Purpose The purpose of this study was to examine the process

Purpose 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. 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 SAR156497 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. Conclusion 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. of adolescent decision-making about PTGFRN participation in an HIV vaccine clinical trial. 2 Methods 2.1 Participants and procedures As part of a larger IRB approved study we conducted qualitative interviews to elicit adolescents’ understanding of an HIV vaccine clinical trial. Adolescents were recruited from four urban U.S. sites that were part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Recruitment venues included youth groups health clinics and community events. Participants were sexually active 16-19 year old males (MSM) SAR156497 or females who had sex with males were HIV-negative and indicated a possible willingness to participate in an HIV vaccine trial. SAR156497 For the qualitative interviews each site recruited 6-9 participants from the larger quantitative study [26]. Informed consent was obtained from each participant and parental consent was waived. Participants underwent a simulated adolescent HIV vaccine trial consent process adapted from adult HIV vaccine trials. Adolescent participants were asked to read through the simulated HIV vaccine trial consent form and then research staff walked participants through the information on purpose procedures risks benefits and compensation as if the participants were going to participate in an actual HIV vaccine trial. As part of the standard consent process participants were given the opportunity to ask questions about the trial. Methods were carried out by experienced ATN study staff – the very individuals who obtain consent for actual adolescent biomedical prevention tests. Following a consent process all participants completed studies and a subset participated in qualitative interviews. This analysis focuses on the qualitative interviews. 2.2 Interviews Semi-structured one-on-one interviews enduring 30-60 min were conducted by trained staff. Questions addressed the decision to participate in HIV vaccine tests such as “If an HIV vaccine medical trial were available could you participate? Why or why not?” Additional questions assessed the involvement of others in the decision-making process risks and benefits of participation and how risks and benefits played a SAR156497 role in the decision to participate (Fig. 1). Fig. 1 Main questions from interview guidebook utilized for analysis of decision making among adolescents regarding participation inside a hypothetical HIV vaccine trial. 2.3 Analysis Interviews were audio-recorded and transcribed. Data were analyzed using ethnographic content material analysis [27] informed by a model of study decision-making from Applebaum and Grisso that identifies four key jobs: (1) understanding relevant information about procedures SAR156497 risks and benefits; (2) appreciating one’s personal scenario and potential effects of participation; (3) reasoning about options; and (4) communicating a choice [28-30]. This model has been used to inform assessments of capacity to consent among adults with psychiatric ailments [31] and adults participating in HIV study [32]. Two experts read transcripts identifying codes surrounding the decision-making process used by adolescents. Data were analyzed using ethnographic content material analysis in which fresh codes were allowed to emerge from data during analysis coding was iterative and a consensus-based processes was used to resolve variations between coders. A preliminary model was created and then tested and modified as subsequent transcripts were go through in an.