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.
|Franks, Julie; Hirsch-Moverman, Yael; Loquere Jr, Avelino S et al. (2018) Sex, PrEP, and Stigma: Experiences with HIV Pre-exposure Prophylaxis Among New York City MSM Participating in the HPTN 067/ADAPT Study. AIDS Behav 22:1139-1149|
|Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912|
|Grant, Robert M; Mannheimer, Sharon; Hughes, James P et al. (2018) Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis 66:1712-1721|
|Hermanstyne, Keith A; Green Jr, Harold D; Cook, Ryan et al. (2018) Social Network Support and Decreased Risk of Seroconversion in Black MSM: Results of the BROTHERS (HPTN 061) Study. J Acquir Immune Defic Syndr 78:163-168|
|Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187|
|Eshleman, Susan H; Piwowar-Manning, Estelle; Sivay, Mariya V et al. (2018) Performance of the BioPlex 2200 HIV Ag-Ab assay for identifying acute HIV infection. J Clin Virol 99-100:67-70|
|Justman, Jessica E; Nair, Gonasagrie Lulu; Hendrix, Craig W et al. (2018) Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing. J Acquir Immune Defic Syndr 78:175-182|
|Fong, Youyi; Shen, Xiaoying; Ashley, Vicki C et al. (2018) Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial. J Infect Dis 217:1280-1288|
|Tieu, Hong-Van; Laeyendecker, Oliver; Nandi, Vijay et al. (2018) Prevalence and mapping of hepatitis C infections among men who have sex with men in New York City. PLoS One 13:e0200269|
|Yang, Cui; Latkin, Carl; Tobin, Karin et al. (2018) An Event-Level Analysis of Condomless Anal Intercourse with a HIV-Discordant or HIV Status-Unknown Partner Among Black Men Who Have Sex with Men from a Multi-site Study. AIDS Behav 22:2224-2234|
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