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Setting the bar high or setting up to fail? Interpretations and implications of the explore study (HPTN 015)

机译：将标高设置为高还是设置失败？探索性研究的解释和启示（HPTN 015）

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Controlled studies show that HIV risk reduction counseling significantly increases condom use, reduces unprotected sex and prevents sexually transmitted infections. Nevertheless, without evidence of reducing HIV incidence, these interventions are generally discarded. One trial, the EXPLORE study, was designed to test whether ten sessions of risk reduction counseling could impact HIV incidence among men who have sex with men in six US cities. Based on epidemiologic models to define effective HIV vaccines, a 35 % reduction in HIV incidence was set a priori as the benchmark of success in this behavioral intervention trial. Results demonstrated a significant effect of the intervention, with more than a 35 % reduction in HIV incidence observed during the initial 12-18 months following counseling. Over an unprecedented 48-month follow-up, however, the effect of counseling on HIV incidence declined to 18 %. The current review examined how the scientific literature has thus far judged the outcomes of the EXPLORE study as well as the policy implications of these judgments. We identified 127 articles that cited the EXPLORE study since its publication. Among articles that discuss the HIV incidence outcomes, 20 % judged the intervention effective and 80 % judged the intervention ineffective. The overwhelmingly negative interpretation of the EXPLORE study outcomes is reflected in public policies and prevention planning. We conclude that using a vaccine standard to define success led to a broad discrediting of the benefits of behavioral counseling and, ultimately, adversely impacted policies critical to the field of HIV prevention.
机译：对照研究表明，减少艾滋病毒的风险咨询可大大增加使用安全套，减少无保护的性行为并防止性传播感染。然而，在没有减少艾滋病毒发生率的证据的情况下，这些干预措施通常被丢弃。 EXPLORE研究是一项试验，旨在测试在美国6个城市与男性发生性关系的男性进行10次降低风险咨询是否会影响艾滋病毒的发病率。根据定义有效HIV疫苗的流行病学模型，将艾滋病毒发病率降低35％的事例确定为该行为干预试验成功的基准。结果证明了干预措施的显着效果，在咨询后的最初12-18个月内观察到的HIV感染率降低了35％以上。然而，在前所未有的48个月的随访中，咨询对HIV发病率的影响降至18％。本篇综述探讨了迄今为止科学文献如何判断EXPLORE研究的结果以及这些判断的政策含义。自发布以来，我们确定了127条引用EXPLORE研究的文章。在讨论艾滋病毒感染结果的文章中，有20％的人认为干预有效，而80％的人认为干预无效。公共政策和预防计划反映了对EXPLORE研究结果的绝大多数负面解释。我们得出的结论是，使用疫苗标准来定义成功会导致人们对行为咨询的益处大打折扣，并最终对艾滋病毒预防领域至关重要的政策产生不利影响。

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