Estimating Mediation and Moderation Effects in HIV Care Continuum Intervention Trials for People who Use Drugs

估计吸毒者艾滋病毒护理连续干预试验中的中介和调节效应

• 批准号: 10676648
• 负责人: Eileen Virtusio Pitpitan
• 金额: $ 74.21万
• 依托单位: SAN DIEGO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10676648
• 关键词: AIDS prevention; Acceleration; Address; Advisory Committees; Affect; Asia; Automobile Driving; Behavior Therapy; Behavioral; Biological; Caring; Clinic; Communities; Continuity of Patient Care; Counseling; Data; Diving; Drug usage; Drug user; Eastern Europe; Epidemic; Evaluation; Evaluation Research; Face; Funding; Future; Goals; Guidelines; HIV; HIV Seropositivity; HIV prevention trials network; Hospitals; Housing; Incidence; Individual; Indonesia; Intervention; Intervention Trial; Knowledge; Light; Masks; Measures; Mediating; Mediation; Mediator; Mental Depression; Methods; Modeling; Outcome; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Population; Prevention trial; Principal Investigator; Process; Publishing; Randomized, Controlled Trials; Reduce health disparities; Reporting; Research; Research Personnel; Resources; Review Literature; Role; Russia; Science; Social support; Subgroup; Substance Use Disorder; System; Techniques; Testing; Time; Treatment Efficacy; Ukraine; United States National Institutes of Health; Vietnam; Viral; Vulnerable Populations; advanced analytics; care outcomes; condomless anal sex; contingency management; cost effective intervention; follow-up; high risk; implementation barriers; improved; improved outcome; injection drug use; insight; intervention effect; medical vulnerability; men; men who have sex with men; mortality; patient navigation; preventive intervention; primary outcome; psychosocial; secondary analysis; social stigma; social vulnerability; stimulant use; substance use; success; systematic review; theories; therapy design; tool; trial design

PROJECT SUMMARY The overall goal of this study is to conduct secondary analyses of available randomized controlled trial (RCT) intervention data to gain actionable knowledge about how to improve HIV care continuum (HIV-CC) outcomes among people living with HIV who use drugs (PLWHUD). Specifically, we will use available data from four different RCTs to their full potential by analyzing mediators and moderators of efficacy that were not tested during the original outcome analysis of the respective trials. The RCTs tested different HIV-CC interventions for PLWHUD: 1) ARCS, which tested a community and individual level stigma reduction intervention for people living with HIV who inject drugs in Vietnam; 2) HOPE, which tested patient navigation and contingency management among hospital patients in the U.S. living with HIV with co-occurring substance use disorder; 3) LINC, which tested a strengths-based patient navigation intervention among hospital patients in Russia living with HIV with co-occurring injection drug use; and 4) HPTN 074, a HIV Prevention Trials Network RCT that tested an intervention involving systems navigation, psychosocial counseling, and ART initiation among people living with HIV who inject drugs in Vietnam, Indonesia, and Ukraine. Specific aims include: 1) Determine how and for whom HIV-CC interventions improve biological outcomes (viral suppression, CD4, mortality) among PLWHUD. For this aim we will test concordant hypotheses across all four trials about theory-based mediators and substance use mediators, as well as moderators, and conditional process models (that simultaneously test mediators and moderators in a single model); 2) Examine which specific mediators primarily affect HIV-CC outcomes among subgroups of PLWHUD using newer causal mediation analysis to strengthen causal inference; and 3) We will review our evidence to date to disseminate how HIV behavioral interventionists can meet improved standards for complete evaluations in RCTs (i.e., test mediators plus moderators). The research is led by experts in HIV prevention and care among vulnerable populations, including people who use drugs, and experts in advanced mediation and moderation analysis. The study activities and deliverables will also be informed by a Scientific Advisory Committee comprised of the original Principal Investigators from each of the four trials, as well as an original Co-Investigator from each of the trials. These individuals include some of the leading experts in HIV-CC engagement for people who use drugs and will be instrumental to informing the analyses and interpretation of results. The research builds on our previous NIH R01-funded research that demonstrated how mediation and moderation analyses help to shed new light on efficacious and non-efficacious results found in HIV prevention RCTs. Moving beyond our previous research, in the current study we will disseminate accessible tools to the HIV field that should improve our evaluation of interventions, and that will accelerate the impact of each future RCT. Last, by analyzing drug use-related variables we gain valuable insight into the role of drug use in the efficacy of HIV-CC interventions for PLWHUD, a critical population to support in order to end the HIV epidemic.

项目摘要 本研究的总体目标是对现有的随机对照试验（RCT）进行二次分析 干预数据，以获得关于如何改善艾滋病毒护理连续体（HIV-CC）结果的可操作知识 艾滋病毒感染者吸毒者（PLWHUD）。具体而言，我们将使用四个可用数据 不同的RCT充分发挥其潜力，通过分析中介和调节剂的疗效，没有测试期间 各试验的原始结果分析。随机对照试验测试了不同的HIV-CC干预措施， PLWHUD：1）ARCS测试了社区和个人层面的减少耻辱感干预措施， 在越南注射毒品的艾滋病毒感染者; 2）HOPE，测试患者导航和应急管理 在美国的医院患者中，艾滋病毒感染者患有共同发生的物质使用障碍; 3）LINC， 在俄罗斯感染艾滋病毒的医院患者中测试了一种基于力量的患者导航干预， 同时发生的注射毒品使用;和4）HPTN 074，艾滋病毒预防试验网络RCT，测试了 干预，包括系统导航，心理咨询和ART启动的人生活 在越南、印度尼西亚和乌克兰注射毒品的艾滋病毒感染者。具体目标包括：1）确定如何和为谁 艾滋病毒/艾滋病干预措施改善了艾滋病毒感染者/艾滋病患者的生物学结果（病毒抑制、CD 4、死亡率）。为此 目的：我们将在所有四项试验中检验关于基于理论的介质和物质使用的一致性假设 调解人，以及主持人，和条件过程模型（同时测试调解人和 在单一模型中的主持人）; 2）检查哪些特定的介质主要影响HIV-CC结果， 使用较新的因果中介分析来加强因果推理的PLWHUD亚组;以及3）我们将 审查我们迄今为止的证据，以宣传艾滋病毒行为干预人员如何达到改进的标准 对于RCT中的完整评价（即，测试中介加主持人）。这项研究由艾滋病专家领导 包括吸毒者在内的弱势群体和先进的预防和护理专家 调解和适度分析。研究活动和可交付成果也将由科学家告知 咨询委员会由四项审判中每项审判的最初主要调查员以及 每项试验的原始合作研究者。这些人包括一些艾滋病毒/艾滋病方面的主要专家 吸毒者的参与，并将有助于为分析和解释 结果这项研究建立在我们以前的NIH R 01资助的研究基础上，该研究证明了中介和 适度分析有助于揭示艾滋病毒预防中发现的有效和无效结果 随机对照试验。超越我们以前的研究，在目前的研究中，我们将传播无障碍工具， 艾滋病毒领域，这应该改善我们对干预措施的评估，并将加速每一个未来的影响 RCT。最后，通过分析与药物使用相关的变量，我们对药物使用在药物使用中的作用有了有价值的了解。 艾滋病毒/艾滋病干预措施对艾滋病毒/艾滋病感染者的有效性，这是结束艾滋病毒流行病需要支持的关键人群。