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

基本信息

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
项目类别：
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

项目摘要

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（适用提供）：美国的注射药物使用率似乎正在增加。然而，几乎没有行为干预措施可以防止注射药物使用开始，并且在严格的大规模随机对照试验（RCT）中，没有证明没有证明是有效的。我们建议通过进行“改变周期”（CTC）的大规模RCT，一项长达一个小时的，长达一个长时间的一对一干预CTC使用信息动机 - 行为 - 行为技能模型（IMB）来照亮药物损害的危害，以增加对药物注射型的动机，并提高行为的启动，将其增加动机的危害，从而使行为损害不断提高行为。 CTC还借鉴了社会学习理论，该理论认为人们通过互动，观察，行为实验和强化学习行为。这与预防注射高度相关启动是因为现有的研究令人信服地表明，活跃的PWID通常是注射者的第一次注射体验的一部分，并且该模型或以其他方式促进注射药物使用的活跃PWID有助于注射药物使用倡议。 CTC通过为PWID提供行为技能来解决这一社会过程，以抵制注射请求和行为，从而有助于促进主动性的社会过程，例如在注射，描述注射和积极地注入非注射器的情况下注射并说出。 CTC试点研究结果发现，注射计划发作和一些注射计划的大幅降低社会学习风险行为；但是，该研究没有对照组。我们提出的大规模RCT CTC是确定新的低阈值干预措施以防止注射倡议的下一个逻辑科学步骤。目标1：测试CTC在降低的效率通过PWID注入的非注射器数量。目标2：测试CTC在减少PWID次数时的效率，要求PWID启动某人注射。目标3：测试注射倡议的社会学习风险（在面前注射，描述注射和对非注射器注射的阳性）充当中介机制，以促进CTC干预对注射的效率和启动结果的要求。为了实现这些目标，在过去的一年中报告了启动某人或具有注入的社会学习风险的PWID（n = 1,076）将被随机分配给接收CTC或同等注意力控制条件。注射倡议和注射计划将在基线，6个月和12个月时整理社会学习风险。多学科团队包括CTC试点研究调查员DRS。罢工和狩猎，以及多个主要调查员博士。 Bluthenthal和Kral，最近完成了一项有关药物注射计划的研究。如果有效，CTC可能是预防药物注射倡议的急需，创新和实用的方法。