Disclosure of pharmacokinetic drug results to understand nonadherence.
Disclosure of pharmacokinetic drug results to understand nonadherence.
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DOI：
10.1097/qad.0000000000000801
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发表时间：
2015-10-23
期刊：
影响因子：
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通讯作者：
Microbicide Trials Network-003D Study Team
中科院分区：
文献类型：
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作者：
van der Straten A;Montgomery ET;Musara P;Etima J;Naidoo S;Laborde N;Hartmann M;Levy L;Bennie T;Cheng H;Piper J;Grossman CI;Marrazzo J;Mensch B;Microbicide Trials Network-003D Study Team
VOICE是一项每日口服和阴道使用替诺福韦预防艾滋病毒的IIB期试验，在所有检测的血浆样本中，接受活性产品的女性中有50%以上检测不到替诺福韦。MTN-003D是一项辅助研究，采用深度访谈（IDIs）和焦点小组讨论（fgd），以及回顾性披露血浆替诺福韦药代动力学（PK）结果，探讨了VOICE期间的依从性挑战。我们系统地招募了具有PK数据（中位数为6份血浆样本）的参与者，根据替诺福韦的检测频率将其分为低（0%，N=79）、不一致（1%-74%，N=28）或高（≥75%，N=20）。在披露PK结果后，反应被捕获，并系统地引出依从性挑战；对IDIs和fgd进行录音、转录、编码和主题分析。我们采访了来自南非、乌干达和津巴布韦的127名参与者。对PK结果最常见的反应包括惊讶（41%，低PK），接受（39%，不一致的PK）和快乐（65%，高PK）。根据参与者的解释，我们开发了一种依从性模式的类型：未开始，停止，错误执行（由于就诊驱动的使用，可变服用，修改剂量或方案）和依从性。对产品副作用/危害的恐惧是一个常见的担忧，参与者之间分享的故事助长了这种担忧。尽管PK水平高的女性报告了类似的担忧，但一些人描述了克服挑战的策略。所有PK水平的妇女建议实时药物监测和反馈，以提高依从性和报告。回顾性提供PK结果似乎促进了围绕不依从和研究参与的坦诚讨论。应在试验中评估实时药物监测和反馈对依从性和报告准确性的影响。
In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, ≥50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic (PK) results, explored adherence challenges during VOICE. We systematically recruited participants with PK data (median 6 plasma samples), categorized as low (0%, N=79), inconsistent (1%-74%, N=28), or high (≥75%; N=20) based on frequency of tenofovir detection. Following disclosure of PK results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded, and thematically analyzed. We interviewed 127 participants from South Africa, Uganda, and Zimbabwe. The most common reactions to PK results included surprise (41%; low PK), acceptance (39%; inconsistent PK), and happiness (65%; high PK). Based on participants’ explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen), and adherence. Fear of product side effects/harm was a frequent concern, fueled by stories shared among participants. Although women with high PK levels reported similar concerns, several described strategies to overcome challenges. Women at all PK levels suggested real-time drug monitoring and feedback to improve adherence and reporting. Retrospective provision of PK results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials.