Game-based health education to improve ART adherence of newly diagnosed young people with HIV: protocol for a stepped-wedge design randomized controlled trial

BACKGROUND: Antiretroviral therapy (ART) is one of the most effective ways for HIV-infected to treat AIDS. However, it is difficult to start ART among young people those newly diagnosed HIV-infection in China, and their adherence to ART is poor. We have designed an AIDS educational game called AIDS Fighter · Health Defense, which could improve the AIDS-related knowledge and has the potential to improve AIDS prevention ability of young students. In this study, AIDS Fighter · Health Defense will be used with newly diagnosed young people with HIV to evaluate the education effect of the game in improving ART adherence. DESIGN: A stepped-wedge design randomized controlled trial will be conducted to confirm the education effect of AIDS Fighter · Health Defense on improving ART adherence of newly diagnosed young people with HIV, and to verify when to start game-based health education could be more effective for newly diagnosed young people with HIV. METHODS: Participants will receive AIDS education from health workers and start ART when diagnosed with HIV and assigned into four groups randomly. The first step group to the fourth step group will receive AIDS Fighter · Health Defense in turn at the star of ART, one week, one month and three months after the start of ART. The primary outcomes are medication adherence, CD4( +) T cell count, and HIV viral load. The secondary outcomes are ART-related knowledge, ART-related skills, psychological resilience, and self-discrimination. Assessments will be completed before the intervention and one week, first month, and third month of the intervention, and then a one-year follow-up evaluation will be conducted after the intervention. DISCUSSION: AIDS Fighter · Health Defense may be an effective approach to help newly diagnosed young people with HIV to improve ART adherence. A stepped-wedge design randomized controlled trial of this study may find the optimal time of AIDS education to improve ART adherence of newly diagnosed young people with HIV. REGISTRATION NUMBER: Chinese Clinical Trial Registry: ChiCTR2200059766, registered 11 May 2022. http://www.chictr.org.cn/showproj.aspx?proj=169420 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-022-14708-2.