The primary objective of this Program is to advance an intravaginal ring formulation of a microbicide combination to safely reduce the sexual transmission of HIV. The overall Program includes 3 Projects and a Scientific Core and is comprised of several critical subcontracts that will enable the scientific team to achieve its goals. The interactions between the investigators, laboratories and clinical research sites are essential to the success of this Program. Consequently, a well-organized, well-defined administrative structure is necessary to optimize the success of this endeavor. The Administrative Core will oversee the day-to-day management of the Program and ensure communication and coordination of all study sites. The members of the Administrative Core will work closely with the investigators, pharmaceutical collaborators, NIH representatives and members of the designated Scientific Advisory Panel.
The aims of the Core are to coordinate the fiscal and organizational aspects of the Program. The Core will be responsible for maintaining and reviewing budgets and will facilitate research related travel. In addition, administrative staff will be responsible for the procurement of non-human primates for studies in Projects 1 and 2 as well as overseeing the shipment of clinical samples between the sites. The Administrative Core staff will arrange all study related conference calls and annual meetings. The Core will also provide guidance to the Program Director, Project and Core Leaders for smooth, inter-institutional complex interactions, including assistance with subcontracts, IRB, and Clinical Research Center submissions and identifying and resolving unanticipated problems.

Public Health Relevance

This Program goal is to advance an intravaginal ring formulation of a microbicide combination to safely reduce the sexual transmission of HIV. The Core will coordinate all fiscal and organizational aspects of the Program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI103461-02
Application #
8606167
Study Section
Special Emphasis Panel (ZAI1-EC-A)
Project Start
Project End
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
2
Fiscal Year
2014
Total Cost
$303,868
Indirect Cost
$80,115
Name
Albert Einstein College of Medicine
Department
Type
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
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Teller, Ryan S; Malaspina, David C; Rastogi, Rachna et al. (2016) Controlling the hydration rate of a hydrophilic matrix in the core of an intravaginal ring determines antiretroviral release. J Control Release 224:176-83
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Irvin, Susan C; Herold, Betsy C (2015) Molecular mechanisms linking high dose medroxyprogesterone with HIV-1 risk. PLoS One 10:e0121135
Murphy, Kerry; Richardson, Barbra A; Dezzutti, Charlene S et al. (2015) Levels of Genital Tract Defensins and Cytokines Differ between HIV-Uninfected US and African Women. Am J Reprod Immunol 74:313-22

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