Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials
Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials
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DOI：
10.1097/00126334-200302010-00008
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发表时间：
2003-02-01
影响因子：
3.6
通讯作者：
Seage, GR
中科院分区：
文献类型：
--
作者：
Coletti, AS;Heagerty, P;Seage, GR
必须制定程序，以确保获得艾滋病毒疫苗效力试验参与者的有效知情同意。在HIV预防试验疫苗准备研究（VPS）中，对4，892名HIV感染高危人群进行了原型知情同意过程评估，这是一项在美国8个大都市地区进行的HIV血清发病率前瞻性队列研究。随机选择20%的VPS参与者在VPS第3个月进行原型知情同意过程。在基线和此后18个月每半年评估和比较参与者对10个关键HIV疫苗试验概念的了解和参与HIV疫苗有效性试验的意愿。基线时对艾滋病毒疫苗试验概念的了解较低。参与原型过程与知识的实质性和持续性增加有关（10个项目的相对风险，1.04-2.26），这些知识在艾滋病毒风险群体、种族/民族和教育水平之间具有相似的程度。建议在今后的艾滋病毒疫苗效力试验以及其他研究领域的临床试验中采用原型知情同意程序。
Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials. A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), a prospective cohort study of HIV seroincidence in eight U.S. metropolitan areas. Twenty percent of VPS participants were selected at random to undergo the prototype informed consent process at VPS month 3. Participants' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months. Knowledge of HIV vaccine trial concepts was low at baseline. Participation in the prototype process was associated with substantial and sustained increases in knowledge (relative risks for the 10 items, 1.04-2.26), which were of similar magnitude across HIV risk groups, race/ethnicity, and educational levels. It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas.