HIV, Buprenorphine, and the Criminal Justice System

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，因此全国四分之一的艾滋病毒阳性患者每年都要通过CJS。因此，CJS是寻求和经验测试干预措施的重要场所，这些干预措施涉及寻求、检测、治疗和保留（STTR）战略，以减少社区范围内的艾滋病毒传播。STTR要求最大限度地抑制HIV，从而降低传染性。HIV阳性囚犯在监禁期间最大限度地抑制HIV复制。不幸的是，病毒抑制在释放后3个月内消失，主要是由于阿片类药物复发。阿片类药物依赖（OD）在全国所有艾滋病毒阳性囚犯中占50%，在东北部占70-85%，因此，OD是一种需要有效治疗的重要合并症。阿片类药物复发与HAART依从性下降、HAART停药和病毒复制环境下艾滋病毒风险行为增加有关——这是艾滋病毒传播的完美风暴。有效治疗吸毒过量阻断了这种关系，并具有改善艾滋病毒结局和减少社区传播的巨大潜力。我们的团队首次证实，用丁丙诺啡（BPN）治疗OD可在释放后3个月的脆弱期持续抑制病毒。尽管美沙酮的疗效得到证实，但由于哲学、安全、监管和人员配备方面的考虑，美沙酮在CJS中的应用很少。BPN是一种部分阿片类激动剂，由于其更安全且监管更少，因此是一种更有吸引力的选择。通用配方现在使人们负担得起。因此，检查BPN有效性的策略，以提高护理的依从性和保持性，具有极大的吸引力，不仅有利于个人，而且还有助于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HIV+ OD囚犯进行BPN的安慰剂对照随机对照试验；2)模拟BPN治疗对减少HIV传播的影响。在这项随机对照试验中，将比较152名释放囚犯的艾滋病毒治疗（HIV-1 RNA水平、CD4计数、抗逆转录病毒治疗依从性、护理留置）、药物滥用（阿片类药物使用复发时间、阿片类药物阴性尿百分比、阿片类药物渴望）和艾滋病毒风险行为（性和药物相关风险）结果，并对其进行12个月的随访。我们汇集了经验丰富的研究人员的优势，他们在艾滋病治疗和依从性，成瘾医学和数学建模领域在CJS进行了20年的研究。BPN作为一种药物辅助疗法，由于缺乏耻耻感，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的成本降低，在CJS中具有很大的吸引力。如果在释放的HIV+囚犯中进行BPN的安慰剂对照试验证明其有效性和安全性，那么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。

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.