A potential microbicide candidate is first assessed in laboratory studies and animal models. If it passes this stage of testing, it enters human clinical trials. In Phase I trials, scientists assess the safety of the product, determine its acceptability, and identify its appropriate dose and formulation. In Phase II trials, scientists again assess safety and acceptability, but among more participants and for a longer period. The final stages of microbicide trials (Phase IIb and Phase III trials) are used to collect information about a product’s long-term safety and evaluate its effectiveness in preventing HIV and, sometimes, other sexually transmitted infections. These trials often enroll thousands of participants who live in communities where the risk of HIV infection is very high.
This section of the toolkit highlights several important issues that must be considered as clinical trials are designed and conducted. A high standard of research ethics, community engagement, and various measures for maintaining the safety of the research participants are all essential. Procedures also need to be in place to help participants adhere to the proper use of the study product and make sure they receive the best possible care for the prevention and treatment of HIV.
Because many of these issues are also relevant to implementation research, you can find related and additional information in the Implementation Research section of the toolkit.