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

• 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
• 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

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，以帮助桑德拉·斯普林格博士的继续研究，她的研究重点是干预措施，以改善对患有共病药物使用障碍的艾滋病毒+刑事司法人群(CJS)的护理，这些人群正在过渡到社区。这一奖项还将增加她致力于指导有同样兴趣的年轻调查人员的时间。艾滋病毒和药物滥用集中在CJS，因此，它是一个重要的地方，可以有针对性地和经验性地测试针对减少社区内艾滋病毒传播战略的干预措施。当艾滋病毒被最大限度地抑制时，传染性就会降低。HIV+囚犯在监禁期间成功实现了抑制，但在释放后3个月失去了病毒抑制，主要是由于复吸毒品和酒精。阿片类药物依赖(OD)和酒精依赖(AD)存在于全国50%-70%的HIV+囚犯中。再次使用药物与停止遵守HAART和增加艾滋病毒危险行为有关，这是艾滋病毒传播的完美风暴。有效治疗强迫症和阿尔茨海默病可以中断这种关系，并有很大潜力改善艾滋病毒的结果。由于哲学、安全、监管和人员配备方面的考虑，阿片替代疗法，特别是美沙酮，在CJS中的吸收有限。同样，针对AD的靶向治疗的药物干预在CJS中基本上不存在。因此，检查FDA批准的用于治疗OD和AD的阿片类拮抗剂纳曲酮(NTX)的有效性，以提高依从性和在护理中的保留率，对造福个人和减少社区内艾滋病毒传播具有巨大的吸引力。施普林格博士获得了两个R01奖(项目1，NIDA R01 DA030762；项目2，R01 AA018944)，作为这一独立科学家奖的研究平台。这两项研究的具体目的都是为过渡到社区的HIV+吸毒者(项目1)和AD(项目2)进行安慰剂控制的缓释NTX随机对照试验(XR-NTX)。安慰剂对照方法进一步加强了任何应该得到证实的发现。将在纽黑文、哈特福德和斯普林菲尔德的CJS受试者中比较艾滋病毒治疗、药物滥用、不良副作用和艾滋病毒危险行为结果。这种治疗方法对CJS很有吸引力，因为它每月注射容易，没有分流，副作用很少，而且对其使用没有对立的哲学担忧。这项建议的力量在于，斯普林格博士在艾滋病毒、成瘾和慢性焦虑症方面经验丰富；在预防吸毒和AD复发的药物干预措施作为改善艾滋病毒结局的一种手段方面具有新颖性；在慢性焦虑症方面进行了7年以上的研究；以及使用XR-NTX治疗吸毒和阿尔茨海默病的新颖性。这些试验可能会证明有效性和安全性，然后XR-NTX很可能成为对获释的HIV+囚犯进行的循证干预。因此，个人、我们的医疗保健系统和社会很有可能受益--特别是在社区内减少艾滋病毒方面。 公共卫生相关性：该奖项将有助于增加对年轻研究人员的指导，这些年轻研究人员对涉及干预措施的研究生涯感兴趣，这些干预措施将有助于治疗患有共发物质使用障碍的艾滋病毒+CJS人群。使用随机、安慰剂对照试验，在艾滋病毒感染的阿片类药物依赖和酒精依赖的囚犯中，检查了艾滋病毒治疗、阿片类药物和酒精治疗以及艾滋病毒危险行为结果，这些囚犯在从管教环境过渡到社区环境时接受了缓释纳曲酮(XR-NTX)治疗。与公共卫生相关的是，这些研究的结果将确定在CJS内使用XR-NTX疗法的药物疗法的有效性、安全性和耐受性，并将XR-NTX疗法确立为对获释艾滋病毒+囚犯的阿片类药物和酒精依赖的有效、循证治疗--这一群体分担了不成比例的发病率和死亡率负担，在现有护理标准下进展不佳。1