Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho The CASCADE Randomized Clinical Trial
Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho The CASCADE Randomized Clinical Trial
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DOI：
10.1001/jama.2018.1818
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发表时间：
2018-03-20
影响因子：
120.7
通讯作者：
Glass, Tracy R.
中科院分区：
文献类型：
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作者：
Labhardt, Niklaus D.;Ringera, Isaac;Glass, Tracy R.
在撒哈拉以南非洲地区，家庭艾滋病毒检测是提高对艾滋病毒状况认识的常用策略。然而，随着转诊到卫生机构，不到一半的人谁测试艾滋病毒阳性链接到护理和启动抗逆转录病毒治疗（ART）.目的为了确定是否提供同一天的家庭为基础的抗逆转录病毒治疗艾滋病毒感染者的患者改善链接到护理和病毒抑制在撒哈拉以南非洲的农村，高流行率的设置.设计，设置和参与者开放标签，2组，随机临床试验（2016年2月22日-2017年9月17日），涉及莱索托北方的6家医疗机构。在来自60个农村村庄和17个城市地区的6655个家庭的家庭艾滋病毒检测期间，来自268个家庭的278名年龄在18岁或18岁以上的艾滋病毒检测阳性和未接受过抗逆转录病毒治疗的人同意并登记。干预参与者被随机分配到同一天的家庭为基础的ART启动（n = 138）和随后的后续间隔1.5，3，6，9，在医疗机构开始治疗或接受常规护理后12个月（n = 140）主要结果和指标主要终点是3个月内与护理的联系率（在家庭访视后90天内在卫生机构就诊）和12个月时的病毒抑制，定义为入组后11至14个月的病毒载量低于100拷贝/mL。（中位年龄，39岁[四分位距，28.0-52.0]; 180名女性[65.7%]），274名（98.6%）被纳入分析（137名在当天组，137名在常规护理组）。在同一天，134（97.8%）表示准备在当天开始抗逆转录病毒治疗，3个月时，当天治疗组68.6%（94例）与常规治疗组43.1%（59例）与治疗有关（绝对差异：25.6%; 95% CI，13.8%至36.3%; P
IMPORTANCE Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART).OBJECTIVE To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa.DESIGN, SETTING, AND PARTICIPANTS Open-label, 2-group, randomized clinical trial (February 22, 2016-September17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group.INTERVENTIONS Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter.MAIN OUTCOMES AND MEASURES Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment.RESULTS Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care (absolute difference, 25.6%; 95% CI, 13.8% to 36.3%; P