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Abstract
Introduction Youth 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.
- world wide web technology
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Footnotes
Contributors XAE: serving as study coordinator, supporting the development and refinement of the mobile application, organising and coordinating the Youth Advisory Panel, and drafting the manuscript. MOJ, TBN and TR contributed substantially to the conception and design of the study and provided critical revisions of the manuscript. PS contributed substantially to the conception of the study design; served as principal investigator of the study; oversaw the research process and ensured consistent, ethical and rigorous study procedures were followed; and provided final approval of the version to publish. BB and ST contributed to the design and development of WYZ, oversight of work with the WYZ development team and provision of revisions to the manuscript. All authors contributed to manuscript revision, and read and approved the submitted version.
Funding Funding for the development of a minimal viable product and phase II trial is being provided through a National Institutes of Health (NIH) and National Institutes of Mental Health (NIMH) Planning Grant (R34MH114604). Formative research and proof of concepts design and development were funded through a Mentored Career Development Grant (K23MH097649).
Competing interests None declared.
Ethics approval This research project involved human subject participants. Prior to initiating any study activities, participants will be allowed sufficient time to review study information and make an informed decision regarding their participation. Consent will be documented in accordance with the Declaration of Helsinki. All recruitment and study procedures will be approved by the Human Research Protection Program (HRPP), the Institutional Review Board at the University of California, San Francisco.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
Patient consent for publication Not required.