Short- and long-term efficacy of modified directly observed antiretroviral treatment in Mombasa, Kenya: a randomized trial
Short- and long-term efficacy of modified directly observed antiretroviral treatment in Mombasa, Kenya: a randomized trial
复制标题
DOI：
10.1097/qai.0b013e3181806bf1
复制
发表时间：
2008-08-15
影响因子：
3.6
通讯作者：
Rutenberg, Naomi
中科院分区：
文献类型：
--
作者：
Sarna, Avina;Luchters, Stanley;Rutenberg, Naomi
目的：为了确定短期和长期的疗效，修改直接观察治疗（m-DOT）对antiretroviral adherence.Design：Randomized controlled trial.Setting和分析方法：从2003年9月至2004年11月，234名HIV感染的成年人被分配m-DOT（24周的每周两次的健康中心访问护士观察药丸摄入，坚持支持，药物收集）或标准护理。随访持续至第72周。报告自我报告和药丸计数依从性，其次是病毒抑制和体重指数测量。结果：在第1-24周期间，9.1%（9/99）的m-DOT参与者报告缺失剂量，而对照组为19.1%（20/105）（P = 0.04）和96.5%（517/571）的m-DOT药丸计数测量值>= 95%，而对照组为86.1%（445/517）[校正比值比= 4.4; 95%置信区间（CI）= 2.6至7.5; P < 0.001。经抑郁和HIV相关住院治疗校正后，m-DOT的依从性增加了4.8倍（95%CI = 2.7 - 8.6; P < 0.001）。在第25-48周，m-DOT的依从性（488/589）与对照组（507/630）相似。在48周时，m-DOT参与者的病毒抑制是对照组的2.0倍（95% CI = 0.8至5.2; P = 0.13）。M-DOT患者在24周时体重指数增加较大（2.2 vs 1.4 kg/m3; P = 0.014）。在接受m-DOT的抑郁症参与者中，病毒抑制在第48周（21/25 vs 13/22; P = 0.057）和第72周（27/30 vs 15/23; P = 0.027）更有可能。
Objectives: To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence.Design: Randomized controlled trial.Setting and Analytic Approach: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center visits for nurse-observed pill ingestion, adherence support, and medication collection) or standard care. Follow-up continued until week 72. Self-reported and pill-count adherence and, secondarily, viral suppression and body mass index measures are reported. Generalized estimating equations adjusted for intraclient clustering and covariates were used.Results: During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were; >= 95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P < 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P < 0.001) with adjustment for depression and HIV-related hospitalization. In weeks 25-48, adherence with m-DOT (488/589) was similar to controls (507/630). Viral suppression at 48 weeks was 2.0 times (95% CI = 0.8 to 5.2; P = 0.13) as likely in m-DOT participants as controls. M-DOT patients had larger body mass index increases at 24 weeks (2.2 vs 1.4 kg/m(3); P = 0.014). Viral suppression was more likely at week 48 (21/25 vs 13/22; P = 0.057) and week 72 (27/30 vs 15/23; P = 0.027) among depressed participants receiving m-DOT.Conclusions: M-DOT increased adherence, most notably among depressed participants.