Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial.
Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial.
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DOI：
10.1371/journal.pmed.1003839
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发表时间：
2021-10
期刊：
影响因子：
15.8
通讯作者：
Labhardt ND
中科院分区：
文献类型：
--
作者：
Amstutz A;Lejone TI;Khesa L;Kopo M;Kao M;Muhairwe J;Bresser M;Räber F;Klimkait T;Battegay M;Glass TR;Labhardt ND
在撒哈拉以南非洲，由非专业工作者提供以社区为基础的抗逆转录病毒疗法是一种重要的差别化服务提供模式。然而，新的护理患者通常被排除在这些模型之外。在家中进行当天抗逆转录病毒治疗正在成为普遍做法，但与诊所的联系具有挑战性。务实的VIBRA（基于村庄的ART再填充）试验比较了现有的非专业村卫生工作者（VHWs）与基于诊所的再填充后，以家庭为基础的同一天开始的ART再填充。VIBRA试验是一项在莱索托2个区（Butha-Buthe和Mokhotlong）20家卫生机构集水区的249个农村村庄进行的随机分组开放标签临床优效性试验。在随机分配到干预组的村庄（群组）中，在挨家挨户的艾滋病毒检测活动中发现艾滋病毒阳性的个人在同一天开始接受抗逆转录病毒治疗，并可选择由VHWs补充。经过培训的VHW分发药物，并在6个月和12个月时安排诊所访视进行病毒载量测量。在随机分配到对照组的村庄中，参与者在同一天开始接受ART治疗，并在诊所接受ART补充治疗。主要结局是12个月的病毒抑制。次要终点包括联系和12个月的护理参与。该试验在ClinicalTrials.gov（NCT 03630549）上注册。从2018年8月16日至2019年5月28日，来自57个集群的108个家庭的118名个体参与了干预组，来自60个集群的130个家庭的139名个体参与了对照组（150名[58%]女性;中位年龄36岁[四分位数范围30-48]; 200名[78%]新诊断）。在干预组中，48/118（41%）选择VHW再灌注。在12个月时，干预组46/118（39%）的参与者和对照组64/139（46%）的参与者实现了病毒抑制（调整后的风险差异为-0.07 [95%CI-0.20至0.06]; p = 0.256）。两组之间的关联相似（调整后的风险差异为0.03 [-0.10至0.16]; p = 0.630），但干预组的护理参与度无显著性降低（调整后的风险差异为-0.12 [-0.23至0.003]; p = 0.058）。干预组和对照组分别有7例和0例死亡。在入组时没有选择从VHW重新填充药物的干预参与者中，41/70（59%）提到信任或冲突问题是主要原因。研究局限性包括样本量相当小，主要终点窗口中缺失9%的病毒载量测量值，干预组中VHW再灌注选项的摄取率较低，以及研究人群中的大量迁移。在同一天开始后提供基于村庄的ART再填充导致与基于诊所的再填充相似的结果。干预措施并没有放大家庭为基础的同一天ART启动单独的效果。研究结果引起了人们对非专业卫生工作者在社区开展抗逆转录病毒治疗后的接受程度和安全性的关注。在Clinicaltrials.gov注册（NCT 03630549）。Alain Amstutz及其同事比较了莱索托艾滋病毒感染者在村庄和诊所接受的抗逆转录病毒治疗。在撒哈拉以南非洲，社区卫生工作者（CHW）提供基于社区的抗逆转录病毒治疗（ART）是一种重要的差异化服务提供（DSD）模式。然而，在最初的6至12个月，新的护理患者通常被排除在此类DSD模型之外。在以家庭为基础的艾滋病毒检测活动期间，当天开始抗逆转录病毒治疗，改善了与护理的联系和参与，但仍有三分之一的患者在12个月内没有与护理联系起来。到目前为止，据我们所知，尚未对在家庭当天ART开始后直接在药物补充中涉及现有附近CHW与基于诊所的补充进行评估。我们在莱索托农村进行的开放标签、务实的随机分组试验，评估了在家庭当天开始ART治疗后，现有非专业CHW干部提供的ART治疗。在干预组中，在挨家挨户检测活动中发现的艾滋病毒感染者可以选择由卫生和福利部补充药物，在6个月时进行第一次例行诊所就诊。在12个月时，干预组和对照组分别有39%和46%的参与者实现了病毒抑制，两组之间没有显著差异。我们发现，手臂与护理的联系是相似的。干预组的护理参与率无显著性降低，干预组和对照组分别有7例和0例死亡。在登记时没有选择从VHW补充药物的干预参与者中，我们发现59%的人提到信任或冲突问题是主要原因。提供以村庄为基础的抗逆转录病毒治疗的补充导致了与以诊所为基础的补充类似的结果，并且没有放大以家庭为基础的当天开始抗逆转录病毒治疗的效果。研究结果引起了人们对非专业卫生工作者在社区启动抗逆转录病毒疗法后提供的抗逆转录病毒疗法的接受程度和安全性的关注。
Community-based antiretroviral therapy (ART) dispensing by lay workers is an important differentiated service delivery model in sub-Sahara Africa. However, patients new in care are generally excluded from such models. Home-based same-day ART initiation is becoming widespread practice, but linkage to the clinic is challenging. The pragmatic VIBRA (Village-Based Refill of ART) trial compared ART refill by existing lay village health workers (VHWs) versus clinic-based refill after home-based same-day ART initiation. The VIBRA trial is a cluster-randomized open-label clinical superiority trial conducted in 249 rural villages in the catchment areas of 20 health facilities in 2 districts (Butha-Buthe and Mokhotlong) in Lesotho. In villages (clusters) randomized to the intervention arm, individuals found to be HIV-positive during a door-to-door HIV testing campaign were offered same-day ART initiation with the option of refill by VHWs. The trained VHWs dispensed drugs and scheduled clinic visits for viral load measurement at 6 and 12 months. In villages randomized to the control arm, participants were offered same-day ART initiation with clinic-based ART refill. The primary outcome was 12-month viral suppression. Secondary endpoints included linkage and 12-month engagement in care. Analyses were intention-to-treat. The trial was registered on ClinicalTrials.gov (NCT03630549). From 16 August 2018 until 28 May 2019, 118 individuals from 108 households in 57 clusters in the intervention arm, and 139 individuals from 130 households in 60 clusters in the control arm, were enrolled (150 [58%] female; median age 36 years [interquartile range 30–48]; 200 [78%] newly diagnosed). In the intervention arm, 48/118 (41%) opted for VHW