Clinical Trials Network Evaluates Microbicides to Reduce Spread of HIV
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Safe and effective microbicides give women the ability to protect themselves when negotiating with sexual partners is difficult or impossible.
Credit: UNAIDS. |
Women and girls account for nearly half of all people living with HIV, according to UNAIDS estimates. 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 used by women daily or prior to sexual intercourse 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. The network has several ongoing studies exploring both new microbicide gel candidates and the use of antiretroviral drugs as an HIV prevention measure in combination with microbicide gels. For example, the MTN 001 trial is examining whether women on a daily basis are more likely to take an oral tablet of the antiretroviral drug tenofovir, a tenofovir-based vaginal gel, or both as measures to protect against HIV infection. Another study, MTN 004, is evaluating the safety, acceptability, and ease of use of VivaGel in sexually active, HIV-negative women ages 18 to 24 to determine if the product warrants testing in a larger clinical trial.
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 (Non-government).
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