Materials and Links

Background:

HIV is having a devastating impact among adolescents and young people around the world. Young people are particularly vulnerable to HIV infection due to various factors, such as increased risk behavior (e.g. substance use), lack of information, insufficient availability of services, and socioeconomic factors that make them more susceptible to engaging in high-risk behaviors for their livelihood.  These risky behaviors are in part, due to the fact that developmentally, adolescents are undergoing changes in brain function that increase risk taking and sensation seeking behaviors compared to adults.

Addressing the needs of at-risk youth is paramount to the successful eradication of HIV domestically and internationally.  Given the need for adolescent and young adult populations to have both behavioral and biomedical tools that can help them avoid HIV infection, it is critical that these populations be included in clinical trials for HIV prevention. Unfortunately, due to regulatory concerns about youth participation in clinical trials, the majority of clinical trials to date testing biomedical HIV prevention strategies have not included this vulnerable population. 

Objective:

In collaboration with Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, National Institute on Drug Abuse, National Institute of Allergy and Infectious Diseases, and the Office of AIDS Research. This consultation will focus on examining and discussing the desirability and timing of as well as barriers to enrollment of adolescents in these trials.  Participants will include representatives from academia, industry, HIV-affected communities, and various branches of the United States government.  These participants will offer an expanse of expertise covering the medical, behavioral, ethical, legal and regulatory ramifications of including or not including adolescents in biomedical prevention trials.

This meeting took place on June 17-19, 2009, at the Doubletree Hotel, located at 1515 Rhode Island Avenue NW, Washington, DC, 20005.