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Clinical Trials Network Evaluates Microbicides to Reduce Spread of HIV

African woman.
Safe and effective microbicides give women the ability to protect themselves when negotiating with sexual partners is difficult or impossible.
Credit: NIAID.

Women and girls account for nearly half of all people living with HIV, according to UNAIDS estimates. In 2009, HIV/AIDS was the leading cause of disease and death among women between the ages of 15 and 44. Globally, the vast majority of women with HIV/AIDS became infected through heterosexual intercourse, frequently in settings where refusing sex or insisting on condom use is not an option because of cultural factors, lack of financial independence, and even the threat of violence.

In response to these and other issues, NIAID established the Microbicide Trials Network (MTN) in 2006 to develop and evaluate products that could be applied topically by women to prevent infection with HIV and other sexually transmitted agents. Safe and effective microbicides would give women the ability to protect themselves when negotiating with sexual partners is difficult or impossible.

The MTN conducts its multicenter studies at sites in Malawi, South Africa, Uganda, Zambia, Zimbabwe, India, and the United States. Its international trials include the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, which compares the safety and effectiveness of a microbicide to pre-exposure prophylaxis (PrEP), another experimental approach to HIV prevention. PrEP involves administering antiretroviral drugs to uninfected people who are at high risk of HIV infection, Like microbicides, PrEP is viewed as a potential HIV prevention method that women can use independently and proactively. VOICE will evaluate these experimental approaches in 5,000 women at sites in South Africa, Uganda, Zambia, and Zimbabwe.

The MTN is structured to allow active representation and participation by community stakeholders in every stage of clinical study development and implementation. In addition to including a community representative on its Executive Committee, the MTN has established a Community Working Group (CWG), comprising one Community Advisory Board member and one community educator from each site. The CWG aims to ensure the successful conduct of studies and to build capacity within local communities for providing input into the planning and conduct of MTN trials.

As part of its effort to be more responsive to the needs and perspectives of local communities, the MTN also has adopted the Regional Physician Model, a successful component of the Bill & Melinda Gates Foundation-funded Partners in Prevention. Regional Physicians are MTN's local ambassadors in Africa, providing support to clinical sites and educating local providers and community groups about microbicide research, MTN-specific trials, and safety measures designed to protect all trial participants.

Learn more about the Microbicide Trials Network.

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Last Updated August 17, 2011