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 这项研究的总体目标是进行可用随机对照试验（RCT）的次要分析 干预数据以获取有关如何改善HIV护理连续体（HIV-CC）结果的可行知识 在使用毒品的艾滋病毒（PLWHUD）的人中。具体来说，我们将使用四个的可用数据 通过分析疗效的调解人和主持人，在没有测试的情况下，不同的RCT具有不同的潜力 相应试验的最初结果分析。 RCT测试了不同的HIV-CC干预措施 plwhud：1）ARCS，该弧测试了社区和个人水平的污名化干预措施 在越南注射毒品的艾滋病毒； 2）希望，测试了患者导航和应急管理 在美国艾滋病毒患有同时发生药物使用障碍的医院患者中； 3）林 在俄罗斯患有艾滋病毒的俄罗斯患者中测试了基于优势的患者导航干预 同时出现的注射药物使用； 4）HPTN 074，一个HIV预防试验网络RCT，测试了 涉及系统导航，社会心理咨询和艺术启动的干预措施 在越南，印度尼西亚和乌克兰注射毒品的艾滋病毒。具体目的包括：1）确定如何以及为谁和谁 HIV-CC干预措施改善了PLWHUD的生物学结果（病毒抑制，CD4，死亡率）。为了这 目的我们将在所有四个有关基于理论的介体和使用物质的试验中测试一致的假设 调解员以及主持人和有条件的过程模型（同时测试了调解人和 单个模型中的主持人）； 2）检查哪些特定介体主要影响HIV-CC结果 PLWHUD的亚组使用新的因果中介分析来增强因果推断； 3）我们将 审查我们迄今为止的证据，以传播艾滋病毒行为干预者如何达到改进的标准 用于对RCT进行完整评估（即测试介质和主持人）。该研究由艾滋病毒专家领导 脆弱人群中的预防和关怀，包括使用毒品的人和高级专家 调解和适度分析。研究活动和可交付成果也将通过科学的信息来告知 咨询委员会由四个试验中的每个试验的原始主要调查员组成，以及 来自每个试验的原始共同研究器。这些人包括HIV-CC领域的一些领先专家 参与使用毒品的人的参与，并有助于告知分析和解释 结果。该研究以我们以前由NIH R01资助的研究为基础，该研究证明了调解和如何调解 适度分析有助于为预防艾滋病毒预防中发现的有效和非高效结果提供新的启示 RCT。超越了我们先前的研究，在当前的研究中，我们将向该研究传播可访问的工具 艾滋病毒领域应该改善我们对干预措施的评估，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，我们可以对使用药物在 HIV-CC干预措施对PLWHUD的疗效，这是为了结束HIV流行而支持的关键人群。