Abstract
BACKGROUND: To sustain viral suppression and lower HIV-related complications, people with HIV must accept lifelong antiretroviral medication (ART). Treatment success is dependent mainly on adherence to ART. However, ART adherence is low among newly diagnosed youth with HIV worldwide, which has a significant impact on AIDS prevention and control. This study aims to increase adherence among newly diagnosed youth with HIV in China by introducing a protocol for a combined education programme (game + health education). DESIGN: To validate the impact of gaming + health education on antiretroviral treatment adherence among newly diagnosed youth with HIV, a randomized controlled trial will be carried out. METHODS: Participants will be randomly assigned to the game + health education group or the usual health education group. Upon enrollment, participants in the regular health education group will receive regular health education; those in the game + health education group will receive routine health education for three months, along with online game-based health education and offline, face-to-face health education. HIV viral load, ART medication adherence, and the CD4 + T lymphocyte count are the primary outcomes; knowledge and skills relevant to ART, resilience, and perceived stigma are the secondary outcomes. Evaluation data will be gathered before the intervention begins and one week, three, six, and twelve months after it begins. DISCUSSION: A combined education program might be a novel and effective approach to increase ART adherence among newly diagnosed young people with HIV by combining the benefits of face-to-face and game-based health education. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2500105239, registered 1 July 2025.