Harrison K, Vlahov D, Jones K, Charron K, Clements M L
Department of International Health, Johns Hopkins School of Hygiene and Public Health, Baltimore, MD, USA.
J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Nov 1;10(3):386-90.
Injection drug users (IDUs) at high risk for human immunodeficiency virus (HIV) infection are being identified as a population for HIV vaccine trials. We studied willingness of drug users to enroll and their comprehension of consent procedures in the context of a Phase II trial at one site. Of 175 people screened for enrollment and whose data sets were complete, 119 (68%) were IDUs. Of the 71 who were eligible, 39 (55%) were IDUs. Exclusion of IDUs was usually for medical reasons. Using a 17-item true/false test, comprehension of the informed consent procedure was high (median score, 16 of 17 for IDUs and non-IDUs); only three subjects (all of whom were IDUs) were excluded from enrollment due to lack of comprehension. Follow-up rates were similar for IDUs and non-IDUs. These data suggest that recruitment of IDUs into HIV vaccine trials is feasible, that IDUs can comprehend and complete the informed consent procedures, and that they return for follow-up visits.
注射吸毒者（IDU）被视为感染人类免疫缺陷病毒（HIV）的高危人群，正被确定为HIV疫苗试验的对象群体。我们在一个试验点进行的II期试验背景下，研究了吸毒者参与试验的意愿以及他们对同意程序的理解。在175名接受入组筛查且数据集完整的人中，119人（68%）为注射吸毒者。在71名符合条件的人中，39人（55%）为注射吸毒者。排除注射吸毒者通常是出于医学原因。通过一项包含17道对错题的测试，对知情同意程序的理解程度较高（注射吸毒者和非注射吸毒者的中位数得分均为17分中的16分）；只有三名受试者（均为注射吸毒者）因理解不足而被排除在入组之外。注射吸毒者和非注射吸毒者的随访率相似。这些数据表明，招募注射吸毒者参与HIV疫苗试验是可行的，注射吸毒者能够理解并完成知情同意程序，而且他们会返回接受随访。
