Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Somkhele, KwaZulu-Natal, South Africa.
Trials. 2013 Jul 23;14:230. doi: 10.1186/1745-6215-14-230.
Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes.
METHODS/DESIGN: A cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters.
We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability.
Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
抗逆转录病毒疗法（ART）可抑制所有身体部位的 HIV 病毒载量，从而降低 HIV 传播的风险。有人提出，ART 不仅有助于预防个体传播，而且还有可能预防人群传播。本试验旨在评估在识别/诊断 HIV 感染者后立即开始 ART（无论 CD4 计数如何）对周围人群 HIV 发病率的影响。整个试验的主要结局是两年内 HIV 的发病率。次要结局包括 i）社会行为结果（重复 HIV 咨询和检测的可接受性、治疗接受和联系护理、性伴侣关系和生活质量）；ii）临床结局（死亡率和发病率、保留在护理中、对 ART 的依从性、病毒学失败和获得性 HIV 耐药性）；iii）干预措施的成本效益。第一阶段将专门关注试验的次要结局。
方法/设计：在南非夸祖鲁-纳塔尔省北部的 34 个（2×17）集群中进行了一项集群随机试验，覆盖了总人口为 34000 名年龄在 16 岁及以上的居民，其中估计有 27200 人在试验开始时未感染 HIV。试验的第一阶段将包括 10 个（2×5）集群。将连续进行基于家庭的 HIV 检测。感染 HIV 的参与者将在专门的试验诊所中接受随访：在干预集群中，无论 CD4 计数和临床阶段如何，他们都将被提供立即开始 ART；在对照集群中，他们将根据国家治疗资格标准（CD4<350 个细胞/μL、世界卫生组织第 3 或 4 期疾病或耐多药/广泛耐药性结核病）提供 ART。第一阶段证明了可接受性和可行性后，试验将推广到更多的集群。
我们旨在提供治疗即预防在降低人群 HIV 发病率方面有效性的原理验证证据。从参与者家中和诊所收集的数据将有助于了解干预措施的社会行为、经济和临床影响以及可行性和普遍性。
Clinicaltrials.gov：NCT01509508；南非试验注册处：DOH-27-0512-3974。
