Stevens Wendy S, Gous Natasha M, MacLeod William B, Long Lawrence C, Variava Ebrahim, Martinson Neil A, Sanne Ian, Osih Regina, Scott Lesley E
*Department of Molecular Medicine and Hematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; †National Health Laboratory Service and National Priority Program of the National Health Laboratory Service, Johannesburg, South Africa; ‡Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; §Department of Global Health, Boston University School of Public Health, Boston, MA; ‖Department of Medicine, Klerksdorp-Tshepong Hospital Complex, Klerksdorp, South Africa; ¶Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; #Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; **Perinatal HIV Research Unit (PHRU), MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Johannesburg, South Africa; ††Right to Care, Johannesburg, South Africa; ‡‡Clinical HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and §§Clinton Health Access Initiative, Inc., Boston, MA.
J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):65-73. doi: 10.1097/QAI.0000000000001456.
BACKGROUND: Lack of accessible laboratory infrastructure limits HIV antiretroviral therapy (ART) initiation, monitoring, and retention in many resource-limited settings. Point-of-care testing (POCT) is advocated as a mechanism to overcome these limitations. We executed a pragmatic, prospective, randomized, controlled trial comparing the impact of POCT vs. standard of care (SOC) on treatment initiation and retention in care. METHODS: Selected POC technologies were embedded at 3 primary health clinics in South Africa. Confirmed HIV-positive participants were randomized to either SOC or POC: SOC participants were venesected and specimens referred to the laboratory with patient follow-up as per algorithm (∼3 visits); POC participants had phlebotomy and POCT immediately on-site using Pima CD4 to assess ART eligibility followed by hematology, chemistry, and tuberculosis screening with the goal of receiving same-day adherence counseling and treatment initiation. Participant outcomes measured at recruitment 6 and 12 months after initiation. RESULTS: Four hundred thirty-two of 717 treatment eligible participants enrolled between May 2012 and September 2013: 198 (56.7%) SOC; 234 (63.6%) POC. Mean age was 37.4 years; 60.5% were female. Significantly more participants were initiated using POC [adjusted prevalence ratio (aPR) 0.83; 95% confidence interval (CI): 0.74 to 0.93; P < 0.0001], the median time to initiation was 1 day for POC and 26.5 days for SOC. The proportion of patients in care and on ART was similar for both arms at 6 months (47 vs. 50%) (aPR 0.96; 95% CI: 0.79 to 1.16) and 12 months (32 vs. 32%) (aPR 1.05; 95% CI: 0.80 to 1.38), with similar mortality rates. Loss to follow-up at 12 months was higher for POC (36% vs. 51%) (aPR 0.82; 95% CI: 0.65 to 1.04). CONCLUSIONS: Adoption of POCT accelerated ART initiation but once on treatment, there was unexpectedly higher loss to follow-up on POC and no improvement in outcomes at 12 months over SOC.
背景：在许多资源有限的环境中，缺乏可及的实验室基础设施限制了艾滋病毒抗逆转录病毒疗法（ART）的启动、监测和维持。即时检验（POCT）被倡导为克服这些限制的一种机制。我们开展了一项实用、前瞻性、随机对照试验，比较POCT与标准护理（SOC）对治疗启动和护理维持的影响。 方法：选定的POCT技术被应用于南非的3家初级卫生诊所。确诊的HIV阳性参与者被随机分为SOC组或POCT组：SOC组参与者接受静脉采血，标本送往实验室，并按照算法进行患者随访（约3次就诊）；POCT组参与者进行静脉穿刺，并立即在现场使用Pima CD4进行POCT以评估ART资格，随后进行血液学、化学和结核病筛查，目标是在当天接受依从性咨询并开始治疗。在入组时、开始治疗后6个月和12个月测量参与者的结局。 结果：2012年5月至2013年9月期间，717名符合治疗条件的参与者中有432名入组：198名（56.7%）为SOC组；234名（63.6%）为POCT组。平均年龄为37.4岁；60.5%为女性。使用POCT启动治疗的参与者明显更多[调整患病率比（aPR）0.83；95%置信区间（CI）：0.74至0.93；P<0.0001]，POCT组的中位启动时间为1天，SOC组为26.5天。两组在6个月时接受护理并接受ART治疗的患者比例相似（47%对50%）（aPR 0.96；95%CI：0.79至1.16），在12个月时也相似（32%对32%）（aPR 1.05；95%CI：0.80至1.38），死亡率相似。POCT组在12个月时的失访率更高（36%对51%）（aPR 0.82；95%CI：0.65至1.
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