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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Study Section
Special Emphasis Panel (ZAI1-RB-A (S2))
Program Officer
Jones, Patricia L
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Columbia University (N.Y.)
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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Latkin, Carl A; Van Tieu, Hong; Fields, Sheldon et al. (2017) Social Network Factors as Correlates and Predictors of High Depressive Symptoms Among Black Men Who Have Sex with Men in HPTN 061. AIDS Behav 21:1163-1170
Verma, Anurag; Bradford, Yuki; Verma, Shefali S et al. (2017) Multiphenotype association study of patients randomized to initiate antiretroviral regimens in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 27:101-111
Kiser, Jennifer J; Lu, Darlene; Rosenkranz, Susan L et al. (2017) Boceprevir and Antiretroviral Pharmacokinetic Interactions in HIV/HCV Co-infected Persons: AIDS Clinical Trials Group Study A5309s. Drugs R D 17:557-567
Chen, Iris; Zhang, Yinfeng; Cummings, Vanessa et al. (2017) Analysis of HIV Integrase Resistance in Black Men Who Have Sex with Men in the United States. AIDS Res Hum Retroviruses 33:745-748
Li, Shuying S; Kochar, Nidhi K; Elizaga, Marnie et al. (2017) DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA. Clin Vaccine Immunol 24:
Sivay, Mariya V; Li, Maoji; Piwowar-Manning, Estelle et al. (2017) Characterization of HIV Seroconverters in a TDF/FTC PrEP Study: HPTN 067/ADAPT. J Acquir Immune Defic Syndr 75:271-279
Richardson, Sharise; Seekaew, Pich; Koblin, Beryl et al. (2017) Barriers and facilitators of HIV vaccine and prevention study participation among Young Black MSM and transwomen in New York City. PLoS One 12:e0181702
Chen, Iris; Chau, Gordon; Wang, Jing et al. (2016) Analysis of HIV Diversity in HIV-Infected Black Men Who Have Sex with Men (HPTN 061). PLoS One 11:e0167629
Nelson, LaRon E; Wilton, Leo; Moineddin, Rahim et al. (2016) Economic, Legal, and Social Hardships Associated with HIV Risk among Black Men who have Sex with Men in Six US Cities. J Urban Health 93:170-88
Landovitz, Raphael J; Tran, Thuy Tien T; Cohn, Susan E et al. (2016) HIV Transmission Risk Behavior in a Cohort of HIV-Infected Treatment-Naïve Men and Women in the United States. AIDS Behav 20:2983-2995

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