Evaluation of Long Acting Injectable (LAI) and Teen clubs in adolescents (ATTUNE)

项目总结 意义：南非是世界上青少年艾滋病毒携带者人数最多的国家，艾滋病毒携带者人数不断增加 预计这一数字将继续下去。然而，南非艾滋病毒携带者青少年的预后很差 艾滋病毒连续护理的每一步。青少年友好型服务和同伴导航的使用可以 用于在评估长效注射抗逆转录病毒疗法之前优化行为干预。长- 代理注射抗逆转录病毒疗法可以克服粘连失效和治疗疲劳 导致艾滋病毒携带者青少年中的病毒失败。创新：这项研究是第一个使用 青少年友好型服务和同伴导航，以优化行为干预，然后调查长期 撒哈拉以南非洲艾滋病毒携带者青少年的注射抗逆转录病毒治疗。这是第一次研究 为了评估长效注射抗逆转录病毒疗法在不同现实环境中的有效性 低收入到中等收入国家的艾滋病毒携带者青少年。我们假设长效注射剂 与每日口服相比，抗逆转录病毒治疗提供了更持久的护理和病毒抑制 抗逆转录病毒疗法，但成本较高，收养程序复杂。方法：使用I型混合动力车 有效性实施设计，我们将评估有效性和相关的实施因素 具有同伴导航和长效注射抗逆转录病毒治疗，添加到对青少年友好的基线 服务。采用阶梯式、延迟实施的整群随机临床试验设计，我们将 与病毒抑制和保留的标准护理相比，衡量同行导航的有效性 将护理作为主要成果(目标1)。一旦我们潜在地将病毒抑制率最大化， 对青少年HIV感染者进行行为干预，我们将进行嵌套个体随机调查 长效抗逆转录病毒治疗对CARE和病毒滞留的疗效评价 艾滋病毒携带者受到病毒抑制的青少年中的抑制。(目标2)同时，我们将使用RE- AIM框架，衡量与同级方案执行战略有关的执行因素 在两种干预措施中，作为临床冠军的导航员以及审计和反馈(目标3)。调查人员：多人 主要调查人员：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， NIH通过R21获得了资金，用于开发过渡准备情况评估，K23用于开发和试验 MHealth干预，和R01(MPI与弓箭)面对面评估和mHealth青少年友好型 服务。Moherndran Archary是南非儿童和青少年艾滋病毒方面的专家。他和扎诺尼医生 自2011年以来一直在合作开发过渡准备情况评估和干预措施，以 改善青少年艾滋病护理。联合调查员：Maryam Shahmanesh是年轻人临床试验方面的专家 在南非夸祖鲁-纳塔尔农村。Lee Fairlie是儿科临床试验和实施方面的专家 科学。凯西·贝斯利是一名高级统计师，在包括阶梯楔形设计在内的临床试验方面拥有专业知识。

PROJECT SUMMARY Significance: South Africa has the highest number of adolescents living with HIV in the world with increasing numbers expected to continue. However, adolescents living with HIV in South Africa have poor outcomes along each step of the HIV continuum of care. The use of adolescent-friendly services and peer navigation can be used to optimize behavioral interventions prior to evaluating long-acting injectable antiretroviral therapy. Long- acting injectable antiretroviral therapy can overcome adherence lapses and treatment fatigue that often contribute to viral failure among adolescents living with HIV. Innovation: This study is the first study to use adolescent-friendly services and peer navigation to optimize behavioral interventions before investigating long- acting injectable antiretroviral therapy for adolescents living with HIV in sub-Saharan Africa. This is the first study to evaluate the effectiveness of long-acting injectable antiretroviral therapy in diverse real-world settings for adolescents living with HIV in a low- to middle- income country. We hypothesize that long-acting injectable antiretroviral therapy provides for more sustained retention in care and viral suppression compared to oral daily antiretroviral therapy but has higher costs and complex adoption procedures. Approach: Using a Type I hybrid effectiveness implementation design, we will evaluate the effectiveness and implementation factors associated with peer navigation and long-acting injectable antiretroviral therapy when added to baseline adolescent-friendly services. Using a stepped-wedge, delayed implementation cluster randomized clinical trial design, we will measure the effectiveness of peer navigation compared to standard of care with viral suppression and retention in care as the primary outcomes (Aim 1). Once we have potentially maximized viral suppression rates in adolescents living with HIV using behavioral interventions, we will conduct a nested individually randomized clinical trial evaluating effectiveness of long-acting antiretroviral therapy on retention in care and viral suppression among virally suppressed adolescents living with HIV. (Aim 2) Simultaneously, we will use the RE- AIM framework to measure the implementation factors associated with the implementation strategies of peer navigators as clinic champions and audit and feedback in both interventions (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 a transition readiness assessment, a K23 to develop and pilot a mHealth intervention, and an R01 (MPI with Archary) evaluating in-person and mHealth adolescent-friendly services. Moherndran 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 HIV care. Co-investigators: Maryam Shahmanesh is an expert in clinical trials among youth in rural KwaZulu-Natal, South Africa. Lee Fairlie is an expert in pediatric clinical trials and implementation science. Kathy Baisley is a senior statistician with expertise in clinical trials including stepped-wedge designs.