Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial.
Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial.
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DOI：
10.1016/s2352-3018(14)00007-1
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发表时间：
2015-01
期刊：
影响因子：
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通讯作者：
ACTG 5234 team
中科院分区：
文献类型：
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作者：
Gross R;Zheng L;La Rosa A;Sun X;Rosenkranz SL;Cardoso SW;Ssali F;Camp R;Godfrey C;Cohn SE;Robbins GK;Chisada A;Wallis CL;Reynolds NR;Lu D;Safren SA;Hosey L;Severe P;Collier AC;ACTG 5234 team
坚持治疗是抗逆转录病毒治疗 (ART) 成功的关键。加强合作伙伴的支持可能会使既往治疗失败的患者受益。我们在 8 个国家的 9 个地点进行了一项 1:1 随机试验，将基于伴侣的改良直接观察疗法 (mDOT) 与标准护理 (SOC) 进行比较。参与者的一线治疗方案失败，HIV RNA > 1000 拷贝/mL，并且有一个愿意的伴侣。随机化是计算机生成的，并按站点进行平衡。参与者和现场调查员不会被隐藏到分组分配中。 ART 包括洛匹那韦/利托那韦（400/100 mg）每天两次，恩曲他滨/富马酸替诺福韦二吡呋酯（200/300 mg）每天一次。训练有素的合作伙伴每天观察一剂 ART 剂量，每周≥5 天，持续 24 周。主要结果是第 48 周前或第 48 周时 HIV RNA >400 拷贝/mL，次要结果是用微电子监测仪测量的依从性。我们将 129 名参与者随机分配到 mDOT，将 128 名参与者随机分配到 SOC，其中 130 名 (51%) 为男性，204 名 (79%) 为非洲裔，52 名 (20%) 为拉丁裔，中位年龄 38 岁。伴侣为父母 57 名（22%）、配偶 55 名（21%）、兄弟姐妹 50 名（19%）、朋友 41 名（16%）和其他 54 名（21%）。第 48 周时，26% (34/129) 的 mDOT 参与者和 18% (23/128) 的 SOC 参与者出现主要结局 (p=0.13)。 mDOT 和 SOC 的中位依从性相似 [Q1：95% vs. 96% p=0.38，Q2：91% vs. 94% p=0.40，Q3：90% vs. 93% p=0.17，Q4：90% vs. 93% p=0.36]。这种干预对结果没有影响。潜在的原因包括研究访问最大限度地提高了两组的依从性，以及已经提供足够支持的对照伙伴。基于合作伙伴的 mDOT 培训似乎并不能提高依从性。在这种情况下，对诊所工作人员进行密集随访可能是一个可行的策略。
Adherence is key to antiretroviral therapy (ART) success. Enhanced partner support may benefit patients with prior treatment failure. We conducted a 1:1 randomized trial of a partner-based modified directly observed therapy (mDOT) compared with standard of care (SOC) at 9 sites in 8 countries. Participants had failed a first-line regimen with HIV RNA >1000 copies/mL and a willing partner. Randomization was computer generated and balanced by site. Participants and site investigators were not masked to group assignment. ART included lopinavir/ritonavir (400/100 mg) twice daily and emtricitabine/tenofovir disoproxil fumarate (200/300 mg) once daily. Trained partners observed one ART dose daily ≥5 days/week for 24 weeks. Primary outcome was HIV RNA >400 copies/mL before or at week 48 and adherence measured with microelectronic monitors was a secondary outcome. We randomized 129 participants to mDOT and 128 to SOC, 130 (51%) males, 204 (79%) of African origin, 52 (20%) Latino, with median age 38 years. Partners were parents, 57 (22%), spouses 55 (21%), siblings 50 (19%), friends 41 (16%), and others 54 (21%). Primary outcome occurred in 26% (34/129) of mDOT and 18% (23/128) of SOC participants at week 48 (p=0.13). Median adherence was similar [Q1: 95% vs. 96% p=0.38, Q2: 91% vs. 94% p=0.40, Q3: 90% vs. 93% p=0.17, Q4: 90% vs. 93% p=0.36] in mDOT and SOC, respectively. This intervention had no effect on outcomes. Potential reasons include study visits maximizing adherence in both groups and control partners already providing sufficient support. Partner-based training with mDOT does not appear promising to enhance adherence. Intensive follow-up with clinic staff may be a viable strategy in this setting.