Microbicide Trials Network
The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health, all of the U.S. National Institutes of Health (NIH). The MTN brings together international investigators and community and industry partners whose work is focused on the development and rigorous evaluation of promising microbicides – products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV.
The operational structure of the MTN consists of three key organizational units: a Leadership and Operations Center (LOC), a Laboratory Center (LC) and a Statistical and Data Management Center (SDMC). Drs. Hillier and McGowan direct the activities of the LOC, with Ward Cates, M.D., of FHI 360, and Connie Celum, M.D., M.P.H., of the University of Washington, leading key components that are critical to the successful implementation of MTN’s trials. Charlene Dezzutti, Ph.D., serves as principal investigator of the LC, also based at the University of Pittsburgh and MWRI, while the SDMC, which is housed within the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center, is under the direction of SDMC principal investigator Elizabeth Brown, Sc.D.
The primary governance body of the MTN is an Executive Committee (EC), which is responsible for the overall scientific direction, development and implementation of policy, procedural decisions and resource allocation. The EC is supported by three committees – the Manuscript Review Committee (MRC), Study Monitoring Committee (SMC) and Network Evaluation Committee (NEC). In addition, three working groups ensure scientific quality, innovation and community perspectives are the hallmarks of every MTN study. The Biomedical Science Working Group (BSWG) brings new ideas and innovative methods into the design of protocols to allow for greater insight in the areas of immunology, microbiology and virology and deeper understanding of clinical trial results overall. The Behavioral Research Working Group (BRWG) provides expertise and perspective in the design of studies to both understand and characterize how an individual’s social context, sexual behaviors, perceptions of risk, and other factors may influence whether or not a product is used. The Community Working Group (CWG) facilitates community engagement and advocates for inclusion of community perspectives throughout all stages of the research process, from concept development to study implementation and results dissemination.
MTN studies are conducted through NIAID-funded Clinical Trial Units (CTUs). Each CTU includes an administrative component with performance and resource management responsibilities and Clinical Research Sites (CRSs)—the hospitals, outpatient clinics and community health centers where clinical trials are conducted. Successful implementation of the MTN research agenda is highly dependent upon CTU and CRS investigators and staff.
More information about the MTN’s governance, operational structure and working groups can be found in the MTN Manual of Operational Procedures.