The overall goal of this application is to establish the Columbia Collaborative HIV/AIDS Clinical Trials Unit (CC-CTU). This application brings together investigators at the Columbia University Medical Center (CUMC), the New York Blood Center (NYBC) and the Harlem Family Center (HFC) of Harlem Hospital to achieve the following specific aims: (1) establish a clinical trials unit in support of the scientific agendas of the AIDS Clinical Trials Group (ACTG), the HIV Vaccine Trials Network (HVTN) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group;(2) actively contribute to the science and leadership of the affiliated Networks (ACTG, HVTN, IMPAACT) through membership on scientific and resource committees and protocol teams;(3) mentor and develop junior investigators as clinical researchers within the context of multicenter HIV clinical trials;and (4) maintain and continue to build strong community relations through a comprehensive community education program, culturally appropriate outreach activities and active Community Advisory Boards.
These aims will be met by bringing together a team of investigators with extensive Division of AIDS (DAIDS)-sponsored Network clinical research experience to form an integrated clinical trials unit which can provide therapeutic and preventive vaccine clinical trial opportunities to populations in New York City which bear a heavy burden of HIV disease or risk of HIV acquisition. The CC-CTU will be administratively centered at CUMC (S. Hammer, PI) and will be composed of five Clinical Research Sites (CRS's) as follows: the HIV Prevention and Treatment CRS at CUMC (S. Hammer, PI) which will participate in ACTG and HVTN trials;the Harlem Family Center CRS (VV. El-Sadr, PI) which will participate in ACTG trials;the NYBC-Bronx and NYBC-Union Square CRS's (B. Koblin, PI) which will participate in HVTN trials;and the IMPAACT CRS at CUMC (P. LaRussa, PI). Strong community partnerships will be key to the success of the CC-CTU and an in-depth community education and outreach program is in place. Two deeply committed CAB's, one focused on therapy and one focused on prevention, will work with the CTU staff to serve the community by offering clinical trials which are relevant to the challenges that individuals face. Integrating HIV prevention and therapeutic research at the CTU level is an effective model for the rapid translation of study results into improvements in care and public health. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-AR-A (M1))
Program Officer
Jones, Patricia L
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Columbia University (N.Y.)
Internal Medicine/Medicine
Schools of Medicine
New York
United States
Zip Code
Goepfert, Paul A; Elizaga, Marnie L; Seaton, Kelly et al. (2014) Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 210:99-110
Lennox, Jeffrey L; Landovitz, Raphael J; Ribaudo, Heather J et al. (2014) Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med 161:461-71
Kuo, Irene; Golin, Carol E; Wang, Jing et al. (2014) Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend 139:93-9
McMahon, James M; Myers, Julie E; Kurth, Ann E et al. (2014) Oral pre-exposure prophylaxis (PrEP) for prevention of HIV in serodiscordant heterosexual couples in the United States: opportunities and challenges. AIDS Patient Care STDS 28:462-74
Tang, Eric C; Sobieszczyk, Magdalena E; Shu, Eileen et al. (2014) Provider attitudes toward oral preexposure prophylaxis for HIV prevention among high-risk men who have sex with men in Lima, Peru. AIDS Res Hum Retroviruses 30:416-24
Usher, DaShawn; Frye, Victoria; Shinnick, Julianna et al. (2014) Recruitment by a geospatial networking application for research and practice: the New York City experience. J Acquir Immune Defic Syndr 67:e143-5
Haas, David W; Kwara, Awewura; Richardson, Danielle M et al. (2014) Secondary metabolism pathway polymorphisms and plasma efavirenz concentrations in HIV-infected adults with CYP2B6 slow metabolizer genotypes. J Antimicrob Chemother 69:2175-82
Haley, Danielle F; Golin, Carol; El-Sadr, Wafaa et al. (2014) Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt) 23:541-51
Haley, Danielle F; Lucas, Jonathan; Golin, Carol E et al. (2014) Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064). AIDS Patient Care STDS 28:206-17
Piwowar-Manning, Estelle; Fogel, Jessica M; Laeyendecker, Oliver et al. (2014) Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening. HIV Clin Trials 15:62-8

Showing the most recent 10 out of 24 publications