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 世界以夸祖鲁纳塔尔省为震中，但青少年对于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能力较差就证明了服务质量。面对面和移动医疗 对青少年友好的干预措施有可能弥补低收入青少年感染艾滋病毒的差距 中等收入国家，但需要更大规模、更有力的随机试验。差异化护理：过渡 准备情况评估可用于识别更脆弱的青少年，并将资源集中于 将从额外干预中受益最多的青少年。创新：本研究是第一项研究 评估干预措施，以支持亚健康地区感染艾滋病毒的青少年从儿科护理过渡到成人护理 撒哈拉非洲。移动医疗此前尚未被用于解决青少年的关键过渡期 感染艾滋病毒。我们假设，面对面或适合青少年的移动健康干预措施将改善病毒传播 对处于低至中等过渡准备状态的艾滋病毒感染者进行抑制 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、采用更容易。方法：使用 I 型混合有效性 - 实施设计，我们将评估面对面或移动医疗提供的青少年友好型的有效性 针对处于低度到中等过渡准备状态的艾滋病毒感染青少年的过渡干预措施。使用 阶梯楔形，延迟实施随机临床试验设计，我们将衡量其有效性 将干预措施与病毒抑制和保留护理的标准护理进行比较（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倡导者的实施策略以及审核和反馈（目标 2）。我们也会 确定干预措施是否会导致过渡准备分数及其潜在领域的变化 未来有针对性的干预措施根据过渡准备情况进一步区分护理（目标 3）。调查人员： 多名首席研究员：Brian Zanoni 自 2006 年以来一直在南非从事青少年艾滋病毒研究， 已通过 R21 获得 NIH 资金来开发过渡准备评估，并通过 K23 来开发 并试点本提案中使用的移动医疗干预措施。 Monerndran Archary 是儿科和儿科领域的专家 南非青少年艾滋病毒。他和 Zanoni 博士自 2011 年以来一直合作开发 过渡准备评估和干预措施，以改善青少年过渡护理。共同研究者： Maryam Shahmanesh 是南非夸祖鲁-纳塔尔省农村地区青年临床试验的专家。杰西卡 Haberer 是针对艾滋病毒感染者制定和实施移动医疗干预措施的专家。 文森特·马可尼 (Vincent Marconi) 是南非实施科学和转化研究方面的专家。凯西·贝斯利 是一位高级统计学家，拥有临床试验（包括阶梯楔形设计）方面的专业知识。