HIV, Buprenorphine, and the Criminal Justice System

艾滋病毒、丁丙诺啡和刑事司法系统

• 批准号: 8213825
• 负责人: FREDERICK LEWIS ALTICE
• 金额: $ 16.44万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8213825
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adopted; Adoption; Agonist; Alcohols; American; Area; Behavioral; Buprenorphine; CD4 Lymphocyte Count; Caring; Chronic; Clinical; Communities; Comorbidity; Criminal Justice; DSM-IV; Detox; Disease; Drug Formulations; Drug Kinetics; Drug usage; Effectiveness; Elements; Epidemic; Generic Drugs; HIV; HIV Infections; HIV-1; Health; Healthcare; Healthcare Systems; Healthy People 2010; Highly Active Antiretroviral Therapy; Homelessness; Human immunodeficiency virus test; Imprisonment; Individual; Intervention; Jail; Knowledge; Life; Medicine; Mental disorders; Methadone; Modeling; Morbidity - disease rate; Neurocognitive; New York; Opiate Addiction; Opioid; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Philadelphia; Placebo Control; Prisoner; Prisons; Public Health; RNA; Randomized; Randomized Controlled Trials; Regulation; Relapse; Reporting; Research; Research Personnel; Risk; Risk Behaviors; Risk-Taking; Safety; Seasons; Societies; Stigmata; Substance Use Disorder; Substance abuse problem; System; Testing; Time; Toxicology; Traction; Treatment outcome; Urine; Viral; Wisconsin; Work; addiction; burden of illness; cost; craving; disability; drug relapse; effective therapy; high risk; high risk behavior; improved; mathematical model; meetings; mortality; mu opioid receptors; overdose death; placebo controlled study; public health relevance; reincarceration; sex risk; social stigma; substance abuse treatment; transmission process; treatment adherence; trial comparing

DESCRIPTION (provided by applicant): The criminal justice system (CJS) is disproportionately impacted by people with HIV and substance use disorders, such that one quarter of all HIV+ persons nationally cycle through the CJS annually. The CJS is therefore an important place to seek and empirically test interventions that address the Seek, Test, Treat and Retain (STTR) strategy to reduce community-wide HIV transmission. STTR requires that HIV is maximally suppressed, thereby resulting in decreased infectiousness. HIV+ prisoners maximally suppress HIV replication during incarceration. Unfortunately, viral suppression is lost within 3 months post-release, mostly as a consequence of relapse to opioids. Opioid dependence (OD) is present in 50% of all HIV+ prisoners nationally and 70-85% in the Northeast - OD is therefore a significant co-morbid condition requiring effective treatment. Opioid relapse is associated with decreased HAART adherence, discontinuation of HAART and increased HIV risk behaviors in the setting of viral replication - the perfect storm for HIV transmission. Effectively treating OD interrupts this relationship and has great potential to improve HIV outcomes and reduce community-wide transmission. Our team has confirmed for the first time that treating OD with buprenorphine (BPN) results in sustained viral suppression over the vulnerable 3-month post-release period. Adoption of methadone, despite its confirmed benefit, is minimal within the CJS due to philosophical, safety, regulatory and staffing concerns. BPN, a partial opioid agonist, is a more attractive option due to its safer profile and reduced regulation. Generic formulation now makes it affordable. Therefore, strategies examining the efficacy of BPN to improve adherence and retention in care, has great appeal to benefit the individual, but also to reduce HIV transmission within the community. Our specific aims are: 1) to conduct a placebo-controlled RCT of BPN for HIV+ prisoners with OD who are transitioning to the community and 2) to model the impact of BPN treatment on reducing HIV transmission. In the RCT, HIV treatment (HIV-1 RNA levels, CD4 count, ART adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), and HIV risk behaviors (sexual and drug-related risks) outcomes will be compared in 152 released prisoners and followed for 12 months. We bring together the strengths of seasoned researchers who have conducted research in the CJS for two decades in the areas of HIV treatment and adherence, Addiction Medicine and mathematical modeling. BPN, as a medication-assisted therapy, has great appeal within CJS due to lack of stigma, its documented safety in HIV+ patients, its unique pharmacology, lack of stringent regulation and its recently reduced cost. If this placebo-controlled trial of BPN among released HIV+ prisoners with OD demonstrates efficacy and safety, it is likely to become more widely adopted. As such, the individual, our health care system and society have a high likelihood to benefit - especially on reducing HIV transmission within the community. PUBLIC HEALTH RELEVANCE: HIV and substance use disorders, especially opioid dependence, is concentrated within the American criminal justice system (CJS). The period after release from CJS is extremely vulnerable and associated with worsening outcomes from HIV treatment, increased relapse to opioids and increased HIV risk behaviors - a perfect storm for an explosive community-wide epidemic. This proposal intends to improve health to the individual and to the community during the crucial period during transition from the prison to the community.

