Despite over two decades of health education on AIDS, the pandemic continues unabated. Approximately 2.5 million new infections are occurring annually. The majority of these infections are in women living in sub-Saharan Africa. There is a critical need to develop new approaches to HIV prevention to help stem this tragic loss of human life. Behavioral interventions that encourage and support abstinence, careful partner selection, and condom usage have value, but maintenance of safe sex practices is difficult in high-risk populations. Some behavioral strategies are not acceptable or feasible for women at risk for HIV for cultural or gender reasons, such as negotiating safe sex with a stable sex partner. Data accumulated during microbicide preparedness studies show that most women living near the sites that are proposed for MTN effectiveness studies are married or in stable relationships, and almost all report having only one sex partner. In areas of high HIV prevalence, a substantial number of HIV-negative women are unknowingly in stable, HIV-discordant partnerships and face challenges in male willingness to accept HIV testing and condom use. Ending the AIDS pandemic will require a comprehensive approach incorporating a range of prevention strategies that includes both microbicides and vaccines.
It is anticipated that more than a decade of further research and development will be needed before an effective vaccine against HIV is developed. Even when an effective HIV vaccine is identified, it will not likely be 100% effective and may not be acceptable to all high-risk groups. Therefore, complementary prevention methods such as microbicides will still be needed.
Microbicides, defined as antimicrobial products for prevention of sexually transmitted infections including HIV, are one of the most promising preventive interventions to emerge over the past decade. Microbicides that are effective, inexpensive, readily available, and widely acceptable would give women who cannot rely on male condom usage or abstinence a method to protect themselves against HIV. Microbicides could be used alone or in combination with physical barriers to provide the ability to block the sexual transmission of HIV. Even a partially effective microbicide has the potential to have a profound impact on the dynamics of the HIV epidemic.
The mission of the MTN is to reduce the sexual transmission of HIV through the development and evaluation of products that reduce the transmission of HIV when applied topically to mucosal surfaces or when taken orally. The goal is to work in a highly efficient manner and conduct scientifically rigorous and ethically sound clinical studies of microbicide safety and effectiveness, which will support licensure of safe and effective products.
The MTN will:
- Develop a highly focused microbicide-development strategy based on a drug-development model
- Maintain outstanding operational execution of protocol development and implementation, laboratory and data management support, and fiscal oversight
- Maintain a performance-oriented culture
- Create and maintain a fast, flexible, leadership
The MTN operates under a cooperative agreement with the DAIDS, US National Institute of Allergy and Infectious Diseases (NIAID), which is the main institute of the US National Institutes of Health (NIH) Consortium. Other members of the NIH Consortium include the National Institute of Child Health and Development (NICHD) and the National Institute of Mental Health (NIMH).
The MTN is governed by the Executive Committee which is responsible for the overall scientific direction, development, and implementation of policy, procedural decisions, and resource allocation.
The components responsible for the operational aspects of the MTN are shown below.
Operationally, the MTN is composed of three committees, three working groups, and protocol teams. The committees (Manuscript Review Committee, Study Monitoring Committee, and Network Evaluation Committee) and working groups (Biomedical Science Working Group, Behavioral Research Working Group, and Community Working Group) assure scientific quality and community relations for MTN studies. Protocol Teams are created for each MTN clinical protocol and have oversight of the MTN clinical protocols and ensure their integrity.