Abstract
BACKGROUND: Young people aged under 25 years make up an increasing proportion of the population in emerging economies such as Kenya, where half of new adult HIV infections are among 15- to 24-year olds. Interventions targeting this age group have the potential to avert HIV infections among an increasingly large at-risk population. Interactive communication technologies offer a promising platform for reaching young people in engaging ways. OBJECTIVE: Tumaini is a narrative-based smartphone game designed to help young Africans protect themselves from HIV. The objective of this study was to pilot test the game, focusing on the data needed to inform a future randomized controlled efficacy trial, including assessments of study feasibility and safety. METHODS: The study took place in Kisumu Town, western Kenya, in spring 2017. The game-based intervention was pilot tested for 16 days with a sample of 60 preadolescents aged 11 to 14 years. Participant recruitment was initiated through schools. Participants were randomly assigned to the control or intervention arms of the study. One parent for each of the intervention arm participants was also recruited (n=30). The intervention arm participants were provided with smartphones on which Tumaini was loaded so that they could play the game at home. Youth completed behavioral surveys at baseline, posttest, and 6-week follow-up. The intervention arm participants provided quantitative feedback on their experience of the game-based intervention at posttest. They and their parents further participated in postintervention focus group discussions. Feasibility-related study metrics were collected on recruitment, enrollment, attrition, safety of participants, and return of phones. RESULTS: Recruitment and enrollment of the 60 preadolescents and parents were successfully completed within 18 days. No participants were lost to follow-up: all youth completed all 3 waves of the survey and 27 intervention arm youth and 22 parents and caregivers participated in the focus groups. No safety concerns were reported. All phones were returned after the intervention period; none were damaged or lost. All intervention arm participants initiated gameplay, recording a mean exposure time just under 27 hours. CONCLUSIONS: Findings indicate that it is feasible and safe to test a smartphone-based HIV prevention intervention for very young adolescents in urban and peri-urban sub-Saharan Africa by initiating recruitment in schools and temporarily providing youth participants with smartphones on which the game is loaded. A randomized controlled trial powered to assess the efficacy of the game-based intervention is being designed to be carried out in the same geographic area as the pilot, using similar methods. TRIAL REGISTRATION: ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/6wjwpX8Bg.). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11209.