Kenyatta National Hospital, Research and Programs, Nairobi, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
Department of Global Health, University of Washington, Seattle, WA, USA.
Lancet HIV. 2022 Dec;9(12):e828-e837. doi: 10.1016/S2352-3018(22)00244-2. Epub 2022 Oct 26.
Transitioning youth living with HIV to adult care is a crucial step in the HIV care continuum; however, tools to support transition in sub-Saharan Africa are insufficient. We assessed the effectiveness of an adolescent transition package (ATP) to improve youth readiness for transition to independent HIV care.
In this hybrid type 1, multicentre, cluster randomised clinical trial, we assessed the effectiveness of an ATP (administered by routine clinic staff, which included standardised assessments and chapter books to guide discussions at scheduled clinic visits) in four counties in Kenya, with HIV clinics randomly assigned 1:1 to ATP or control (standard-of-care practice). Clinics were eligible to participate if they had at least 50 youth (aged 10-24 years) living with HIV enrolled in care. We used restricted randomisation to achieve cluster balance and an independent biostatistician used computer-generated random numbers to assign clinics. We excluded very large clinics with more than 1000 youth, clinics with fewer than 50 youth, paediatric-only clinics, clinics with logistical challenges, and the smallest clinics in Homa Bay county. Youth were eligible for the transition intervention if they were enrolled in participating clinics, were aged 15-24 years, and were aware of their positive HIV diagnosis. Study staff assessed transition readiness scores overall and by four domains (HIV literacy, self-management, communication, and support) in youth with HIV, which were then compared between groups by use of mixed-effects linear regression models. Analysis was by intention-to-treat and was adjusted for multiple comparisons. This trial is registered with ClinicalTrials.gov, NCT03574129.
We identified 35 clinics in four counties; of these, ten were assigned to the intervention group and ten to the control group. Of 1066 youth with HIV enrolled between Nov 1, 2019, and March 18, 2020, 578 (54%) were in intervention and 488 (46%) in control sites. Mean baseline transition readiness score was 12·1 (SD 3·4) in ATP sites and 11·4 (3·7) in control sites. At 1 year, adjusting for baseline scores, age, and months since HIV disclosure, participants in the ATP group had significantly higher overall transition readiness scores (adjusted mean difference 1·7, 95% CI 0·3-3·1, p=0·024), and higher scores in HIV literacy domain (adjusted mean difference 1·0, 0·2-1·7, p=0·011). At 12 months, 15 serious adverse events were recorded, none of which were thought to be related to study participation.
Integrating ATP approaches could enhance long-term HIV care in youth with HIV as they age into adulthood.
US National Institutes of Health.
将感染艾滋病毒的青年过渡到成人护理是艾滋病毒护理连续体中的关键步骤；然而，支持撒哈拉以南非洲地区过渡的工具仍然不足。我们评估了青少年过渡方案（ATP）在改善青年准备过渡到独立艾滋病毒护理方面的有效性。
在这项混合类型 1、多中心、集群随机临床试验中，我们评估了 ATP（由常规诊所工作人员提供，其中包括标准化评估和章节书籍，以指导在预定诊所就诊时的讨论）在肯尼亚的四个县的有效性，艾滋病毒诊所被随机分配 1:1 接受 ATP 或对照（标准护理实践）。如果至少有 50 名年龄在 10-24 岁之间的感染艾滋病毒的青年在护理中登记，诊所就有资格参加。我们使用限制随机化来实现集群平衡，独立的生物统计学家使用计算机生成的随机数来分配诊所。我们排除了超过 1000 名青年的大型诊所、青年少于 50 名的诊所、儿科诊所、存在后勤挑战的诊所以及霍马贝县最小的诊所。如果青年符合以下条件，即可参加过渡干预：参加参与诊所，年龄在 15-24 岁之间，并且知晓自己的艾滋病毒阳性诊断。研究人员评估了艾滋病毒青年的总体和四个领域（艾滋病毒知识、自我管理、沟通和支持）的过渡准备得分，然后通过使用混合效应线性回归模型比较两组之间的得分。分析采用意向治疗，并针对多次比较进行了调整。这项试验在 ClinicalTrials.gov 上注册，编号为 NCT03574129。
我们在四个县确定了 35 家诊所；其中，10 家被分配到干预组，10 家被分配到对照组。在 2019 年 11 月 1 日至 2020 年 3 月 18 日期间登记的 1066 名感染艾滋病毒的青年中，578 名（54%）在干预组，488 名（46%）在对照组。ATP 组的平均基线过渡准备评分是 12.1（标准差 3.4），对照组的平均基线过渡准备评分是 11.4（标准差 3.7）。在 1 年时，调整基线评分、年龄和艾滋病毒暴露后月数，ATP 组的参与者的整体过渡准备评分显著更高（调整后的平均差异为 1.7，95%CI 为 0.3-3.1，p=0.024），并且在艾滋病毒知识领域的得分更高（调整后的平均差异为 1.0，0.2-1.7，p=0.011）。在 12 个月时，记录了 15 例严重不良事件，没有一例被认为与研究参与有关。
将 ATP 方法纳入其中可以增强青年感染艾滋病毒后过渡到成年期的长期艾滋病毒护理。
美国国立卫生研究院。
