The MTN was established in 2006 to bring together international HIV/AIDS investigators with community and industry partners who are devoted to reducing the transmission of HIV to explore another avenue for prevention of HIV/AIDS transmission. Network investigators and partners work together to develop and evaluate microbicides-products taken orally or applied topically-to prevent HIV transmission.
The Network is co-funded by the National Institute of Allergy and Infectious Diseases, the NICHD Maternal and Pediatric Infectious Disease Branch (MPIDB) (formerly the Pediatric, Adolescent, and Maternal AIDS Branch), and the National Institute of Mental Health. Funding from the NICHD specifically supports the MTN leadership group for the conduct of studies in adolescents and pregnant and breastfeeding women. Funding is provided through a Cooperative Agreement (UM1) funding mechanism.
Because the effectiveness of a product is also dependent on its use, behavioral and social science is embedded within each microbicide study to gain understanding of the needs and desires of different high-risk groups. MTN’s research agenda includes populations considered among those at highest risk, including women in Sub-Saharan Africa, adolescents, pregnant and breastfeeding women, transgender women and men who have sex with men (MSM).
32 clinical trial research sites in 9countries are affiliated with the MTN: the United States, Peru, Thailand, Malawi, Zambia, Uganda, Zimbabwe, India, and South Africa, with affiliated sites being added in Peru and Thailand. In addition, the MTN collaborates with the NICHD Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) for domestic clinical trials of microbicides to prevent HIV transmission in adolescents.
ASPIRE and The Ring Study are the first effectiveness trials of a vaginal ring for HIV prevention, as well as of an HIV prevention product that contains an antiretroviral drug other than tenofovir or a tenofovir combination. As sister studies, the two trials are designed to provide the strength of evidence to support potential licensure of the dapivirine vaginal ring for preventing HIV in women. Approval of the dapivirine ring will also be contingent on data from a suite of studies, including a Phase I safety study, MTN-023/IPM 30, of the dapivirine vaginal ring in adolescent girls, which is being conducted by the ATN and the MTN.
MTN Organization and Structure
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).
Each MTN study has its own protocol team consisting of investigators from clinical trial sites and representatives from different specialty areas and disciplines. The MTN relies on three working groups to ensure scientific quality and consideration of community perspectives, including:
- The Biomedical Science Working Group. Provides input and innovative ideas to enhance understanding or monitoring of patient safety (e.g., biomarkers) and specimen collection.
- The Behavioral Research Working Group. Provides expertise and perspective in the design of studies to better understand and address the complex interplay between human behavior and HIV risk and prevention.
- The Community Working Group. Ensures the successful conduct of studies through community-researcher partnerships and engagement and participation of the community at the site level.
MTN-affiliated researchers and partners work within a unique infrastructure specifically designed to facilitate the research required to support licensure of the tested products for widespread use.
By the end of 2013, when its first funding period had come to a close, the MTN had completed 13 trials, including VOICE, a major effectiveness study involving more than 5,000 women; and 11 more trials were planned or in progress, including MTN’s current flagship studies, ASPIRE and MTN-017. The MTN will also evaluate different formulations of rectal microbicides, new classes of antiretroviral drugs formulated as either vaginal or rectal products – or that can be used as both, and vaginal rings with the dual purpose of preventing both HIV and unwanted pregnancy.
- Microbicide Safety Trials. MTN researchers are conducting the only studies involving the use of HIV prevention microbicides during pregnancy and breastfeeding to evaluate the safety of their use in women and infants. These studies are critical because women need a product that will be safe and effective to use in all stages of life, including during pregnancy, when the risk of acquiring HIV from an infected partner is particularly high. Because women often continue to use medications when they are pregnant or breastfeeding, knowing whether microbicides are safe to use in this population before they become readily available is also vitally important.
- Prevention Trials of Existing Antiretroviral Therapies. Emphasis has been on the evaluation of antiretroviral (ARV)-based prevention strategies, examining whether some of the same ARVs commonly used to treat HIV can also be used for prevention. This preventive approach is called pre-exposure prophylaxis (PrEP). Formulations currently being tested for prevention include vaginal gels and oral tablets.
- Efficacy Studies of New Formulations for Women, including adolescent girls (in collaboration with the ATN). In addition to gel microbicides, the MTN is exploring other types of formulations, including vaginal rings. Unlike a vaginal gel that must be used every day or at the time of sexual activity, the vaginal rings currently being studied are inserted monthly and release the active ingredient slowly so that a woman would have long-lasting protection against HIV.
- Efficacy Studies of Additional Formulations. Although the majority of microbicide research focuses on products to prevent HIV during vaginal sex, anal sex is common among men who have sex with men, and among some women around the world. The MTN is making significant contributions in the area of rectal microbicide research and is leading the way toward developing a microbicide to protect against HIV transmitted through receptive anal sex.
For a complete list of MTN studies, visit http://www.mtnstopshiv.org/studies .
The MTN currently has more than 32 clinical trial research sites in the following countries:
- South Africa
- United States
- MTN Web Site (Maintained by MTN core group at University of Pittsburgh/Magee Women's Hospital)
- NICHD Contact: Denise Russo