BackgroundThe two main objectives were to evaluate the COVID-19 point prevalence and the test performance of the WHO case definition to diagnose COVID-19 clinically in people with HIV in West Ukraine.MethodsMulticenter cross-sectional study in Lviv, Ukraine, from October 2020-November 2021. COVID-19 unvaccinated people with HIV were included regardless of COVID-19 symptoms at routine clinical visits and had standardized medical, quality of life (EQ(5D)) and SARS-CoV-2 serology assessments. Reported symptoms indicating potential COVID-19 events at inclusion or between March 2020 and inclusion were classified by the WHO case definition as suspected, probable or confirmed. A clinical COVID-19 case was defined as being SARS-CoV-2 seropositive with at least a suspected COVID-19 according to the WHO case definition. The primary endpoints were the clinical COVID-19 prevalence and the test characteristics of the WHO case definition with SARS-CoV-2 serology as reference. (Clinicaltrials.gov:NCT04711954).ResultsThe 971 included people with HIV were median 40 years, 38.8% women, 44.8% had prior AIDS, and 55.6% had comorbidities. SARS-CoV-2 seroprevalence was 40.1% (95%CI:37.0–43.1) and 20.5% (95%CI:18.0–23.1) had clinical COVID-19 median 4 months (IQR:2–7) before inclusion. Clinical COVID-19 occurred less frequently in people with HIV with tuberculosis history, injecting drug use, CD4+ T-cells <200/mL and unemployment. The quality of life was not impacted after COVID-19. An at least probable COVID-19 classification by the WHO case definition had 44.1% sensitivity (95%CI:38.7–49.7), 85.2% specificity (95%CI:81.5–88.4), 66.6% positive predictive value (95%CI:59.8–73.0) and 69.5% negative predictive value (95%CI:65.5–73.3) to diagnose COVID-19.ConclusionsCOVID-19 unvaccinated people with HIV from Ukraine had a significant COVID-19 rate and using the WHO case definition had insufficient diagnostic accuracy to diagnose these cases. The lower burden in vulnerable people with HIV was unexpected but might reflect a shielding effect.

中文翻译：

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COVID-19 流行病学以及 WHO 临床算法在乌克兰 HIV 感染者中诊断 COVID-19 的性能

背景两个主要目标是评估西乌克兰 HIV 感染者的 COVID-19 点流行率和 WHO 病例定义临床诊断 COVID-19 的测试性能。方法从 2020 年 10 月至乌克兰利沃夫进行多中心横断面研究2021 年 11 月。未接种 COVID-19 疫苗的 HIV 感染者在例行临床就诊时，无论 COVID-19 症状如何，均被纳入其中，并进行了标准化医疗、生活质量 (EQ(5D)) 和 SARS-CoV-2 血清学评估。报告的症状表明在纳入时或 2020 年 3 月至纳入之间存在潜在的 COVID-19 事件，根据 WHO 病例定义将其分类为疑似、可能或确诊。根据 WHO 病例定义，临床 COVID-19 病例被定义为 SARS-CoV-2 血清阳性且至少疑似 COVID-19。主要终点是 COVID-19 的临床患病率以及以 SARS-CoV-2 血清学为参考的 WHO 病例定义的测试特征。（Clinicaltrials.gov：NCT04711954）。结果 971 名艾滋病毒感染者的中位年龄为 40 岁，其中 38.8% 为女性，44.8% 患有艾滋病，55.6% 患有合并症。SARS-CoV-2 血清阳性率为 40.1% (95%CI:37.0–43.1)，20.5% (95%CI:18.0–23.1) 在纳入前中位 4 个月 (IQR:2–7) 时患有临床 COVID-19。临床 COVID-19 在有结核病史、注射吸毒、CD4+ T 细胞 <200/mL 和失业的 HIV 感染者中发生的频率较低。COVID-19 后，生活质量没有受到影响。根据 WHO 病例定义，至少可能的 COVID-19 分类具有 44.1% 的敏感性（95%CI：38.7–49.7）、85.2% 的特异性（95%CI：81.5–88.4）、66.6% 的阳性预测值（95%CI：诊断 COVID-19 的阴性预测值 (59.8–73.0) 和 69.5% 阴性预测值 (95%CI:65.5–73.3)。 结论 来自乌克兰的未接种疫苗的 COVID-19 艾滋病病毒感染者具有显着的 COVID-19 率，并且使用 WHO 病例定义诊断不足诊断这些病例的准确性。艾滋病毒易感人群的负担降低出乎意料，但可能反映了屏蔽效应。