Medication Assisted Therapy as a Conduit to Care for HIV+ CJS Populations Transit

药物辅助治疗作为护理艾滋病毒的渠道 CJS 人群转运

基本信息

批准号：
8209872
负责人：
SANDRA Ann SPRINGER
金额：
$ 15.42万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-01 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8209872
关键词：
Acquired Immunodeficiency Syndrome Address Adherence Administrator Adverse effects Agonist Alcohol consumption Alcohol dependence Alcohol or Other Drugs use Alcohols Area Award Awareness Behavior Buprenorphine CD4 Positive T Lymphocytes Caring Clinical Communicable Diseases Communities Consensus Continuity of Patient Care Criminal Justice Development Drug abuse Drug usage Education Evidence based intervention Evidence based treatment FDA approved Funding Goals Grant HIV Health Policy Healthcare Systems Highly Active Antiretroviral Therapy Imprisonment Incidence Independent Scientist Award Individual Injection of therapeutic agent Interdisciplinary Study International Intervention K-Series Research Career Programs Link Medical Medicine Mental Health Mentors Mentorship Methadone Methodology Methods Morbidity - disease rate NCI Scholars Program Naloxone Naltrexone Narcotic Antagonists National Institute of Drug Abuse National Institute on Alcohol Abuse and Alcoholism Neurocognitive Opiate Addiction Opioid Opioid Rotation Outcome Outcome Study Overdose Persons Pharmaceutical Preparations Pharmacotherapy Physicians Placebo Control Policy Making Population Postdoctoral Fellow Prevalence Prevention therapy Prisoner Productivity Protocols documentation Public Health Publications Qualifying RNA Recording of previous events Relapse Research Research Activity Research Personnel Risk Risk Behaviors Risk-Taking Safety Societies Substance Use Disorder Substance abuse problem System Testing Therapeutic Time Training United States United States National Institutes of Health Universities Viral Viral Load result Wood material Work addiction adverse outcome alcohol abuse therapy alcohol relapse antiretroviral therapy career community setting cost disorder later incidence prevention drug relapse experience hazardous drinking improved interest meetings model development mortality novel platform-independent pre-doctoral prevent programs public health relevance randomized placebo controlled trial response standard of care substance abuse treatment transmission process uptake

项目摘要

DESCRIPTION (provided by applicant): This is an independent scientist award to assist in the continued research of Dr. Sandra Springer, who focuses her research on interventions that will improve linkages to care for HIV+ criminal justice populations (CJS) with co-morbid substance use disorders who are transitioning to the community. This award will also increase her time to devote towards mentoring young investigators who share this interest. HIV and drug abuse is concentrated within the CJS, therefore, it is an important place to target and empirically test interventions that address strategies to reduce HIV transmission within the community. When HIV is maximally suppressed decreased infectiousness is the result. HIV+ prisoners successfully achieve suppression during incarceration, however 3 months post-release viral suppression is lost, mostly due to relapse to drugs and alcohol. Opioid dependence (OD) and alcohol dependence (AD) are present in 50-70% of HIV+ prisoners nationally. Relapse to substance use is associated with discontinuation of HAART adherence and increased HIV risk behaviors, the perfect storm for HIV transmission. Effectively treating OD and AD interrupts this relationship and has great potential to improve HIV outcomes. Opioid substitution therapy, especially methadone, has had limited uptake within the CJS due to philosophical, safety, regulatory and staffing concerns. Similarly, pharmacologic interventions to target treatment of AD are essentially nonexistent within the CJS. Therefore, strategies examining the efficacy of naltrexone (NTX), an opioid antagonist approved by the FDA for treatment of both OD and AD, to improve adherence and retention in care, has great appeal to benefit the individual and to reduce HIV transmission within the community. Dr. Springer has been awarded 2 R01s (Project 1, NIDA R01 DA030762; and Project 2, R01 AA018944) that serve as the research platform for this independent scientist award. The specific aim of both studies is to conduct a placebo-controlled RCT of extended-release NTX (XR- NTX) for HIV+ prisoners with OD (project 1) and AD (project 2) who are transitioning to the community. The placebo-control methodology further strengthens any findings that should be demonstrated. HIV treatment, substance abuse, adverse side effects and HIV risk behavior outcomes will be compared in subjects within CJS in New Haven, Hartford and Springfield. This therapeutic approach has great appeal by the CJS, given the ease of monthly injections, lack of diversion, few side effects and no antagonistic philosophical concerns about its use. The strength of this proposal is that Dr. Springer is experienced in HIV, addiction and the CJS; the novel use of pharmacologic interventions to prevent relapse to OD and AD as a means to improve HIV outcomes; over 7 years of conducting research in the CJS; and the novelty of using XR-NTX for the treatment of OD and AD. These trials may demonstrate efficacy and safety, and then XR-NTX is likely to become an evidence-based intervention with released HIV+ prisoners. As such, the individual, our health care system and society have a high likelihood to benefit - especially on the reduction of HIV within the community. PUBLIC HEALTH RELEVANCE: This award will assist in increasing mentorship of young investigators who are interested in a research career involving interventions that will assist in treatment of HIV+ CJS populations with co-occurring substance use disorders. Using randomized, placebo-controlled trials, HIV treatment, opioid and alcohol treatment and HIV risk behavior outcomes are examined among HIV-infected prisoners with opioid dependence and alcohol dependence who are treated with extended-release naltrexone (XR-NTX) as they are transitioning from the correctional to the community setting. The public health relevance is that outcomes from these studies will establish the efficacy, safety and tolerability of pharmacological therapy using XR-NTX treatment among HIV+ persons within the CJS and establish XR-NTX treatment as an effective, evidence-based treatment for opioid and alcohol dependence for released HIV+ prisoners - a population who shares a disproportionate burden of morbidity and mortality and has fared poorly using the existing standard of care. 1

