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

National Institute On Drug Abuse

Investigators

Linked publications & trials

Abstract

The NIDA IRP is developing and conducting extensive cutting edge research as part of its Clinical HIV Research Portfolio. The NIDA IRP HIV portfolio includes projects geared towards 1) reducing the incidence of HIV and 2) 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 Clinical Core include HIV testing, counseling, and referral to treatment as indicated for over 600 individuals screened annually for research participation at the NIDA IRP. Additionally we support a project utilizing geographical momentary assessment to determine activity space and social networks of HIV+ individuals to identify possible hotspots of HIV transmission and determine where to target prevention efforts such as vaccines, PrEP (Pre-exposure prophylaxis), testing, and addiction and Hepatitis C treatment. A third NIDA IRP HIV project supported by the NIDA Clinical Core is designed to reduce the incidence of HIV and address HIV-associated health disparities, comorbidities, coinfections, and complications. This multi-institute collaboration looks to improve engagement in, adherence to, and retention in hepatitis C and buprenorphine treatment and PrEP (Pre-exposure prophylaxis) as HIV prevention. Of note, the HIV/GMA project has completed enrollment of 300 individuals, viral phylogenetic analysis is currently being conducted in collaboration with George Washington University and data management and analysis has begun. In Jan 2019 the NIDA IRP hired a new clinical tenure-track investigator whose focus is on passive data collection through social media usage and she is currently planning a study with African American women at risk for HIV transmission via heterosexual contact for which the OCD will provide support. During FY2019/2020 the OCD has also supported the efforts to begin a collaboration with industry trial of depot injection buprenorphine in individuals with HIV and Opioid Use Disorder (OUD). Dedicated clinical care and research support for these studies in the NIDA IRP HIV Research Portfolio is provided by the NIDA IRP Clinical Core and accounts for approximately 40% of our resource utilization. NIDA IRP HIV Portfolio-committed Clinical Core personnel at 40% effort include 5 nurses, 2 PAs, one physician, 1 counselor, 1 clinic manager, and 6 research assistants. Additionally, the NIDA IRP Clinical Core, through resources dedicated specifically to the NIDA IRP HIV Research Portfolio, supports all laboratory testing, radiology, consult, inpatient, and emergency care needs of all participants in NIDA IRP HIV Research Portfolio studies through a contract with the Johns Hopkins. The NIDA IRP Clinical Core provides human subjects protection and participant safety monitoring through its Human Regulatory Support Team (1 Team Lead, 1 Human Regulatory Specialist, 1 Protocol Navigator) which 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 Research Portfolio, projects which due to the complicated medical and social histories of the participants require the highest level of monitoring. The NIDA IRP Clinical Core provides dedicated HIV Research Portfolio pharmacy support for all NIDA IRP HIV Research Portfolio projects (2 pharmacists + 1 pharmacy tech). Through contracts with outside vendors, the NIDA IRP Clinical Core facilitates the advertising, outreach, and compensation efforts needed to generate unique specific advertising and recruitment materials for all potential candidates for NIDA IRP HIV Research Portfolio projects. The NIDA IRP Clinical Core also provides participant screening and support services for all HIV Research Portfolio study candidates.