Comprehension of a simplified assent form in a vaccine trial for adolescents
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
Published Date
- 2013
Published In
Volume / Issue
- 39 / 6
Start / End Page
- 410 - 412
International Standard Serial Number (ISSN)
- 0306-6800
Digital Object Identifier (DOI)
- 10.1136/medethics-2013-101515