Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study.
Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study.
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DOI：
10.1080/09540121.2015.1039958
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发表时间：
2015
期刊：
影响因子：
1.7
通讯作者：
Grant RM
中科院分区：
文献类型：
--
作者：
Koester KA;Liu A;Eden C;Amico KR;McMahan V;Goicochea P;Hosek S;Mayer KH;Grant RM
在艾滋病毒暴露前预防（PrEP）研究领域，为研究参与者提供药物水平测试的药代动力学结果以指导依从性咨询的兴趣正在兴起。iPrEx随机对照试验是首个在人体中产生有意义的PrEP结果的研究。在iPrEx开放标签扩展（OLE）研究中，在参与研究的前12周收集的血浆样本进行了替诺福韦/恩曲他滨的检测，这些药物会损害PrEP。研究临床医生在24周的访问中与参与者分享了结果（可检测/不可检测）。我们评估了一部分iPrEx OLE参与者接受这些结果的可接受性。我们对在波士顿、芝加哥和旧金山注册的参与者（有和没有检测到毒品的）进行了深度访谈（n=59），以评估他们接受毒品检测反馈的经历。将药物检测结果纳入临床研究访视的效果良好，无不良反应。对于大约一半的参与者来说，收到他们的药物检测实验室结果是有用的，而对其他人来说，这并不重要。在少数情况下，没有检测到药物的结果导致加大了持续服用PrEP的努力，在大多数情况下，加强了对遗漏剂量的公开讨论。参与者报告说，希望有更大的特异性，特别是保护所需的定量药物水平。我们建议探索提高药物水平结果的显着性的策略，包括使用反馈来进行针对性的依从性咨询，并缩短标本采集，测试和收到结果之间的时间。未来的研究应评估使用长期暴露于PrEP的生物标志物（如头发/干血斑）提供更具体的定量药物水平的可行性和影响。
In the world of HIV pre-exposure prophylaxis (PrEP) research, there is emerging interest in providing study participants with pharmacokinetic results from drug-level testing to guide adherence counseling. The iPrEx randomized control trial was the first study to produce meaningful results of PrEP in humans. In the iPrEx open-label extension (OLE) study, blood plasma samples collected in the first 12 weeks of study participation were tested for the presence of tenofovir/emtricitabine – the drugs which compromise PrEP. Study clinicians shared results (detectable/undetectable) with participants at their 24-week visit. We evaluated the acceptability of receiving these results among a subset of iPrEx OLE participants. We conducted in-depth interviews (n=59) with participants (those with and those without drug detected) enrolled in Boston, Chicago and San Francisco to assess their experiences with receiving drug detection feedback. Incorporating drug-detection results into the clinical study visit was well received and no negative reactions were expressed. For about half of participants, receiving their drug detection lab result was useful while for others it was not important. In a few cases, no drug detected results led to increased efforts to take PrEP consistently and in most cases enhanced open discussion of missed doses. Participants reported a desire for greater specificity, particularly quantitative drug levels needed for protection. We recommend exploring strategies to increase the salience of drug-level results, including using feedback to target adherence counseling, and reducing the time between specimen collection, testing and receipt of results. Future studies should evaluate the feasibility and impact of providing more specific quantitative drug-levels using biomarkers of longer-term PrEP exposure ie, hair/dried blood spots.
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影响因子：
3.2
作者：
Hsieh, HF;Shannon, SE
通讯作者：
Shannon, SE
影响因子：
4.6
作者：
Stirratt, Michael J;Gordon, Christopher M
通讯作者：
Gordon, Christopher M
影响因子：
1.7
作者：
Guest, Greg;Bunce, Arwen;Johnson, Laura
通讯作者：
Johnson, Laura
影响因子：
3.7
作者：
Liu AY;Yang Q;Huang Y;Bacchetti P;Anderson PL;Jin C;Goggin K;Stojanovski K;Grant R;Buchbinder SP;Greenblatt RM;Gandhi M
通讯作者：
Gandhi M
影响因子：
17.1
作者：
Anderson PL;Glidden DV;Liu A;Buchbinder S;Lama JR;Guanira JV;McMahan V;Bushman LR;Casapía M;Montoya-Herrera O;Veloso VG;Mayer KH;Chariyalertsak S;Schechter M;Bekker LG;Kallás EG;Grant RM;iPrEx Study Team
通讯作者：
iPrEx Study Team