NIDA IRP Clinical Core support of the NIDA IRP HIV Clinical Program

NIDA IRP 临床 NIDA IRP HIV 临床计划的核心支持

• 批准号: 10928632
• 负责人: Lorenzo Leggio
• 金额: $ 161.14万
• 依托单位: NATIONAL INSTITUTE ON DRUG ABUSE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10928632
• 关键词: Address; Adherence; Adult; Advertising; Area; Baltimore; Biometry; Black race; Characteristics; Clinical; Clinical Investigator; Clinical Research; Clinical Trials Data Monitoring Committees; Cognitive; Communities; Community Outreach; Compensation; Consult; Contracts; Counseling; Cross-Sectional Studies; Data; Data Analyses; Data Scientist; Decision Making; Dedications; Development; Drug Addiction; Drug usage; Education; Emergency Care; Environment; Esthesia; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV risk; Head; Health Benefit; Hepatitis C virus; Home; Human; Human immunodeficiency virus test; Impaired cognition; Impulsivity; Incidence; Individual; Infrastructure; Institutional Review Boards; Intramural Research Program; Laboratories; Learning; Left; Link; Liver diseases; Magnetic Resonance Imaging; Maryland; Medical; Medicine; Monitor; National Institute of Drug Abuse; Neighborhoods; Newly Diagnosed; Outcome; Paper; Participant; Persons; Pharmaceutical Preparations; Pharmacy facility; Phenotype; Prefrontal Cortex; Preparation; Psychoneuroendocrinology; Radiology Specialty; Reporting; Research; Research Personnel; Research Support; Resources; Retirement; Risk Behaviors; Role; Safety; Sampling; Self-control as a personality trait; Services; Sexual and Gender Minorities; Spectrum Analysis; Substance Use Disorder; System; Technology; Testing; Transcranial magnetic stimulation; Translational Research; Underserved Population; United States National Institutes of Health; Work; addiction; aging brain; alcohol use disorder; clinical care; co-infection; college; comorbidity; data management; deep learning; design; digital; emotion regulation; executive function; health disparity; high risk; human subject protection; improved; inpatient service; intravenous drug use; male; medication compliance; meetings; men who have sex with men; metropolitan; neuroimaging; neuropsychopharmacology; novel; outreach; participant safety; pharmacologic; pre-exposure prophylaxis; programs; recruit; screening; secondary analysis; substance use; tenure track; treatment research

The NIDA IRP HIV portfolio includes projects geared towards 1) reducing the incidence of HIV; 2) better understanding the link between HIV and substance use disorders (SUD); and 3) addressing HIV-associated health disparities, comorbidities, coinfections, and complications. NIDA IRP HIV projects seeking to reduce the incidence of HIV and supported by the NIDA IRP OCD include HIV testing, counseling, and referral to treatment for research participation at the NIDA IRP. Another NIDA IRP HIV project supported by the NIDA IRP OCD is designed to reduce the incidence of HIV and address HIV-associated health disparities, comorbidities, coinfections, and complications. In one project conducted by the NIDA IRP OCD via the NIDA IRP HIV portfolio, 243 HIV+ participants were drawn from a sample of 300 people recruited to a cross-sectional study in Baltimore, Maryland. The main results show that neither home neighborhood characteristics nor impulsivity and sensation seeking were strongly associated with HIV-medication adherence. Possible associations between self-control and medication adherence may merit further study, for example by additional assessment of executive function. In another study, 300 adults (61% male; 85% HIV-positive) from Baltimore, MD were included in an analysis investigating the potential association with emotional regulation. The main conclusion was that people with greater difficulty with emotion regulation reported more HIV-risk behavior related to drug use but not sexual behavior, and this relationship was not impacted by their home neighborhood environment. More dynamic assessments of environmental influences (e.g., activity space) may reveal differences not captured by the home neighborhood. The research work summarized above was presented at the College on Problems of Drug Dependence (CPDD) meeting by NIDA IRP staff and trainees and related papers are in preparation. Dedicated clinical care and research support for these studies in the NIDA IRP HIV Portfolio is provided by the NIDA IRP OCD. Additionally, the NIDA OCD, through