Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.
South African Medical Research Council, HIV Prevention Research Unit, Durban, South Africa.
J Glob Health. 2022 Feb 5;12:04004. doi: 10.7189/jogh.12.04004. eCollection 2022.
South Africa, with the highest burden of HIV infection globally, has made huge strides in its HIV/ART programme, but AIDS deaths have not decreased proportionally to ART uptake. Advanced HIV disease (CD4 < 200 cells/mm) persists, and CD4 count testing is being overlooked since universal test-and-treat was implemented. Point-of-care CD4 testing could address this gap and assure differentiated care to these vulnerable patients with low CD4 counts.
A time randomised implementation trial was conducted, enrolling 603 HIV positive non-ART, not pregnant patients at a primary health care clinic in Durban, South Africa. Weeks were randomised to either point-of-care CD4 testing (n = 305 patients) or standard-of-care central laboratory CD4 testing (n = 298 patients) to assess the proportion initiating ART at 3 months. Cox regression, with robust standard errors adjusting for clustering by week, were used to assess the relationship between treatment initiation and arm.
Among the 578 (299 point-of-care and 279 standard-of-care) patients eligible for analysis, there was no significant difference in the number of eligible patients initiating ART within 3 months in the point-of-care (73%) and the standard-of-care (68%) groups ( = 0.112). The time-to-treat analysis was not significantly different in patients with CD4 counts of 201-500 cells/mm which could have been due to appointment scheduling to cope with the large burden of cases. However, in patients with advanced HIV disease (CD4 < 200cells/mm) 65% more patients started ART earlier in the point-of-care group (HR 1.65 (95% confidence interval (CI) = 0.99-2.75; = 0.052) compared to the standard-of-care group.
Point-of-care testing decreased time-to-treatment in those with advanced HIV disease. With universal test and treat for HIV, rollout of simple point-of-care CD4 testing would ensure early diagnosis of advanced HIV disease and facilitate differentiated care for these vulnerable patients as per the World Health Organisation 2020 target product profile for point-of-care CD4 testing.
ISRCTN14220457.
南非是全球 HIV 感染负担最重的国家，在 HIV/ART 项目方面取得了巨大进展，但艾滋病死亡人数并未相应减少。先进的 HIV 疾病（CD4<200 个细胞/mm）仍然存在，并且由于实施了普遍检测和治疗，CD4 计数检测被忽视了。即时检测 CD4 可以解决这一差距，并确保这些 CD4 计数较低的脆弱患者得到差异化的护理。
在南非德班的一家初级保健诊所，我们进行了一项时间随机实施试验，共纳入 603 名未接受抗逆转录病毒治疗（ART）且未怀孕的 HIV 阳性患者。将周数随机分配给即时检测 CD4（n=305 名患者）或标准护理中心实验室 CD4 检测（n=298 名患者），以评估 3 个月时开始 ART 的比例。采用 Cox 回归，使用稳健标准误差对按周聚类进行调整，评估治疗起始与手臂之间的关系。
在 578 名（即时检测 299 名，标准护理 279 名）符合分析条件的患者中，即时检测组（73%）和标准护理组（68%）在 3 个月内开始 ART 的合格患者数量无显著差异（P=0.112）。CD4 计数为 201-500 个细胞/mm 的患者的治疗时间分析无显著差异，这可能是由于为了应对大量病例而安排了预约。然而，在 CD4<200 个细胞/mm 的晚期 HIV 疾病患者中，即时检测组中有 65%的患者更早开始接受 ART（HR 1.65（95%置信区间（CI）=0.99-2.75；P=0.052）与标准护理组相比。
即时检测缩短了晚期 HIV 疾病患者的治疗时间。随着 HIV 的普遍检测和治疗，推出简单的即时检测 CD4 检测将确保早期诊断晚期 HIV 疾病，并根据世界卫生组织 2020 年即时检测 CD4 检测目标产品概况为这些脆弱患者提供差异化护理。
ISRCTN85014467。
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