Abstinence Reinforcing Contingency Management to Suppress HIV Viral Load

描述（由申请人提供）：尽管艾滋病毒治疗取得了进展，但艾滋病毒感染的吸毒者的治疗结果仍然很差。由于艾滋病毒治疗欠佳，艾滋病毒感染控制不力，吸毒者很有可能将艾滋病毒感染传染给其伴侣，导致严重的公共卫生后果。很少有研究测试干预措施，以改善艾滋病毒感染的吸毒者的结果，许多人专注于提高HAART坚持。在活跃的药物使用者中，这些干预措施提高了依从性，但不影响药物使用，导致病毒载量（VL）抑制的适度改善（如果有的话）。在药物使用者中，不解决药物使用的情况下，不太可能实现和维持具有临床意义的VL抑制。尽管如此，我们并不知道有任何研究调查了旨在减少毒品使用的干预措施是否改善了艾滋病毒相关的结果。由于禁欲强化应急管理（CM）极大地减少了药物使用，减少药物使用与改善艾滋病毒的结果，禁欲强化CM的好处可能会扩大到改善艾滋病毒治疗的结果。然而，这还没有被研究过。我们的研究将是第一个测试CM是否加强一种行为（实现禁欲）导致其他相关行为（实现VL抑制）的结果改善的研究。我们建议测试是否禁欲加强CM干预改善VL抑制HIV感染的吸毒者。我们将招募202名接受次优药物和HIV治疗的受试者（在接受阿片类激动剂治疗时使用可卡因或阿片类药物，在处方HAART时可检测到VL），以测试16周的禁欲强化CM对VL抑制的干预。受试者将被随机分配至禁欲强化CM干预或表现反馈（对照条件）。CM组可以根据无毒尿液赚取1320美元。参与者将被随访28周，数据来源包括血液和尿液测试，问卷调查和药丸计数。主要结局将是VL的变化，次要结局包括CD 4计数、禁欲和HAART依从性。我们的研究目的是：1）测试16周禁欲强化应急管理干预对VL抑制的有效性，2）检查我们的禁欲强化CM干预实现VL抑制的机制。我们假设随机分配到CM组（与对照组相比）的患者将具有更大的VL抑制，CM组将具有更大的禁欲，导致更高的依从性，从而导致更大的VL抑制。我们的建议是创新的，并响应RFA DA-11-001。众所周知，加强禁欲的CM减少了药物使用，而药物使用的减少与艾滋病毒治疗的改善有关。目前尚不清楚的是，这项研究将阐明的是，禁欲加强CM是否有效地改善VL抑制，以及这种作用的机制。鉴于CM现在在大型公共卫生试验中发挥的核心作用，我们的研究结果将对公共卫生产生重大影响。

DESCRIPTION (provided by applicant): Despite advances in HIV treatment, HIV-infected drug users continue to have poor treatment outcomes. With suboptimal HIV treatment and poorly controlled HIV infection, drug users have great potential to transmit HIV infection to their partners, leading to serious public health consequences. Few studies test interventions to improve outcomes among HIV-infected drug users, and many focus on improving HAART adherence. In active drug users, these interventions, which improve adherence but do not affect drug use, lead to modest, if any, improvement in viral load (VL) suppression. In drug users, achieving and maintaining clinically significant VL suppression without addressing drug use is unlikely. Despite this, we are not aware of any study that has examined whether an intervention that aims to reduce drug use improves HIV-related outcomes. Because abstinence-reinforcing contingency management (CM) overwhelmingly reduces drug use, and reduction in drug use is associated with improved HIV outcomes, the benefits of abstinence-reinforcing CM are likely to extend to improving HIV treatment outcomes. However, this has not been studied. Our study will be among the first to test whether CM that reinforces one behavior (achieving abstinence) leads to improved outcomes in other related behaviors (achieving VL suppression). We propose to test whether an abstinence-reinforcing CM intervention improves VL suppression in HIV-infected drug users. We will enroll 202 participants with suboptimal drug and HIV treatment (using cocaine or opioids while receiving opioid agonist treatment, with detectable VL while prescribed HAART) to test a 16-week intervention of abstinence-reinforcing CM on VL suppression. Participants will be randomized to the abstinence-reinforcing CM intervention or performance feedback (control condition). The CM group can earn $1320 based on drug-free urine. Participants will be followed for 28 weeks, and data sources will include blood and urine tests, questionnaires, and pill counts. The primary outcome will be change in VL, and secondary outcomes include CD4 count, abstinence, and HAART adherence. Our study aims are to: 1) test the efficacy of a 16-week abstinence-reinforcing contingency management intervention on VL suppression, and 2) examine mechanisms of achieving VL suppression with our abstinence-reinforcing CM intervention. We hypothesize that those randomized to the CM (vs. control) group will have greater VL suppression, and that the CM group will have greater abstinence, leading to higher adherence, leading to greater VL suppression. Our proposal is innovative and responsive to RFA DA-11-001. It is well-established that abstinence-reinforcing CM reduces drug use, and reduction in drug use is associated with improvements in HIV treatment. What is not known, and what this study will elucidate, is whether abstinence-reinforcing CM is efficacious in improving VL suppression, and the mechanisms underlying this effect. Given the central role that CM is now playing in large public health trials, our findings will have substantial public health implications.