title: Youth-specific considerations in the development of preexposure prophylaxis, microbicide, and vaccine research trials.
abstract: Preventing HIV infection in adolescents and young adults will require a multimodal targeted approach, including individual-directed behavioral risk reduction, community-level structural change, and biomedical interventions to prevent sexual transmission. Trials testing biomedical interventions to prevent HIV transmission will require special attention in this population due to the unique psychosocial and physiologic characteristics that differentiate them from older populations. For example, microbicide research will need to consider acceptability, dosing requirements, and coinfection rates that are unique to this population. Preexposure prophylaxis studies also will need to consider potential unique psychosocial issues such as sexual disinhibition and acceptability as well as unique pharmacokinetic parameters of antiretroviral agents. Vaccine trials also face unique issues with this population, including attitudes toward vaccines, risks related to false-positive HIV tests related to vaccine, and different immune responses based on more robust immunity. In this article, we will discuss issues around implementing each of these biomedical prevention modalities in trials among adolescents and young adults to help to guide future successful research targeting this population.
authors.affiliation: Department of Pediatrics, New York University School of Medicine, New York, NY, USA.
authors.forename: Bret J
authors.initials: BJ
authors.lastname: Rudy
authors.forename: Bill G
authors.initials: BG
authors.lastname: Kapogiannis
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Lally
authors.forename: Glenda E
authors.initials: GE
authors.lastname: Gray
authors.forename: Linda-Gail
authors.initials: LG
authors.lastname: Bekker
authors.forename: Paul
authors.initials: P
authors.lastname: Krogstad
authors.forename: Ian
authors.initials: I
authors.lastname: McGowan
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use; D000282:Administration, Intravaginal; D000285:Administration, Rectal; D000293:Adolescent; D000367:Age Factors; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006679:HIV Seropositivity; D006801:Humans; D008297:Male
chemical_list: D016915:AIDS Vaccines; D019380:Anti-HIV Agents; D000891:Anti-Infective Agents, Local