Randomization of clusters into sequences.

While the incidence of Human Immunodeficiency Virus (HIV) infection is decreasing in most age groups worldwide, it is rising among adolescents and young adults, who also face a higher rate of HIV-related deaths. This tech-savvy demographic may benefit from an online patient portal designed to enhance patient activation—empowering them to manage their health independently. However, the effectiveness of such digital health interventions on young HIV patients in Kenya remains uncertain. We will conduct a 12-month stepped wedge cluster randomized trial involving 15-24-year-old HIV patients with smartphone access. The primary outcome will be patient activation, with secondary outcomes including self-reported adherence, social engagement and viral suppression. We will also evaluate the portal’s functionality, usability, fidelity, and costs. Participants will be recruited from 47 antiretroviral treatment (ART) sites with electronic medical records (EMR), forming 16 clusters of 30 participants each. Clusters will be randomized into three sequences for intervention every three months. Baseline measurements (patient activation, adherence, social engagement and viral suppression) will be collected over two weeks, followed by checks at 3, 6, and 12 months. Data will be analyzed using generalized linear mixed models and adjusted for cluster effects and potential confounders. Results will be disseminated through stakeholder forums, scientific conferences, peer-reviewed publications, and the media.

尽管全球多数年龄组的人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）感染发病率呈下降趋势，但青少年与青年人群的HIV感染率却持续攀升，且该群体的HIV相关死亡率亦处于更高水平。这一精通数字技术的人群或可从旨在强化患者激活的在线患者门户中获益——助力其自主管理健康。然而，此类数字健康干预措施对肯尼亚年轻HIV患者的有效性仍不明确。本研究将开展一项为期12个月的阶梯式整群随机试验，研究对象为拥有智能手机使用条件的15~24岁HIV感染者。本研究的主要结局指标为患者激活水平，次要结局指标包括自我报告的治疗依从性、社会参与度与病毒抑制情况。此外，本研究还将评估该患者门户的功能、可用性、实施保真度与实施成本。研究参与者将从47家配备电子病历（Electronic Medical Records, EMR）的抗逆转录病毒治疗（Antiretroviral Treatment, ART）门诊招募，共组建16个整群，每个整群包含30名参与者。整群将被随机分为3个干预序列，每3个月开展一轮干预。将在两周内收集基线测量数据（涵盖患者激活水平、治疗依从性、社会参与度与病毒抑制情况），随后分别在第3、6、12个月进行随访评估。数据将采用广义线性混合模型进行分析，并对整群效应与潜在混杂因素进行校正。研究结果将通过利益相关方论坛、学术会议、同行评议期刊发表及媒体渠道进行传播。