HIV sexual risk behavior over 36 months of follow-up in the world's first HIV vaccine efficacy trial
HIV sexual risk behavior over 36 months of follow-up in the world's first HIV vaccine efficacy trial
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DOI：
10.1097/01.qai.0000143600.41363.78
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发表时间：
2005-05-01
影响因子：
3.6
通讯作者：
Mastro, TD
中科院分区：
文献类型：
--
作者：
Bartholow, BN;Buchbinder, S;Mastro, TD
艾滋病毒疫苗有效性试验参与者的风险行为增加一直是一个令人担忧的问题。这项研究评估了5095名HIV阴性男男性接触者（MSM）和308名女性的HIV性风险行为，这些男性和女性参加了一项随机、双盲、安慰剂对照的二价rgp 120疫苗有效性试验，试验在61个地点进行，主要在北美。在基线和每半年收集一次性风险行为数据，持续36个月。总体而言，在试验期间，性风险行为没有超过基线水平。在男男性接触者中，年龄较轻（± 30岁）、自觉接种疫苗和非黑人种族与无保护肛交的可能性增加相关。在女性中，无保护的阴道性行为最初减少，但在24个月时与基线统计学相当，而与HIV感染伴侣的无保护阴道性行为从基线减少，并在整个试验期间保持不变。HIV性风险行为在试验参与者中没有增加;然而，在整个试验期间都很明显。一致的高风险行为水平和这些行为的相关性，以感知分配和人口统计学变量强调需要警惕艾滋病毒风险降低咨询，知情同意，并在艾滋病毒疫苗疗效试验的背景下教育过程。
Increased risk behavior among participants in HIV vaccine efficacy trials has been a concern. This study evaluated HIV sexual risk behavior among 5095 HIV-negative men who have sex with men (MSM) and 308 women enrolled in a randomized, double-blind, placebo-controlled efficacy trial of a bivalent rgp120 vaccine at 61 sites, primarily in North America. Sexual risk behavior data were collected at baseline and semiannually for 36 months. Overall, sexual risk behavior did not exceed baseline levels during the trial. Among MSM, younger age (+/- 30 years), perceived assignment to vaccine, and nonblack race were associated with an increased probability of unprotected anal sex. Among women, unprotected vaginal sex initially decreased but was statistically equivalent to baseline by 24 months, whereas unprotected vaginal sex with HIV-infected partners decreased from baseline, where it remained throughout the trial. HIV sexual risk behavior did not increase among trial participants; however, it was substantial throughout the trial. Consistently high levels of risk behavior and the association of these behaviors to perceived assignment and demographic variables underscore the need for vigilant HIV risk reduction counseling, informed consent, and educational processes in the context of HIV vaccine efficacy trials.