Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection.
Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection.
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DOI：
10.1097/qai.0000000000000216
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发表时间：
2014-08-15
期刊：
影响因子：
--
通讯作者：
Grant R
中科院分区：
文献类型：
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作者：
Amico KR;Marcus JL;McMahan V;Liu A;Koester KA;Goicochea P;Anderson PL;Glidden D;Guanira J;Grant R
旨在评估安慰剂对照、暴露前预防 (PrEP) HIV 预防试验 (iPrEx) 参与者的自我报告（面对面访谈或计算机辅助自我访谈 [CASI]）估计的依从性、诊所内药物计数、药房配药记录和药物检测之间的一致性。对 510 名参与者进行横断面评估，这些参与者拥有第 24 周研究访视的药物浓度数据和匹配的依从性评估。通过 (1) 访谈和 (2) CASI 调查、(3) 通过药丸计数估计的依从性和 (4) 药物持有率 (MPR) 收集的自我报告依从性与可检测的药物浓度水平（二磷酸替诺福韦 [TFV-DP] 或三磷酸恩曲他滨 [FTC-TP]）以及剂量一致的证据（TFV-DP≥16 fmol/106 个细胞）进行对比，重点关注阳性预测总体值和按研究地点划分的值 (PPV)。总体而言，自我报告和药房记录表明产品使用率很高（遵守率超过 90%）；然而，这些措施和药物检测之间存在很大差异，不同地点之间差异很大（PPV 从 34% 到 62%）。依从性衡量标准在美国研究中心总体表现良好，但在其他研究中心的准确性较差。 MPR 的表现优于其他指标，但歧视性仍然相对较低。某些地区的依从性测量和药物检测之间存在巨大差异，凸显了可能激励人们努力表现出依从性的因素的潜在贡献。了解在某些情况下（而非其他情况下）推动依从性报告的流程对于找到提高产品使用测量准确性的有效方法至关重要，并且可以推广到开放标签 PrEP 的推广工作。
To evaluate the concordance between adherence estimated by self-report (in-person interview or computer-assisted self-interview [CASI]), in-clinic pill counts, and pharmacy dispensation records and drug detection among participants in a placebo-controlled, pre-exposure prophylaxis (PrEP) 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 via (1) interview and (2) CASI surveys, (3) adherence estimated by pill count, and (4) medication possession ratio (MPR) were 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 (TFV-DP≥16 fmol/106 cells), focusing on positive predictive values (PPV), 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 (PPV from 34% to 62%). Measures of adherence performed generally well in the US sites, but had poor accuracy in other research locations. MPR 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 appear 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 PrEP.