Adolescent decision making about participation in a hypothetical HIV vaccine trial |
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| Affiliation: | 1. Massachusetts General Hospital for the Dana-Farber/Harvard Cancer Center, Boston, MA, USA;2. University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA;3. University of Chicago Medical Center, Chicago, IL, USA;4. Hematology and Oncology Specialists, LLC, Marrero, LA, USA;5. MD Anderson Cancer Center, Orlando, FL, USA;6. Gynecologic Oncology Associates, Inc., Hollywood, USA;7. Dana-Farber Cancer Institute, Boston, MA, USA;8. Royal Marsden Hospital, Surrey, England, UK;9. Mayo Clinic, Rochester, MN, USA;10. Royal Marsden Hospital, London, England, UK;11. University of Texas MD Anderson Cancer Center, Houston, TX, USA;12. Eli Lilly and Company, Indianapolis, IN, USA;13. ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA;14. Inova Fairfax Hospital, Falls Church, VA, USA |
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| Abstract: | PurposeThe 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.MethodsAs 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.ResultsTwelve 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.ConclusionThe 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. |
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| Keywords: | HIV vaccine trial Decision making Adolescent Qualitative research |
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