*Center for Health Intervention and Prevention, University of Connecticut, Storrs, CT; †Applied Health Research, Brighton, MI; ‡Gladstone Institutes, San Francisco, CA; §University of California, San Francisco, CA; ‖Center for AIDS Prevention Studies, University of California, San Francisco, CA; ¶Investigaciones Medicas en Salud, Lima, Peru; and #University of Colorado Denver, Aurora, CO.
J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):530-7. doi: 10.1097/QAI.0000000000000216.
To evaluate the concordance between adherence estimated by self-report (in-person interview or computer-assisted self-interview), in-clinic pill counts, and pharmacy dispensation records and drug detection among participants in a placebo-controlled pre-exposure prophylaxis HIV prevention trial (iPrEx).
Cross-sectional evaluation of 510 participants who had drug concentration data and matched adherence assessments from their week-24 study visit.
Self-reported adherence collected through (1) interview and (2) computer-assisted self-interview surveys, (3) adherence estimated by pill count, and (4) medication possession ratio was contrasted to having a detectable level of drug concentrations [either tenofovir diphosphate (TFV-DP) or emtricitabine triphosphate (FTC-TP)], as well as to having evidence of consistent dosing (tenofovir diphosphate ≥ 16 fmol/10⁶ cells), focusing on positive predictive values, overall and by research site.
Overall, self-report and pharmacy records suggested high rates of product use (over 90% adherence); however, large discrepancies between these measures and drug detection were noted, which varied considerably between sites (positive predictive values from 34% to 62%). Measures of adherence performed generally well in the US sites but had poor accuracy in other research locations. Medication possession ratio outperformed other measures but still had relatively low discrimination.
The sizable discrepancy between adherence measures and drug detection in certain regions highlights the potential contribution of factors that may have incentivized efforts to seem adherent. Understanding the processes driving adherence reporting in some settings, but not others, is essential for finding effective ways to increase accuracy in measurement of product use and may generalize to promotion efforts for open-label pre-exposure prophylaxis.
评估通过自我报告（面对面访谈或计算机辅助自我访谈）、门诊药物计数和药房配药记录估计的依从性与安慰剂对照暴露前预防 HIV 预防试验（iPrEx）参与者中的药物检测之间的一致性。
对 510 名参与者进行横断面评估，这些参与者在第 24 周研究访视时具有药物浓度数据和匹配的依从性评估。
通过（1）访谈和（2）计算机辅助自我访谈调查收集自我报告的依从性，（3）通过药物计数估计的依从性，以及（4）药物占有比与检测到药物浓度（替诺福韦二磷酸（TFV-DP）或恩曲他滨三磷酸（FTC-TP））以及一致剂量（替诺福韦二磷酸≥16 fmol/10⁶ 细胞）的证据进行对比，重点关注阳性预测值，总体和按研究地点。
总体而言，自我报告和药房记录表明产品使用率很高（超过 90%的依从性）；然而，这些措施与药物检测之间存在很大差异，并且在不同地点之间差异很大（阳性预测值从 34%到 62%）。在美国的研究地点，这些依从性措施的表现一般较好，但在其他研究地点的准确性较差。药物占有比优于其他措施，但仍然具有相对较低的区分能力。
在某些地区，依从性措施与药物检测之间存在相当大的差异，这突出了可能促使人们努力表现出依从性的因素的潜在贡献。了解某些环境中依从性报告的驱动因素，但在其他环境中则不然，对于找到提高产品使用测量准确性的有效方法至关重要，并且可能推广到开放标签暴露前预防的推广努力。
