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临床试验/NCT01410123
NCT01410123已完成不适用

Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Yale University5 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
319
试验地点
5
主要终点
Alcohol abuse or dependence: Drinks per week

研究概览

简要总结

The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.

详细描述

Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV uninfected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction physician management (APM) including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be HIV-infected and receiving HIV care at one of the participating medical centers.
  • •Meet one of the following criteria for unhealthy alcohol use:
  • •At-risk Drinking Study- greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over
  • •Alcohol Abuse or Dependence Study - Meet DSM-IV TR criteria for alcohol abuse or dependence, not in remission.
  • •Moderate Alcohol + Liver Disease Study - Report alcohol consumption in the past month, are HCV co-infected, confirmed by HCV viral load or have liver fibrosis - Fib-4 (>1.45). Do not meet criteria for at-risk drinking, alcohol abuse or dependence.
  • •Be able to understand English and provide informed consent.

排除标准

  • •Be acutely suicidal, or with a psychiatric condition that affects the ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
  • •Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
  • •Have medical conditions that would preclude completing or be of harm during the course of the study.
  • •Pregnant or nursing women or women who do not agree to use a reliable form of birth control.

研究组 & 干预措施

Integrated Stepped Care (ISC)

Other

干预措施: Integrated Stepped Care (ISC) (Other)

Treatment as Usual (TAU)

Other

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Alcohol abuse or dependence: Drinks per week

时间窗: 6 months

At risk drinking: Drinks per week

时间窗: 6 months

Moderate Alcohol + Liver Disease group: Abstinence.

时间窗: 6 months

次要结局

  • Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker(6 months)
  • Change in biological markers as measured by the VACS index.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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