The Administrative Core (Core A) will direct and coordinate several major areas contributing to the activities of the Development of Rectal Enema as Microbicide (DREAM) Program whose overall goal it is to develop a single dose tenofovir prodrug enema to provide one week of protection from HIV infection following unprotected receptive anal intercourse. These activities include (1) administrative oversight of the entire program including all Projects and Cores, (2) providing financial oversight of the program, (3) act as primary liaison with the NIAID/DAIDS appointed Program Officer with responsibility for the Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention U19 Program, (4) coordinate the monthly conference calls for the Steering Committee (SC) and disseminate agendas / meeting minutes in a timely fashion, (5) organize the annual IP/CP meeting, (5) in collaboration with NIAID/DAIDS, establish and provide logistical support for a Scientific Advisory Panel facilitation, and (6) undertake website maintenance, education, publication assistance, library maintenance, and general administrative support. The Core will link the various project leaders and programs as well as integrate the related milestones of each project and ensuring communication between project leaders. The SC, composed of the Principal Investigator and each Project Leader/Associate-Leader, Core Leader/Associate Leader, and select key personnel, will be the central mechanism in assuring communication between Projects, Project sites, and Cores. The Administrative Core will also produce twice-yearly internal progress reports for the SC. These will be available to interested key personnel and the NIH's Scientific Advisory Panel (SAP).

Public Health Relevance

The DREAM Program plans development of a single dose tenofovir enema to protect from rectal HIV infection. The Administrative Core will be the primary mechanism to provide administrative, logistical, and financial support for the DREAM Projects and Cores as they pursue their milestones.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19AI113127-01
Application #
8768692
Study Section
Special Emphasis Panel (ZAI1-BP-A (M2))
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$285,125
Indirect Cost
$60,976
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Pines, H A; Strathdee, S A; Hendrix, C W et al. (2018) Oral and vaginal HIV pre-exposure prophylaxis product attribute preferences among female sex workers in the Mexico-US border region. Int J STD AIDS :956462418793038
Pines, Heather A; Semple, Shirley J; Strathdee, Steffanie A et al. (2018) Vaginal washing and lubrication among female sex workers in the Mexico-US border region: implications for the development of vaginal PrEP for HIV prevention. BMC Public Health 18:1009
Figueroa, Dominique B; Madeen, Erin P; Tillotson, Joseph et al. (2018) Genetic Variation of the Kinases That Phosphorylate Tenofovir and Emtricitabine in Peripheral Blood Mononuclear Cells. AIDS Res Hum Retroviruses 34:421-429
Presnell, Aubrey L; Chuchuen, Oranat; Simons, Morgan G et al. (2018) Full depth measurement of tenofovir transport in rectal mucosa using confocal Raman spectroscopy and optical coherence tomography. Drug Deliv Transl Res 8:843-852
Carballo-DiƩguez, Alex; Lentz, Cody; Giguere, Rebecca et al. (2018) Rectal Douching Associated with Receptive Anal Intercourse: A Literature Review. AIDS Behav 22:1288-1294
Hoang, Thuy; Date, Abhijit A; Ortiz, Jairo Ortiz et al. (2018) Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema. Eur J Pharm Biopharm :
Hummert, Pamela; Parsons, Teresa L; Ensign, Laura M et al. (2018) Validation and implementation of liquid chromatographic-mass spectrometric (LC-MS) methods for the quantification of tenofovir prodrugs. J Pharm Biomed Anal 152:248-256
Carballo-Dieguez, Alex; Giguere, Rebecca; Lentz, Cody et al. (2018) Rectal Douching Practices Associated with Anal Intercourse: Implications for the Development of a Behaviorally Congruent HIV-Prevention Rectal Microbicide Douche. AIDS Behav :
Xiao, Peng; Gumber, Sanjeev; Marzinke, Mark A et al. (2018) Hypo-osmolar Formulation of Tenofovir (TFV) Enema Promotes Uptake and Metabolism of TFV in Tissues, Leading to Prevention of SHIV/SIV Infection. Antimicrob Agents Chemother 62:
Aung, Wutyi S; Bakshi, Rahul P; Breakey, Jennifer et al. (2018) Fecal Coliform Bacterial Detection to Assess Enema Adherence in HIV Prevention Clinical Studies. AIDS Behav :

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