A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes
A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes
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DOI：
10.1371/journal.pmed.1000422
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发表时间：
2011-03-01
期刊：
影响因子：
15.8
通讯作者：
John-Stewart, Grace C.
中科院分区：
文献类型：
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作者：
Chung, Michael H.;Richardson, Barbra A.;John-Stewart, Grace C.
背景：促进抗逆转录病毒药物依从性的行为干预可能会减少HIV治疗失败。撒哈拉以南非洲的抗逆转录病毒治疗方案面临着越来越多的财政限制，以提供全面的艾滋病毒护理，其中包括依从性干预措施。本研究比较了咨询和使用报警设备的影响，在资源有限的setting.Methods和调查结果：随机对照，析因设计的试验在肯尼亚的内罗毕。以固定剂量复方药丸（d4 T，3 TC和奈韦拉平）形式开始免费高效抗逆转录病毒治疗（HAART）的抗逆转录病毒初治个体被随机分为四组：咨询（HAART启动前后的三次咨询），警报（携带6个月的口袋电子药丸提醒），咨询加警报，既不咨询也不警报。参与者在HAART启动后随访18个月。主要研究终点包括每6个月一次的血浆HIV-1 RNA和CD 4计数、死亡率和通过每月药丸计数测量的依从性。在2006年5月至2008年9月期间，400人参加了研究，362人开始了HAART治疗，310人完成了随访。与未接受咨询的受试者相比，接受咨询的受试者每月依从性降低29%（= 5，000拷贝/ml）（HR 0.41; 95% CI 0.21-0.81; p=0.01）。与未使用警报的受试者相比，使用警报对依从性差（HR 0.93; 95% CI 0.65-1.32; p=0.7）或病毒失败（HR 0.99; 95% CI 0.53-1.84; p=1.0）无显著影响。无论是咨询，也不报警与死亡率或免疫reconstitution.Conclusions率显着相关：密集的早期坚持咨询HAART启动导致持续的，在18个月的随访中的依从性和病毒学治疗失败的显着影响，而使用报警设备没有效果。随着抗逆转录病毒治疗诊所的扩大，以满足撒哈拉以南非洲地区日益增长的艾滋病毒护理需求，应实施依从性咨询，以减少治疗失败和耐药艾滋病毒传播的发展。
Background: Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.Methods and Findings: A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naive individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence = 5,000 copies/ml) (HR 0.41; 95% CI 0.21-0.81; p=0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p=0.7) or viral failure (HR 0.99; 95% CI 0.53-1.84; p=1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.Conclusions: Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.