title: Adolescent decision making about participation in a hypothetical HIV vaccine trial.
abstract: OBJECTIVE
  The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences.
  
  
  METHODS
  As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized.
  
  
  RESULTS
  Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate.
  
  
  CONCLUSIONS
  The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.
authors: Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, 410 West 10th Street, HS 1001, Indianapolis, IN 46202, United States. Electronic address: andreia.alexander@gmail.com.
authors: Andreia B
authors: AB
authors: Alexander
authors: Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, 410 West 10th Street, HS 1001, Indianapolis, IN 46202, United States. Electronic address: maott@iu.edu.
authors: Mary A
authors: MA
authors: Ott
authors: Department of Medicine, Alpert Medical School of Brown University, Box G-A1, Providence, RI 02912, United States. Electronic address: Michelle_Lally_MD@brown.edu.
authors: Michelle A
authors: MA
authors: Lally
authors: Department of Pediatrics, University of California, 505 Parnassus Avenue M696, Box 0110, San Francisco, CA 94143, United States. Electronic address: sniecinskisf@aol.com.
authors: Kevin
authors: K
authors: Sniecinski
authors: Section of Adolescent Medicine, Department of Pediatrics, Tulane University School of Medicine, 1440 Canal Street, TW-42, New Orleans, LA 70112, United States. Electronic address: abaker4@tulane.edu.
authors: Alyne
authors: A
authors: Baker
authors: Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, 410 West 10th Street, HS 1001, Indianapolis, IN 46202, United States. Electronic address: gzimet@iu.edu.
authors: Gregory D
authors: GD
authors: Zimet
mesh_terms: D016915:AIDS Vaccines; D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D003657:Decision Making; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D008297:Male; D009042:Motivation; D010358:Patient Participation; D035842:Research Subjects; D012725:Sexual Behavior / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines
keywords: Adolescent; Decision making; HIV vaccine trial; Qualitative research
references: J Med Ethics. 2013 Dec;39(12):765-71
references: 23355050
references: Am J Psychiatry. 1995 Jul;152(7):1033-7
references: 7793439
references: Arch Pediatr Adolesc Med. 2011 Jun;165(6):533-9
references: 21646586
references: J Allergy Clin Immunol. 2004 Nov;114(5):1138-45
references: 15536422
references: Pediatrics. 2006 Oct;118(4):1800-1; author reply 1801
references: 17015581
references: Am Psychol. 1988 Jan;43(1):49-55
references: 3348539
references: J Adolesc Health. 2014 Aug;55(2):254-9
references: 24613097
references: N Engl J Med. 1988 Dec 22;319(25):1635-8
references: 3200278
references: Pediatrics. 1995 Nov;96(5 Pt 1):981-2
references: 7478854
references: BMC Med Ethics. 2007;8:5
references: 17498316
references: Vital Health Stat 23. 2010 Jun;(30):1-47
references: 21548441
references: N Engl J Med. 1982 May 27;306(21):1259-62
references: 7070445
references: Am J Psychiatry. 2002 Jul;159(7):1201-7
references: 12091200
references: J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2:S155-60
references: 23764629
references: Child Dev. 1990 Feb;61(1):1-16
references: 2307031
references: J Adolesc Health. 2003 Nov;33(5):396-409
references: 14596961
references: Lancet Infect Dis. 2011 Jul;11(7):507-15
references: 21570355
references: Dev Rev. 2008 Mar;28(1):78-106
references: 18509515
references: N Engl J Med. 2007 Nov 1;357(18):1834-40
references: 17978292
references: Health Psychol. 1996 Sep;15(5):344-54
references: 8891713
references: Am J Psychiatry. 2006 Aug;163(8):1323-34
references: 16877642
references: J Int Assoc Physicians AIDS Care (Chic). 2005 Dec;4(4):89-92
references: 16533797
references: Adv Psychol Res. 2004;32:163-73
references: 16986221
references: J Adolesc Health. 2001 Jan;28(1):30-5
references: 11137903
references: N Engl J Med. 2009 Dec 3;361(23):2209-20
references: 19843557
references: J Adolesc Health. 2008 Aug;43(2):201-4
references: 18639797
references: AIDS Educ Prev. 2003 Apr;15(2):159-71
references: 12739792
references: Theor Med Bioeth. 2003;24(2):107-20
references: 12943266
references: J Am Coll Dent. 2014 Summer;81(3):4-13
references: 25951677