本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.2177

摘要内容如下：

重要性

尽管抗逆转录病毒疗法（ART）广泛可用，但HIV感染者入院后的死亡率仍然很高。

目的

确定旨在解决HIV护理参与障碍的联系病例管理干预措施（在斯瓦希里语中称为“ Daraja ”[“桥”]）是否可以改善住院后的结果。

设计、设置和参与者

评估Daraja干预有效性的单盲、个体随机临床试验。这项研究在坦桑尼亚西北部的20家医院进行。在2019年3月至2022年2月期间，招募了500名未接受治疗（未接受ART治疗）或已停止ART治疗并因任何原因住院的HIV感染者。参与者按1:1的比例随机分配接受Daraja干预或强化标准护理，并随访12个月至2023年3月。

干预

Daraja干预组（n=250）在3个月内接受了由一名社会工作者在医院、家中和艾滋病毒诊所进行的最多5次治疗。强化标准护理组（n=250）接受出院前HIV咨询，并协助安排HIV门诊预约。

主要成果和措施

主要转归是入组后12个月的全因死亡率。从HIV医疗记录中提取与HIV门诊就诊、抗逆转录病毒治疗（ART）使用和病毒载量抑制相关的次要结果。自我报告抗逆转录病毒治疗依从性，药房记录证实完全依从性。

结果

平均年龄为37（SD，12）岁，76.8%为女性，35.0%的患者CD4细胞计数低于100/μl，80.4%未接受ART治疗。干预的保真度和吸收率都很高。共有85名参与者（17.0%）死亡（干预组43人；强化标准护理组42例）；死亡率在试验组之间没有差异（干预组17.2%vs标准护理组16.8%；危险比[HR]，1.01；95%可信区间为0.66~1.55；P=.96）。与强化标准护理相比，干预减少了与HIV临床联系的时间（HR，1.50；95%可信区间为1.24~1.82；P<.001）和ART启动（HR，1.56；95%可信区间为1.28~1.89；P<.001）。干预参与者也获得了更高的HIV门诊保留率（87.4%比76.3%；P=.005），ART依从性（81.1%vs 67.6%；P=.002）和HIV病毒载量抑制（78.6%vs 67.1%；12个月时P=.01）。Daraja干预的平均成本约为每位参与者22美元，包括启动成本。

结论和相关性

在住院的HIV感染者中，关联病例管理干预并没有降低12个月的死亡率。这些发现可能有助于做出有关HIV住院患者中关联病例管理的潜在作用的决策。

试用注册

ClinicalTrials.gov标识符：NCT03858998。

英文原文如下：

Abstracts

Importance  Despite the widespread availability of antiretroviral therapy (ART), people with HIV still experience high mortality after hospital admission.

Objective  To determine whether a linkage case management intervention (named "Daraja" ["bridge" in Kiswahili]) that was designed to address barriers to HIV care engagement could improve posthospital outcomes.

Design, Setting, and Participants  Single-blind, individually randomized clinical trial to evaluate the effectiveness of the Daraja intervention. The study was conducted in 20 hospitals in Northwestern Tanzania. Five hundred people with HIV who were either not treated (ART-naive) or had discontinued ART and were hospitalized for any reason were enrolled between March 2019 and February 2022. Participants were randomly assigned 1:1 to receive either the Daraja intervention or enhanced standard care and were followed up for 12 months through March 2023.

Intervention  The Daraja intervention group (n = 250) received up to 5 sessions conducted by a social worker at the hospital, in the home, and in the HIV clinic over a 3-month period. The enhanced standard care group (n = 250) received predischarge HIV counseling and assistance in scheduling an HIV clinic appointment.

Main Outcomes and Measures  The primary outcome was all-cause mortality at 12 months after enrollment. Secondary outcomes related to HIV clinic attendance, ART use, and viral load suppression were extracted from HIV medical records. Antiretroviral therapy adherence was self-reported and pharmacy records confirmed perfect adherence.

Results  The mean age was 37 (SD, 12) years, 76.8% were female, 35.0% had CD4 cell counts of less than 100/μL, and 80.4% were ART-naive. Intervention fidelity and uptake were high. A total of 85 participants (17.0%) died (43 in the intervention group; 42 in the enhanced standard care group); mortality did not differ by trial group (17.2% with intervention vs 16.8% with standard care; hazard ratio [HR], 1.01; 95% CI, 0.66-1.55; P = .96). The intervention, compared with enhanced standard care, reduced time to HIV clinic linkage (HR, 1.50; 95% CI, 1.24-1.82; P < .001) and ART initiation (HR, 1.56; 95% CI, 1.28-1.89; P < .001). Intervention participants also achieved higher rates of HIV clinic retention (87.4% vs 76.3%; P = .005), ART adherence (81.1% vs 67.6%; P = .002), and HIV viral load suppression (78.6% vs 67.1%; P = .01) at 12 months. The mean cost of the Daraja intervention was about US $22 per participant including startup costs.

Conclusions and Relevance  Among hospitalized people with HIV, a linkage case management intervention did not reduce 12-month mortality outcomes. These findings may help inform decisions about the potential role of linkage case management among hospitalized people with HIV.

Trial Registration  ClinicalTrials.gov Identifier: NCT03858998.

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