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

NIDA IRP艾滋病毒项目组合包括面向以下目标的项目：1）减少艾滋病毒的发病率; 2）更好地 了解艾滋病毒和药物使用障碍之间的联系; 3）解决艾滋病毒相关的 健康差异、合并症、合并感染和并发症。NIDA IRP艾滋病毒项目旨在降低艾滋病毒的发病率，并得到NIDA IRP OCD的支持，包括艾滋病毒检测，咨询和转诊到NIDA IRP的研究参与治疗。另一个由NIDA IRP OCD支持的NIDA IRP HIV项目旨在降低HIV的发病率，并解决HIV相关的健康差异、合并症、合并感染和并发症。 在NIDA IRP OCD通过NIDA IRP HIV组合进行的一个项目中，243名HIV+参与者 从马里兰州巴尔的摩的一项横断面研究中招募的300人样本中抽取。主要研究结果表明，无论是家庭邻里的特点，也没有冲动和感觉寻求强烈相关的艾滋病毒药物治疗的依从性。自我控制和药物依从性之间可能的关联可能值得进一步研究，例如通过执行功能的额外评估。 在另一项研究中，来自马里兰州巴尔的摩的300名成年人（61%为男性; 85%为HIV阳性）被纳入一项分析，调查与情绪调节的潜在关联。主要结论是，情绪调节困难的人报告了更多与吸毒有关的艾滋病毒风险行为，而不是性行为，这种关系不受他们的家庭邻里环境的影响。对环境影响进行更动态的评估（例如，活动空间）可以揭示未被家庭邻域捕获的差异。以上总结的研究工作最近由NIDA IRP工作人员和学员在2022年药物依赖问题学院（CPDD）会议上提出，相关论文正在编写中。 NIDA IRP HIV组合中这些研究的专用临床护理和研究支持由NIDA IRP OCD提供，其中包括5名护士，2名PA，1名医生，1名顾问和1名研究协调员。此外，NIDA OCD通过专门用于NIDA IRP HIV组合的资源，通过与约翰霍普金斯的合同，支持NIDA IRP HIV组合研究中所有参与者的所有实验室检测、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保护和受试者安全监测，监督数据安全和监测委员会（DSMB），校内研究计划审核委员会（IRPAC），并协助临床研究者提供NIDA IRP HIV组合的监管合规支持。通过与外部供应商的合同，NIDA IRP OCD促进广告，推广和补偿工作，为NIDA IRP HIV组合项目的所有潜在候选人制作独特的特定广告和招聘材料。 NIDA IRP OCD还为所有HIV组合研究候选人提供参与者筛选和支持服务。 此外，NIDA IRP OCD最近聘请了一名全职外联协调员，其作用包括外联社区，特别强调服务不足的人口。值得注意的是，这些社区的艾滋病毒和艾滋病毒相关的合并症和并发症的风险较高。最后，NIDA IRP OCD正在招聘一名全职数据科学家/生物统计学家，其职责包括开发IRB批准的与NIDA IRP HIV组合相关的二级分析，充分利用NIDA IRP在过去20年中收集的HIV相关数据。这些新的努力将包括探索性和假设驱动的项目，旨在开展尖端工作，重点是艾滋病毒危险行为，艾滋病毒感染， HIV相关合并症（例如，HCV、肝病等）的SUD。

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 recently presented at the 2022 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, which includes 5 nurses, 2 PAs, one physician, 1 counselor, and 1 study coordinator. 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. Through contracts with outside vendors, the NIDA IRP OCD 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, the NIDA IRP OCD has recently 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. Finally, the NIDA IRP OCD is in the process of hiring a full-time Data Scientist / Biostatistician, whose roles will 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 new efforts will 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.