Study protocol for a multi-center stepped-wedge cluster randomized trial to explore the usability and outcomes among young people living with HIV in Kiambu and Kirinyaga counties of Kenya, using an online health portal

Abstract

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.