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

 描述（由申请人提供）：药物滥用在南非（SA）的艾滋病毒护理中基本上没有得到解决。这是尽管事实上，SA有最多的人生活在 报告还指出，全球艾滋病毒/艾滋病感染率很高，药物滥用很普遍，与抗逆转录病毒疗法的坚持性较差有关。对艾滋病毒护理中的药物滥用和抗逆转录病毒疗法不依从性实施循证干预措施，可以改善艾滋病毒治疗和预防。研究战略。目前的研究采用了理论驱动的方法，以适应和评估在SA的艾滋病毒护理中药物滥用和ART不依从性的准专业人员提供的干预。三个阶段包括：（1）定性评估阶段，通过对患者、提供者和工作人员的深入个人访谈，对实施的障碍和促进因素进行定性评估（n=30）;（2）基于目标1中的定性分析的治疗适应阶段;以及（3）随机导频混合有效性-实现试验1（n=60），在6个月内，与加强标准护理（SOC）相比，辅助专业人员提供干预。有效性成果包括：（1）抗逆转录病毒疗法依从性（实时无线电子监测）;（2）物质使用（尿液分析和自我报告）;（3）病毒载量 （探索性）。实施结果遵循该领域的建议，包括可行性、可接受性以及实施的障碍和促进因素。2 K23为R 01奠定了基础，R 01提出了一项更大规模的试验，使用基于临床的随机化来评估干预措施的实施。培训计划。Magidson博士将接受指导和培训，以符合以下目标：（1）在资源有限的全球环境中实施与药物滥用治疗和艾滋病毒护理相关的科学方法;（2）进行独立的全球临床研究的能力;和（3）定性分析。导师制。K23导师提供对项目目标至关重要的补充专业知识。她的主要导师Bangsberg博士是在资源有限的全球环境中进行ART依从性实施研究的专家，并指导K获奖者过渡到独立研究者。她的共同导师结合联合收割机专业知识干预发展的ART坚持和精神科comorbital（Safren），在SA（乔斯卡）艾滋病毒诊所设置药物滥用筛查，并开发和评估基于证据的干预措施，在SA使用实施科学和定性方法（迈尔斯）。这种指导是由一个顾问团队谁包括国际公认的研究人员在抗逆转录病毒疗法的坚持，定性分析，药物滥用和艾滋病毒，生物统计学，并在SA实施研究的支持。候选人Magidson博士是一名富有成效的早期职业研究人员（有38篇出版物，22篇第一作者，以及专注于国内艾滋病毒和药物滥用有效性研究的F31和R36）。K23将扩大她的职业重点，成为一名独立的调查员，在资源有限的环境中拥有药物滥用和艾滋病毒实施科学的专业知识。

 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.