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Clinical Science Core

The main mission of the Clinical Sciences Core (CSC) is to create knowledge related to key intersecting goals of minimizing HIV comorbidities and eradicating or suppressing HIV reservoirs in people living long term with treated HIV. To achieve these goals, the CSC facilitates clinical and translational investigation focused on people living with HIV on antiretroviral therapy (ART), who can expect nearly normal life expectancy, but who experience excess non-AIDS comorbidities and who require chronic HIV treatment to stay immunologically healthy. Issues related to extended survival necessitate focus on the gaps in our understanding of the epidemiology, etiologies, and needed interventions for complications of treated HIV. A better understanding of these long-term complications – including frailty, cancer, co-infections, neurological and cardiovascular diseases – would enable progress in optimizing health for people in the US and globally. The interaction between comorbidities and HIV persistence is poorly understood but is of vital importance to people who hope for HIV remission but are now on life-long ART. Yale and UPR have multiple mutual synergies that make them uniquely positioned to achieve these goals. The CSC builds on the following four key strengths: (1) Access to diverse patients and well-established cohorts linked to Yale and UPR, including numerous international cohorts and unique cohorts for studies of women and children, (2) Existing academic partnerships, (3) Strengths in translational investigation, (4) Existing strong links between UPR and Yale.

Specific Aims

  1. Enable clinical, basic and translational science, and behavioral investigators to gain appropriate and ethical access to and participation of study participants, biological specimens, and clinical and behavioral data across institutions. a) Leverage the current structure and operation of existing clinics, networks, and research cohorts to create a centralized data library that enables investigators access to study participant clinical data in existing cohorts and biorepository samples. b) Provide core services for participant recruitment, demographic and clinical data, sample acquisition and processing, and database management for pilot projects. c) Include PLH meaningfully in research to ensure ethical and patient-centered approaches towards abundant participant opportunities for minorities, persons who inject drugs, women.
  2. Create a Methods sub-Core, a resource for biostatistical support for pilot studies and grant proposals. Leverage existing resources at Yale and UPR for methods support for HIV studies and provide expert consultation for design and interpretation of studies through a dedicated and collaborative effort of biostatisticians, epidemiologists, and others with expertise in HIV research.
  3. Enhance synergies between trainees, basic scientists, clinicians and implementation scientists through formalized interactive programs. Seminars and consultative workshops will provide a real time service and roadmap for the integration of implementation science opportunities with clinical and basic science. Innovative collaborative efforts spawn novel mentoring opportunities to recruit investigators into the HIV field and promoting new avenues of joint investigation.

The Yale-UPR D-CFAR CSC is focused on the support of novel and transformative investigation into major knowledge and implementation gaps regarding HIV persistence and comorbidities associated with long-term HIV infection.

Leadership

  • Co-director

    Professor of Medicine (Infectious diseases); HIV / AIDS Care Program Director, Infectious Diseases; Donaldson Firm Chief, Infectious Diseases

    Dr. Villanueva is Director of the HIV/AIDS Program and Associate Professor of Medicine at Yale University School of Medicine. She obtained her undergraduate degree at Harvard University and MD at Washington University. She completed Internal Medicine Residency training at Duke University and subspecialty fellowship training in Infectious Diseases at Yale.After fellowship, she left academia to work at Waterbury Hospital, a community hospital, where she was Chief of Infectious Diseases. During this time, she established the Ryan White-funded HIV clinic which worked closely with community based AIDS organizations. Her experience in promoting collaborations became the basis for subsequent research interests and her recruitment back to Yale.A major focus of her academic work has been on developing HIV educational curricula for medical providers including Yale house staff and community providers throughout CT. She also serves as the Principal Investigator for the New Haven Ryan White HIV Continuum, a collaboration between different clinics and community organizations which promotes service coordination to improve quality of care for HIV patients, particularly those that are underserved. Her research interests focus on optimizing models of care that capitalize on partnerships between the medical establishment and community support.
  • Co-director

    Carmen Zorrilla is a professor of obstetrics and gynecology at the UPR School of Medicine, certified by the American Board of Obstetrics and Gynecology and the American Academy of HIV Medicine. In 1987, she established the first longitudinal clinic for women living with HIV in Puerto Rico. She participated in the PACTG 076 as one of the first 10 pilot sites and was instrumental in making AZT available to pregnant women living with HIV in Puerto Rico. Her clinic, in which more than 600 infants have been born to HIV-positive women, has had a nearly zero transmission rate during the past 16 years. Dr. Zorrilla implemented a program for group prenatal care at the University Hospital, the first in Puerto Rico. This new model of care evidenced a reduction in preterm births. She is one of leaders who spearheaded the research response to the emerging Zika epidemic among pregnant women in Puerto Rico and established a multidisciplinary clinic for pregnant women with Zika. She is the site PI for the Zika in Infants and Pregnancy (ZIP Study) in San Juan.