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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要意义：南非的青少年数量最多预计将继续。但是，在南非有艾滋病毒的青少年的结果很差艾滋病毒连续体的每个步骤。使用青少年友好的服务和同行导航可能是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措施。长的- 作用可注射的抗逆转录病毒疗法可以克服依从性的失误和治疗疲劳，而治疗疲劳通常艾滋病毒感染的青少年导致病毒衰竭。创新：这项研究是首次使用的研究青少年友好的服务和同行导航，以优化行为干预措施，然后再研究长期撒哈拉以南非洲患艾滋病毒的青少年的表演抗逆转录病毒疗法。这是第一个研究评估长效注射抗逆转录病毒疗法在不同现实世界中的有效性在低收入的国家中，艾滋病毒居住的青少年。我们假设长效注射与每天口服相比抗逆转录病毒疗法，但具有更高的成本和复杂的采用程序。方法：使用I型混合动力车有效性实施设计，我们将评估相关的有效性和实施因素当添加到基线青少年友好的基线时，使用同行导航和长效注射抗逆转录病毒疗法服务。使用阶梯式北向，延迟实施集群随机临床试验设计，我们将与病毒抑制和保留率相比，测量同伴导航的有效性作为主要结果的照顾（目标1）。一旦我们有可能最大化病毒抑制率使用行为干预措施使用HIV的青少年，我们将进行嵌套的单独随机临床试验评估长效抗逆转录病毒疗法对保留和病毒的有效性病毒抑制艾滋病毒的青少年抑制。（目标2）同时，我们将使用重新目的框架以衡量与同行的实施策略相关的实施因素导航员在两种干预措施中都是诊所冠军，审计和反馈（AIM 3）。调查人员：多个首席研究人员：布莱恩·扎诺尼（Brian Zanoni）自2006年以来一直在南非的青少年艾滋病中工作，通过R21获得了NIH资金，以开发过渡准备性评估，用于开发和试点的K23 MHealth干预措施，以及评估面对面和MHealth青少年友好型的R01（带有鉴别的MPI）服务。 Moherndran Archary是南非儿科和青少年艾滋病毒的专家。他和扎诺尼博士自2011年以来，一直在共同努力，以开发过渡准备性评估和干预措施改善青少年艾滋病毒护理。共同研究人员：玛丽亚姆·沙曼什（Maryam Shahmanesh）是青年临床试验的专家在南非的夸祖鲁 - 纳塔尔省农村。 Lee Fairlie是儿科临床试验和实施专家科学。凯西·贝斯利（Kathy Baisley）是一位高级统计学家，在临床试验中具有专业知识，包括阶梯式设计。