Introduction: Paving the way for biomedical HIV prevention interventions in youth.

The HIV epidemic among youth continues to grow at alarming proportions throughout the world. Efficacious and comprehensive biomedical prevention interventions are desperately needed for this vulnerable population if a reduction in global HIV incidence is to be achieved. To succeed at enrolling youth in studies of such modalities, communities whose youth will be participating must be highly engaged throughout the spectrum of research concept development to implementation and later translation into programs. In this process, there are numerous challenges, both intrinsic and extrinsic to the youth themselves. Intrinsic ones include developmental considerations in physiology, pharmacology, and behavior; extrinsic considerations are those in the community, ethical, legal, and regulatory arenas and those in designing clinical trials for youth to feasibly participate. We convened a consultative meeting to deliberate over these considerations among a variety of experts representing youth and their community, advocacy groups, academia, industry, regulators, and others in the federal government. Broad recommendations aimed at many stakeholders in the adolescent HIV prevention research agenda were made and were to improve the timely inclusion of youth in this research to ensure that prevention agents can be used safely by youth as soon as they become available to adults.