title: Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.
abstract: BACKGROUND
  The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA.
  
  
  OBJECTIVE
  We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts.
  
  
  METHODS
  This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis.
  
  
  RESULTS
  This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland's Ministry of Health Ethics and Scientific committee. Results are expected in February 2017.
  
  
  CONCLUSIONS
  This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA.
  
  
  BACKGROUND
  University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a).
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Bhekumusa Wellington
authors.identifier: http://orcid.org/0000-0001-6429-638X
authors.initials: BW
authors.lastname: Lukhele
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Patou
authors.identifier: http://orcid.org/0000-0002-8203-4532
authors.initials: P
authors.lastname: Musumari
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Christina
authors.identifier: http://orcid.org/0000-0002-3993-9029
authors.initials: C
authors.lastname: El-Saaidi
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Teeranee
authors.identifier: http://orcid.org/0000-0001-8324-653X
authors.initials: T
authors.lastname: Techasrivichien
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: S Pilar
authors.identifier: http://orcid.org/0000-0002-8447-9172
authors.initials: SP
authors.lastname: Suguimoto
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Masako
authors.identifier: http://orcid.org/0000-0002-1995-2920
authors.initials: M
authors.lastname: Ono Kihara
authors.affiliation: Kyoto University, Department of Global Health and Socio Epidemiology, Kyoto University, Kyoto, Japan.
authors.forename: Masahiro
authors.identifier: http://orcid.org/0000-0002-1361-3928
authors.initials: M
authors.lastname: Kihara
keywords: HIV prevention; Internet; eHealth; gamification; innovation; mHealth