Integrated Behavioral Activation and HIV Risk Reduction Counseling for MSM with Stimulant Abuse

背景：有问题的兴奋剂(如冰毒、可卡因、可卡因)的使用是 男男性行为者(MSM)中普遍存在的治疗难治性问题，对两者都有很高的预测性 无避孕套的性行为和艾滋病毒感染。此应用程序建立在我们成功的形成性和试验性工作的基础上，并 旨在评估Impact-a项目在三组随机对照试验(RCT)中的疗效 行为干预减少有HIV风险的MSM兴奋剂使用障碍患者的高危性行为 收购。该干预将降低风险咨询与行为激活(BA)相结合，以帮助 参与者重新参与愉快而有意义的生活活动，而不涉及毒品。行为激活是一种 以循证、易于管理的认知行为方法治疗抑郁症和其他问题 重点是帮助个人重新参与能够产生愉悦感的活动(即掌握和 荣幸之至)。我们为患有兴奋剂使用障碍的MSM选择了这一策略，因为我们的形成工作揭示了 滥用兴奋剂的男男性同性恋者报告说，他们变得无法享受他们以前喜欢的活动 持续使用兴奋剂的结果。这种缺乏享受性(即快感缺乏，这是 抑郁)在不涉及兴奋剂使用或性行为的活动中有助于继续使用兴奋剂 以及潜在的不安全性行为。我们开发了这种干预措施，并在NIDA资助的非 随机试点(R03 DA023393)，并随后进行了NIDA资助的试点RCT(R34 DA031028) 这种干预与标准护理条件(SOC)进行了比较，发现它是可行的、可接受的，并且 成功地减少了无套肛交和兴奋剂的使用。拟议的疗效试验将是下一次 这是研究计划中合乎逻辑的一步。 概念模型：概念模型侧重于快感缺乏症--对以前的兴趣丧失 享受活动--作为持续使用兴奋剂的结果。因此，对于使用兴奋剂的个人来说 无序，吸毒成为获得快乐的主要手段，因此BA会增加艾滋病毒的风险 减量咨询。 研究计划概述：286名有感染艾滋病毒风险并符合DSM-5诊断的MSM 兴奋剂(苯丙胺)使用障碍的标准将从两个研究地点招募[(1)新英格兰： 波士顿/普罗维登斯和(2)迈阿密]有很好的接触这些人口的机会。样品的五分之二(n=114) 将随机接受影响干预；五分之二(n=114)接受积极、可信的时间匹配对照 (放松和教育支持)，五分之一(n=58)接受标准护理(SOC)控制。参与者将 随访12个月。主要结果包括无避孕套肛交行为的数量 准备(主要)和使用兴奋剂的次数(次要)。我们还将收集资源利用率 和成本数据，以检查干预的成本效益。

Background: Problematic stimulant (i.e., crystal methamphetamine [meth], cocaine, crack) use is a prevalent and treatment refractory problem in men who have sex with men (MSM), and highly predictive of both condomless sex and HIV infection. This application builds off of our successful formative and pilot work and is designed to assess the efficacy, in a three-arm randomized controlled trial (RCT), of Project IMPACT—a behavioral intervention to reduce high-risk sex in MSM with stimulant use disorder who are at risk for HIV acquisition. The intervention incorporates risk reduction counseling with behavioral activation (BA) to help participants re-engage in enjoyable and meaningful life activities not involving drugs. Behavioral activation is an evidence-based, easy to administer, cognitive behavioral approach to treat depression and other problems that focuses on helping individuals reengage in activities that generate feelings of enjoyment (i.e., mastery and pleasure). We chose this strategy for MSM with stimulant use disorder because our formative work revealed that MSM who abuse stimulants report becoming unable to enjoy activities that they previously enjoyed as a result of ongoing stimulant use. This lack of enjoyment (i.e., anhedonia, one of the core symptoms of depression) in activities that do not involve stimulant use or sex contributes to the continued use of stimulants and potentially unsafe sex. We developed and openly field-tested this intervention in a NIDA-funded non- randomized pilot (R03 DA023393), and, subsequently, conducted a NIDA-funded pilot RCT (R34 DA031028) of this intervention compared to a standard of care condition (SOC) and found it to be feasible, acceptable, and successful at reducing both condomless anal sex and stimulant use. The proposed efficacy trial is the next logical step in this program of research. Conceptual Model: The conceptual model focuses on anhedonia—a loss of interest in previously enjoyed activities—as a consequence of continued stimulant use. Accordingly, for individuals with stimulant use disorder, drug use becomes the central means for obtaining enjoyment, and hence BA will augment HIV risk reduction counseling. Research Plan Overview: 286 MSM who are at risk for HIV infection and meet DSM-5 diagnostic criteria for stimulant (amphetamine) use disorder will be recruited from two study sites [(1) New England: Boston/Providence and (2) Miami] with excellent access to this population. Two-fifths of the sample (n = 114) will be randomized to the IMPACT intervention; two-fifths (n = 114) to an active, credible time-matched control (relaxation and educational support), and one-fifth (n = 58) to a standard-of- care (SOC) control. Participants will be followed for 12 months. Main outcomes include number of condomless anal sex acts without protection of PrEP (primary) and the number of stimulant use episodes (secondary). We will also collect resource utilization and cost data to examine the cost-effectiveness of the intervention.