Comparing Self-Report Pre-Exposure Prophylaxis Adherence Questions to Pharmacologic Measures of Recent and Cumulative Pre-Exposure Prophylaxis Exposure
Comparing Self-Report Pre-Exposure Prophylaxis Adherence Questions to Pharmacologic Measures of Recent and Cumulative Pre-Exposure Prophylaxis Exposure
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DOI：
10.3389/fphar.2019.00721
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发表时间：
2019-07-05
影响因子：
5.6
通讯作者：
Moore, David J.
中科院分区：
文献类型：
--
作者：
Blumenthal, Jill;Pasipanodya, Elizabeth C.;Moore, David J.
由于暴露前预防（PrEP）的有效性与依从性密切相关，我们试图确定某些自我报告措施是否可以用于告知客观的PrEP依从性。我们研究了TAPIR研究（一项多中心随机研究，每日短信支持高危人群坚持PrEP）的参与者，这是一项为期48周的随机对照试验，受试者为未感染艾滋病毒的男男性行为者（MSM），随机接收短信以支持坚持与标准治疗。目的通过细胞内替诺福韦二磷酸（ttfv - dp）和三磷酸恩曲他滨（FTC-TP）的干血斑（DBS）测定PrEP依从性。在第12周和第48周使用验证性因子分析对七个依从性项目的反应进行依从性总结。自我报告问题与药物浓度之间的相关性用连续结局的Pearson相关和二分结局的点双列相关来估计。进行受试者工作特征（ROC）分析，以评估自我报告措施在预测保护性或完美ttfv - dp浓度方面的表现。在完成第12周或第48周访问的369名参与者中，平均年龄为35岁（标准差为9岁），其中79%为白人，12%为黑人，29%为西班牙裔。自我报告依从性测量（包括个体项目和依从性因子）与可量化的FTC-TP和连续ttfv - dp浓度之间的相关性表明，所有自我报告测量都与这些客观测量显著相关。与自我报告依从性的总结测量相比，4周服用问题药物回忆的百分比是唯一与最近依从性和长期保护性和完美依从性在第12周和第48周相似或更强烈相关的自我报告项目。ROC分析还显示，在预测保护性ttfv - dp浓度时，4周受访百分比的AUC（第12周0.798，第48周0.758）合理。所有评估PrEP依从性的单项自我报告问题都与生物标志物量化显著相关，其中第4周的百分比表现最佳。因此，在没有药物浓度测量的情况下，4周的自我报告百分比问题可能是PrEP依从性的良好单项测量。
As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence.