This application to continue as the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN) is one of three applications comprising the Leadership Group of the MTN. To address the overall scientific goal described in RFA-AI-12-008, the development of a safe and effective microbicide for HIV prevention, the MTN SDMC scientific agenda includes the following aims: 1. Ensure the collection of complete, high quality data by providing state-of-the-art secure data management systems and training according to best data and clinical management practices. 2. Provide statistical and epidemiologic leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. 3. Develop and implement innovative statistical and epidemiological approaches to improve the scientific understanding of HIV risk, how microbicides reduce this risk and how this reduction may be modified or influenced by biological and behavioral factors. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies. The scientific leadership of the faculty engaged in the MTN SDMC will ensure MTN trials are designed to obtain reliable answers to the most pressing questions in microbicides development. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New microbicides will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will support the leadership group with timely and accurate reporting of MTN studies throughout follow-up to study completion. We will continue to support the MTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials.

Public Health Relevance

The HIV/AIDS epidemic continues to affect many regions of the world and HIV vulnerable populations are in need of safe, cost-effective, convenient and discreet methods to protect themselves from acquiring HIV. Microbicides have the potential to deliver this protection. The MTN SDMC will provide the highest quality of clinical trial design, data management and statistical analysis to ensure scientifically sound and robust results for MTN trials.

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 #
5UM1AI068615-13
Application #
9605055
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2018-12-01
Budget End
2019-11-30
Support Year
13
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Abbai, Nathlee S; Nyirenda, Makandwe; Naidoo, Sarita et al. (2018) Prevalent Herpes Simplex Virus-2 Increases the Risk of Incident Bacterial Vaginosis in Women from South Africa. AIDS Behav 22:2172-2180
Laborde, Nicole D; Pleasants, Elizabeth; Reddy, Krishnaveni et al. (2018) Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex. AIDS Behav 22:437-446
Montgomery, Elizabeth T; Noguchi, Lisa M; Dai, James Y et al. (2018) Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States. AIDS Behav 22:402-411
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
Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E et al. (2018) Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials 19:8-14
Balkus, Jennifer E; Brown, Elizabeth R; Palanee-Phillips, Thesla et al. (2018) Performance of a Validated Risk Score to Predict HIV-1 Acquisition Among African Women Participating in a Trial of the Dapivirine Vaginal Ring. J Acquir Immune Defic Syndr 77:e8-e10
Musara, Petina; Montgomery, Elizabeth T; Mgodi, Nyaradzo M et al. (2018) How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe. AIDS Behav 22:877-886
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
Makanani, Bonus; Balkus, Jennifer E; Jiao, Yuqing et al. (2018) Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy. J Acquir Immune Defic Syndr 79:566-572

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