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

Abstract

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.

  • Informed Consent
  • HIV Infection and AIDS
  • Minors/Parental Consent
  • Clinical trials

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