Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa

 描述(由申请人提供)：在南非(SA)的艾滋病毒护理中，药物滥用基本上没有得到解决。这是尽管南卡罗来纳州有最多的人与 艾滋病毒/艾滋病在全球普遍存在，药物滥用与更差的抗逆转录病毒疗法(抗逆转录病毒疗法)依从性有关。对药物滥用和辅助专业人员在艾滋病毒护理中不坚持抗逆转录病毒疗法实施循证干预可能会改善艾滋病毒的治疗和预防。研究策略。目前的研究使用了一种理论驱动的方法来适应和评估由准专业人员提供的针对SA艾滋病毒护理中的药物滥用和ART不遵守的干预措施。三个阶段包括：(1)通过对患者、提供者和工作人员进行深入的个人访谈，对实施的障碍和促进者进行定性评估(n=30)；(2)基于目标1中的定性分析的治疗适应阶段；(3)随机试点混合有效性-实施试验1(n=60)，以评估经过调整的、准专业提供的干预措施与增强的护理标准(SOC)相比的6个月。有效性结果包括：(1)抗逆转录病毒治疗依从性(实时无线电子监测)；(2)药物使用(尿液分析和自我报告)；以及(3)病毒载量。 (探索性)。实施结果遵循现场建议，包括可行性、可接受性以及实施的障碍和促进者。2 K23为R01提议使用基于临床的随机化来评估干预实施情况的更大规模试验奠定了基础。培训计划。在研究计划的协调下，马吉德森博士将接受指导和培训，以符合以下每个目标：(1)在资源有限的全球环境中与药物滥用治疗和艾滋病毒护理相关的实施科学方法；(2)进行独立的全球临床研究的能力；以及(3)定性分析。师徒关系。K23导师提供以项目目标为核心的补充专业知识。她的主要导师邦斯伯格博士是在资源有限的全球环境下进行ART遵守实施研究的专家，并指导K获奖者过渡到独立调查人员。她的共同导师结合了关于抗逆转录病毒治疗依从性和精神共病的专业干预开发(SAFREN)、在SA艾滋病毒诊所环境中筛查药物滥用(Joska)，以及使用实施科学和定性方法(Myers)开发和评估SA药物使用的循证干预措施。这种指导得到了一个顾问团队的支持，他们包括在遵守ART、定性分析、药物滥用和艾滋病毒、生物统计学和SA实施研究方面的国际公认的调查人员。候选人。作为一名早期职业研究人员，马吉德森博士卓有成效(发表了38篇论文，22篇第一作者，F31和R36专注于国内艾滋病毒和药物滥用有效性研究)。K23将扩大她的职业重点，成为一名独立调查员，在资源有限的情况下，拥有药物滥用和艾滋病毒实施科学方面的专业知识。

 DESCRIPTION (provided by applicant): Substance abuse is largely not addressed in HIV care in South Africa (SA). This is despite the fact that SA has the largest number of people living with HIV/AIDS globally, and that substance abuse is prevalent and associated with worse antiretroviral therapy (ART) adherence. Implementing evidence-based interventions for substance abuse and ART nonadherence in HIV care by paraprofessionals may improve HIV treatment and prevention. Research Strategy. The current study uses a theoretically-driven approach to adapt and evaluate a paraprofessional-delivered intervention for substance abuse and ART nonadherence in HIV care in SA. Three phases include: (1) Qualitative assessment phase of barriers and facilitators to implementation using in-depth individual interviews with patients, providers and staff (n=30); (2) Treatment adaptation phase based upon qualitative analysis in Aim 1; and (3) Randomized pilot hybrid effectiveness-implementation trial1 (n=60) to evaluate the adapted, paraprofessional delivered intervention compared to enhanced standard of care (SOC) over 6 months. Effectiveness outcomes include: (1) ART adherence (real-time wireless electronic monitoring); (2) substance use (urinalysis and self-report); and (3) viral load (exploratory). Implementation outcomes follow recommendations in the field and include feasibility, acceptability, and barriers and facilitators to implementation.2 The K23 lays the groundwork for an R01 to propose a larger-scale trial using clinic-based randomization to evaluate the implementation of the intervention. Training Plan. Coordinated with the research plan, Dr. Magidson will receive mentorship and training to correspond with each aim in the following: (1) implementation science methodology relevant to substance abuse treatment and HIV care in resource-limited global settings; (2) competence for conducting independent, global clinical research; and (3) qualitative analysis. Mentorship. K23 mentors offer complementary expertise central to project aims. Her primary mentor, Dr. Bangsberg, is an expert in ART adherence implementation research in resource-limited global settings, and mentoring K awardees to transition to independent investigators. Her co-mentors combine expertise intervention development for ART adherence and psychiatric comorbidity (Safren), screening for substance abuse in HIV clinic settings in SA (Joska), and developing and evaluating evidence-based interventions for substance use in SA using implementation science and qualitative methods (Myers). This mentorship is supported by a team of consultants who comprise internationally recognized investigators in ART adherence, qualitative analysis, substance abuse and HIV, biostatistics, and implementation research in SA. Candidate. Dr. Magidson has been productive as an early career researcher (with 38 publications, 22 first author, and an F31 and R36 focused on domestic HIV and substance abuse effectiveness research). The K23 would expand her career focus to become an independent investigator with expertise in implementation science for substance abuse and HIV in resource-limited settings.