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

项目总结 本研究的总体目标是对可用的随机对照试验(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 在使用药物(PLWHUD)的艾滋病毒携带者中。具体地说，我们将使用来自四个 不同的随机对照试验通过分析未经测试的有效性的调节剂和调节剂来充分发挥其潜力 各次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，它测试了对生活在社区和个人层面的人们减少污名的干预措施 在越南注射毒品的艾滋病毒感染者；2)HOPE，它测试了患者导航和应急管理 在美国艾滋病毒携带者的住院患者中，患有共生物质使用障碍；3)LINC，它 在俄罗斯感染艾滋病毒的医院患者中测试了基于优势的患者导航干预 以及4)HPTN 074，一个HIV预防试验网络RCT，测试了一个 涉及系统导航、心理社会咨询和艺术启蒙的干预措施 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)确定方式和对象 HIV-CC干预改善了PLWHUD中的生物学结果(病毒抑制、CD4、死亡率)。为了这个 目的：我们将在所有四个关于基于理论的介体和物质使用的试验中测试一致的假设。 调解人以及主持人，以及条件流程模型(同时测试调解人和 单一模型中的主持人)；2)检查以下哪些特定的媒介主要影响HIV-CC结果 PLWHUD的子群使用新的因果中介分析来加强因果推理；以及3)我们将 回顾我们迄今的证据，以传播艾滋病毒行为干预者如何达到改进的标准 在随机对照试验中进行完整的评估(即测试调解人加上主持人)。这项研究是由艾滋病专家领导的 预防和护理弱势人群，包括吸毒者和先进技术专家 调解与缓和分析。研究活动和交付成果也将由科学专家通知 咨询委员会，由四项审判的原首席调查员以及一名 每一次试验的原始联合调查员。这些人包括一些艾滋病毒-CC领域的顶尖专家 对吸毒者的参与，并将有助于为分析和解释 结果。这项研究建立在我们之前由NIH R01资助的研究的基础上，该研究证明了调解和 适度分析有助于揭示艾滋病毒预防的有效和无效结果 RCT。超越我们以前的研究，在当前的研究中，我们将向 艾滋病毒领域应该改进我们对干预措施的评价，这将加速每个未来的影响 RCT。最后，通过分析与药物使用相关的变量，我们获得了有价值的洞察药物使用在 HIV-CC干预措施对PLWHUD的有效性，PLWHUD是为结束艾滋病毒流行而需要支持的关键人群。

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.