This HIV Prevention Trials Network (HPTN) Coordinating and Operations Center (CORE) application is submitted by Family Health International with applications from two affiliated organizations, John Hopkins University as the Central Laboratory (CL) and the Fred Hutchinson Cancer Research Center as the Statistical and Data Management Center (SDMC). The CORE application describes a coordinated research agenda designed to evaluate the safety and efficacy of emerging interventions to prevent sexual, perinatal, and parenteral transmission of HIV using HIV incidence as primary trial endpoint. To address these routes of transmission, six key scientific areas with unique research priorities have been delineated-perinatal transmission, microbicides, sexual behavior, STD control, antiretroviral therapies, and injection drug use. The special opportunities offered by this HPTN application involve: 1) its leadership by experts in the prevention sciences to set research priorities amidst a rapidly evolving HIV scientific arena; 2) its coordinated domestic-international research agenda; 3) its multi- disciplinary study teams of behavioral, clinical, epidemiologic, and statistical scientists; 4) its streamlined process for moving from study concept to study operation; and 5) its ability to conduct cross-cultural comparisons. The HPTN has be designed to allow for: 1) rapid consideration of hypothesis-driven concept plans by six science working groups, 2) prioritization and approval of a coordinated research agenda at the Executive Committee level, 3) implementation by pluripotential HPTN sites, and 4) careful oversight and rigorous evaluation by the Prevention Leadership Group. Close linkages available through the leadership in HPTN will assure that emerging knowledge about effective HIV prevention interventions is scaled up through domestic prevention agencies (CDC) and international donors (USAID, World Bank; UNAIDS). The HPTN and CORE organizational structure and operation, and a transition plan for moving HIVNET operations into the HPTN strategic plan are also described in this application. In summary, over the next five years, this HTPN application is proposing an aggressive, state-of-the-art prevention science research agenda designed to advance knowledge in the complex arena of reducing HIV transmission. This research agenda will be implemented under the direction of Willard Cates, Jr., MD, MPH and a leadership team comprised of world class scientists and supported by the CORE at Family Health International.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI046749-05
Application #
6655604
Study Section
Special Emphasis Panel (ZAI1-KWR-A (S1))
Program Officer
Ryan, Kevin W
Project Start
1999-09-30
Project End
2009-01-31
Budget Start
2003-07-01
Budget End
2009-01-31
Support Year
5
Fiscal Year
2003
Total Cost
$23,960,389
Indirect Cost
Name
Family Health International
Department
Type
DUNS #
067180786
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27713
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Koelle, David M; Norberg, Peter; Fitzgibbon, Matthew P et al. (2017) Worldwide circulation of HSV-2?×?HSV-1 recombinant strains. Sci Rep 7:44084
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Marshall, Brandon D L; Shoveller, Jean A; Kahler, Christopher W et al. (2015) Heavy drinking trajectories among men who have sex with men: a longitudinal, group-based analysis. Alcohol Clin Exp Res 39:380-9
Woodsong, Cynthia; Mutsambi, John Michael; Ntshele, Smangalisa et al. (2014) Community and research staff collaboration for development of materials to inform microbicide study participants in Africa. J Int AIDS Soc 17:19156
Mirochnick, Mark; Taha, Taha; Kreitchmann, Regis et al. (2014) Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. J Acquir Immune Defic Syndr 65:33-41
Gorbach, Pamina M; Kelly, Clifton W; Borgerding, Joleen A et al. (2014) Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035). AIDS Behav 18:855-61

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