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 MTN is also committed to the development of dual purpose products that would offer women a means for both HIV protection and contraception.
Whether a Phase I safety and acceptability study or a large-scale Phase III effectiveness trial, every MTN study is designed and conducted to support the potential licensure of products. Because the effectiveness of a product often depends on its consistent use, behavioral science is a key feature within trials and across the MTN portfolio to gain understanding of the needs and desires of different high-risk groups. These include adolescent girls and young women, pregnant and breastfeeding women, transgender individuals and men who have sex with men (MSM). More than 25 clinical research sites on four continents have partnered with the MTN in the conduct of its clinical trials.
The MTN is led by principal investigator Sharon L. Hillier, Ph.D., of the University of Pittsburgh and Magee-Womens Research Institute (MWRI), and co-principal investigator Jared M. Baeten, M.D., Ph.D., of the University of Washington.
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 Baeten direct the activities of the LOC, with Kristine Torjesen, M.D., of FHI 360, and Connie Celum, M.D., M.P.H., of the University of Washington, leading key components. Charlene Dezzutti, Ph.D., serves as principal investigator of the LC, which includes specialized laboratories at the University of Pittsburgh and MWRI, where she is based, and at Johns Hopkins University and the University of Colorado.. The SDMC, under the direction of SDMC principal investigator Elizabeth Brown, Sc.D., is housed within the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center in Seattle.
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 – the Biomedical Science Working Group (BSWG), Behavioral Research Working Group (BRWG) and Community Working Group (CWG) – ensure scientific quality, innovation and community perspectives are the hallmarks of every MTN study.
MTN studies are conducted through NIAID-funded Clinical Trial Units (CTUs) at affiliated Clinical Research Sites. 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.