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

长效注射剂 (LAI) 和青少年俱乐部 (ATTUNE) 的评估

• 批准号: 10749156
• 负责人: Moherndran Archary
• 金额: $ 104.56万
• 依托单位: KWAZULU-NATAL RESEARCH INSTITUTE TB-HIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-24 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10749156
• 关键词: AIDS prevention; Address; Adherence; Adolescence; Adolescent; Adoption; Africa South of the Sahara; Age; Behavior Therapy; Caring; Cessation of life; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Cohort Studies; Complex; Conflict (Psychology); Continuity of Patient Care; Country; Dose; Effectiveness; Elderly; Enrollment; Evaluation; Failure; Fatigue; Feedback; Friends; Funding; HIV; HIV-infected adolescents; Improve Access; Income; Individual; Injectable; International; Intervention; Maintenance; Measures; Oral; Outcome; Perinatal; Persons; Pharmaceutical Preparations; Principal Investigator; Procedures; Protocols documentation; Publishing; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Recommendation; Research; Research Personnel; Resource-limited setting; Rural; Schools; Services; Social support; South Africa; Supervision; Teenagers; Training; United States National Institutes of Health; Viral; Viral Load result; Visit; World Health Organization; Youth; antiretroviral therapy; clinical implementation; cost; design; effectiveness evaluation; effectiveness measure; effectiveness/implementation design; experience; follow-up; forgetting; implementation determinants; implementation evaluation; implementation measures; implementation science; implementation strategy; improved; improved outcome; innovation; internalized stigma; mHealth; medication administration; meetings; mortality; pediatric human immunodeficiency virus; peer; peri-urban; pill; primary outcome; randomized, clinical trials; rural area; scale up; side effect; social; social stigma; standard care; standard of care; uptake; urban area

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.

项目摘要 重要性：南非是世界上感染艾滋病毒的青少年人数最多的国家， 数字预计将继续。然而，南非感染艾滋病毒的青少年沿着 艾滋病连续护理的每一步。使用方便快捷的服务和对等导航可以 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- 有效的可注射抗逆转录病毒疗法可以克服依从性失误和治疗疲劳， 导致感染艾滋病毒的青少年的病毒失效。创新：这项研究是第一项使用 友好的服务和同行导航，以优化行为干预之前，调查长期- 为撒哈拉以南非洲感染艾滋病毒的青少年提供注射抗逆转录病毒疗法。这是第一项研究 评估长效注射抗逆转录病毒治疗在不同现实环境中的有效性， 在一个低收入到中等收入的国家，艾滋病病毒感染的青少年。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更持久的护理和病毒抑制 抗逆转录病毒疗法，但费用较高，收养程序复杂。方法：使用I型混合物 有效性实施设计，我们将评估相关的有效性和实施因素 与同伴导航和长效注射抗逆转录病毒治疗时，添加到基线艾滋病友好 服务使用阶梯楔形、延迟实施的整群随机临床试验设计，我们将 测量同伴导航与具有病毒抑制和保留的标准治疗相比的有效性 作为主要目标（目标1）。一旦我们有可能最大化病毒抑制率， 使用行为干预的青少年艾滋病病毒感染者，我们将进行一个嵌套的单独随机 评价长效抗逆转录病毒治疗对保持护理和病毒感染的有效性的临床试验 在感染艾滋病毒的受病毒抑制青少年中，(Aim 2）同时，我们将使用RE- AIM框架测量与同行实施策略相关的实施因素 在两种干预措施中，导航员作为诊所倡导者，并进行审计和反馈（目标3）。研究者：多名 主要研究人员：Brian Zanoni自2006年以来一直在南非从事青少年艾滋病毒研究， 通过R21获得NIH资助，以开发过渡准备评估，K23开发和试点 一个mHealth干预，和一个R01（MPI与Archary）评估在人和mHealth方便 服务Moherndran Archary是南非儿科和青少年艾滋病毒专家。他和扎诺尼医生 自2011年以来，我们一直在共同制定过渡准备评估和干预措施， 改善青少年艾滋病毒护理。共同研究者：Maryam Shahmanesh是年轻人临床试验的专家 在南非的夸祖鲁-纳塔尔农村。李费尔利是儿科临床试验和实施方面的专家 科学Kathy Baisley是一名高级统计学家，擅长临床试验，包括阶梯楔形设计。