Ott Mary A, Alexander Andreia B, Lally Michelle, Steever John B, Zimet Gregory D
Section of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, , Indianapolis, Indiana, USA.
J Med Ethics. 2013 Dec;39(12):765-71. doi: 10.1136/medethics-2012-100821. Epub 2013 Jan 25.
Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrolment in a prevention intervention trial.
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 understanding and opinions related to enrolment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants' understanding of HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation.
Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts.
Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials.
尽管青少年感染艾滋病毒的比例很高，但他们获得生物医学预防干预研究的机会非常有限。一个担忧是青少年是弱势群体，试验有可能造成伤害，这就要求研究人员采取额外的预防措施。特别令人担忧的是预防性误解，即高估参与预防干预试验所提供的个人保护作用。
作为青少年艾滋病毒疫苗试验中预防性误解的一项更大规模研究的一部分，我们采访了33名16至19岁与男性发生性行为的男性和女性。参与者经历了模拟的艾滋病毒疫苗试验同意过程，然后完成了一次关于他们对参与艾滋病毒疫苗试验的理解和看法的半结构化访谈。扎根理论分析寻找共同概念，并关注青少年参与者对艾滋病毒疫苗接种的理解内容和过程以及预防性误解的组成部分，包括试验、安慰剂和随机分组。
在所有访谈中，青少年都积极处理信息，他们向采访者提问，根据所提供的信息口头得出答案，并自我纠正。我们观察到对研究概念有各种各样的理解。虽然大多数人理解试验和安慰剂，但理解随机分组的人较少。即使他们不理解更基本的概念，所有人都明白需要采取更安全的性行为。
在未来的生物医学预防试验中，可能有必要开展与临床试验相关的基本概念教育、留出时间让人们吸收材料并评估理解情况。
