Weighing the gold in the gold standard: challenges in HIV prevention research.
Weighing the gold in the gold standard: challenges in HIV prevention research.
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DOI：
10.1097/qad.0b013e328337798a
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发表时间：
2010-03-13
期刊：
影响因子：
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通讯作者：
Wasserheit JN
中科院分区：
文献类型：
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作者：
Padian NS;McCoy SI;Balkus JE;Wasserheit JN
很少有艾滋病毒预防干预措施在随机对照试验（RCTs）中得到评估。我们检查了在HIV预防试验中可能限制检测阳性或不良影响的设计、实施和背景因素。预防HIV性传播的后期随机对照试验的系统综述1)随机分配干预组和对照组；2)评估预防非怀孕人群性传播的干预措施；3)报告艾滋病毒发病率作为主要或次要结局。检索PubMed/MEDLINE、其他电子数据库和近期HIV/ aids相关会议的电子会议记录，以确定符合纳入标准的已发表或未发表的试验。从每个试验中提取描述性、方法学和背景因素。该综述包括36项艾滋病毒预防随机对照试验，报告了38种独特的干预措施。只有6项随机对照试验（全部评估生物医学干预措施）证明了对艾滋病毒发病率的明确影响。6项随机对照试验中有5项显著降低了艾滋病毒感染：所有3项男性包皮环切试验、1项性传播感染治疗和护理试验以及1项疫苗试验。壬氧醇-9凝胶的一项杀菌剂试验产生了不良结果。缺乏统计效力，依从性差，以及对照组干预的稀释版本可能是其他显示“平淡”结果的试验的重要问题。几乎90%的艾滋病毒预防试验结果“平淡”，这可能归因于试验的设计和/或实施。艾滋病毒预防界不仅必须检查重要的随机对照试验的证据，还必须检查扁平试验，并解决限制检测效果的设计和实施问题。
Few HIV prevention interventions have been evaluated in randomized controlled trials (RCTs). We examined design, implementation, and contextual considerations that may limit detection of a positive or adverse effect in HIV prevention trials. A systematic review of late phase RCTs for prevention of sexual transmission of HIV that 1) randomly allocated intervention and comparison groups; 2) evaluated interventions to prevent sexual transmission in non-pregnant populations; and 3) reported HIV incidence as the primary or secondary outcome. PubMed/MEDLINE, other electronic databases, and electronic conference proceedings of recent HIV/AIDS-related conferences were searched to identify published or unpublished trials meeting the inclusion criteria. Descriptive, methodological, and contextual factors were abstracted from each trial. The review included 36 HIV prevention RCTs reporting on 38 unique interventions. Only six RCTs, all evaluating biomedical interventions, demonstrated definitive effects on HIV incidence. Five of the six RCTs significantly reduced HIV infection: all three male circumcision trials, one trial of STI treatment and care, and one vaccine trial. One microbicide trial of nonoxynol-9 gel produced adverse results. Lack of statistical power, poor adherence, and diluted versions of the intervention in comparison groups may have been important issues for the other trials that demonstrated “flat” results. Almost 90% of HIV prevention trials had “flat” results, which may be attributable to trial design and/or implementation. The HIV prevention community must not only examine evidence from significant RCTs, but must also examine flat trials, and address design and implementation issues that limit detection of an effect.