*University of North Carolina Project, Lilongwe, Malawi; †Department of Pediatrics, Division of Pulmonology, Johns Hopkins School of Medicine, Baltimore, MD; ‡Department of Pediatrics, Baylor College of Medicine, Houston, TX; §Department of Pediatrics, Division of Infectious Diseases, University of Colorado, Aurora, CO; ‖Baylor College of Medicine Children's Foundation Malawi, Lilongwe, Malawi; and ¶Department of Medicine, Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC.
J Acquir Immune Defic Syndr. 2014 May 1;66(1):e23-30. doi: 10.1097/QAI.0000000000000080.
Many African infants fail to receive their diagnostic HIV molecular test results and subsequently, antiretroviral therapy (ART). To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants, we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction (Rapid PCR) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks (standard care).
Randomized controlled trial.
Hospitalized HIV-exposed Malawian infants aged <12 months were randomized into Rapid PCR or standard care. Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART, similar to a point-of-care test. Standard care infants meeting clinical criteria were also offered inpatient ART. The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants.
Three hundred infants were enrolled. A greater proportion of HIV-infected infants receiving Rapid PCR, versus standard care, started inpatient ART (72.3% vs 47.8%, P = 0.016). Among molecular test-negative infants, 26.9% receiving standard care unnecessarily initiated inpatient ART, versus 0.0% receiving Rapid PCR (P < 0.001). Rapid PCR modestly reduced the median days to ART (3.0 vs 6.5, P = 0.001) but did not influence outpatient follow-up for HIV-infected infants (78.1% vs 82.4%, P = 0.418).
Rapid PCR, versus an optimized standard care, increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants, without meaningfully impacting time to ART initiation or follow-up rates.
许多非洲婴儿未能获得其诊断性 HIV 分子检测结果，继而无法接受抗逆转录病毒治疗（ART）。为了确定即时检测 HIV 分子检测是否能增加马拉维住院婴儿接受 ART 的机会，我们使用快速 HIV RNA 聚合酶链反应（Rapid PCR）模拟即时检测，并将患者结局与包括采用世界卫生组织 HIV 感染临床算法评估以及需要数周周转时间的 DNA PCR 的优化标准护理进行比较（标准护理）。
随机对照试验。
将年龄<12 个月的 HIV 暴露的马拉维住院婴儿随机分为 Rapid PCR 组或标准护理组。Rapid PCR 婴儿在 48 小时内获得分子检测结果，以促进立即开始 ART，类似于即时检测。符合临床标准的标准护理婴儿也提供住院 ART。主要结局是 DNA 或 RNA PCR 确诊 HIV 感染婴儿在院内接受适当的 ART。
共纳入 300 名婴儿。与标准护理相比，接受 Rapid PCR 的 HIV 感染婴儿中更多的婴儿开始接受住院 ART（72.3% vs. 47.8%，P=0.016）。在分子检测阴性的婴儿中，26.9%接受标准护理不必要地开始接受住院 ART，而接受 Rapid PCR 的婴儿为 0.0%（P<0.001）。Rapid PCR 适度缩短了开始 ART 的中位时间（3.0 天 vs. 6.5 天，P=0.001），但对 HIV 感染婴儿的门诊随访没有影响（78.1% vs. 82.4%，P=0.418）。
与优化的标准护理相比，Rapid PCR 增加了开始接受 ART 的住院 HIV 感染婴儿的比例，并减少了分子检测阴性婴儿的 ART 暴露，而对开始 ART 的时间或随访率没有显著影响。
