Study protocol for a multi-centre stepped-wedge cluster randomised 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

IntroductionWhile the incidence of HIV declines in most age groups globally, it continues to rise among adolescents and young adults who also experience a higher rate of HIV-related deaths. These tech-savvy individuals might benefit from an online patient portal aimed at increasing awareness, building skills, and promoting patient activation - the willingness and capacity to independently manage their health. However, the impact of such portals on young HIV patients in Kenya remains uncertain. Methods and analysisHIV patients aged 15-24 with smartphone access will participate in a 12-month stepped wedge cluster randomized trial. The main focus will be the portals effect on patient activation, with secondary outcomes being self-reported adherence, viral suppression, and social involvement. The study also aims to understand the portals development, implementation, functionality, usability, and cost. From 47 antiretroviral therapy (ART) sites with electronic medical recording systems, 16 clusters of 30 participants each will be formed. These clusters, over 12 months, will be randomized into 3 intervention sequences every 3 months. Baseline measurements, covering patient activation, adherence, viral load, and social engagement, will be recorded over two weeks, with subsequent checks at 3, 6, and 12 months. Data will be analyzed using generalised linear mixed models. Ethics and disseminationThe protocol has received approval from the AMREF Health Africa Ethics & Scientific Review Committee (ESRC) and local governments. Findings will be shared through stakeholder forums, conferences, publications, and media. Author SummaryO_ST_ABSWhat is the issue?C_ST_ABSHIV infections among teenagers and young adults are increasing, particularly in Kenya. Given their technological inclination, an online portal might help them manage their health. The effectiveness of this approach remains uncertain. What are our actions?We are running a year-long study in Kenya with HIV-positive individuals aged 15 to 24 who have smartphones. The goal is to see if the portal aids their health management. Were assessing health readiness, medication adherence, HIV control, and social connection. The study involves groups from 47 HIV treatment centers, with new groups engaging with the portal every three months. What are our assessment methods?We will use statistical methods to gauge the portals impact on health management. Is the study approved?Yes. It has endorsements from AMREF Health Africa and local governments. Results will be shared with the community, at conferences, in scientific journals, and in the media.