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Background In the United States, adolescents and young adults are disproportionately affected by HIV and have poorer HIV-related health outcomes than adults. Health care transition (HCT) from pediatric or adolescent to adult-oriented HIV care is associated with disruptions to youths’ care retention, medication adherence, and viral suppression. However, no evidence-based interventions exist to improve HCT outcomes for youth living with HIV. Objective There are 2 phases of this project. Phase 1 involves the iterative development and usability testing of a Social Cognitive Theory–based mobile health (mHealth) HIV HCT intervention (iTransition). In phase 2, we will conduct a pilot implementation trial to assess iTransition’s feasibility and acceptability and to establish preliminary efficacy among youth and provider participants. Methods The iterative phase 1 development process will involve in-person and virtual meetings and a design team comprising youth living with HIV and health care providers. The design team will both inform the content and provide feedback on the look, feel, and process of the iTransition intervention. In phase 2, we will recruit 100 transition-eligible youth across two clinical sites in Atlanta, Georgia, and Philadelphia, Pennsylvania, to participate in the historical control group (n=50; data collection only) or the intervention group (n=50) in a pilot implementation trial. We will also recruit 28 provider participants across the pediatric or adolescent and adult clinics at the two sites. Data collection will include electronic medical chart abstraction for clinical outcomes as well as surveys and interviews related to demographic and behavioral characteristics; Social Cognitive Theory constructs; and intervention feasibility, acceptability, and use. Analyses will compare historical control and intervention groups in terms of HCT outcomes, including adult care linkage (primary), care retention, and viral suppression (secondary). Interview data will be analyzed using content analysis to understand the experience with use and acceptability. Results Phase 1 (development) of iTransition research activities began in November 2019 and is ongoing. The data collection for the phase 2 pilot implementation trial is expected to be completed in January 2023. Final results are anticipated in summer 2023. Conclusions The development and pilot implementation trial of the iTransition intervention will fill an important gap in understanding the role of mHealth interventions to support HCT outcomes for youth living with HIV. International Registered Report Identifier (IRRID) DERR1-10.2196/24565

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