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首页> 外文期刊>JAIDS: Journal of acquired immune deficiency syndromes >HIV testing outside of the study among men who have sex with men participating in an HIV vaccine efficacy trial.
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HIV testing outside of the study among men who have sex with men participating in an HIV vaccine efficacy trial.

机译：与参加HIV疫苗功效试验的男性发生性关系的男性中，在研究之外进行HIV测试。

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OBJECTIVES: Participants who obtain an HIV test outside of an HIV vaccine efficacy trial could potentially unblind themselves which could result in differential behavior change and loss to follow-up based on assignment status. In a reanalysis of the VaxGen VAX004 data, the objectives were to determine: 1) the proportion of participants who were tested for HIV outside of the study (despite instructions not to do this) and reasons why; 2) demographic and risk factors associated with reported testing outside of the study; and 3) if outside testing was related to participant loss to follow-up. METHODS: Analyses were restricted to men who have sex with men (MSM) who completed a survey at one or more annual visits in a randomized, double-blind, placebo-controlled efficacy trial of a bivalent rgp 120 vaccine conducted from 1998-2002. A generalized linear mixture model assessed associations with outside testing. RESULTS: Despite instructions to the contrary, 16.9% (791/4670) of MSM reported being tested for HIV outside of the study, with the top two reasons being a) medical provider request (28.1%) and b) insurance requirement (17.1%). Increased odds of self-reported outside testing was associated with site location, reporting one or more sexually transmitted infections (STIs), joining the trial because of the belief that participation might confer some protection against HIV infection, engaging in unprotected anal sex, and being lost to follow-up. Decreased odds of self-reported outside testing was associated with perceived study arm assignment to vaccine or uncertainty about study arm assignment compared to placebo. CONCLUSIONS: To avoid biases such as differential risk behavior and loss to follow-up based on perceived assignment status, initiating additional procedures to reduce the likelihood of outside testing will be important to assure the validity of future study results.
机译：目的：在HIV疫苗功效试验之外获得HIV检测的参与者可能会使其自己失去视力，这可能会导致行为差异变化以及根据任务状态而导致的随访失败。在对VaxGen VAX004数据的重新分析中，目标是确定：1​​）在研究之外接受过HIV检验的参与者的比例（尽管指示不这样做）和原因; 2）与研究之外报告的测试相关的人口统计学和风险因素; 3）外部测试是否与参与者失去随访有关。方法：分析仅限于在1998年至2002年进行的一项随机，双盲，安慰剂对照的双价rgp 120疫苗随机对照试验中，在一次或多次年度访问中完成一项调查的男男性接触者（MSM）。广义线性混合模型评估了与外部测试的关联。结果：尽管有相反的指示，但仍有16.9％（791/4670）的MSM报告在研究之外接受了HIV检测，其中最主要的两个原因是a）医疗提供者要求（28.1％）和b）保险要求（17.1％） ）。自我报告外部测试的几率增加与现场位置，报告一种或多种性传播感染（STIs）相关，加入该试验的原因是，他们认为参与试验可能会提供一定的保护措施，以防止HIV感染，进行未保护的肛交以及失去后续行动。与安慰剂相比，自我报告的外部测试可能性降低与疫苗的研究组分配或研究组分配的不确定性有关。结论：为避免偏差，例如差异性的风险行为和基于感知到的任务状态而导致的后续损失，启动额外的程序以减少外部测试的可能性对于确保未来研究结果的有效性至关重要。

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