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

背景：有问题的兴奋剂（即，冰毒、可卡因、快克）的使用是一种 在男男性行为者（MSM）中普遍存在的和治疗难治性的问题，并且高度预测两者 无安全套性行为和艾滋病毒感染。这个应用程序建立了我们成功的形成和试点工作， 旨在评估IMPACT-a项目在三组随机对照试验（RCT）中的疗效 行为干预对减少HIV高危人群中有兴奋剂使用障碍的MSM高危性行为的影响 采集该干预措施将风险降低咨询与行为激活（BA）结合起来， 参与者重新参与不涉及毒品的愉快和有意义的生活活动。行为激活是一种 以证据为基础，易于管理，认知行为的方法来治疗抑郁症和其他问题， 专注于帮助个人重新参与产生享受感的活动（即，掌握和 快乐）。我们选择这种策略治疗有兴奋剂使用障碍的男男性接触者，因为我们的形成性工作揭示了 滥用兴奋剂的男男性行为者报告说，他们无法享受他们以前作为一个 持续使用兴奋剂的结果。这种缺乏乐趣（即，快感缺乏症， 抑郁症）在不涉及兴奋剂使用或性的活动中有助于继续使用兴奋剂 和潜在的不安全性行为我们开发和公开实地测试这种干预在一个NIDA资助的非- 随机化试点（R 03 DA 023393），随后进行了一项由NIDA资助的试点RCT（R34 DA 031028）， 将该干预与标准护理条件（SOC）进行比较，发现其可行、可接受， 成功地减少了无安全套肛交和兴奋剂的使用。拟议的疗效试验是下一个 这是研究计划中的一个逻辑步骤。 概念模型：概念模型侧重于快感缺失-对先前的兴趣丧失 喜欢的活动-作为持续使用兴奋剂的结果。因此，对于使用兴奋剂的人来说， 在精神障碍的情况下，药物使用成为获得享受的主要手段，因此BA将增加HIV风险 减少咨询。 研究计划概述：286名有艾滋病毒感染风险并符合DSM-5诊断标准的MSM 兴奋剂（安非他明）使用障碍的标准将从两个研究中心招募[（1）新英格兰： 波士顿/普罗维登斯和（2）迈阿密]与这一人口的良好访问。样本的五分之二（n = 114） 将随机分配至IMPACT干预组;五分之二（n = 114）分配至活性、可信的时间匹配对照组 （放松和教育支持），五分之一（n = 58）的标准护理（SOC）控制。参与者将 跟踪12个月。主要结果包括无避孕套肛交行为的数量， PrEP（主要）和兴奋剂使用事件的数量（次要）。我们还将收集资源利用率 和成本数据，以检查干预措施的成本效益。

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.