Ehrenkranz Peter D, Pagán José A, Begier Elizabeth M, Linas Benjamin P, Madison Kristin, Armstrong Katrina
Department of General Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Am J Prev Med. 2009 Jul;37(1):57-63. doi: 10.1016/j.amepre.2009.03.011. Epub 2009 May 7.
Almost 1 million Americans are infected with HIV, yet it is estimated that as many as 250,000 of them do not know their serostatus. This study examined whether people residing in states with statutes requiring written informed consent prior to HIV testing were less likely to report a recent HIV test.
The study is based on survey data from the 2004 Behavioral Risk Factor Surveillance System. Logistic regression was used to assess the association between residence in a state with a pre-test written informed-consent requirement and individual self-report of recent HIV testing. The regression analyses controlled for potential state- and individual-level confounders.
Almost 17% of respondents reported that they had been tested for HIV in the prior 12 months. Ten states had statutes requiring written informed consent prior to routine HIV testing; nine of those were analyzed in this study. After adjusting for other state- and individual-level factors, people who resided in these nine states were less likely to report a recent history of HIV testing (OR=0.85; 95% CI=0.80, 0.90). The average marginal effect was -0.02 (p<0.001, 95% CI=-0.03, -0.01); thus, written informed-consent statutes are associated with a 12% reduction in HIV testing from the baseline testing level of 17%. The association between a consent requirement and lack of testing was greatest among respondents who denied HIV risk factors, were non-Hispanic whites, or who had higher levels of education.
This study's findings suggest that the removal of written informed-consent requirements might promote the non-risk-based routine-testing approach that the Centers for Disease Control and Prevention (CDC) advocates in its new testing guidelines.
近100万美国人感染了艾滋病毒，但据估计，其中多达25万人不知道自己的血清学状态。本研究调查了居住在要求在艾滋病毒检测前进行书面知情同意的州的人们报告近期艾滋病毒检测的可能性是否较低。
该研究基于2004年行为危险因素监测系统的调查数据。采用逻辑回归评估居住在有检测前书面知情同意要求的州与个人自我报告近期艾滋病毒检测之间的关联。回归分析控制了潜在的州级和个人层面的混杂因素。
近17%的受访者报告称，他们在过去12个月内接受过艾滋病毒检测。有10个州制定了在常规艾滋病毒检测前要求书面知情同意的法规；本研究分析了其中9个州。在调整了其他州级和个人层面的因素后，居住在这9个州的人报告近期有艾滋病毒检测史的可能性较低（比值比=0.85；95%置信区间=0.80，0.90）。平均边际效应为-0.02（p<0.001，95%置信区间=-0.03，-0.01）；因此，书面知情同意法规与艾滋病毒检测率从基线检测水平的17%下降12%相关。在否认有艾滋病毒危险因素、非西班牙裔白人或教育水平较高的受访者中，同意要求与未检测之间的关联最为明显。
本研究结果表明，取消书面知情同意要求可能会促进疾病控制和预防中心（CDC）在其新检测指南中倡导的非基于风险的常规检测方法。
