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

Academic 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.
  • Authors

    Published In

    Digital Object Identifier (doi)

    Author List

  • Lee S; Kapogiannis BG; Flynn PM; Rudy BJ; Bethel J; Ahmad S; Tucker D; Abdalian SE; Hoffman D; Wilson CM
  • Start Page

  • 410
  • End Page

  • 412
  • Volume

  • 39
  • Issue

  • 6