Optimizing the Use of Long-Acting Antiretrovirals for Youth Living withHIV

优化长效抗逆转录病毒药物对青少年艾滋病毒感染者的使用

• 批准号: 10487556
• 负责人: Ethel Derby Weld
• 金额: $ 19.87万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10487556
• 关键词: 18 year old; AIDS clinical trial group; AIDS/HIV problem; Address; Adherence; Adolescent; Adult; Age-Years; Anti-Retroviral Agents; Assessment tool; Award; Awareness; Behavior; Behavioral; Biological Assay; Biometry; Blood; Caring; Categories; Characteristics; Clinical; Clinical Pharmacology; Clinical Trials; Clinical Trials Network; Cognition; Cognitive; Cold Chains; Collection; Communicable Diseases; Communities; Data; Decision Making; Development; Dose; Drug Kinetics; Drug Monitoring; Ensure; Family; Foundations; Frequencies; Funding; Goals; HIV; HIV-infected adolescents; Healthcare; Impulsivity; Individual; Injections; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Intervention Studies; Investigation; Knowledge; Lead; Learning; Link; Longevity; Matched Group; Measurement; Measures; Mental Depression; Mental Health; Mental disorders; Mentors; Methodology; Methods; Modeling; Morbidity - disease rate; Oral; Outcome; Participant; Personal Satisfaction; Persons; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Plasma; Population; Procedures; Property; Quality of life; Questionnaires; Research; Research Personnel; Role; Safety; Social Network; Societies; Source; Spottings; Subgroup; Surveys; Technology; Testing; Therapeutic; Therapeutic Uses; Training; Treatment outcome; Viral; Viral Load result; Welding; Youth; aged; assay development; base; biopsychosocial; brain health; career; clinical care; cognitive neuroscience; design; executive function; experience; health disparity; improved; improved outcome; interest; mortality; neurobehavioral; novel; novel therapeutics; pediatric human immunodeficiency virus; pharmacokinetic model; programs; psychosocial; research clinical testing; skills; social health determinants; social stigma; stem; substance use; success; therapy design; tool; transmission process; treatment as prevention; treatment group; treatment strategy

PROJECT SUMMARY/ ABSTRACT Youth with HIV and adherence struggles stand to benefit from long-acting antiretrovirals (LAARV), soon to be available in the U.S., more than other groups. Youth living with HIV between 13 and 29 years of age are less engaged in all steps of the HIV care cascade, resulting in exaggerated HIV-related disparities in health and an low rates of overall viral suppression in this group. Stigma, mental health issues, deficits in cognition and executive functioning, and obstacles within multiple categories of social determinants of health can hamper youths’ ability to sustain antiretroviral adherence and reap the benefits of this technology for themselves, their families, and their social networks and communities. The primary goal of this project, nested within the funded trial International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) 2022, is to develop an independent scholarly research program addressing the optimization of the use of LAARV in youth, with the ultimate goal of designing practical interventions to maximize their benefit. This four-year training and research program will consist of: 1) employing novel methods to understand the role of biopsychosocial and cognitive factors in the success of LAARV and potentially establish predictors of the efficacy of LAARV based on various pre-use characteristics in youth; 2) developing and piloting novel bioassays to enable in-the-field collections of Dried Blood Spot (DBS) or Dried Plasma Extractor (DPE) LAARV measurements for use in clinical trials or as therapeutic drug monitoring among YLHIV receiving LAARV; and 3) Learning and leveraging population PK modelling approaches to understand the sources of PK variability in YHIV on LAARV. The training will include formal coursework, direct mentoring, and guided practice-based experience with new methodologies in biostatistics, cognitive neuroscience, quantitative pharmacology and assay development, and advanced population pharmacokinetics. By gaining training from her mentors and collaborators in all these methods, Dr. Weld will establish herself as a clinician-researcher in long-acting infectious disease therapeutics equipped to assess new delivery strategies and technologies as they emerge, and capable of transforming her field. Results of the investigations conducted during the award period will establish a foundation for the subsequent design of interventional studies to improve HIV-related outcomes in youth with less-frequent dosing strategies, and submission of further funding proposals to support this line of inquiry.

项目总结/摘要 感染艾滋病毒和坚持斗争的青年将受益于长效抗逆转录病毒药物（LAARV）， 在美国有售，超过其他群体。13至29岁的艾滋病毒感染者人数较少， 参与艾滋病毒护理级联的所有步骤，导致在健康和艾滋病毒感染方面与艾滋病毒有关的差距扩大， 这一组的总体病毒抑制率较低。污名、心理健康问题、认知缺陷和 执行功能，以及多种类别的健康社会决定因素中的障碍， 年轻人坚持抗逆转录病毒治疗并为自己获得这项技术的好处的能力， 家庭，以及他们的社交网络和社区。该项目的主要目标，嵌套在受资助的 2022年国际孕产妇儿童青少年艾滋病临床试验组（IMPAACT）将制定一项 独立的学术研究计划，致力于优化LAARV在青年中的使用， 最终目标是设计切实可行的干预措施，使其效益最大化。为期四年的培训和研究 该计划将包括：1）采用新的方法来了解生物心理社会和认知的作用 LAARV成功的因素，并根据各种因素潜在地建立LAARV疗效的预测因子。 青年使用前的特点; 2）开发和试点新的生物测定，使在外地收集的 干血斑（DBS）或干血浆提取器（DPE）LAARV测量，用于临床试验或作为 接受LAARV的YLHIV中的治疗药物监测;和3）学习和利用群体PK 建模方法，以了解LAARV上YHIV的PK变异性来源。培训将包括 正式的课程，直接指导，并指导实践为基础的经验与新的方法， 生物统计学，认知神经科学，定量药理学和分析开发，以及高级 群体药代动力学通过从她的导师和合作者那里获得所有这些方法的培训， 焊接将确立自己作为一个临床研究人员在长效传染病治疗装备， 评估新的交付战略和技术，因为他们出现，并能够改变她的领域。 在授予期间进行的调查结果将为随后的 设计干预性研究，以改善使用较低频率给药策略的青少年的艾滋病毒相关结局， 并提交进一步的供资建议，以支持这一调查路线。