Graham Susan M, Shah Prakesh S, Aesch Zoë Costa-von, Beyene Joseph, Bayoumi Ahmed M
Department of Medicine, University of Washington, Seattle, Washington, USA.
HIV Clin Trials. 2009 Nov-Dec;10(6):413-31. doi: 10.1310/hct1006-413.
Several randomized, controlled trials (RCTs) have tested strategies to prevent sexual acquisition of HIV infection, but their quality has been variable. We aimed to identify, describe, and evaluate the quality of RCTs studying biomedical interventions to prevent HIV acquisition by sexual transmission.
We conducted a systematic review to identify all RCTs evaluating the efficacy of biomedical HIV prevention interventions. We assessed seven generic and content-specific quality components important in HIV prevention trials, factors influencing study power, co-interventions provided, and trial ethics.
We identified 26 eligible RCTs. The median number of quality components judged to be in adequate or unclear was 3 (range 1-4) in 1992-1998, 3 (range 1-4) in 1999-2003, and 0 (range0-2) in 2004-2008 (p < .001). Common problems that may have biased results included low retention (median 84%), poor adherence to interventions requiring on going use (median < or =78%), and lower HIV incidence than expected a priori (in 8 of 11 trials where evaluable).
Reporting of trials of biomedical HIV prevention interventions has improved over time. However, quality improvement is needed in several key areas that influence study power, including participant retention, adherence to interventions, and estimation of expected HIV incidence.
多项随机对照试验（RCT）已对预防通过性行为感染艾滋病毒的策略进行了测试，但其质量参差不齐。我们旨在识别、描述并评估研究生物医学干预措施以预防性传播艾滋病毒感染的随机对照试验的质量。
我们进行了一项系统评价，以识别所有评估生物医学艾滋病毒预防干预措施疗效的随机对照试验。我们评估了艾滋病毒预防试验中重要的七个通用和特定内容的质量组成部分、影响研究效能的因素、提供的联合干预措施以及试验伦理。
我们识别出26项符合条件的随机对照试验。在1992 - 1998年，被判定为质量组成部分充足或不明确的中位数为3（范围1 - 4）；在1999 - 2003年，为3（范围1 - 4）；在2004 - 2008年，为0（范围0 - 2）（p <.001）。可能导致结果有偏差的常见问题包括保留率低（中位数84%）、对需要持续使用的干预措施依从性差（中位数≤78%）以及艾滋病毒发病率低于先验预期（在11项可评估的试验中有8项）。
随着时间推移，生物医学艾滋病毒预防干预试验的报告情况有所改善。然而，在影响研究效能的几个关键领域仍需提高质量，包括参与者保留率、对干预措施的依从性以及预期艾滋病毒发病率的估计。
