Clinical and Translational Science Core

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 birthART 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.

Recent publications supported by the Clinical and Translational Science Core

  • *Breslow AS, Fazzari M, Franz PJ, Hanna DB, Felsen UR, Cavic E, Fisher MR, Bauman L (2023). Longitudinal associations of psychiatric risk factors with non-psychiatric hospitalization in a large cohort of people living with HIV in New York City. AIDS Behav 27: 3487-3497. Pubmed
  • *Chyten-Brennan J, Patel VV, Anastos K, Hanna DB (2022). Role of gender-affirming hormonal care in HIV care continuum outcomes when comparing transgender women with cisgender sexual minority men. JAIDS 91: 255-260. Pubmed
  • *Fisher MC, Fazzari MJ, Felsen UR, Hanna DB, Tappan N, Wyatt CM, Abramowitz MK, Ross MJ (2023). Association of HIV and viral suppression status with hospital acute kidney injury in the era of antiretroviral therapy. Kidney Intl 104: 1008-1017. Pubmed
  • *Hanna DB, Felsen UR, Anastos K, Bauman LJ, Fiori KP, Ginsberg MS, Watnick D, Chambers EC (2022). Association of unmet social needs with uncontrolled viremia in people with HIV. AIDS Behav 26: 3740-3745. Pubmed
  • Hanna DB, Patel VV (2023). Public HIV stigma: Still common around the world. HIV Med, ePub 25 Sept 2023. Pubmed
  • *Klugman M, Fazzari M, Xue X, Ginsberg M, Rohan T, Halmos B, Hanna DB, Shuter J, Hosgood HD (2022). The associations of CD4 count, CD4/CD8 ratio, and HIV viral load with survival from non-small cell lung cancer in persons living with HIV. AIDS Care, 34: 1014-1021. Pubmed
  • Spieldenner A, Santella AJ, Cooper SC, Rosales K, Goedel WC, Jones HE (2022). Knowledge, attitudes, and practices towards PrEP from cisgender men and transgender women who have sex with men in the largest suburban HIV epidemic. Int J Environ Res Public Health 19: 11640. Pubmed
  • *Yoon H, Hemmige VS, Lee A, Conway-Pearson LS, Pirofski L-A, Felsen UR (2022). Cryptococcal antigen screening and missed opportunities for earlier diagnosis among people with HIV and poor virologic control in the Bronx, NY. JAIDS 91: 390-396. Pubmed

*Uses the HIV Clinical Cohort Database.

COMPLETE LIST OF PUBLICATIONS SUPPORTED BY THE CLINICAL AND TRANSLATIONAL SCIENCE CORE