Abstinence Reinforcing Contingency Management to Suppress HIV Viral Load

描述(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。由于艾滋病毒治疗不佳，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播给他们的伴侣，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，许多研究都侧重于提高HAART的依从性。在活跃的吸毒者中，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)抑制的轻微改善(如果有的话)。在吸毒者中，在不解决药物使用问题的情况下，实现和维持临床上显著的VL抑制是不可能的。尽管如此，我们不知道有任何研究调查了旨在减少药物使用的干预措施是否改善了艾滋病毒相关的结果。由于加强戒毒的应急管理(CM)压倒性地减少了药物使用，而减少药物使用与改善艾滋病毒结果相关，因此加强禁欲的应急管理的好处可能扩展到改善艾滋病毒的治疗结果。然而，这还没有被研究过。我们的研究将是第一批测试CM是否加强一种行为(实现禁欲)是否会改善其他相关行为(实现VL抑制)的结果的研究之一。我们建议测试加强戒断的CM干预是否能改善HIV感染的吸毒者的VL抑制。我们将招募202名接受次优药物和艾滋病毒治疗的参与者(在接受阿片类激动剂治疗的同时使用可卡因或阿片类药物，在开HAART的同时检测到VL)，以测试加强戒断的CM对VL抑制的为期16周的干预。参与者将被随机分配到强化戒酒的CM干预或绩效反馈(控制条件)。CM组基于无药物尿液可以赚取1320美元。参与者将被跟踪28周，数据来源将包括血液和尿液测试、问卷调查和药片计数。主要结果将是VL的改变，次要结果包括CD4计数、禁欲和HAART依从性。本研究的目的是：1)检验为期16周的戒断强化应急管理干预对VL抑制的有效性；2)考察戒毒强化CM干预实现VL抑制的机制。我们假设，那些被随机分配到CM组(与对照组相比)的患者将有更大的VL抑制，并且CM组将有更大的禁欲，导致更高的依从性，导致更大的VL抑制。我们的建议是创新的，符合RFA DA-11-001。众所周知，加强戒毒的CM可以减少药物使用，减少药物使用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，加强戒断的CM是否在改善VL抑制方面有效，以及这种效果背后的机制。鉴于CM目前在大型公共卫生试验中扮演的核心角色，我们的发现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.