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: ? ? ?
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