Background: 

Pre-exposure prophylaxis (PrEP) is only effective in preventing new HIV infections when taken consistently. In clinical practice, asking a patient about their adherence (self-report) is the predominant method of assessing adherence to PrEP. Although inexpensive and noninvasive, self-report is subject to social desirability and recall biases. Several clinical trials demonstrate a discrepancy between self-reported adherence and biomarker-based recent adherence. Less is known about the accuracy of self-report in real-world clinical settings. This brief report addresses this knowledge gap and describes the concordance between self-reported adherence and biomarker-based adherence in real-world clinical settings.

Methods: 

A liquid chromatography–mass spectrometry urine test for tenofovir was developed and used clinically to detect recent nonadherence (no dose in at least 48 hours) for each individual. Two clinics' standard operating procedures recommend utilization of the urine-based adherence test for patients who self-report that they are not struggling with adherence. Those who self-report struggling with adherence receive enhanced adherence support without the need for additional testing. The number of results indicating recent nonadherence from these 2 clinics were analyzed to assess the concordance between self-reported adherence and biomarker-based adherence.

Results: 

Across 2 clinics, 3987 tests were conducted from patients self-reporting as “adherent,” and 564 [14.1%; 95% confidence interval (CI): 13.1% to 15.2%] demonstrated recent nonadherence with the liquid chromatography–mass spectrometry test. At clinic #1 in Florida, 3200 tests were conducted, and 465 (14.5%; 95% CI: 13.3% to 15.8%) demonstrated recent nonadherence. At clinic #2 in Texas, 787 tests were conducted, and 99 (12.6%; 95% CI: 10.4% to 14.9%) demonstrated recent nonadherence.

Conclusions: 

Utilization of biomarker-based adherence monitoring at these 2 clinics resulted in 564 additional patients receiving enhanced adherence support who otherwise would not have been identified as nonadherent to their prescribed PrEP regimen. These findings suggest that objective adherence monitoring can be used clinically to enable providers to identify nonadherent patients and allocate support services accordingly.

中文翻译：

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自我报告的依从性与真实环境中的依从性生物标志物之间的差异

背景： 

持续服用前，暴露前预防（PrEP）仅对预防新的HIV感染有效。在临床实践中，向患者询问其依从性（自我报告）是评估对PrEP依从性的主要方法。尽管自我报告便宜且无创，但其自我报告仍受到社会的欢迎和召回偏见。几项临床试验表明自我报告的依从性与基于生物标志物的近期依从性之间存在差异。关于自我报告的准确性知之甚少在现实世界中的临床环境中。这份简短的报告解决了这一知识鸿沟，并描述了在实际临床环境中自我报告的依从性与基于生物标志物的依从性之间的一致性。

方法： 

开发了替诺福韦的液相色谱-质谱尿检技术，并在临床上用于检测每个人最近的不依从性（至少48小时内未服用）。二诊标准操作程序建议以血尿为主的利用率坚持测试谁的病人自我报告，他们没有挣扎坚持。那些自我报告挣扎于依从性的人将获得增强的依从性支持，而无需进行其他测试。分析了表明这两家诊所最近未坚持治疗的结果数量，以评估自我报告的坚持治疗之间的一致性和基于生物标志物的依从性。

结果： 

在两家诊所中，自我报告为“依从性”的患者进行了3987项测试，其中564项[14.1％；95％的置信区间（CI）：13.1％至15.2％]证明了液相色谱-质谱分析法最近未遵守规定。在佛罗里达州第一诊所中，进行了3​​200次测试，其中465次（14.5％； 95％CI：13.3％至15.8％）表现出近期的不依从性。在德克萨斯州2号诊所，进行了787项测试，其中99项（12.6％； 95％CI：10.4％至14.9％）表现出近期的不依从性。

结论： 

在这两个诊所中使用基于生物标志物的依从性监测导致了另外564名患者获得了增强的依从性支持，否则这些患者将不会被确定为不遵守其处方PrEP方案。这些发现表明，客观的依从性监测可以在临床上用于使提供者能够识别出未依从的患者并相应地分配支持服务。