The HIV epidemic among youth continues

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 behaviour; extrinsic considerations are those in the community, ethical, legal, and regulatory arenas and those in designing clinical trials for youth to feasibly participate. Kapogiannis and colleagues 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.

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Editors’ note: This article is the introductory summary for a journal supplement devoted exclusively to discussions of the feasibility of, timing of, and barriers to the enrolment of adolescents and young adults in clinical trials to test microbicides, pre-exposure prophylaxis, and HIV vaccines. Obtaining data on adolescents as early as ethically possible will help avoid the pitfalls of off-label use of products that are proven to be effective in adults. Further, if youth-labelling indications are concurrent with adult licensure,young people will not have a slower access track than adults to safe, effective products. Data from adults cannot simply be extrapolated to adolescents – unique psychosocial and physiological changes during adolescent development could mean ineffective dosing strategies for oral and topical antiretroviral products and sub-optimal vaccine regimens. Among the challenges to inclusion of sexually active adolescents in trials are jurisdictional age of consent definitions and reporting requirements for statutory rape (sex under a specific age). At a minimum, adolescent-specific safety and toxicity data should be required for regulatory approval of any biomedical prevention product and risk compensation research should be uniformly conducted to determine how adolescents perceive products and how they might use new technologies. Determining when to enrol young people in biomedical HIV prevention research is a complex issue but the incidence observed among 16 and 17 year olds in some settings oblige us to address this issue head-on.