Preventing injection initiation: The Change The Cycle Randomized Controlled Trial

防止开始注射：改变周期随机对照试验

• 批准号: 9114553
• 负责人: Ricky N Bluthenthal
• 金额: $ 72.13万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9114553
• 关键词: Accounting; Address; Attention; Behavior; Behavior Therapy; Behavioral; Blood; Cities; Communicable Diseases; Communities; Computer Assisted; Control Groups; Drug usage; Education; Employee Strikes; Endocarditis; Health; Hour; Injecting drug user; Injection of therapeutic agent; Intervention; Interview; Legal; Los Angeles; Mediating; Mental disorders; Methods; Modeling; Motivation; Outcome; Overdose; Participant; Pattern; Persons; Pharmaceutical Preparations; Pilot Projects; Population; Prevention; Preventive Intervention; Principal Investigator; Process; Provider; Psychological reinforcement; Public Health; Randomized; Randomized Controlled Trials; Reporting; Research; Research Personnel; Risk; Risk Behaviors; San Francisco; Soft Tissue Infections; Special Equipment; Testing; Time; Training; Translating; behavior observation; demographics; efficacy testing; experience; improved; information model; injection drug use; innovation; learned behavior; multidisciplinary; novel; prevent; rehearsal; response; skills; social; social cognitive theory; social learning; uptake

 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.

 描述(由申请人提供)：在美国，注射毒品的使用似乎正在增加。然而，很少有行为干预措施来预防注射毒品的开始，而且在严格的大规模随机对照试验(RCT)中没有一项被证明是有效的。我们建议通过开展大规模的“改变周期”(CTC)随机对照试验(CTC)来满足这一关键的公共卫生需求，CTC是一种单节、长达一小时的一对一干预措施，旨在通过鼓励活跃的注射吸毒者(PWID)不提倡注射毒品、模拟注射行为、描述如何注射或协助注射器的注射开始来减少注射开始。CTC使用信息-动机-行为技能模型(IMB)来说明注射毒品的危害，增加不模拟注射行为的动机，并提高行为技能以抵制促使非注射者注射毒品的请求。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。它与预防注射密切相关。 这是因为现有研究令人信服地表明，活跃的PWID通常是注射幼稚的人第一次注射经历的一部分，而模拟或以其他方式促进注射吸毒的活跃的PWID有助于注射吸毒的启动。CTC通过向PWID提供抵制注射启动请求的行为技能和促进社交启动过程的行为来解决这一社交过程，如在非注射者面前注射、向非注射者描述注射以及对非注射者积极评价注射。CTC初步研究结果发现，注射开始次数和一些注射开始时间显著减少 社交学习风险行为；然而，这项研究没有设立对照组。我们提出的大规模CTC随机对照试验是确定一种新的低阈值干预措施以预防注射启动的下一个合乎逻辑的科学步骤。目的1：检测四氯化碳对小鼠的抗肿瘤作用。 由PWID启动注入的非喷射器数量。目的2：测试CTC在减少PWID被要求开始注射的次数方面的效果。目的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对非注射者积极评价注射)是否作为CTC干预对开始和开始结果请求的有效性的中介机制。为了实现这些目标，报告在过去一年中启动了某人或有注射启动社交学习风险的PWID(N=1,076)将被随机分配到接受CTC或同等注意控制条件。注射开始和注射开始社会学习风险将在基线、6个月和12个月被收集。多学科团队包括CTC先导研究调查人员Strike博士和Hunt博士，以及多名首席调查人员Bluthenthal博士和Kral博士， 他们最近完成了一项关于注射毒品的研究。如果有效，四氯化碳可能是预防药物注射启动的一种急需的、创新的和实用的方法。