact of Substance Use on HIV by providing a uniform, broadly available resource to gain access to subjects, specimens, and collected data for basic, translational, clinical, epidemiological, behavioral, and psychosocial studies of HIV disease. Currently, the Core has a searchable registry with longitudinal history of virtually all HIV-infected patients followed in the MetroHealth System (MHS) ID clinic, the largest HIV provider in Northeast Ohio, and will establish a biorepository linked to this clinical data. Core D will enable investigators to conduct studies that require access to populations that are typically difficult to reach, recruit, and retain. The Database will leverage the robust electronic health record (EHR) that has been in place since 1999 at MHS. The EHR has embedded search tools to (i) enable population health research, (ii) identify subjects for research and registries, (iii) track populations, and (iv) retrieve extensive clinical information with data extending back to 1999. The Specimen Repository will be linked to the Database and offers researchers ready access to stored samples complete with comprehensive, longitudinal, clinical, patient reported outcomes, behavioral, and laboratory data. Core D will leverage existing studies of patients who use illicit substances to develop a comprehensive database and specimen repository of persons with substance use disorder and HIV and then expand to include HIV-negative at-risk for HIV substance using individuals. The linked repository will include a robust expansive program for longitudinal semi-annual collection of peripheral blood mononuclear cells, plasma, serum, stool, rectal swabs, vaginal swabs, and urine. The repository will also collect and store tonsillar tissue, CSF, and colonic biopsies. Participants will receive client centered assistance to treat addiction from staff trained to use motivational interviewing. Core D will integrate public and mental health activities in Northeast Ohio regarding persons with HIV and Substance Use Disorder through clinical and community outreach with our neighboring public and mental health organizations, that include urban (Cleveland), suburban (Cuyahoga), and suburban/rural (Lorain) populations. Finally, Core D leadership will assist investigators in formulating research questions that take full advantage of the clinical Database and specimen Repository, while avoiding pitfalls and potential biases that result from incomplete understanding of the data structure, patient-related data, and patient characteristics.

项目摘要核心 D – 临床和行为服务核心 临床和行为服务核心 D 进一步推进了该案例的科学使命 西储大学药物使用影响卓越中心 HIV 通过提供统一的、广泛可用的资源来获取受试者、样本、 并收集了基础、转化、临床、流行病学、行为和社会心理方面的数据 艾滋病毒疾病的研究。目前，Core 有一个可搜索的注册表，其纵向历史记录为 几乎所有 HIV 感染者都在 MetroHealth System (MHS) ID 诊所接受随访，该诊所是最大的 俄亥俄州东北部的艾滋病毒提供者将建立一个与该临床数据相关的生物储存库。 核心 D 将使研究人员能够开展需要接触以下人群的研究： 通常难以接触、招募和留住。该数据库将利用强大的电子 MHS 自 1999 年起就已建立健康记录 (EHR)。 EHR 已嵌入搜索 (i) 实现人口健康研究，(ii) 确定研究和登记主题的工具， (iii) 追踪人群，以及 (iv) 检索广泛的临床信息，数据可追溯到 1999. 标本存储库将链接到数据库，为研究人员提供准备 访问存储的样本，包括全面的、纵向的、临床的、患者报告的 结果、行为和实验室数据。 Core D 将利用对以下患者的现有研究： 使用非法物质开发综合数据库和人员样本库 患有物质使用障碍和艾滋病毒，然后扩大到包括艾滋病毒阴性的艾滋病毒高危人群 物质使用个人。链接的存储库将包括一个强大的扩展程序，用于 每半年纵向采集一次外周血单核细胞、血浆、血清、粪便、 直肠拭子、阴道拭子和尿液。该储存库还将收集和储存扁桃体组织， 脑脊液和结肠活检。参与者将获得以客户为中心的治疗成瘾的援助 来自接受过动机访谈培训的员工。核心 D 将整合公共健康和心理健康 俄亥俄州东北部针对艾滋病毒和药物使用障碍患者开展的活动 与邻近的公共和心理健康组织进行临床和社区外展， 其中包括城市（克利夫兰）、郊区（凯霍加）和郊区/农村（洛兰）人口。 最后，核心 D 领导层将协助研究人员制定研究问题，这些问题需要 充分利用临床数据库和标本存储库，同时避免陷阱和 由于对数据结构、患者相关的不完全理解而导致的潜在偏差 数据和患者特征。