Comprehension of a simplified assent form in a vaccine trial for adolescents.
BACKGROUND
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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal Pediatric Infectious Disease Branch, Bethesda, Maryland, USA. leesonia@mail.nih.gov
Sonia
S
Lee
Bill G
BG
Kapogiannis
Patricia M
PM
Flynn
Bret J
BJ
Rudy
James
J
Bethel
Sushma
S
Ahmad
Diane
D
Tucker
Sue Ellen
SE
Abdalian
Dannie
D
Hoffman
Craig M
CM
Wilson
Coleen K
CK
Cunningham
D016915:AIDS Vaccines / Q000008:administration & dosage; D000293:Adolescent; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D032882:Comprehension; D032962:Consent Forms; D005260:Female; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D057828:Informed Consent By Minors / Q000941:ethics / Q000592:standards*; D008297:Male; D018579:Patient Selection / Q000941:ethics*; D012107:Research Design; D011795:Surveys and Questionnaires; D014481:United States; D014611:Vaccination / Q000009:adverse effects / Q000941:ethics; D055815:Young Adult
D016915:AIDS Vaccines; D017325:Hepatitis B Vaccines
Clinical trials; HIV Infection and AIDS; Informed Consent; Minors/Parental Consent