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Cell Phone Technology Targeting ART Adherence and Drug Use (TXT-CBT)

2022年4月22日 更新者:Suzette Glasner-Edwards、University of California, Los Angeles
The objective of the current research is to improve treatment for injection opioid users by augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.

研究概览

详细说明

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) for HIV-infected adults with opioid dependence; 2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of TXT-CBT over and above standard care (SC) on opioid use, HIV medication adherence, and healthcare outcomes. Both SC and SC+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. The investigators hypothesize that TXT-CBT delivered in conjunction with SC will produce greater reductions in opioid use and HIV-risk behaviors, and will improve HIV treatment regimen adherence, relative to MM alone. Further, the investigators expect that SC+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.

研究类型

介入性

注册 (实际的)

62

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90025
        • UCLA Isap Ocrc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion criteria for participants in both Phase I and Phase II will be:

  1. Age 18 or older;
  2. DSM-IV diagnosis of Opioid Dependence;
  3. HIV-infected serostatus;
  4. Able to provide informed consent;
  5. Willing and able to participate in study procedures,
  6. Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participant should be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians.

Exclusion Criteria:

  1. Lack of proficiency in English;
  2. Currently homeless (unless residing in a recovery home for which contact information can be provided);
  3. Dependence on an illicit substance for which medical detoxification is imminently needed.
  4. Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis, acute mania, or suicide risk that would require immediate treatment or make study compliance difficult.

    -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:短信 CBT (TXT-CBT)
这种情况将接收基于 CBT 的文本消息 (TXT-CBT)。 那些被分配到 TXT-CBT 的人还将获得一份治疗手册(在第一阶段开发),其中包含每周核心治疗内容/主题的描述。 感染 HIV 的参与者将与 CBT 临床医生进行初次会面,以审查 Life-Steps 概念。 将确定 3 种最适用的药物依从性技能,以在定制信息中加以强调。 研究协调员将在整个干预阶段的数据收集访问中每周与参与者会面,以回答任何技术问题并确保干预计划正常运行。
那些被分配到 TXT-CBT 的人将获得一份治疗手册(在第一阶段开发),其中包含每周核心治疗内容/主题的描述。 感染 HIV 的参与者将与 CBT 临床医生进行初次会面,以审查促进 ART 依从性的核心 CBT 概念。 将确定 3 种最适用的药物依从性技能,以在定制信息中加以强调。 研究协调员将在整个干预阶段的数据收集访问中每周与参与者会面,以回答任何技术问题并确保干预计划正常运行。
Standard care will include usual treatment for HIV and a pamphlet that will be provided to the participants with information about ART adherence and relapse prevention.
有源比较器:Standard Care
Those assigned to the Standard Care condition will receive the standard monthly medical management physician visit typically associated with HIV care. In addition, a pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition.
Standard care will include usual treatment for HIV and a pamphlet that will be provided to the participants with information about ART adherence and relapse prevention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Substance Use
大体时间:The ASI is to be collected at baseline (week 0), treatment-end (week 12), and Follow-Up (wek 24). UDS is collected weekly during the intervetion.
Addiction Severity Index (ASI) is an instrument widely used in addiction research to quantify drug use frequency and related problem areas. Urine Drug Screen (UDS). Urine drug screens will be collected monthly using temperature controlled test cups. An FDA-approved one-step test will be used. During the 12-week treatment period, one full-screen panel and two panels only testing for opioids (heroin and prescription opioids) will be conducted. The UDS will test for the presence of: amphetamines, benzodiazepines, methadone, cocaine, methamphetamine, morphine (heroin), hydrocodone (Vicodin), oxycodone (OxyContin), and marijuana. The participants' change in substance use over time (as assessed by the ASI and UDS results) is being assessed from each timepoint to the next.
The ASI is to be collected at baseline (week 0), treatment-end (week 12), and Follow-Up (wek 24). UDS is collected weekly during the intervetion.
Change in HIV Risk Behaviors
大体时间:RBS will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
Risk Behavior Survey (RBS): The RBS (Darke et al., 1991) is a brief interview assessing involvement in HIV risk behaviors in the areas of drug use and sex in the previous 30 days. Additional items include whether the sexual partner uses or injects drugs. The participants' change in RBS scores is being assessed from each timepoint to the next.
RBS will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
Change in treatment adherence
大体时间:Pill bottle collection will be weekly during the intervention. Pill counts and Viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24).
ART Adherence. The investigator will use monthly phone-based unannounced pill counts (UPCs); Pharmacy information from pill bottles will also be collected to verify the number of pills dispensed between calls. Self-reported adherence will be assessed monthly using a brief adherence survey developed by Lu et al. Viral load will serve as a biological indicator of adherence. Consistent with the typical frequency with which viral load is assessed in clinical settings, data concerning viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24) via chart review from the participant's medical provider. The participants' change in Adherence scores is being assessed from each timepoint to the next.
Pill bottle collection will be weekly during the intervention. Pill counts and Viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24).

次要结果测量

结果测量
措施说明
大体时间
Change in health-related quality of life
大体时间:week 0, week 12 and week 24
Data concerning health-related quality of life during and after treatment will be collected using the SF-12 Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view
week 0, week 12 and week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Suzette Glasner, PhD、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2013年5月24日

首先提交符合 QC 标准的

2013年6月19日

首次发布 (估计)

2013年6月21日

研究记录更新

最后更新发布 (实际的)

2022年4月29日

上次提交的符合 QC 标准的更新

2022年4月22日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1R34DA033196 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

艾滋病病毒的临床试验

短信 CBT (TXT-CBT)的临床试验

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