WYZ: a pilot study protocol for designing and developing a mobile health application for engagement in HIV care and medication adherence in youth and young adults living with HIV.

introductionYouth and young adults bear a disproportionate share of the HIV burden and there is a critical need for interventions to curb health disparities experienced among these age groups. The purpose of our research is to build on our theory-guided model and formative research to develop a mobile health application, called WYZ, for improved engagement in HIV care and antiretroviral therapy adherence, and pilot test it among youth and young adults living with HIV (YLWH). In this paper, we explain the design and development of WYZ for YLWH, describe the design of a forthcoming pilot trial for evaluating the feasibility and acceptability of WYZ and compare WYZ with other mobile health applications being developed to improve engagement in HIV care and antiretroviral medication adherence. METHODS AND ANALYSIS: We used an agile methodology, shown to be useful in software development, and elicited feedback during beta testing to develop WYZ. WYZ is a modular, adaptive and personalised intervention delivered via a mobile phone. It is grounded in the information, motivation, behaviouralskills model which has been valuable for understanding and guiding the development of interventions for complex health behaviours. WYZ was created in collaboration with YLWH aged 18-29 years using a human-centred design approach that emphasises understanding the perspective of the users of the technology. WYZ is intended to improve engagement in HIV care by: (1) enhancing medication adherence self-efficacy, (2) increasing awareness and use of community resources, (3) reducing barriers to communication between youth and their healthcare team, and (4) providing a secure platform for the formation of a private online community of YLWH. We will conduct a 6-month single-arm pilot study to examine feasibility and acceptability of WYZ among 76 YLWH who live or receive care in the San Francisco Bay Area. All study activities, including recruitment, screening, enrolment, study assessments, provision of incentives and exit interviews, will be conducted remotely. We will explore feasibility and acceptability outcomes of the intervention using quantitative and qualitative methods. ETHICS AND DISSEMINATION: Study staff will obtain written consent for study participation from all participants. This study and its protocols have been approved by the University of California San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the participants and the community using presentations, community forums, journal publications and/or social media. TRIAL REGISTRATION NUMBER: NCT03587857; Pre-results.