BACKGROUND We assessed the impact of point-of-care (PoC) test-and-treat at birth on clinical outcomes and viral suppression among HIV-positive infants in Mozambique and Tanzania. METHODS This cluster-randomized trial allocated health facilities to intervention, providing PoC-testing and antiretroviral treatment (ART) at birth and week 4-8, or control, starting these at week 4-8. The primary outcome was proportions of clinical events (mortality, morbidity, retention, virological failure, toxicity) among HIV-positive infants at month-18. We estimated incidence rate ratios adjusted for timing of HIV-detection (aIRR) and reported viral suppression <1000 copies/mL. FINDINGS Among 6602 neonates enrolled October 2019-September 2021, 125 were diagnosed HIV-positive by week 12. In the intervention arm, 38/69 (55.1%) were diagnosed at birth with 35 initiating ART within two days. In the control arm, 27/56 (48.2%) were retrospectively detected HIV-positive at birth, of whom 6/56 (10.7%) died or were lost to follow-up before testing. Median age at ART initiation was 6 (intervention) versus 33 days (control). Birth test-and-treat was not associated with a significant reduction in clinical outcomes up to month-18 [53 (76.8%) versus 48 (85.7%); aIRR 0.857; 95% CI 0.505-1.492], but showed a 68% relative reduction in 6-month mortality. Viral suppression was poor overall, but improved in the intervention group at month 18 (65.7% versus 29.6%; p=0.005). INTERPRETATION PoC test-and-treat at birth is feasible in resource-poor settings and resulted in clinically-relevant reduction of early infant mortality, though improved clinical outcomes were not sustained to month-18. Poor viral suppression may undermine early survival benefits, calling for better paediatric treatments and tailored adherence interventions.

中文翻译：

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床旁出生检测和治疗对 HIV 感染婴儿临床结局的影响：莫桑比克和坦桑尼亚的一项整群随机试验。


背景 我们评估了出生时即时 （PoC） 检测和治疗对莫桑比克和坦桑尼亚 HIV 阳性婴儿临床结局和病毒抑制的影响。方法 这项整群随机试验将卫生设施分配给干预，在出生时和第 4-8 周提供 PoC 检测和抗逆转录病毒治疗 （ART），或对照，从第 4-8 周开始。主要结局是 HIV 阳性婴儿在 18 个月时临床事件 （死亡率、发病率、保留率、病毒学失败、毒性） 的比例。我们估计了根据 HIV 检测时间 （aIRR） 调整的发病率比，并报告了病毒抑制 <1000 拷贝/mL。结果 在 2019 年 10 月至 2021 年 9 月入组的 6602 名新生儿中，125 名在第 12 周时被诊断为 HIV 阳性。在干预组中，38/69 （55.1%） 在出生时被诊断出，其中 35 人在 2 天内开始 ART。在对照组中，27/56 （48.2%） 在出生时回顾性检测到 HIV 阳性，其中 6/56 （10.7%） 死亡或在检测前失访。ART 开始时的中位年龄为 6 天（干预）和 33 天（对照组）。出生试验和治疗与第 18 个月临床结局的显著减少无关 [53 （76.8%） vs 48 （85.7%）;aIRR 0.857;95% CI 0.505-1.492]，但显示 6 个月死亡率相对降低 68%。病毒抑制总体上较差，但在第 18 个月时干预组有所改善 （65.7% 对 29.6%;p=0.005）。解释 出生时 PoC 检测和治疗在资源匮乏的环境中是可行的，并导致临床上相关的早期婴儿死亡率降低，尽管改善的临床结果没有持续到 18 个月。 病毒抑制效果不佳可能会破坏早期生存获益，需要更好的儿科治疗和量身定制的依从性干预措施。