Cell Phone Technology Targeting ART Adherence and Drug Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in Substance Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Lack of proficiency in English;
- •Currently homeless (unless residing in a recovery home for which contact information can be provided);
- •Dependence on an illicit substance for which medical detoxification is imminently needed.
- •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.
结局指标
主要结局
Change in Substance Use
时间窗: 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.
Change in treatment adherence
时间窗: 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.
Change in HIV Risk Behaviors
时间窗: 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.
次要结局
- Change in health-related quality of life(week 0, week 12 and week 24)
研究者
Suzette Glasner-Edwards
Principal Investigator
University of California, Los Angeles