Preventing injection initiation: The Change The Cycle Randomized Controlled Trial

 描述（由申请人提供）：美国的注射药物使用似乎正在增加。然而，很少有行为干预，以防止注射毒品使用的开始，并没有被证明是有效的，在一个严格的，大规模的随机对照试验（RCT）。我们建议通过开展一项大规模的“改变周期”（CTC）随机对照试验来解决这一关键的公共卫生需求，CTC是一种单次、长达一小时、一对一的干预措施，旨在通过鼓励活跃的注射毒品者（PWID）不促进药物注射、模拟注射行为、描述如何注射或协助注射者开始注射来减少注射。CTC使用信息-动机-行为技能模型（IMB）来阐明药物注射的危害，增加不模仿注射行为的动机，并提高行为技能以抵制要求启动非注射者进行药物注射。CTC还借鉴了社会学习理论，该理论认为人们通过互动、观察、行为实验和强化来学习行为。它与预防注射具有高度相关性 因为现有的研究令人信服地证明，主动PWID通常是未接受过注射的人的第一次注射经历的一部分，并且模拟或以其他方式促进注射药物使用的主动PWID有助于注射药物使用的开始。CTC通过为PWID提供抵制注射启动请求的行为技能和促进启动社会过程的行为来解决这个社会过程，例如在非注射者面前注射，向非注射者描述注射，并积极谈论注射。CTC初步研究结果发现，注射启动事件和一些注射启动事件显著减少， 社会学习风险行为;然而，该研究没有对照组。我们提出的CTC的大规模RCT是确定新的低阈值干预以防止注射开始的下一个合乎逻辑的科学步骤。目的1：测试CTC在降低 通过PWID启动喷射的非喷射器数量。目的2：测试CTC在减少要求PWID启动某人进行注射的次数方面的功效。目标3：测试注射启动社会学习风险（在非注射者面前注射、向非注射者描述注射以及向非注射者积极谈论注射）是否作为CTC干预对启动和请求启动结果的有效性的中介机制。为了实现这些目标，在过去一年中报告已经启动某人或有注射启动社会学习风险的PWID（N= 1，076）将被随机分配接受CTC或同等注意力控制条件。将在基线、6个月和12个月时收集注射启动和注射启动社会学习风险。多学科团队包括CTC试点研究调查员Strike和Hunt博士，以及多名主要研究员Bluthenthal和Kral博士， 他们最近完成了一项关于药物注射开始的研究。如果有效，CTC可能是一种急需的，创新的和实用的方法，以防止药物注射开始。

 DESCRIPTION (provided by applicant): Injection drug use appears to be increasing in the US. Yet, there are few behavioral interventions to prevent injection drug use initiation and none have been proven to be efficacious in a rigorous, large scale randomized controlled trial (RCT). We propose to address this critical public health need by conducting a large-scale RCT of "Change the Cycle" (CTC), a single- session, hour-long, one-on-one intervention that aims to reduce injection initiation by encouraging active people who inject drugs (PWID) to not promote drug injection, model injection behavior, describe how to inject, or assist in injection initiations of on-injectors. CTC uses the Information-Motivation-Behavioral skills model (IMB) to illuminate harms of drug injection, increase motivation to not model injection behaviors, and improve behavioral skills to resist request to initiate non-injectors into drug injection. CTC also draws upon social learning theory which posits that people learn behaviors through interaction, observation, behavioral experimentation, and reinforcement. It is highly relevant to the prevention of injection initiation because existing research convincingly demonstrates that active PWID are usually part of an injection-naive person's first injection experience and that active PWID that model or otherwise promote injection drug use contribute to injection drug use initiation. CTC addresses this social process by providing PWID with behavioral skills to resist injection initiation request and behaviors that facilitate the social process of initiation, such as injecting in front of, describing injection to, and speaking positively about injection to non-injectors. CTC pilot study results found significant reductions in injection initiation episodes and some injection initiation social learning risk behaviors; however, the study did not have a control group. Our proposed, large-scale RCT of CTC is the next logical scientific step in identifying a new, low-threshold intervention to prevent of injection initiation. Aim 1: To test the efficacy of CTC on reducing the number of non-injectors initiated into injection by PWID. Aim 2: To test the efficacy of CTC on reducing the number of times PWID are asked to initiate someone into injection. Aim 3: To test whether injection initiation social learning risks (injecting in front of, describing injection to,and speaking positive about injection to non-injectors) act as mediational mechanisms for the efficacy of the CTC intervention on initiation and request to initiate outcomes. To achieve these aims, PWID who report having initiated someone or who have injection-initiation social learning risks in the past year (N=1,076) will be randomly assigned to receive CTC or an equal attention control condition. Injection initiation and injection initiation social learning risks will be collcted at baseline, 6 months, and 12 months. The multidisciplinary team includes the CTC pilot study investigators Drs. Strike and Hunt, and multiple principal investigators Drs. Bluthenthal and Kral, who have recently completed a study on drug injection initiation. If efficacious, CTC could be a much-needed, innovative and practical approach to preventing drug injection initiation.