Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.
Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.
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DOI：
10.1002/jia2.25610
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发表时间：
2020-09
影响因子：
6
通讯作者：
Okello V
中科院分区：
文献类型：
--
作者：
Khan S;Spiegelman D;Walsh F;Mazibuko S;Pasipamire M;Chai B;Reis R;Mlambo K;Delva W;Khumalo G;Zwane M;Fleming Y;Mafara E;Hettema A;Lejeune C;Chao A;Bärnighausen T;Okello V
世界卫生组织建议所有艾滋病毒阳性患者接受抗逆转录病毒治疗（ART），无论其CD 4计数或疾病阶段如何，称为“人人获得抗逆转录病毒治疗抢先体验”（EAAA）。实施EAAA对卫生系统的影响尚不清楚。本试验在政府管理的公共卫生系统中实施，旨在检查EAAA对护理保留和病毒抑制的“真实的世界”影响。在这项阶梯式随机对照试验中，斯威士兰的14家公共部门卫生机构被配对并随机分配到从标准治疗（SoC）逐步过渡到EAAA。年龄≥18岁且未妊娠或哺乳的ART初治受试者有资格入组。我们使用考克斯比例风险模型，在诊所过渡时删失，以估计EAAA对护理保留和保留与病毒抑制组合的影响。2014年9月至2017年8月，共招募了3405名参与者。在SoC和EAAA中，12个月的HIV护理保留率分别为80%（95% CI：77至83）和86%（95% CI：83至88）。SoC组的12个月合并保留和病毒抑制终点率为44%（95% CI：40 - 48），而EAAA组为80%（95% CI：77 - 83）。EAAA增加了滞留（HR：1.60，95% CI：1.15至2.21，p = 0.005）以及滞留和病毒抑制的组合（HR：4.88，95% CI：2.96至8.05，p < 0.001）。我们还发现，目前卫生系统提供病毒载量（VL）监测的能力存在重大差距，80%的SoC参与者和66%的EAAA参与者在最后一次接触时缺少VL。观察到的护理保留以及合并保留和病毒抑制的改善为EAAA提供了重要的共同受益，至少在短期内是HIV阳性成人本身。我们在这个“真实的世界”卫生系统试验中的结果强烈支持EAAA用于斯威士兰和具有类似艾滋病毒流行和卫生系统的国家。VL监测需要扩大，以进行适当的护理管理。
The WHO recommends antiretroviral treatment (ART) for all HIV‐positive patients regardless of CD4 count or disease stage, referred to as “Early Access to ART for All” (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government‐managed public health system with the aim to examine the “real world” impact of EAAA on care retention and viral suppression. In this stepped‐wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART‐naïve participants ≥18 years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined. Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12‐month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12‐month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1·60, 95% CI: 1·15 to 2·21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact. The observed improvement in retention in care and on the combined retention and viral suppression provides an important co‐benefit of EAAA to HIV‐positive adults themselves, at least in the short term. Our results from this “real world” health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.
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影响因子：
56.3
作者：
Baernighausen, Till;Chaiyachati, Krisda;Chimbindi, Natsayi;Peoples, Ashleigh;Haberer, Jessica;Newell, Marie-Louise
通讯作者：
Newell, Marie-Louise
DOI：
10.1097/qai.0b013e3182075ae2
发表时间：
2011-03-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Lessells RJ;Mutevedzi PC;Cooke GS;Newell ML
通讯作者：
Newell ML
影响因子：
2
作者：
Govindarajulu, Usha S.;Spiegelman, Donna;Eisen, Ellen A.
通讯作者：
Eisen, Ellen A.
影响因子：
3
作者：
Chao, A.;Spiegelman, D.;Okello, V
通讯作者：
Okello, V
影响因子：
16.1
作者：
Haber, Noah;Tanser, Frank;Barnighausen, Till
通讯作者：
Barnighausen, Till