Cell Phone Technology Targeting ART and Suboxone Adherence and Injection Drug Use

描述（由申请人提供）：当前研究的目的是通过创新的短信策略增强丁丙诺啡药物治疗来改善注射阿片类药物使用者的治疗，以促进复发预防技能，减少HIV风险行为，并改善丁丙诺啡和HIV治疗方案的依从性。本申请是对PAS-10-098“对艾滋病毒药物滥用人群的基于技术的依从性干预”的回应，该申请鼓励“社会科学家、医学研究人员和技术专家之间的多学科合作，以开发和完善移动的技术仪器.作为干预措施（或干预措施的一部分），促进对艾滋病毒治疗方案的坚持。“与PAS的这一既定目标一致，本研究的具体目标是：1）根据用户反馈，开发和完善基于认知行为疗法的短信干预（TXT-CBT），以加强对艾滋病毒感染者的丁丙诺啡药物治疗，注射毒品使用者（IDUs）与阿片类药物依赖; 2）进行一项初步随机临床试验，以评估招募和保留个体进行大规模研究的可行性，并确定TXT的效应量。CBT超过了使用丁丙诺啡（MM）对阿片类药物使用，HIV药物依从性，丁丙诺啡依从性和医疗保健结果的药物管理。MM和MM+TXT-CBT受试者将在基线、治疗结束和治疗后12周进行评估; 3）检查TXT-CBT的潜在作用机制，包括自我效能、情感调节和社会支持。我们假设TXT-CBT与MM联合使用将使阿片类药物的使用和HIV风险行为减少，并将改善丁丙诺啡和HIV治疗方案的依从性。此外，我们预计MM+TXT-CBT将促进负面情绪，自我效能和社会支持的更大变化，这些变化 将与物质使用的结果有关。CBT结合了特定的物质和坚持为重点的认知治疗技术，同时强调减少艾滋病毒的风险行为。通过提供支持，以最大限度地提高艾滋病毒治疗方案的依从性，再加上应对技能，以解决戒断症状和压力，阿片类药物复发的两个重要因素，TXT-CBT可以提供一个有前途的，具有成本效益的，易于部署的增强策略，用于治疗艾滋病毒感染的阿片类药物使用者。 公共卫生相关性：拟议的研究具有相当大的公共卫生意义，因为它将提供有关使用移动的电话技术作为阿片类药物依赖艾滋病毒感染者行为支持的传递媒介的基础信息，这是一个具有广泛影响的严重药物问题。如果证明有效，该方案可能有助于减少接受治疗者中的类阿片使用，从而有效减少药物滥用和相关后果，如犯罪活动、社会破坏以及由于不安全性活动和抗逆转录病毒药物不依从频率增加而导致的艾滋病毒传播/感染风险增加，这两个问题在注射吸毒者中尤为突出。除了预防复发外，新的干预措施还将针对艾滋病毒风险 通过量身定制的互动式短信干预措施，直接改善艾滋病毒/艾滋病患者的行为和抗逆转录病毒治疗的依从性。拟议的项目将确定创新干预方案的临床效用，该方案有可能快速和广泛地部署到艾滋病毒感染和传播风险最大的阿片类药物依赖者。

DESCRIPTION (provided by applicant): The objective of the current research is to improve treatment for injection opioid users by augmenting buprenorphine pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve buprenorphine and HIV treatment regimen adherence. This application is in response to PAS-10-098, "Technology Based Adherence Interventions for Substance Abusing Populations With HIV," which encourages "multidisciplinary colaboration between social scientists, medical researchers, and technology experts to develop and refine mobile technological instrumentation....as interventions (or part of interventions) that foster adherence to HIV treatment regimens." Consistent with this stated objective of the PAS, the specific aims of this research are 1) To develop and refine, with user feedback, a cognitive behavioral therapy-based text-messaging intervention (TXT-CBT) to augment buprenorphine pharmacotherapy in HIV-infected,injection drug users (IDUs) with opioid dependence; 2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a lrge scale study and to determine the effect size of TXT-CBT over and above medication management with buprenorphine (MM) on opioid use, HIV medication adherence, buprenorphine adherence, and healthcare outcomes. Both MM and MM+TXT-CBT participants will be assessed at baseline, treatment-end, and 12 weeks post-treatment; and 3) To examine potential mechanisms of action of TXT-CBT, including self-efficacy, affect regulation, and social support. We hypothesize that TXT-CBT delivered in conjunction with MM will produce greater reductions in opioid use and HIV-risk behaviors, and will improve buprenorphine and HIV treatment regimen adherence, relative to MM alone. Further, we expect that MM+TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes. TXT- CBT incorporates specific substance- and adherence-focused cognitive therapy techniques with a concurrent emphasis on reducing HIV-risk behaviors. By providing support to maximize HIV treatment regimen adherence, coupled with coping skills to address withdrawal symptoms and stress, two important factors in opioid relapse, TXT-CBT may provide a promising, cost-effective, and easily deployable augmenting strategy for the treatment of opioid users who are HIV-infected. PUBLIC HEALTH RELEVANCE: The proposed research is of considerable public health significance in that it will provide foundational information on the use of mobile phone technology as a delivery medium for behavioral support for HIV-infected with opioid dependence, a serious drug problem with extensive impacts. If proven effective, the protocol could be useful in reducing opioid use among treated individuals, thereby efficiently reducing drug abuse and related consequences such as criminal activity, social disruption, and elevated risk of HIV transmission/infection due to increased frequency of unsafe sexual activities and antiretroviral nonadherence, both of which are particularly prominent problems among injection drug users. In addition to relapse prevention, the novel intervention proposed will target HIV risk behaviors and antiretroviral treatment adherence directly through a tailored and interactive text-messaging intervention. The proposed project will determine clinical utility of an innovative intervention protocol with potential for rapid and broad deployment to opioid-dependent individuals at the greatest risk for HIV infection and transmission.