Clinical and Translational Science Core
David Hanna, PhD
Co-Director (Einstein)
Associate Professor of Epidemiology & Population Health
Uriel Felsen, MD
Co-Director (Einstein)
Assistant Professor of Medicine at Einstein
Heidi Jones, PhD
Associate Director (CUNY)
Associate Professor of Epidemiology & Biostatistics, CUNY SPH; Director, Epidemiology Doctoral Program
Marina Caskey, MD
Associate Director (Rockefeller University)
Professor of Clinical Investigation
To help meet the United States government’s goal of Ending the HIV Epidemic (EHE), the Einstein-Rockefeller-CUNY Center for AIDS Research (ERC-CFAR) has formed strong collaborations both within and beyond our partner institutions, including with the New York City Department of Health and Mental Hygiene and the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, to catalyze and support research that best serves the public’s health: to eradicate HIV infection, prevent new HIV infections, and improve the health of people living with HIV (PWH).
The overarching goal of the ERC-CFAR and the Clinical and Translational Science Core (CTSC) is to support the EHE mission by creating a broad and robust HIV clinical research resource available to researchers locally, nationally and globally. Our synergistic partnership provides a broad range of support for clinical, translational, health services, and implementation science investigations. By leveraging the resources of the Einstein CTSA-funded Harold and Muriel Block Institute for Clinical and Translational Research, the CTSC provides access to a robust study design consultative service, clinical database and multiple biorepositories.
For further information, please contact our study coordinator, Ms. Yocheved Halberstam, at cfar-clinical-core@einsteinmed.edu.
Through CTSC resources, the clinical population at Montefiore Einstein is linked to the cutting-edge research in HIV eradication HIV clinical trials being conducted at Rockefeller University, which lacks access to defined cohorts of PWH. The CTSC also links this population to research studies being performed by investigators at City University of New York (CUNY), leaders in implementation science who are assessing the factors that influence our ability to impact favorably on the public’s health with interventions of proven efficacy. The CTSC is integrated into the HIV and Mental Health Scientific Working Group, a driver of the ERC-CFAR’s scientific direction, to provide optimal support to foster the emerging research activities of SWG members, and foster scientific cross-fertilization among cores and the SWG. We leverage Einstein’s Center for Health Data Innovations and use of state-of-the-art informatics methods, including natural language processing and machine learning, to catalyze and facilitate new research in primary prevention of HIV infection, while maintaining our extensive support of well-established research areas.
HIV Biorepository
Serum, plasma and PBMC research specimens available in the ERC-CFAR Biorepository
The Einstein-Rockefeller-CUNY Center for AIDS Research (ERC-CFAR) has archived frozen sera, plasma, and peripheral blood mononuclear cells (PBMCs) donated by people living with HIV for IRB-approved research studies. 874 specimens were collected from 108 persons living with HIV (PLWH) between 2012 and 2014. Of the 108 PLWH, 67 participants (62%) provided specimens at multiple time points. Furthermore, 31 (29%) provided specimens prior to ART initiation, and 2 of these 31 (6%) also provided specimens after ART initiation.
Available specimens (N=874), by year
| Year | Serum | Plasma | PBMCs |
|---|---|---|---|
| 2012 | 89 | 89 | 89 |
| 2013 | 164 | 164 | 154 |
| 2014 | 51 | 51 | 23 |
| Total | 304 | 304 | 266 |
Additional characteristics of these individuals, who were patients at the Center for Positive Living (aka the AIDS Center) at the time of specimen collection, are below:
Selected characteristics of patients with specimens in the ERC-CFAR biorepository (N=108)
| N (%) | N (%) | ||
|---|---|---|---|
| Sex at birth | ART regimen | ||
| Male | 62 (57) | Integrase inhibitor-based | 9 (8) |
| Female | 46 (43) | NNRTI-based | 31 (29) |
| Age, years | PI-based | 28 (26) | |
| 18-29 | 19 (18) | NRTI-based | 5 (5) |
| 30-39 | 18 (17) | Other ART regimen | 4 (4) |
| 40-49 | 19 (18) | Unavailable or not documented | 31 (29) |
| 50-59 | 27 (25) | HIV viral load | |
| 60-69 | 22 (20) | Suppressed (<200 cp/mL) | 60 (58) |
| 70+ | 3 (3) | <40 cp/mL (undetectable) | 47 (44) |
| Race/ethnicity | 40-199 cp/mL | 13 (12) | |
| Black, non-Hispanic | 47 (44) | Unsuppressed (200+ cp/mL) | 48 (44) |
| Hispanic/Latino | 48 (44) | CD4+ T-cell count | |
| White, non-Hispanic | 2 (2) | <200 cells/uL | 19 (18) |
| Other | 11 (10) | 200-499 cells/uL | 25 (23) |
| HIV transmission risk category | 500+ cells/uL | 64 (59) | |
| Men who have sex with men | 27 (25) | New HIV infection | 5 (5) |
| Injection drug use history | 20 (19) | Newly diagnosed with HIV | 35 (32) |
| Heterosexual transmission | 60 (56) | Elite controller | 5 (5) |
| Other/unknown | 1 (1) | Viral controller | 8 (7) |
| Hepatitis C virus co-infection | 43 (40) | Long-term non-progressor | 14 (13) |
All characteristics reported at first specimen collection. Other clinical characteristics available upon request. New HIV infection: evidence for newly acquired infection in the last 12 months. Newly diagnosed with HIV: Diagnosed with HIV in last 12 months, but no evidence for newly acquired infection. Elite controller: Diagnosed with HIV for at least two years, repeatedly undetectable HIV VL (last value in the last six months), no history of ARTs. Viral controller: Diagnosed with HIV for at least two years, all known HIV VL 2,000 copies/mL, all known CD4 >500 cells/uL, no history of ART. Long-term non-progressor: Diagnosed with HIV for ≥ 10 years, all known CD4 >500 cells/uL, no history of ART.
Due to the expense of maintaining these specimens in storage indefinitely, we encourage ERC-CFAR investigators to consider whether these specimens may be useful for current or upcoming studies. If you are interested in learning more about or obtaining these specimens, please contact Dr. Uriel Felsen at ufelsen@montefiore.org.
HIV Clinical Cohort Database
The Clinical Cohort Database (CCDB), derived from the Montefiore Einstein clinical services, contains >20,000 PWH and >500,000 HIV-negative patients; >6,000 PWH are in active care; 40% are women, >33% Hispanic/Latinx and >40% African American. This comprehensive, longitudinal database provides ERC-CFAR investigators with access to Montefiore’s extensive clinical infrastructure and has catalyzed an explosion of clinical, epidemiologic, translational, health services, and implementation science research on HIV treatment, epidemiology and prevention. In addition, we facilitate enrollment of well-characterized patients (including HIV-negative controls) into new research protocols, particularly treatment and PrEP studies.
Our summary slides contain a detailed overview of the database and summary statistics for our populations.
To propose a project utilizing the HIV Clinical Cohort Database, please complete the Collaboration Concept Sheet Submission Form. Please direct all inquiries to the study coordinator at cfar-clinical-core@einsteinmed.edu.
*Uses the HIV Clinical Cohort Database
COMPLETE LIST OF PUBLICATIONS SUPPORTED BY THE CLINICAL AND TRANSLATIONAL SCIENCE CORE