描述(由申请人提供)：刑事司法系统(CJS)受到艾滋病毒携带者和药物使用障碍患者的不成比例的影响，因此全国所有艾滋病毒+者中有四分之一每年通过CJS循环。因此，CJS是寻求和经验性地测试干预措施的重要场所，这些干预措施解决了旨在减少社区范围艾滋病毒传播的寻求、检测、治疗和保留(STTR)战略。STTR要求最大限度地抑制艾滋病毒，从而降低传染性。艾滋病毒+囚犯在监禁期间最大限度地抑制艾滋病毒复制。不幸的是，病毒抑制在释放后3个月内消失，主要是阿片类药物复发的结果。阿片类药物依赖(OD)存在于全国所有HIV+囚犯中的50%，在东北地区--OD是一种严重的合并症，需要有效的治疗。在病毒复制的背景下，阿片类药物的复发与HAART依从性的下降、HAART的终止和艾滋病毒危险行为的增加有关--这是艾滋病毒传播的完美风暴。有效地治疗吸毒可以中断这种关系，并具有改善艾滋病毒结果和减少社区传播的巨大潜力。我们的团队首次证实，丁丙诺啡(BPN)治疗OD可以在脆弱的释放后3个月内持续抑制病毒。尽管美沙酮的益处已得到证实，但由于哲学、安全、监管和人员配备方面的考虑，美沙酮在CJS中的应用微乎其微。BPN是一种部分阿片激动剂，由于其更安全的外形和更少的监管，是一个更有吸引力的选择。仿制药现在让它变得负担得起。因此，检查BPN的有效性以提高依从性和保留率的策略，不仅对个人有利，而且对减少社区内的艾滋病毒传播具有巨大的吸引力。我们的具体目标是：1)对正在过渡到社区的HIV+吸毒者进行BPN的安慰剂对照RCT；2)模拟BPN治疗对减少艾滋病毒传播的影响。在随机对照试验中，将比较152名获释囚犯的艾滋病毒治疗(HIV-1RNA水平、CD4计数、ART依从性、护理滞留)、药物滥用(复发至阿片类药物使用的时间、阿片类药物阴性尿液、阿片类药物渴求的百分比)和艾滋病毒危险行为(性和药物相关风险)的结果，并跟踪观察12个月。我们汇集了经验丰富的研究人员的力量，他们在CJS进行了20年的艾滋病毒治疗和依从性、成瘾医学和数学建模领域的研究。作为一种药物辅助治疗，BPN在CJS中有很大的吸引力，因为它没有耻辱，它对HIV+患者的安全性有文献记载，它独特的药理，缺乏严格的监管和最近降低的成本。如果这项在获释的HIV+吸毒者中进行的BPN安慰剂对照试验证明了有效性和安全性，它很可能会得到更广泛的采用。因此，个人、我们的卫生保健系统和社会很有可能受益--特别是在减少社区内艾滋病毒传播方面。 公共卫生相关性：艾滋病毒和物质使用障碍，特别是阿片类药物依赖，集中在美国刑事司法系统(CJS)。CJS出院后的一段时间非常脆弱，与艾滋病毒治疗结果恶化、阿片类药物复吸增加和艾滋病毒危险行为增加有关--这是一场爆炸性全社区流行的完美风暴。这项提议意在从监狱向社区过渡的关键时期改善个人和社区的健康。