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.

项目概要 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，以获得有关如何改善艾滋病毒护理连续体（HIV-CC）结果的可行知识 吸毒艾滋病毒感染者 (PLWHUD)。具体来说，我们将使用来自四个方面的可用数据 通过分析期间未测试的功效调节因子和调节因子，充分发挥不同随机对照试验的潜力 各个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，测试了针对生活在社区和个人层面的减少耻辱的干预措施 在越南注射吸毒的艾滋病毒携带者； 2) HOPE，测试了患者导航和应急管理 在美国住院的艾滋病毒感染者中，同时存在药物使用障碍； 3）LINC，其中 在俄罗斯医院感染艾滋病毒的患者中测试了基于优势的患者导航干预 同时发生注射吸毒； 4) HPTN 074，一项 HIV 预防试验网络 RCT，测试了 干预措施包括系统导航、社会心理咨询和对患有艾滋病的人进行抗逆转录病毒治疗（ART）启动 越南、印度尼西亚和乌克兰注射吸毒者中的艾滋病毒感染者。具体目标包括： 1) 确定如何以及为谁 HIV-CC 干预措施可改善 PLWHUD 的生物学结果（病毒抑制、CD4、死亡率）。为了这 目标是我们将在所有四项试验中检验关于基于理论的中介因素和物质使用的一致假设 中介者、调节者和条件过程模型（同时测试中介者和调节者） 单一模型中的主持人）； 2) 检查哪些特定介质主要影响 HIV-CC 结果 PLWHUD 亚组使用更新的因果中介分析来加强因果推理； 3) 我们将 回顾我们迄今为止的证据，以传播艾滋病毒行为干预专家如何达到改进的标准 用于 RCT 的完整评估（即测试调解者加调解者）。该研究由艾滋病毒专家领导 弱势群体（包括吸毒者）和先进专家的预防和护理 中介和调节分析。研究活动和可交付成果也将由科学专家告知 咨询委员会由四项试验的原首席研究员以及一名 每个试验的原始联合研究者。这些人包括一些 HIV-CC 领域的顶尖专家 吸毒者的参与，并将有助于为吸毒者的分析和解释提供信息 结果。这项研究建立在我们之前 NIH R01 资助的研究的基础上，该研究展示了调解和 适度分析有助于揭示艾滋病毒预防中有效和无效结果的新线索 随机对照试验。超越我们之前的研究，在当前的研究中，我们将向人们传播可用的工具 艾滋病毒领域应该改善我们对干预措施的评估，并将加速每个未来的影响 随机对照试验。最后，通过分析与药物使用相关的变量，我们获得了关于药物使用在经济中的作用的宝贵见解。 HIV-CC 干预措施对 PLWHUD 的有效性，PLWHUD 是结束 HIV 流行需要支持的关键人群。