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临床试验/NCT02610517
NCT02610517已完成不适用

Integration of Evidence-based Alcohol Interventions Into HIV Care (ARCH-IRA) (Phases 1- Provider Training and 2- Patient Intervention)

University of Alabama at Birmingham6 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2013年6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
117
试验地点
6
主要终点
Binge drinking episodes

研究概览

简要总结

Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting.

详细描述

This study is divided into 2 phases: provider training (Phase 1) and patient level intervention (Phase 2). Phase 1, provider training, is managed through an administrative grant at Johns Hopkins. Providers will be notified of the research project locally but all training and assessments will be through Johns Hopkins.

Phase 1:

Training providers to offer alcohol pharmacotherapy (APT) to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. However, it is unknown how Infectious Disease providers will feel about treating alcohol use disorders within HIV clinics. Further it is uncertain the specific provider and clinic barriers to implementing this type of program in a primary care setting. A web-based alcohol pharmacotherapy provider training will be provided across the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. At the two intervention sites (University of Alabama at Birmingham and the University of Washington), providers will receive an on-site training in addition to the web-based training on alcohol pharmacotherapy administered at all 8 sites.

The following are the specific aims of this project:

Aim 1: To evaluate provider attitudes before and after alcohol pharmacotherapy training.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
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

  • At least 18 years or older
  • Receiving HIV care at The UAB 1917 Clinic
  • Hazardous drinkers as defined by an at-risk alcohol use score on the alcohol related, self-report data collected through the CNICS PRO.
  • English speaking
  • Willing to participate and provide informed consent

排除标准

  • Pregnant or nursing women will be referred to social work for more intensive intervention per standard of care.
  • Cognitive impairment such as they cannot provide informed consent
  • Non-English speaker
  • A visibly intoxicated person will be deferred for consent by the research assistant but will remain eligible for the study
  • Patients who previously declined to participate in the project

结局指标

主要结局

Binge drinking episodes

时间窗: up to 1 year after enrollment

The Mini-International Neuropsychiatric Interview (MINI) instrument will be used to assess binge drinking episodes. This is a self-reported instrument.

Drinks per week

时间窗: up to 1 year after enrollment

The Alcohol Use Disorders Identification Test (AUDIT) instrument will be used to assess drinks per week. This is a self-reported instrument.

次要结局

  • Number of participants that initiate antiretroviral therapy (ART)(every 3 - 6 months after enrollment and at 12 months after enrollment)
  • Mean number of participants that adhere to HIV clinic visits(for 1 year after enrollment)
  • Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml(1 year post enrollment)
  • Number of participants that initiate/request alcohol pharmacotherapy(at enrollment and after visit 2 (3 - 6 months after enrollment))
  • Number of participants that complete a CNICS Patient Reported Outcome (PRO)(every 3 - 6 months after enrollment and at 12 months after enrollment)

研究者

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

Michael Saag, MD

Professor

University of Alabama at Birmingham

研究点 (6)

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