Supporting Study Product Use and Accuracy in Self-Report in the iPrEx Study: Next Step Counseling and Neutral Assessment
Supporting Study Product Use and Accuracy in Self-Report in the iPrEx Study: Next Step Counseling and Neutral Assessment
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DOI：
10.1007/s10461-012-0182-5
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发表时间：
2012-07-01
影响因子：
4.4
通讯作者：
Liu, Albert
中科院分区：
文献类型：
--
作者：
Amico, K. R.;McMahan, Vanessa;Liu, Albert
最近成功的生物医学艾滋病毒预防方法引发了相当大的辩论的可扩展性，可行性和可接受性的暴露前预防（PrEP）作为一种广泛的预防策略，男性与男性发生性关系和变性。PrEP坚持的预期困难和对最佳支持所需资源的担忧削弱了PrEP示范项目和推广的热情。虽然目前还没有支持PrEP使用的循证方法，但在PrEP的双盲、随机、安慰剂对照试验的背景下，已经开发了许多方法，这些方法可以为推动开放标签PrEP使用的真实的世界支持提供指导。我们提出了下一步咨询（NSC）和中立评估（NA）的可行性和可接受性的开发，实施和评估，在iPrEx研究的后期阶段使用的准确报告方法的依从性支持和推广。从七个不同国家15，000多场国家指导委员会会议的实施者的角度对该方法进行了评价，有近2，000名iPrEx参与者，为国家指导委员会提供了支持，其简短性（平均每次后续会议约14分钟）以及总体可接受性和可行性。NA也得到了普遍良好的支持，大多数研究工作人员认为这种方法是可行的和可接受的;然而，在报告NA的工作人员中注意到NA某些方面的可接受性较低，这与他们之前的访谈方法不同。从实施者收集的定量和定性数据用于进行修改，以支持在iPrEx的开放标签扩展中使用PrEP。
The recent successes of biomedical HIV prevention approaches have sparked considerable debate over the scalability, feasibility, and acceptability of pre-exposure prophylaxis (PrEP) as a widespread prevention strategy for men who have sex with men and trans-gender. Anticipated difficulties with PrEP adherence and concerns about resources required to best support it have tempered enthusiasm of PrEP demonstration projects and roll-out. While no evidence-based approach for supporting PrEP use is presently available, a number of approaches have been developed in the context of double-blind, randomized, placebo-controlled trials of PrEP that can provide guidance in moving forward with real world support of open label PrEP use. We present the development, implementation and evaluation of feasibility and acceptability of next-step counseling (NSC) and neutral assessment (NA), the adherence support and promotion of accurate reporting approaches used in the late phases of the iPrEx study. Evaluation of the approach from the perspective of implementers of over 15,000 NSC sessions in seven different countries with almost 2,000 iPrEx participants provided support for NSC, its brevity (averaging similar to 14 min per follow-up session) and overall acceptability and feasibility. NA also was generally well supported, with a majority of study staff believing this approach was feasible and acceptable; however, lower acceptability for certain aspects of NA was noted amongst staff reporting NA was different from their previous interview approach. Quantitative and qualitative data gathered from implementers were used to make modifications for supporting PrEP use in the open-label extension of iPrEx.