Bekker Linda-Gail, Jaspan Heather, McIntyre James, Wood Robin, Gray Glenda
The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Molecular Medicine, University of Cape Town Faculty of Health Sciences, Cape Town 7925, South Africa.
J Int Assoc Physicians AIDS Care (Chic). 2005 Dec;4(4):93-7. doi: 10.1177/1545109705284836.
Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.
全球青少年面临着感染艾滋病毒的高风险,这使他们成为艾滋病毒疫苗试验的重要候选对象。然而,让青少年参与此类试验会给试验地点带来影响。青少年被视为易受伤害的受试者,除了他们自己的同意之外,还需要代理同意,这就涉及到保密和获取信息的问题。艾滋病毒疫苗试验地点通常没有招募和留住青少年以及营造让监护人感到舒适的适合青少年环境的经验。这包括开发针对青少年及其父母的教育材料。由于这些试验对个人的益处微乎其微,试验地点可能需要以医疗保健和支持性结构的形式为青少年提供服务。最后,存在多种试验设计选项,研究人员需要像对待与青少年参与艾滋病毒疫苗试验相关的所有问题一样,权衡每种选项的风险和益处。