Comprehension of a simplified assent form in a vaccine trial for adolescents.

Journal Article (Journal Article)

INTRODUCTION: Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. METHODS: Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. RESULTS: 123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. CONCLUSIONS: Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.

Full Text

Duke Authors

Cited Authors

  • Lee, S; Kapogiannis, BG; Flynn, PM; Rudy, BJ; Bethel, J; Ahmad, S; Tucker, D; Abdalian, SE; Hoffman, D; Wilson, CM; Cunningham, CK; Adolescent Medicine Trials Network for HIV/AIDS Interventions,

Published Date

  • June 2013

Published In

Volume / Issue

  • 39 / 6

Start / End Page

  • 410 - 412

PubMed ID

  • 23349510

Pubmed Central ID

  • PMC3655100

Electronic International Standard Serial Number (EISSN)

  • 1473-4257

Digital Object Identifier (DOI)

  • 10.1136/medethics-2012-101286


  • eng

Conference Location

  • England