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临床试验/NCT01317277
NCT01317277已完成不适用

Personalized Text Messages to Improve ART Adherence in HIV+ Methamphetamine Users

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Overall MEMS Adherence to Antiretroviral Medication

研究概览

简要总结

Methamphetamine (METH) is a debilitating and frequently abused substance that is often comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+) have several characteristics, in addition to their substance use, that make them particularly susceptible to nonadherence to antiretroviral treatment (ART) including elevated rates of neurocognitive impairment, co-occurrence of psychiatric disorders, and unstable living situations. The investigators propose an intervention development study designed to address these potential mechanisms of nonadherence with the following Specific Aims: 1) To further develop and refine a personalized, automated, real-time, mobile phone, text messaging intervention (iTAB) designed to improve adherence to ART medications among HIV+/METH+ persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the improvement of objectively measured medication adherence among HIV+/METH+ persons; and 3) To examine predictors of within-person trajectories of nonadherence using the longitudinal data collected over the study. In order to realize these aims, the investigators will leverage the infrastructure of two unique UCSD resources increasing likelihood of study success, impact, and innovation: 1) the Translational Methamphetamine AIDS Research Center (TMARC), which is a NIDA-funded center that focuses on the combined effects of METH and HIV infection, and 2) the California Institute for Telecommunications and Information Technology (Calit2), which conducts research on state-of-the-art wireless means of health promotion. Initially, the investigators will refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of HIV+/METH+ persons via focus groups and rapid prototyping. Once refined, the proposed iTAB intervention will use text messages that are automated, scalable, personalized, interactive, flexible, and motivating. The investigators will assess the acceptability and effectiveness of iTAB in improving objectively measured adherence (i.e., MEMS caps) over a 6-week period via a pilot RCT with 40 HIV+/METH+ assigned to the iTAB intervention and 20 HIV+/METH+ assigned to a psychoeducational control. Predictors of nonadherence including frequency of METH use, neuropsychological impairment, and mood will be examined to determine whether iTAB is better able to compensate for these factors associated with nonadherence as compared to CTRL. Further refinement to the iTAB intervention will be made in order to pursue a large-scale R01 using our tailored intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Ability to provide informed consent
  • 18 years or older at the time of enrollment
  • HIV-infected
  • DSM-IV diagnosis of methamphetamine abuse or dependence in the past 30 days
  • Taking at least one medication to treat HIV illness
  • Indication of less than 100% adherence to antiretroviral (ART) medication
  • Willingness to use electronic monitoring caps to track ART medication
  • Willingness to respond to text messages

排除标准

  • Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
  • Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
  • Unwillingness or inability to use electronic medication monitoring technology
  • Unwillingness or inability to use daily text messaging

结局指标

主要结局

Overall MEMS Adherence to Antiretroviral Medication

时间窗: 6 weeks

Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].

MEMS Adherence to Antiretroviral Medication Based on Dose Timing

时间窗: 6 weeks

Adherence using Medication Event Monitoring Systems (MEMS) based on dose timing; i.e., \[(# of bottle openings within a +/- 2-hour time window of the intended dosing time)/(# of prescribed doses)\*100\].

次要结局

  • Text-reported METH Use(Completion of 6-week intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David J. Moore, Ph.D.

Associate Professor of Psychiatry

University of California, San Diego

研究点 (2)

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