resources dedicated specifically to the NIDA IRP HIV Portfolio, supports all laboratory testing, radiology, consult, inpatient, and emergency care needs of all participants in NIDA IRP HIV Portfolio studies through a contract with Johns Hopkins. The NIDA IRP OCD provides human subjects protection and participant safety monitoring through human regulatory support, oversees the Data Safety and Monitoring Board (DSMB), the Intramural Research Program Auditing Committee (IRPAC), and assists clinical investigators with regulatory compliance support of the NIDA IRP HIV Portfolio. The NIDA IRP OCD also facilitates the advertising, outreach, and compensation efforts needed to generate unique specific advertising and recruitment materials for all potential candidates for NIDA IRP HIV Portfolio projects. The NIDA IRP OCD also provides participant screening and support services for all HIV Portfolio study candidates. Furthermore, since 2022, the NIDA IRP OCD has hired a full-time Outreach Coordinator whose role includes outreach community, with a special emphasis on underserved populations. Of note, these are communities at higher risk of HIV and HIV-related comorbidities and complications. In addition to all ongoing activities outlined above, in the past months, the following new efforts have been initiated and are ongoing: The NIDA IRP OCD recently hired a full-time Data Scientist / Biostatistician, whose roles include the development of IRB-approved secondary analyses related to the NIDA IRP HIV Portfolio that take full-advantage of the HIV-related data collected during the past 2 decades in the NIDA IRP. These efforts are currently under way and include exploratory and hypothesis-driven projects aimed at conducting cutting-edge work that will focus on the intersection between HIV risky behaviors, HIV infection, HIV-related comorbidities (e.g., HCV, liver diseases, etc.) and SUD. The NIDA IRP clinical portfolio has gone significant changes following the departure or retirement of several senior staff and the hiring of new senior staff, including two new clinical investigators and a new core director. In 2022/2023, the Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides clinical research support to (6) independent Laboratories/Clinical investigators, (4 Tenure Track/Unit Chiefs and 2 Senior Investigators/Branch Chiefs) and a recently formerly Core/Facility Head. Specifically, the Cognitive and Pharmacological Neuroimaging Unit (PI: Dr. Amy Janes) was formed and together with the Magnetic Resonance Imaging and Spectroscopy Section (PI: Dr. Yihong Yang), is part of the Neuroimaging Research Branch (NRB). The Learning and Decision-Making Unit (PI: Dr. Thorsten Kahnt) was formed and is part of the Cellular and Neurocomputational Systems Branch. The Real-world Assessment, Prediction, and Treatment Unit (PI: Dr. David Epstein), the Technology and Translational Research Unit (Dr. Brenda Curtis) and the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section (PI: Dr. Lorenzo Leggio) form the Translational Addiction Medicine Branch (TAMB). The following four HIV-related projects have been started this year by three of the six Clinical Investigators / Senior Investigators, hence representing a significant increase in PI-driven HIV projects in the NIDA IRP clinical program: 1. Digital Phenotyping & Deep Learning: Substance Use Impact on PrEP Adherence among Black Sexual and Gender Minorities (PI: Dr. Brenda Curtis, TAMB) 2. Investigating the effects of novel medications for alcohol and substance use disorders in improving HIV-related outcomes and providing health benefits in people living with HIV (PI: Dr. Lorenzo Leggio, TAMB) 3. Impact of comorbidity of HIV infection and substance use disorder on brain aging and cognitive impairment (Dr. Yihong Yang, NRB) 4. Reducing HIV risk behavior with transcranial magnetic stimulation of the left dorsolateral prefrontal cortex (Dr. Yihong Yang, NRB) As such, important new efforts of the NIDA IRP Office of Clinical Director (OCD) are focused and re-directed in supporting the new revamped NIDA IRP HIV clinical portfolio by providing the necessary scientific, research, biostatistical (including data management and analysis), clinical, managerial, and administrative support and infrastructure necessary to start up and initiative the conductance of this quite significant new volume of clinical HIV projects in the NIDA IRP Clinical Portfolio.

