? ? The objective of this application is to establish the CORE Leadership Group and a Network Laboratory for the Microbicide Trials Network (MTN). The objective of the Leadership Group is to provide oversight and coordination of a portfolio of clinical trials on topical microbicides for prevention of HIV. The mission of the Microbicide Trials Network is to reduce the sexual transmission of HIV through the development and evaluation of products which reduce the transmission of HIV when applied topically to mucosal surfaces. The goal is to conduct scientifically rigorous and ethically sound clinical trials of microbicide safety and effectiveness which will support licensure of these products. The MTN CORE and Network Laboratory will be headquartered in Pittsburgh under the direction of Dr. Sharon Hillier (CORE) and Dr. Charlene Dezzutti (Network Laboratory). CORE support for the MTN will be coordinated through Pittsburgh in collaboration with investigators at the University of Washington in Seattle and UCLA in Los Angeles, as well as Family Health International, in Raleigh North Carolina. The Network Laboratory is composed of a Comparative Assessment Core, a Site Support and Diagnostic Testing Core, a Virology Gore, a Pharmacology Core, and a Immunology Core. The MTN proposes a portfolio of 15 new clinical trials which span early safety to effectiveness studies. In addition, the MTN will assume direction for two ongoing microbicide studies which were developed under the HPTN, HPTN 035 and 059. Clinical trial sites will be located in the US and in Africa. The MTN will collaborate with other DAIDS sponsored networks and groups engaged in microbicide research internationally. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI068633-01
Application #
7068359
Study Section
Special Emphasis Panel (ZAI1-ML-A (J1))
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2006-06-29
Budget End
2007-05-31
Support Year
1
Fiscal Year
2006
Total Cost
$14,281,793
Indirect Cost
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Giguere, Rebecca; Brown III, William; Balán, Ivan C et al. (2018) Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc 25:393-400
Giguere, Rebecca; Rael, Christine Tagliaferri; Sheinfil, Alan et al. (2018) Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav 22:388-401
Brown 3rd, William; Giguere, Rebecca; Sheinfil, Alan et al. (2018) Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform 80:78-86
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
Leu, Cheng-Shiun; Giguere, Rebecca; Bauermeister, José A et al. (2018) Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care :1-9
Montgomery, Elizabeth T; Stadler, Jonathan; Naidoo, Sarita et al. (2018) Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS 32:1517-1525
Mensch, Barbara S; Richardson, Barbra A; Husnik, Marla et al. (2018) Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE. AIDS Behav :
Carballo-Diéguez, Alex; Giguere, Rebecca; Dolezal, Curtis et al. (2017) Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men. AIDS Behav 21:3336-3345
Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark et al. (2017) Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. J Acquir Immune Defic Syndr 76:330-337
Montgomery, Elizabeth T; van der Straten, Ariane; Chitukuta, Miria et al. (2017) Acceptability and use of a dapivirine vaginal ring in a phase III trial. AIDS 31:1159-1167

Showing the most recent 10 out of 86 publications