Fenway Community Health (FCH), a Boston community-health center, which has conducted HIV/AIDS research for more than two decades, proposes to establish a Clinical Trials Unit (based on its experience coordinating HIVNET and HPTN consortia), which has been invited to be affiliated with two HIV/AIDS Clinical Trial Leadership Groups: Prevention of HIV (HPTN) and Microbicides (MTN). FCH will oversee the Administrative Component of the CTU and will coordinate the activities of three Clinical Research Sites in southeastern New England including: FCH, Latin American Health Institute (LHI, Boston, MA) and The Miriam Hospital (TMH, Providence, Rl). The CTU proposes to enroll a racially and ethnically diverse cohort of participants in the following protocols: 1. to reduce HIV seroincidence in cocaine and stimulant users (N=250);2. to assess the efficacy of novel antiretrovirals for pre-exposure prophylaxis to prevent HIV transmission (250);3. to decrease HIV incidence in IDU with buprenorphine (150);4. to assess and develop interventions for individuals acutely infected with HIV (100);5. to enroll high risk women in microbicide preparedness studies (100);6. to assess oral versus topical tenofovir (20);6. to evaluate a novel microbicide (20);7. to compare a new microbicide with a placebo gel in a Phase II study (40);8. to enroll high risk women in a Phase III study (200);9. to enroll recently infected trial participants into observational studies (over 90% of newly infected patients). All 3 CRSs have worked together in the HPTN, enrolling distinctive populations of at risk and HIV-infected people, with FCH focusing on MSM, LHI on Latinos, and TMH on women. The current proposal demonstrates the ability of each CRS to increase and diversify its ability to enroll relevant populations for these trials. Each CRS has the infrastructure necessary for the conduct of effective and ethical trials, including well-trained, GCP-compliant staff;clinical and laboratory resources, experience with data collection, transmittal, and analysis;IRBs with FWAs;independent community advisory boards. The leadership of the CTU and participating CRS has worked together on multiple USPHS -funded research protocols, and demonstrate in this proposal the mechanisms to optimize the complementary strengths of the collaborative investigators, including experience working with diverse populations, plans for maximal efficiency in resource utilization, and mentoring of new investigators. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069480-06
Application #
8402557
Study Section
Special Emphasis Panel (ZAI1-TP-A (M2))
Program Officer
Potter, Dara G
Project Start
2008-09-08
Project End
2014-11-30
Budget Start
2012-12-01
Budget End
2014-11-30
Support Year
6
Fiscal Year
2013
Total Cost
$944,912
Indirect Cost
$786,260
Name
Fenway Community Health Center
Department
Type
DUNS #
072366156
City
Boston
State
MA
Country
United States
Zip Code
02215
Mayer, Kenneth H; Grinsztejn, Beatriz; El-Sadr, Wafaa M (2016) Transgender People and HIV Prevention: What We Know and What We Need to Know, a Call to Action. J Acquir Immune Defic Syndr 72 Suppl 3:S207-9
Scott, Hyman M; Irvin, Risha; Wilton, Leo et al. (2015) Sexual Behavior and Network Characteristics and Their Association with Bacterial Sexually Transmitted Infections among Black Men Who Have Sex with Men in the United States. PLoS One 10:e0146025
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Hall, Grace; Li, Keala; Wilton, Leo et al. (2015) A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). AIDS Behav 19:2214-23
Irvin, Risha; Vallabhaneni, Snigdha; Scott, Hyman et al. (2015) Examining levels of risk behaviors among black men who have sex with Men (MSM) and the association with HIV acquisition. PLoS One 10:e0118281
Mannheimer, Sharon B; Wang, Lei; Wilton, Leo et al. (2014) Infrequent HIV testing and late HIV diagnosis are common among a cohort of black men who have sex with men in 6 US cities. J Acquir Immune Defic Syndr 67:438-45
Irvin, R; Wilton, L; Scott, H et al. (2014) A study of perceived racial discrimination in Black men who have sex with men (MSM) and its association with healthcare utilization and HIV testing. AIDS Behav 18:1272-8
Magnus, Manya; Franks, Julie; Griffith, Sam et al. (2014) Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing--lessons learned from HPTN 061, the BROTHERS study. J Public Health Manag Pract 20:E1-9
Sugarman, Jeremy; Mayer, Kenneth H (2013) Ethics and pre-exposure prophylaxis for HIV infection. J Acquir Immune Defic Syndr 63 Suppl 2:S135-9

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