Interactive Transition Support for Adolescents Living with HIV Comparing Virtual and In-person delivery through a stepped-wedge cluster randomized clinical trial in South Africa

项目摘要：意义：南非是世界上青少年艾滋病毒感染者人数最多的国家。 在以夸祖鲁-纳塔尔为中心的世界，青少年对从儿童到成人的过渡准备不足 过渡期后的护理保留率和病毒抑制率差证明了这一点。个人和mHealth 对艾滋病毒感染者友好的干预措施有可能弥补低收入国家青少年艾滋病毒感染者之间的差距。 中等收入国家，但需要更大的，有把握的随机试验。差异化护理：过渡 准备评估可用于确定更脆弱的青少年，并将资源集中在 青少年将从额外的干预措施中受益最多。创新：这项研究是第一项研究， 评估干预措施，以支持从儿科到成人护理的青少年艾滋病毒感染者的过渡， 撒哈拉非洲。移动健康以前没有被用于解决青少年的关键过渡期 艾滋病毒携带者我们假设，亲自或mHealth对艾滋病毒友好的干预措施将改善病毒感染， 在过渡准备程度低至中等的感染艾滋病毒的青少年过渡到 成人护理我们还假设，移动医疗干预措施可以提供与面对面干预措施相同的益处。 成本更低，覆盖范围更广，更容易采用。方法：使用第一类混合有效性- 实施设计，我们将评估在人或mHealth提供的方便快捷的有效性 为过渡准备程度从低到中等的感染艾滋病毒的青少年提供过渡干预。使用 阶梯楔形，延迟实施随机临床试验设计，我们将衡量的有效性 与标准治疗相比，干预措施对病毒抑制和保持护理（目标1）。 同时，我们将使用RE-AIM框架来衡量与 同伴教育者作为诊所倡导者的实施战略以及审计和反馈（目标2）。我们还将 确定干预措施是否会导致过渡准备得分及其基础领域的变化， 未来有针对性的干预措施进一步根据过渡准备情况提供差异化护理（目标3）。研究者： 多个主要研究者：Brian Zanoni自2006年以来一直在南非从事青少年艾滋病毒研究， 已经通过R21获得了NIH的资金，以开发过渡准备评估，K23开发 并试行本提案中使用的移动医疗干预措施。Monerndran Archary是儿科专家， 南非的艾滋病患者。自2011年以来，他和Zanoni博士一直在共同开发 过渡准备评估和干预措施，以改善青少年过渡期护理。合作研究者： Maryam Shahmanesh是南非夸祖鲁-纳塔尔农村地区青年临床试验的专家。杰西卡 Haberer是为艾滋病毒感染者制定和实施移动健康干预措施的专家。 Vincent Marconi是南非实施科学和转化研究的专家。凯西·贝斯利 是一名高级统计学家，具有临床试验（包括阶梯楔形设计）方面的专业知识。

Project Summary: Significance: South Africa has the highest number of adolescents living with HIV in the world with KwaZulu-Natal the epicenter, yet adolescents are poorly prepared for transition from pediatric to adult services as evidenced by poor retention in care and viral suppression after transition. In-person and mHealth adolescent-friendly interventions have potential to remedy the disparities for adolescents living with HIV in low to middle income countries but larger, powered randomized trials are needed. Differentiated care: Transition readiness assessments can be used to identify the more vulnerable adolescents and focus resources on adolescents who would benefit most from additional interventions. Innovation: This study is the first study to evaluate interventions to support transition from pediatric to adult care for adolescents living with HIV in sub- Saharan Africa. mHealth has not previously been used to address the critical transition period for adolescents living with HIV. We hypothesize that in-person or mHealth adolescent-friendly interventions will improve viral suppression for adolescents living with HIV with low to intermediate transition readiness as they transition to adult care. We also hypothesize that mHealth interventions can provide equal benefits to in-person interventions with lower costs, broader reach, and easier adoption. Approach: Using a Type I hybrid effectiveness- implementation design, we will evaluate the effectiveness of in-person or mHealth delivered adolescent-friendly transition interventions for adolescents living with HIV with low to intermediate transition readiness. Using a stepped-wedge, delayed implementation randomized clinical trial design we will measure the effectiveness of the interventions compared to standard of care on viral suppression and retention in care (Aim 1). Simultaneously, we will use the RE-AIM framework to measure the implementation factors associated with the implementation strategies of peer educators as clinic champions and audit and feedback (Aim 2). We will also determine if the interventions lead to changes in transition readiness scores and their underlying domains for future targeted interventions further differentiating care based on transition readiness (Aim 3). Investigators: Multiple Principal Investigators: Brian Zanoni has been working in adolescent HIV in South Africa since 2006, has received NIH funding through an R21 to develop the transition readiness assessment and K23 to develop and pilot the mHealth intervention used in this proposal. Monerndran Archary is an expert in pediatric and adolescent HIV in South Africa. He and Dr. Zanoni have been working together since 2011 in developing transition readiness assessments and interventions to improve adolescent transition care. Co-investigators: Maryam Shahmanesh is an expert in clinical trials among youth in rural KwaZulu-Natal, South Africa. Jessica Haberer is an expert in the development and implementation of mHealth interventions for people living with HIV. Vincent Marconi is an expert in implementation science and translational research in South Africa. Kathy Baisley is a senior statistician with expertise in clinical trials including stepped-wedge designs.