阿姆斯特丹 PrEP 示范项目中每日日记报告的 PrEP 摄入量与红细胞内替诺福韦二磷酸酯 (TFV-DP) 之间的一致性。

IF 3.4 2区 医学 Q3 IMMUNOLOGY
AIDS Pub Date : 2024-07-01 Epub Date: 2024-03-20 DOI:10.1097/QAD.0000000000003889
Eline S Wijstma, Vita W Jongen, Anders Boyd, Mark A M van den Elshout, Henry J C de Vries, Udi Davidovich, Peter L Anderson, Maria Prins, Elske Hoornenborg, Maarten F Schim van der Loeff
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引用次数: 0

摘要

目的我们评估了日记应用程序中自我报告的口服暴露前预防药物(PrEP)摄入量与红细胞内药物代谢物浓度之间的关联性和一致性:AMPrEP是一项前瞻性示范研究,为荷兰阿姆斯特丹的男男性行为者提供每日和事件驱动的PrEP(2015-2020年):方法:参与者可在日记应用程序中记录自己的 PrEP 摄入量。在6、12、24和48个月时采集干血斑(DBS),分析替诺福韦二磷酸酯(TFV-DP)和恩曲他滨三磷酸酯(FTC-TP)的浓度。我们纳入的 TFV-DP 测定结果之前,6 周内至少有 90% 的天数完成了日记记录。我们使用tobit回归法研究了自我报告的PrEP摄入量(即药片数量)与TFV-DP浓度之间的关系,并为每位参与者设置了随机截距。我们还计算了分类 PrEP 摄入量(即药片数量)与 TFV-DP 浓度之间的一致性:共纳入了 282 名 MSM 的 759 次 DBS 测量。自我报告的 PrEP 摄入量与 TFV-DP 浓度呈强正相关(β = 0.77,95% CI = 0.70-0.84,P 结论:自我报告的 PrEP 摄入量与 TFV-DP 浓度呈强正相关:日记应用程序中自我报告的PrEP摄入量与实际使用情况密切相关,因此用于比较不同组间的PrEP依从性是可靠的。尽管如此,在评估个人报告的 6 周依从性时,根据临床相关类别得出的标准有效性仍不够理想,因此需要谨慎。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Concordance between daily diary reported pre-exposure prophylaxis intake and intraerythrocytic tenofovir diphosphate in the Amsterdam Pre-exposure Prophylaxis demonstration project.

Objective: We assessed the association and concordance between self-reported oral pre-exposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations.

Design: AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020).

Methods: Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa.

Results: Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration ( β  = 0.77, 95% CI = 0.70-0.84, P  < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate ( κ  = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect ( κ  = 0.83, 95% CI 0.76-0.90).

Conclusion: Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals.

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来源期刊
AIDS
AIDS 医学-病毒学
CiteScore
5.90
自引率
5.30%
发文量
478
审稿时长
3 months
期刊介绍: ​​​​​​​​​​​​​​​​​Publishing the very latest ground breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of significant advances. The Editors, themselves noted international experts who know the demands of your work, are committed to making AIDS the most distinguished and innovative journal in the field. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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