Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Jos University Teaching Hospital, Jos, Nigeria.
Clin Infect Dis. 2023 Feb 8;76(3):e681-e691. doi: 10.1093/cid/ciac605.
Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring.
We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability.
During April 2018-October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at <1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P = .096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P = .012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P = .02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care.
POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care.
NCT03533868.
即时检测（POC）病毒载量（VL）检测可在数小时内得出结果，从而实现当天的治疗干预。我们评估了 POC 与标准护理（SOC）VL 监测在治疗中的结果。
我们在尼日利亚的一家城市和农村医院开展了一项随机对照试验。接受抗逆转录病毒疗法（ART）的参与者按 1:1 比例随机分配，通过即时检测 Cepheid Xpert 或 SOC Roche COBAS（v2.0）HIV-1 VL 检测进行监测。通过意向治疗（ITT）和符合方案（PP）分析，比较病毒抑制（VS）和 12 个月时的治疗保留率。对 POC 患者和医护人员（HCW）进行事后调查，评估其可接受性。
在 2018 年 4 月至 2019 年 10 月期间，SOC 组 268 例患者和 POC 组 273 例患者入组该试验。在 ITT 分析中，12 个月时病毒载量<1000 拷贝/ml 的患者，POC 组为 59.3%（162/273），SOC 组为 52.2%（140/268）（P =.096），在 PP 分析中，POC 组为 77.1%（158/205），SOC 组为 65.9%（137/208）（P =.012）。在 ITT 分析中，保留率无显著差异，但在 PP 分析中，POC 组为 85.9%，SOC 组为 76.9%（P =.02）。POC 组的 VS 增加归因于保留率提高和 VL 结果记录。90.2%（147/163）的患者和 100%（15/15）的 HCW 更喜欢 POC 监测而不是 SOC，认为它有助于患者护理。
对于那些检测结果阳性的患者，POC VL 监测并未提高 12 个月时的 VS，但确实提高了保留率和 VS 记录，且大多数患者和 HCW 都倾向于使用 POC 监测。进一步的研究可以提供最佳的 POC 实施条件和方法，以优化患者护理。
NCT03533868。
