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Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial

机译：考虑艾滋病毒疫苗试验的青少年基于网络的同意的开发和评估

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HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n = 60) or investigator-administered paper assent with (n = 29) or without (n = 31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t(118) = -0.08, p = 0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t(58) = 1.96, p = 0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.
机译：针对未成年人的艾滋病毒疫苗试验可能需要获得父母的许可并得到青少年的知情同意。为了使这一过程有效，需要以促进青少年理解的方式提供信息。先前的研究表明，青少年对同意的理解往往不足。我们开发了一个基于网络的交互式同意，其中包括一个假设的HIV疫苗试验的穿插测验问题。将基于网络的同意的有效性与有或没有穿插式问题的标准论文进行了比较。来自五个社区组织的一百二十名年龄在15-17岁之间的青少年参与者被随机分配到自我管理的基于网络的同意（n = 60）或由研究者管理的论文同意（n = 29）或不具有（n = 31）穿插测验问题。复习同意书后，参与者完成了27个项目的理解测试。比较各组的理解分数。完整论文组的正确回答问题的平均数量为21.2，基于网络的组为21.1（t（118）= -0.08，p = 0.94）。没有散​​布问题子组的论文得分为20.2，有散布问题子组的论文得分为22.1（t（58）= 1.96，p = 0.055）。基于网络的小组的参与者在理解测试上的表现与论文小组中的表现一样好，有问题小组的论文中的参与者比无问题小组的论文中的参与者表现更好，这表明散布的测验问题可能增进对传统论文的理解。最少的调查时间和基于Web的同意的标准化管理以及针对不正确的理解测试响应所标识的主题定制同意讨论的能力，值得进一步研究。

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