NIDA IRP HIV投资组合包括针对1）降低艾滋病毒发病率的项目； 2）更好 了解艾滋病毒与物质使用障碍之间的联系（SUD）； 3）解决与HIV相关的问题 健康差异，合并症，共同感染和并发症。 NIDA IRP HIV项目旨在减少艾滋病毒的发病率并得到NIDA IRP OCD的支持，包括艾滋病毒测试，咨询和转介到NIDA IRP的研究参与治疗。 NIDA IRP OCD支持的另一个NIDA IRP HIV项目旨在降低HIV的发生率并解决与HIV相关的健康差异，合并症，共同感染和并发症。 在NIDA IRP OCD通过NIDA IRP HIV投资组合进行的一个项目中，有243名HIV+参与者是 从招募300人的样本中绘制为马里兰州巴尔的摩的横断面研究。主要结果表明，家庭邻里的特征，冲动和寻求感觉都与艾滋病毒隔离性密切相关。自我控制与依从性之间的可能关联可能值得进一步研究，例如，通过对执行功能的其他评估。 在另一项研究中，马里兰州巴尔的摩的300名成年人（61％男性； 85％的HIV阳性）被包括在研究与情绪调节的潜在关联的分析中。主要的结论是，情绪调节困难更大的人报告了与吸毒相关但没有性行为的艾滋病毒风险行为，而这种关系也没有受到其家庭邻里环境的影响。对环境影响的更动态评估（例如，活动空间）可能揭示了家庭社区未捕获的差异。 NIDA IRP员工和受训人员和相关论文正在准备上面的研究工作，上面概述了有关毒品依赖问题（CPDD）会议的研究。 NIDA IRP OCD提供了NIDA IRP HIV投资组合中这些研究的专用临床护理和研究支持。此外，NIDA OCD通过专门针对NIDA IRP HIV投资组合的资源，支持所有NIDA IRP HIV HIV Portfolio研究参与者通过与Johns Hopkins合同的NIDA IRP HIV Portfolio研究中所有参与者的实验室测试，放射学，咨询，住院和紧急护理需求。 NIDA IRP OCD通过人类监管支持提供人类受试者的保护和参与者的安全监控，负责监督数据安全和监测委员会（DSMB），校内研究计划审计委员会（IRPAC），并协助临床研究人员对NIDA IRP HIV HIV投资组合的监管合规性支持。 NIDA IRP OCD还促进了为NIDA IRP IRP HIV投资组合项目的所有潜在候选人生成独特的特定广告和招聘材料所需的广告，推广和补偿工作。 NIDA IRP OCD还为所有HIV投资组合研究候选人提供参与者筛查和支持服务。此外，自2022年以来，NIDA IRP OCD聘请了一名全职外展协调员，其角色包括外展社区，特别强调了服务不足的人群。值得注意的是，这些社区患HIV和与HIV相关的合并症和并发症的风险更高。 除了上面概述的所有正在进行的活动外，在过去的几个月中，已经开始并正在进行以下新的努力： NIDA IRP OCD最近雇用了一名全日制数据科学家 /生物统计学家，其角色包括与NIDA IRP HIV投资组合有关的IRB批准的二级分析的发展，该分析对NIDA IRP的过去20年中收集的HIV相关数据进行了全面优势。这些努力目前正在进行中，包括探索性和假设驱动的项目，旨在进行尖端工作，该项目将重点介绍HIV危险行为，HIV感染，艾滋病毒感染， 与HIV相关的合并症（例如HCV，肝病等）和SUD。 NIDA IRP临床投资组合在几名高级职员的离开或退休后以及雇用新的高级职员，包括两名新的临床调查人员和一名新核心主管后发生了重大变化。在2022/2023年，国家药物滥用研究所（NIDA）临床主任办公室（OCD）办公室（IRP），NIH为（6）独立实验室/临床研究人员提供临床研究支持（4个任期/单位轨道/单位首领和2名高级研究员/分支机构/分支机构/分支机构）和最近的核心/核心/设施。具体而言，形成了认知和药理学神经影像学单位（PI：Amy Janes博士），并与磁共振成像和光谱部分（PI：PI：Yihong Yang博士）一起组成了神经影像学研究部（NRB）的一部分。学习和决策单位（PI：Thorsten Kahnt博士）成立了，是细胞和神经计算系统分支的一部分。现实世界中的评估，预测和治疗部门（PI：David Epstein博士），技术和转化研究部（Brenda Curtis博士）以及临床心理肌内部分裂性和神经心理药理学科（PI：Lorenzo Leggio博士）形式的翻译成瘾医学分支（TAMB）。以下四个与HIV相关的项目已于今年由六名临床调查人员 /高级研究人员中的三个开始，因此，NIDA IRP临床计划中PI-DRIAN HIV项目的大幅增加： 1。数字表型和深度学习：物质使用对黑人性行为和性别少数群体的准备遵守的影响（PI：Brenda Curtis博士，TAMB） 2。研究新型药物对酒精和药物使用障碍的影响在改善与艾滋病毒相关的结果并为艾滋病毒患者提供健康益处（PI：Lorenzo Leggio博士，TAMB） 3。艾滋病毒感染和药物使用障碍合并症对脑老化和认知障碍的影响（Yihong Yang博士，NRB） 4。通过左侧外侧前额叶皮层的经颅磁刺激降低HIV风险行为（Yihong Yang博士，NRB） 因此，NIDA IRP临床主任办公室（OCD）的重要新努力是通过提供必要的科学，研究，生物统计学（包括数据管理和分析），临床，管理和基础结构的启动和基础启动的必要新数量来支持新的NIDA IRP HIV临床投资组合，以支持新的NIDA IRP HIV临床组合的重要新努力，并 文件夹。