Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique

Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique
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DOI:
10.1097/qai.0b013e318153f7ba
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发表时间:
2007-10-01
影响因子:
3.6
通讯作者:
Gloyd, Stephen S.
Gloyd, Stephen S.
中科院分区:
医学3区
文献类型:
--
作者:
Pearson, Cynthia R.;Micek, Mark A.;Gloyd, Stephen S.

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目的:在莫桑比克临床人群中评估同伴递送干预促进HAART短期(6个月)和长期(12个月)依从性的有效性。设计:从2004年10月到2006年6月进行了一项双臂随机对照试验。参与者:发起HAART的350名男性和女性(>=18岁)中,53.7%是女性,97%接受一种固定剂量的联合药片,每天两次。干预:参与者被随机分配接受6周(周一至周五;每天30次)的同行递送、改良直接观察疗法(MDOT)或标准护理。同龄人提供关于治疗和依从性的教育,并试图确定和减轻依从性障碍。结果:参与者在开始HAART 6个月和12个月后对自我报告的药物依从性进行了评估。依从性定义为在过去7天内服用处方剂量的比例。结果:与标准护理组相比,干预组患者在6个月(92.7%比84.9%,差异7.8,95%可信区间:0.0.02,13.0)和12个月(94.4%比87.7%,差异6.8,95%可信区间:0.9,12.9)的平均服药依从性显著高于标准护理组。在图表提取的CD4计数中,手臂之间没有差异。
Objective: To assess the efficacy of a peer-delivered intervention to promote short-term (6-month) and long-term (12-month) adherence to HAART in a Mozambican clinic population. Design: A 2-arm randomized controlled trial was conducted between October 2004 and June 2006.Participants: Of 350 men and women (>= 18 years) initiating HAART, 53.7% were female, and 97% were on 1 fixed-dose combination pill twice a day.Intervention: Participants were randomly assigned to receive 6 weeks (Monday through Friday; 30 daily visits) of peer-delivered, modified directly observed therapy (mDOT) or standard care. Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers.Outcome: Participants' self-reported medication adherence was assessed 6 months and 12 months after starting HAART. Adherence was defined as the proportion of prescribed doses taken over the previous 7 days. Statistical analyses were performed using intention-to-treat (missing = failure).Results: Intervention participants, compared to those in standard care, showed significantly higher mean medication adherence at 6 months (92.7% vs. 84.9%, difference 7.8, 95% confidence interval [CI]: 0.0.02, 13.0) and 12 months (94.4% vs. 87.7%, difference 6.8, 95% CI: 0.9, 12.9). There were no between-arm differences in chartabstracted CD4 counts.