UrSure, Inc., Boston, MA.
Houston Health Department, Houston, TX; and.
J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):454-457. doi: 10.1097/QAI.0000000000002486.
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.
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.
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.
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.
暴露前预防（PrEP）只有在持续服用时才能有效预防新的 HIV 感染。在临床实践中，询问患者其服药依从性（自我报告）是评估 PrEP 服药依从性的主要方法。尽管自我报告廉价且非侵入性，但它容易受到社会期望和回忆偏差的影响。几项临床试验表明，自我报告的服药依从性与基于生物标志物的近期服药依从性之间存在差异。在现实临床环境中，自我报告的准确性知之甚少。本简要报告旨在填补这一知识空白，并描述现实临床环境中自我报告的服药依从性与基于生物标志物的服药依从性之间的一致性。
开发了一种用于检测替诺福韦的液相色谱-质谱尿液检测方法，并在临床上用于检测每个个体最近的非依从性（至少 48 小时未服药）。两家诊所的标准操作程序建议对自我报告没有服药依从性困难的患者使用基于尿液的依从性检测。那些自我报告有服药依从性困难的患者会得到增强的服药依从性支持，而无需额外的检测。分析这两家诊所的结果，以评估自我报告的服药依从性与基于生物标志物的服药依从性之间的一致性。
在这两家诊所中，有 3987 名自我报告为“依从”的患者接受了检测，其中 564 名（14.1%；95%置信区间（CI）：13.1%至 15.2%）的患者通过液相色谱-质谱检测显示最近存在非依从性。在佛罗里达州的诊所 #1 进行了 3200 次检测，其中 465 次（14.5%；95%CI：13.3%至 15.8%）显示最近存在非依从性。在德克萨斯州的诊所 #2 进行了 787 次检测，其中 99 次（12.6%；95%CI：10.4%至 14.9%）显示最近存在非依从性。
这两家诊所使用基于生物标志物的依从性监测方法，发现了 564 名额外的患者需要接受增强的服药依从性支持，否则他们不会被认为没有遵循 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帮助提供者识别不依从的患者，并相应地分配支持服务。
