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: 8490328
• 负责人: FREDERICK LEWIS ALTICE
• 金额: $ 84.53万
• 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/8490328
• 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 risk; 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; 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; 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.

描述（由申请人提供）：刑事司法系统（CJS）受到艾滋病毒和药物使用障碍患者的不成比例的影响，例如全国四分之一的艾滋病毒+患者每年都通过CJS循环。因此，社区卫生服务中心是一个重要的地方，可以寻求和经验性地测试干预措施，这些干预措施涉及“寻找、测试、治疗和保留”战略，以减少整个社区的艾滋病毒传播。STTR要求最大限度地抑制HIV，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个月内丧失，主要是由于阿片类药物复发。阿片类药物依赖（OD）存在于全国50%的艾滋病毒阳性囚犯和70-85%的东北部-因此，OD是一个重要的共病条件，需要有效的治疗。阿片类药物复发与HAART依从性降低、HAART中止和病毒复制背景下HIV风险行为增加相关-这是HIV传播的完美风暴。有效治疗OD中断这种关系，并有很大的潜力，以改善艾滋病毒的结果，减少社区范围内的传播。我们的团队首次证实，用丁丙诺啡（BPN）治疗OD会在释放后的3个月内持续抑制病毒。采用美沙酮，尽管其确认的好处，是最小的CJS由于哲学，安全性，监管和人员配置的问题。BPN是一种部分阿片类激动剂，由于其更安全的特性和减少的监管，是一种更有吸引力的选择。通用配方现在使其负担得起。因此，研究BPN的有效性以提高护理的依从性和保留率的策略，不仅对个人有很大的吸引力，而且还可以减少社区内的艾滋病毒传播。我们的具体目标是：1）对正在向社区过渡的艾滋病毒阳性吸毒成瘾囚犯进行BPN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RCT中，将在152名获释囚犯中比较HIV治疗（HIV-1 RNA水平、CD 4计数、ART依从性、护理保留）、物质滥用（阿片类药物使用复发时间、阿片类药物阴性尿液百分比、阿片类药物渴求）和HIV风险行为（性和药物相关风险）结局，并随访12个月。我们汇集了经验丰富的研究人员的优势，他们在艾滋病毒治疗和坚持，成瘾医学和数学建模领域进行了二十年的研究。BPN作为一种药物辅助治疗，由于缺乏耻辱感，其在HIV+患者中的安全性，其独特的药理学，缺乏严格的监管以及最近降低的成本，在CJS中具有很大的吸引力。如果在释放的艾滋病毒阳性囚犯中进行的安慰剂对照试验证明了BPN的有效性和安全性，它可能会被更广泛地采用。因此，个人、我们的卫生保健系统和社会都很有可能受益，特别是在减少社区内艾滋病毒传播方面。