School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
Paediatr Drugs. 2012 Oct 1;14(5):331-5. doi: 10.2165/11599280-000000000-00000.
The effectiveness of traditional adherence measurements used in adolescent populations is difficult to assess. Antiretroviral (ARV) adherence research among adolescents living with HIV in resource-constrained countries is particularly challenging and little evidence is available.
The primary objective of this study was to determine the feasibility of a large-scale, long-term study using electronic adherence monitoring in Uganda. The secondary objective was to compare accuracy of pill count (PC) and self-report (SR) adherence with electronic medication vials (eCAPs™).
Adolescents receiving ARV therapy at the Joint Clinical Research Centre in Kampala, Uganda, were recruited. ARVs were dispensed in eCAPs™ for 1 year. Person-pill-days (PPDs) [1 day where adherence was measured for one medication in one patient] were calculated and a weighted paired t-test was used to compare the levels of adherence among subjects for three different adherence measurement methods.
Fifteen patients were included: 40% were female, mean age was 14 years, mean baseline CD4+ cell count was 244 cells/μL, and average treatment duration was 9 months at study entry. Overall, 4721 PPDs were observed. Some eCAPs™ required replacement during the study resulting in some data loss. Consent rate was high (94%) but was slow due to age limit cut-points. Overall adherence for SR was 99%, PC was 97% and eCAP™ was 88% (p<0.05 for all comparisons). 93%, 67% and 23% of patients had an adherence of greater than 95% as measured by SR, PC and eCAP™ methods, respectively.
A large-scale adherence study in Uganda would be feasible using a more robust electronic monitoring system. Adherence measurements produced by PCs and self-reporting methods appear to overestimate adherence measured electronically.
在青少年人群中，传统的依从性测量方法的有效性难以评估。在资源有限的国家中，对感染艾滋病毒的青少年进行抗逆转录病毒（ARV）依从性研究极具挑战性，而且几乎没有相关证据。
本研究的主要目的是确定在乌干达使用电子依从性监测进行大规模、长期研究的可行性。次要目的是比较电子药瓶（eCAPs）与药物计数（PC）和自我报告（SR）的依从性测量的准确性。
在乌干达坎帕拉联合临床研究中心招募接受 ARV 治疗的青少年。ARV 以 eCAPs 形式发放 1 年。计算患者-药物-天（PPD）[1 天内对 1 名患者的 1 种药物进行测量]，并使用加权配对 t 检验比较三种不同依从性测量方法的受试者依从性水平。
共纳入 15 名患者：40%为女性，平均年龄 14 岁，平均基线 CD4+细胞计数为 244 个/μL，研究入组时平均治疗持续时间为 9 个月。共观察到 4721 个 PPD。在研究过程中，一些 eCAPs 需要更换，导致部分数据丢失。同意率很高（94%），但由于年龄限制，同意过程缓慢。总的来说，SR 为 99%，PC 为 97%，eCAP 为 88%（所有比较均 p<0.05）。分别有 93%、67%和 23%的患者根据 SR、PC 和 eCAP 方法的测量，其依从性大于 95%。
乌干达采用更强大的电子监测系统进行大规模依从性研究是可行的。PC 和自我报告方法得出的依从性测量结果似乎高估了电子测量得出的依从性。
