RT Journal Article
SR Electronic
T1 Comprehension of a simplified assent form in a vaccine trial for adolescents
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 410
OP 412
DO 10.1136/medethics-2012-101286
VO 39
IS 6
A1 Sonia Lee
A1 Bill G Kapogiannis
A1 Patricia M Flynn
A1 Bret J Rudy
A1 James Bethel
A1 Sushma Ahmad
A1 Diane Tucker
A1 Sue Ellen Abdalian
A1 Dannie Hoffman
A1 Craig M Wilson
A1 Coleen K Cunningham
A1 Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
YR 2013
UL http://jme.bmj.com/content/39/6/410.abstract
AB 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.