National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania.
Institute for Medical Research and Training, University Teaching Hospital, Lusaka, Zambia.
Lancet. 2015 May 30;385(9983):2173-82. doi: 10.1016/S0140-6736(15)60164-7. Epub 2015 Mar 10.
Mortality in people in Africa with HIV infection starting antiretroviral therapy (ART) is high, particularly in those with advanced disease. We assessed the effect of a short period of community support to supplement clinic-based services combined with serum cryptococcal antigen screening.
We did an open-label, randomised controlled trial in six urban clinics in Dar es Salaam, Tanzania, and Lusaka, Zambia. From February, 2012, we enrolled eligible individuals with HIV infection (age ≥18 years, CD4 count of <200 cells per μL, ART naive) and randomly assigned them to either the standard clinic-based care supplemented with community support or standard clinic-based care alone, stratified by country and clinic, in permuted block sizes of ten. Clinic plus community support consisted of screening for serum cryptococcal antigen combined with antifungal therapy for patients testing antigen positive, weekly home visits for the first 4 weeks on ART by lay workers to provide support, and in Tanzania alone, re-screening for tuberculosis at 6-8 weeks after ART initiation. The primary endpoint was all-cause mortality at 12 months, analysed by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISCRTN 20410413.
Between Feb 9, 2012, and Sept 30, 2013, 1001 patients were randomly assigned to clinic plus community support and 998 to standard care. 89 (9%) of 1001 participants in the clinic plus community support group did not receive their assigned intervention, and 11 (1%) of 998 participants in the standard care group received a home visit or a cryptococcal antigen screen rather than only standard care. At 12 months, 25 (2%) of 1001 participants in the clinic plus community support group and 24 (2%) of 998 participants in the standard care group had been lost to follow-up, and were censored at their last visit for the primary analysis. At 12 months, 134 (13%) of 1001 participants in the clinic plus community support group had died compared with 180 (18%) of 998 in the standard care group. Mortality was 28% (95% CI 10-43) lower in the clinic plus community support group than in standard care group (p=0·004).
Screening and pre-emptive treatment for cryptococcal infection combined with a short initial period of adherence support after initiation of ART could substantially reduce mortality in HIV programmes in Africa.
European and Developing Countries Clinical Trials Partnership.
在开始接受抗逆转录病毒疗法（ART）的非洲艾滋病毒感染者中，死亡率很高，尤其是在疾病晚期的患者中。我们评估了短期社区支持来补充基于诊所的服务，并结合血清隐球菌抗原筛查的效果。
我们在坦桑尼亚达累斯萨拉姆和赞比亚卢萨卡的六个城市诊所进行了一项开放性、随机对照试验。从 2012 年 2 月开始，我们招募了符合条件的艾滋病毒感染者（年龄≥18 岁，CD4 计数<200 个细胞/μL，ART 初治），并按照国家和诊所，按区组大小为 10 个进行随机分配，分别接受基于诊所的标准护理加社区支持或仅基于诊所的标准护理。诊所加社区支持包括筛查血清隐球菌抗原，对抗原阳性的患者进行抗真菌治疗，在 ART 开始后的前 4 周由非专业人员每周进行一次家庭访视，提供支持，仅在坦桑尼亚，在 ART 开始后 6-8 周重新筛查结核病。主要终点是 12 个月时的全因死亡率，按意向治疗进行分析。该试验在国际标准随机对照试验编号注册处注册，编号为 ISCRTN 20410413。
2012 年 2 月 9 日至 2013 年 9 月 30 日，1001 名患者被随机分配到诊所加社区支持组，998 名患者被分配到标准护理组。在诊所加社区支持组中，89 名（9%）患者未接受指定的干预措施，而在标准护理组中，有 11 名（1%）患者接受了家庭访视或隐球菌抗原筛查，而不是仅接受标准护理。在 12 个月时，诊所加社区支持组的 1001 名参与者中有 25 名（2%）和标准护理组的 998 名参与者中有 24 名（2%）失访，并且在主要分析中，他们在最后一次就诊时被删失。在 12 个月时，诊所加社区支持组的 134 名（13%）参与者死亡，而标准护理组的 180 名（18%）参与者死亡。在诊所加社区支持组中，死亡率比标准护理组低 28%（95%CI 10-43%）（p=0.004）。
筛查和抢先治疗隐球菌感染，并在开始 ART 后最初一段时间内提供依从性支持，可以大大降低非洲艾滋病毒规划中的死亡率。
欧洲和发展中国家临床试验合作组织。
