This section gives an overview of the many research steps between the first idea for a new biomedical HIV prevention strategy and the conclusion of a clinical trial evaluating its impact on reducing the risk of HIV infection. This is a long and complex process, and only a fraction of the ideas for new prevention strategies make it through all these stages. For example, over nearly two decades, there have been dozens of different HIV vaccines tested in Phase I trials, but only three candidates have been evaluated in large-scale efficacy trials, and only one has shown any prevention benefit.
Basic scientific research refers to a broad category of activities focused on understanding how and why different processes happen.
In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals.
Candidate strategies that meet certain criteria in laboratory and animal studies move into clinical trials in humans. Clinical trials enroll human participants to evaluate scientific or medical interventions like drugs or vaccines.
Results to Program Implementation
Implementation steps that start once trial results are in:
- Licensing and regulatory approval
- Pilot projects or pre-introductory studies
- Phase IV studies
- Operations research
Important implementation steps that can happen on an ongoing basis:
- Community input and engagement
- Planning and leadership from WHO, UNAIDS
- Country-level communications and consultations
- Access plans for trial participants and communities
- Manufacturing scale-up