Comprehension of a simplified assent form in a vaccine trial for adolescents
- Sonia Lee1,
- Bill G Kapogiannis1,
- Patricia M Flynn2,
- Bret J Rudy3,
- James Bethel4,
- Sushma Ahmad4,
- Diane Tucker5,
- Sue Ellen Abdalian6,
- Dannie Hoffman7,
- Craig M Wilson8,
- Coleen K Cunningham9,
- Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
- 1Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal Pediatric Infectious Disease Branch, Bethesda, Maryland, USA
- 2St. Jude Children's Research Hospital, Memphis, Tennessee, USA
- 3New York University School of Medicine, New York, New York, USA
- 4Westat, Rockville, Maryland, USA
- 5Children's Hospital of Los Angeles, Los Angeles, California, USA
- 6Tulane University, New Orleans, Louisiana, USA
- 7University of California, Los Angeles, California, USA
- 8University of Alabama at Birmingham, Birmingham, Alabama, USA
- 9Duke University Medical Center, Durham, North Carolina, USA
- Correspondence to Dr Sonia Lee, NICHD, Maternal Pediatric Infectious Disease Branch, 6100 Executive Blvd, Room 4B11K, Bethesda, MD 20892, USA;
- Received 12 December 2012
- Revised 17 December 2012
- Accepted 18 December 2012
- Published Online First 24 January 2013
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.