A microbicide – even one which is only partially effective – can put the power of HIV protection into the hands of women around the world, potentially saving millions of lives. But microbicide development is a long and expensive process. Safety trials can take one to two years while efficacy trials can last three years or longer, involve thousands of people and cost hundreds of millions of dollars.

Although no microbicides have yet been approved for use, there is growing scientific consensus that safe, effective and affordable microbicides can be developed for developing countries. Already, dozens of agents that interrupt HIV infection have been identified and are currently under extensive study and testing for use as microbicides.

How are Microbicides Tested for Safety and Efficacy?
After pre-clinical testing, candidate microbicides advance through a series of human clinical trials designed to test safety and efficacy (ability to prevent HIV infection.) Clinical efficacy trials involve large numbers of women and need to be conducted in locations where new HIV infections are occurring at a high rate. This way, researchers can compare infection rates among those who use the candidate microbicides with those who use placebos.

To get safe and effective microbicides into the hands of women as quickly as possible, IPM works to increase the efficiency and speed of product testing by:

• expanding clinical trial capacity for HIV-prevention trials;
  
• identifying and preparing new clinical trial sites;
  
• partnering with communities where trials will be conducted to ensure they are fully engaged in the process; and
  
• liaising with local policy makers so that they understand and support the process of microbicide development and testing.

>> Read IPM’s Issue Brief on Clinical Trials
>> View a complete list of IPM clinical trials and their status

Community Outreach Programs

In countries where clinical trials are conducted, IPM implements broad-based programs of community engagement. Information about microbicides and clinical trials is offered to key stakeholders including women’s groups, ministries of health, medical professionals, the media, traditional leaders and healers, nurse-midwives and others. Ongoing training, networking and support for those involved in the actual testing process – clinical investigators, research scientists, nurse coordinators, counselors, accountants and project management staff – is also provided.

IPM places great importance on ensuring that local communities understand that due to the extensive outreach services offered to study participants including safe sex education, treatment of sexually transmitted infections and the provision of condoms.

All IPM trials are conducted according to universally accepted regulatory guidelines to protect trial participants and to guarantee the ethical and scientific integrity of the results. IPM has also developed its own comprehensive guidelines for the conduct of its clinical trials, which are available on-line.

>> Community Engagement Plan