Clinical, Translational and Implementation Science Core

The overarching goal of the ERC-CFAR’s Clinical, Translational and Implementation Science Core (CTISC) is to provide a regional research platform to support the initiation and expansion of HIV-related clinical, translational and implementation research. The CTISC will assist researchers in participant recruitment for both clinical trials (e.g. eradication research or pathogenesis) and for observational studies by active recruitment of patients with rare phenotypes (e.g. elite or viremic controllers) for studies anywhere in the United States. It also provides support for research projects assessing policy, contextual, clinic/practice and individual factors impacting uptake and outcomes of delivered services, and access to and analysis of data from three databases.

The CTISC provides access to three robust clinical databases. The HIV Clinical Cohort, from the Montefiore/Einstein clinical services, contains demographic, clinical and laboratory data on over 18,000 HIV-infected and 420,000 HIV-negative patients. This dynamic, comprehensive, longitudinal database accesses Montefiore’s extensive clinical infrastructure to facilitate enrollment of well-characterized patients (including HIV-negative controls) into new research protocols. The Amida Care Cohort leverages the informatics resources of Amida Care, the largest Medicaid Special Needs Plan in NYS, with >6,000 PLWH in NYC. The Master Research Cohort has centralized data and specimen information from ~4700 participants in 31 funded research studies. With seed funding from Einstein, these three resources have stimulated many new clinical, implementation and translational investigations within Einstein, with the primary partners (Rockefeller and CUNY) and with other investigators in NYC and nationally. The maintenance of the HIV Clinical Cohort Database succeeds through collaboration with Einstein’s Institute for Clinical and Translational Research (ICTR), an NIH-funded site in the Clinical and Translational Science Awards (CTSA) program, and its integration into the ICTR’s Informatics Commons. CTISC maintains an infrastructure to facilitate recruitment and enrollment from all three cohorts into clinical trials, observational and translational studies requiring new specimens or special studies (e.g. functional MRI) in HIV-infected individuals with specified clinical characteristics.

  • Provide a clinical research platform to serve basic, clinical/epidemiologic, translational, behavioral and implementation science investigators in New York City or beyond.
    • Leverage our large patient population (18,000 PLWH, representing 150,000 person-years) seen since 1997 to catalyze new research and recruit participants for investigators conducting clinical trials or other studies.
    • Use state-of-the-art informatics provided through Einstein’s ICTR to maintain databases derived from Montefiore/Einstein’s integrated electronic health informatics system and Amida Care to support new investigations in diverse, underrepresented groups (e.g. women, pregnancy, MSM of color, HIV-exposed) through support in study design, biostatistics, database access and specimen collection.
    • Integrate with the ERC-CFAR’s Behavioral Science Core and the Scientific Working Groups (Eradication, Patient and Population Health Outcomes Research) to support the entire ERC-CFAR’s scientific goals.
     
  • Advance collaboration under the umbrella of implementation science
    • Support research to identify multi-level factors that influence timely and sustained achievement of HIV Care/Prevention Continuum outcomes (e.g. uptake of PrEP, early diagnosis, sustained viral suppression) in specific populations.
     
  • Support bench scientists in translational investigation (e.g. virologic, immunologic, genetic) studies
    • Provide human specimens, both through the existing research and clinical biorepositories (Master Research Cohort), and through rapidly sourcing, enrolling and consenting patients with specific characteristics, assisting in IRB approval, and supporting fresh specimen collection, transport and processing.
     
  • For further information, please contact our study coordinator, Ms. Madeline Torres, at ctisc-admin@einstein.yu.edu.  

 

HIV Clinical Cohort Database

The HIV Clinical Cohort Database is an epidemiologic resource containing de-identified demographic, clinical, laboratory, prescription, and outcomes data on over 18,000 HIV-infected and 420,000 HIV-negative patients seen in the Montefiore Health System since 1997.

This dynamic, comprehensive, longitudinal database based on Montefiore’s extensive clinical infrastructure, including the Epic electronic medical record, serves two purposes:

  1. To facilitate the development of epidemiologic studies, including those focused on implementation science
  2. To serve as potential source of study participants for clinical studies.

Data cleaning and other quality assurance activities are conducted on datasets that are generated twice each year, with a focus on key HIV-related variables. Data dictionaries summarize the major variables that are maintained in the database. The database is managed by the Epidemiology Informatics and Study Management Unit (EISMU) of Albert Einstein College of Medicine, and all study activities are managed by the CTISC.

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 ctisc-admin@einstein.yu.edu.

 

Recent publications supported by the Clinical, Translational and Implementation Science Core

  • Grov C, Westmoreland DA, Carneiro PB, Stief M, MacCrate C, Mirzayi C, Pantalone DW, Patel VV, Nash D (2019). Recruiting vulnerable populations to participate in HIV prevention research: Findings from the Together 5000 cohort study. Ann Epidemiol 35: 4-11. Pubmed  
  • Hanna DB, Ramaswamy C, Kaplan RC, Kizer JR, Daskalakis DC, Anastos K, Braunstein SL (2019). Sex- and poverty-specific patterns in HIV-associated cardiovascular mortality in New York City, 2007-2017. Clin Infect Dis, ePub 28 Aug 2019. Pubmed 
  • Kong AM, Pozen A, Anastos K, Kelvin EA, Nash D (2019). Non-HIV comorbid conditions and polypharmacy among people living with HIV age 65 or older compared with HIV-negative individuals age 65 or older in the United States: A retrospective claims-based analysis. AIDS Patient Care STDs 33: 93-103. Pubmed  
  • *Lankowski AJ, Bien-Gund CH, Patel VV, Felsen UR, Silvera R, Blackstock OJ (2019). PrEP in the real world: Predictors of 6-month retention in a diverse urban cohort. AIDS Behav 23: 1797-1802. Pubmed  
  • McCarthy KJ, Gollub EL, Ralph L, van de Wijgert J, Jones H (2019). Hormonal contraceptives and the acquisition of sexually transmitted infections: An updated systematic review. Sex Transm Dis 46: 290-296. Pubmed  
  • *Shitole SG, Srinivas V, Berkowitz JL, Shah T, Park MJ, Herzig S, Christian A, Patel N, Xue X, Scheuer J, Kizer JR (2019). Hyperglycaemia, adverse outcomes and impact of intravenous insulin therapy in patients presenting with acute ST‐elevation myocardial infarction in a socioeconomically disadvantaged urban setting: The Montefiore STEMI Registry. Endocrinol Diab Metab ePub 14 Aug 2019.

*Uses the HIV Clinical Cohort Database. 

Complete list of publications supported by the Clinical, Translational and Implementation Science Core