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

通过南非的阶梯楔形集群随机临床试验对艾滋病毒感染青少年提供交互式过渡支持，比较虚拟和面对面的交付

• 批准号: 10689138
• 负责人: Moherndran Archary
• 金额: $ 51.25万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689138
• 关键词: Absenteeism; Address; Adolescence; Adolescent; Adoption; Adult; Advocacy; Africa South of the Sahara; Age; Appointment; COVID-19 pandemic; Caring; Cessation of life; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Cohort Studies; Communication; Country; Development; Disclosure; Disparity; Effectiveness; Enrollment; Failure; Feedback; Friends; Funding; Future; HIV; HIV-infected adolescents; Healthcare; Hour; Improve Access; Income; Individual; Intervention; Lead; Maintenance; Measures; Mediating; Observational Study; Outcome; Perinatal; Persons; Pharmacy facility; Principal Investigator; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Research; Research Personnel; Resources; Rural; Schools; Services; Site; Social support; South Africa; Translational Research; United States National Institutes of Health; Validation; Viral; Viral Load result; World Health Organization; Youth; acceptability and feasibility; antiretroviral therapy; comparison intervention; cost; design; effectiveness evaluation; effectiveness measure; effectiveness/implementation design; evidence base; follow-up; health care delivery; health literacy; hybrid type 1 design; implementation determinants; implementation evaluation; implementation measures; implementation science; implementation strategy; improved; improved outcome; innovation; mHealth; mortality; pediatric human immunodeficiency virus; peer; peer support; programs; randomized trial; randomized, clinical trials; rural setting; scale up; service intervention; social; social media; social stigma; standard care; standard of care; uptake; urban setting; virtual; virtual intervention; vulnerable adolescent

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.

项目摘要：意义：南非是世界上感染艾滋病毒的青少年人数最多的国家 以夸祖鲁-纳塔尔为震中的世界，然而青少年对从儿科到成人的过渡准备不足 过渡后的护理保留率和病毒抑制率较低就证明了这些服务。面对面和移动健康 对青少年友好的干预措施有可能弥补低收入地区艾滋病毒携带者青少年之间的差异 到中等收入国家，但需要更大规模的、强有力的随机试验。差别化护理：过渡 就绪性评估可用于识别更易受伤害的青少年，并将资源集中在 将从额外干预中获益最多的青少年。创新：这项研究是第一次研究 评估支持从儿童护理过渡到成人护理的干预措施，以帮助亚 撒哈拉非洲。移动健康以前没有被用来解决青少年的关键过渡期 艾滋病毒携带者。我们假设，对青少年友好的面对面或移动健康干预将改善病毒 对艾滋病毒携带者过渡到低到中等过渡准备的青少年的抑制 成人护理。我们还假设，移动健康干预可以提供与面对面干预相同的好处 成本更低、覆盖范围更广、更易于采用。方法：使用第一类混合有效性-- 实施设计，我们将评估面对面或mHealth提供的青少年友好型服务的有效性 针对低到中等过渡准备的艾滋病毒感染青少年的过渡干预。使用 阶梯楔形、延迟实施随机临床试验设计我们将衡量 干预措施与护理标准在病毒抑制和保留护理方面的比较(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冠军以及审计和反馈的实施战略(目标2)。我们还将 确定干预措施是否会导致以下各项的过渡准备就绪分数及其基础领域发生变化 未来有针对性的干预措施进一步区分基于过渡准备情况的护理(目标3)。调查人员： 多名首席调查员：布莱恩·扎诺尼自2006年以来一直致力于南非青少年艾滋病毒的研究， 已通过R21获得NIH资金以开发过渡准备情况评估，并通过K23开发 并试点这项提案中使用的移动健康干预措施。Monerndran Archary是儿科和 南非的青少年艾滋病毒。自2011年以来，他和扎诺尼博士一直在合作开发 过渡准备情况评估和干预，以改善青少年过渡护理。共同调查人员： Maryam Shahmanesh是南非夸祖鲁-纳塔尔农村地区年轻人临床试验的专家。杰西卡 哈贝勒是为艾滋病毒携带者开发和实施移动健康干预措施的专家。 文森特·马可尼是南非实施科学和翻译研究方面的专家。凯西·贝斯利 是一名高级统计学家，在包括阶梯楔形设计在内的临床试验方面拥有专业知识。