Tanner Amanda E, Dowshen Nadia, Philbin Morgan M, Rulison Kelly L, Camacho-Gonzalez Andres, Lee Susan, Moore Shamia J, Fortenberry J Dennis, Hussen Sophia A
Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC, United States.
Craig-Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
JMIR Res Protoc. 2021 Apr 7;10(4):e24565. doi: 10.2196/24565.
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.
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.
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.
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.
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.
在美国，青少年和青年受艾滋病毒的影响尤为严重，与成年人相比，他们的艾滋病毒相关健康结果更差。从儿科或青少年期的艾滋病毒护理向以成人为主的护理的医疗保健过渡（HCT）与青少年的护理持续率、药物依从性和病毒抑制的中断有关。然而，目前尚无基于证据的干预措施来改善艾滋病毒感染青年的医疗保健过渡结果。
该项目分为两个阶段。第一阶段涉及基于社会认知理论的移动健康（mHealth）艾滋病毒医疗保健过渡干预措施（iTransition）的迭代开发和可用性测试。在第二阶段，我们将进行一项试点实施试验，以评估iTransition的可行性和可接受性，并在青年和提供者参与者中确立初步疗效。
第一阶段的迭代开发过程将包括面对面和虚拟会议，以及一个由艾滋病毒感染青年和医疗保健提供者组成的设计团队。该设计团队将为内容提供信息，并对iTransition干预措施的外观、感觉和流程提供反馈。在第二阶段，我们将在佐治亚州亚特兰大和宾夕法尼亚州费城的两个临床地点招募100名符合过渡条件的青年，参加历史对照组（n = 50；仅收集数据）或试点实施试验中的干预组（n = 50）。我们还将在这两个地点的儿科或青少年诊所和成人诊所招募28名提供者参与者。数据收集将包括用于临床结果的电子病历摘要，以及与人口统计学和行为特征、社会认知理论结构以及干预措施的可行性、可接受性和使用情况相关的调查和访谈。分析将在医疗保健过渡结果方面比较历史对照组和干预组，包括与成人护理的联系（主要）、护理持续率和病毒抑制（次要）。访谈数据将使用内容分析法进行分析，以了解使用体验和可接受性。
iTransition研究活动的第一阶段（开发）于2019年11月开始，目前仍在进行中。第二阶段试点实施试验的数据收集预计于2023年1月完成。最终结果预计在2023年夏季得出。
iTransition干预措施的开发和试点实施试验将填补在理解移动健康干预措施对支持艾滋病毒感染青年的医疗保健过渡结果方面所起作用方面的一个重要空白。
国际注册报告识别码（IRRID）：DERR1-10.2196/24565