refill. At 12 months, 46/118 (39%) participants in the intervention arm and 64/139 (46%) in the control arm achieved viral suppression (adjusted risk difference −0.07 [95% CI −0.20 to 0.06]; p = 0.256). Arms were similar in linkage (adjusted risk difference 0.03 [−0.10 to 0.16]; p = 0.630), but engagement in care was non-significantly lower in the intervention arm (adjusted risk difference −0.12 [−0.23 to 0.003]; p = 0.058). Seven and 0 deaths occurred in the intervention and control arm, respectively. Of the intervention participants who did not opt for drug refill from the VHW at enrollment, 41/70 (59%) mentioned trust or conflict issues as the primary reason. Study limitations include a rather small sample size, 9% missing viral load measurements in the primary endpoint window, the low uptake of the VHW refill option in the intervention arm, and substantial migration among the study population. The offer of village-based ART refill after same-day initiation led to similar outcomes as clinic-based refill. The intervention did not amplify the effect of home-based same-day ART initiation alone. The findings raise concerns about acceptance and safety of ART delivered by lay health workers after initiation in the community. Registered with Clinicaltrials.gov (NCT03630549). Alain Amstutz and co-workers compare village- and clinic-based antiretroviral refills for people with HIV infection in Lesotho. Community-based antiretroviral therapy (ART) dispensing by community health workers (CHWs) is an important differentiated service delivery (DSD) model in sub-Saharan Africa. However, patients new in care are generally excluded from such DSD models for the first 6 to 12 months. Same-day ART initiation during home-based HIV testing campaigns yields improved linkage and engagement in care, but still a third of patients do not link to care within 12 months. To date, to our knowledge, involving existing nearby CHWs in drug refills directly after home-based same-day ART start, versus clinic-based refill, has not been evaluated yet. Our open-label, pragmatic cluster-randomized trial in rural Lesotho evaluated ART delivery by an existing lay CHW cadre following home-based same-day ART initiation. In intervention clusters, persons found living with HIV during a door-to-door testing campaign could opt for drug refill by the CHW, with a first routine clinic visit at 6 months. At 12 months, 39% and 46% participants in the intervention and control arm, respectively, achieved viral suppression, with no significant difference between arms. We found that arms were similar in linkage to care. Engagement in care was non-significantly lower in the intervention arm. Seven and 0 deaths occurred in the intervention and control arms, respectively. Of the intervention participants who did not opt for drug refill from the VHW at enrollment, we found that 59% mentioned trust or conflict issues as the primary reason. The offer of village-based ART refill led to similar outcomes as clinic-based refill and did not amplify the effect of home-based same-day ART initiation alone. The findings raise concerns about the acceptance and safety of ART delivered by lay health workers after ART initiation in the community.
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DOI：
10.1016/s2214-109x(20)30385-5
发表时间：
2020-10
期刊：
The Lancet. Global health
影响因子：
--
作者：
Nachega JB;Fatti G;Zumla A;Geng EH
通讯作者：
Geng EH
在莱索托（Lesotho）基于家庭的当天抗逆转录病毒疗法启动之后，参与护理，病毒抑制，耐药性和非参与的原因：级联试验的两年随访。
DOI：
10.1093/cid/ciz1126
发表时间：
2020-12-17
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
Amstutz A;Brown JA;Ringera I;Muhairwe J;Lejone TI;Klimkait T;Glass TR;Labhardt ND
通讯作者：
Labhardt ND
影响因子：
7.2
作者：
Localio, A. Russell;Margolis, David J.;Berlin, Jesse A.
通讯作者：
Berlin, Jesse A.
影响因子：
2.5
作者：
Amstutz, Alain;Lejone, Thabo Ishmael;Labhardt, Niklaus Daniel
通讯作者：
Labhardt, Niklaus Daniel
影响因子：
120.7
作者：
Labhardt, Niklaus D.;Ringera, Isaac;Glass, Tracy R.
通讯作者：
Glass, Tracy R.