描述（由申请人提供）：这是一个独立的科学家奖，旨在协助桑德拉·斯普林格（Sandra Springer）博士的持续研究，后者将研究重点放在干预措施上，这些干预措施将改善与艾滋病毒+刑事司法人群（CJS）与正在向社区过渡的共同食物使用障碍的联系。该奖项还将增加她投入指导分享这一兴趣的年轻调查员的时间。艾滋病毒和药物滥用集中在CJ中，因此，它是针对和经验测试干预措施的重要场所，以解决减少社区内艾滋病毒传播的策略。当HIV最大抑制后，传染性降低是结果。艾滋病毒+囚犯在监禁期间成功实现了抑制，但是释放后病毒后的3个月丢失了，这主要是由于毒品和酒精的复发。阿片类药物依赖（OD）和酒精依赖（AD）在全国艾滋病毒+囚犯中有50-70％存在。复发到药物使用与停止HAART依从性和增加的HIV风险行为有关，这是HIV传播的理想风暴。有效地处理OD和AD会中断这种关系，并具有改善HIV结局的巨大潜力。由于哲学，安全，监管和人员处理，阿片类药物替代疗法，尤其是美沙酮，在CJS中的吸收有限。同样，在CJS中，针对AD的靶向治疗的药理干预措施本质上不存在。因此，研究了Naltrexone（NTX）的效力，NTX是FDA批准的OD和AD治疗的阿片类药物拮抗剂，以提高护理中的依从性和保留率，具有使个人受益并减少社区内的HIV传播的呼吁。 Springer博士被授予2 R01（项目1，NIDA R01 DA030762;和Project 2，R01 AA018944），后者是该独立科学家奖的研究平台。这两项研究的具体目的是针对与OD（项目1）和AD（项目2）过渡到社区的HIV+囚犯的扩展释放NTX（XR-NTX）的安慰剂对照RCT。安慰剂控制方法进一步增强了应证明的任何发现。将在纽黑文，哈特福德和斯普林菲尔德的CJ中比较艾滋病毒治疗，药物滥用，不良副作用和艾滋病毒风险行为结果。考虑到每月注射，缺乏转移，副作用很少，对其使用的抗衡哲学问题，这种治疗方法对CJS具有很大的吸引力。该提议的优势在于，施普林格博士在艾滋病毒，成瘾和CJS方面经验丰富。药理学干预措施的新型使用以防止复发到OD和AD作为改善HIV结局的一种手段；在CJS进行了7年以上的研究；以及使用XR-NTX治疗OD和AD的新颖性。这些试验可能表明有效性和安全性，然后XR-NTX可能会成为与释放的HIV+囚犯的循证干预措施。因此，个人，我们的医疗保健系统和社会很有可能受益 - 尤其是在社区内减少艾滋病毒的情况下。公共卫生相关性：该奖项将有助于增加对研究职业感兴趣的年轻调查人员的指导，这些研究职业涉及干预措施，该研究将有助于治疗HIV+ CJS种群，并具有同时发生的药物使用障碍。使用随机的，安慰剂对照试验，HIV治疗，阿片类药物和酒精治疗以及HIV风险行为结果在受艾滋病毒感染的囚犯中进行了阿片类药物依赖性和酒精依赖性，这些囚犯正在通过延长释放的naltrexone（XR-NTX）进行从矫正到社区环境过渡，以进行扩展释放naltrexone（XR-NTX）。公共卫生相关性是，这些研究的结果将在CJS中使用XR-NTX治疗来确定药理学治疗的功效，安全性和耐受性，并建立XR-NTX治疗作为一种有效的，基于循证的治疗方法，用于对释放的HIV+囚犯的依赖性和差异不足的人口，具有较差的型号和诺尔替代性和差异性，并具有差异性和差异性，并具有较差的型号，并且是对士兵的差异和差异的差异。 1