This proposal seeks to establish the Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials Unit (CTU) in two of the world's HIV epicenters, New York City and Swaziland. Drs. Scott Hammer and Wafaa El-Sadr will serve as CTU Principal Investigators (PIs) and will lead a highly dedicated and experienced group of investigators and staff to achieve the following aims: (1) support the scientific agendas of the Division of AIDS (DAIDS) Clinical Research Networks (CRNs) addressing HIV therapeutic strategies (ACTG), integrated HIV prevention strategies (HPTN), vaccines to prevent HIV infection (HVTN), microbicide strategies to prevent HIV infection (MTN), and strategies to address HIV infection in pediatric and maternal populations (IMPAACT); (2) contribute to the scientific agendas of these CRNs through robust accrual and retention, active participation in the affiliated CRNs' governance and scientific committees, protocol team leadership/membership, and junior investigator development; (3) craft a CTU administrative structure that is outstanding in its capabilities and streamlined in its procedures; (4) engage the community as full partners through community education, outreach, special events and active and well supported community advisory boards (CABs); (5) provide outstanding pharmacy, clinical trials laboratory, regulatory affairs, data management, quality assurance and staff training capabilities; (6) align the 8 constituent Clinical Research Sites (CRSs), inclusive of 7 CRSs in New York City and 1 in Swaziland into a synergistic whole which will be truly pluripotent, integrated and efficient; and (7) describe the Columbia Partnership CTU's interest in participating in the Antibacterial Resistance CRN. The 8 CRSs and their leaders are: College of Physicians & Surgeons (M. Sobieszczyk); ICAP Bronx Prevention Center (J. Justman); ICAP Harlem Prevention Center (S. Mannheimer); ICAP Swaziland Prevention Center (W. El-Sadr); New York Blood Center (B. Koblin); Einstein-Montefiore (M. Keller); Bronx-Lebanon Hospital Center (E. Telzak) and New York University-Bellevue (J. Aberg). Integrating HIV prevention and therapeutic research at the CTU level will facilitate achieving the overarching goal of durably controlling and ultimately ending the HIV epidemic.
Progress in combatting HIV has been impressive but many unanswered questions remain. The Columbia Partnership Clinical Trials Unit is situated in two hot spots of HIV activity. New York City and Swaziland, and is uniquely positioned to perform the state-of-the-art clinical research studies sponsored by the Division of AIDS Clinical Research Networks which will bring durable control and ultimately the end of the HIV epidemic.
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