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

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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.