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临床试验/NCT02501057
NCT02501057已完成不适用

HealthCall: Enhancing Brief Intervention for HIV Primary Care Alcohol Dependence

Research Foundation for Mental Hygiene, Inc.0 个研究点目标入组 133 人开始时间: 2016年8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
133
主要终点
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.

研究概览

简要总结

The purpose of this study is to compare the effects of interventions for drinking-reduction and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smart phone application that tracks drinking and other aspects of health. These meetings will either be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, intermediate among participants who receive the enhanced Clinician's Guide, and lowest among participants who receive enhanced Motivational Interviewing.

详细描述

HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. This study aims to evaluate two evidence-based approaches when combined with an innovative smart phone application designed to help users track drinking and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

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

入选标准

  • Age 18 and older
  • Patient had 4 or more drinks on any day in prior 30 days
  • Patient meets criteria for DSM-IV current alcohol dependence

排除标准

  • Patient is psychotic, suicidal, or homicidal
  • Patient has gross cognitive impairment
  • Patient does not speak English or Spanish
  • Patient has plans to leave the greater New York metropolitan area within the study period
  • Patient has vision/hearing impairment that would preclude participation

结局指标

主要结局

Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.

时间窗: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months

As measured by number of drinks per drinking day and percentage of days abstinent.

次要结局

未报告次要终点

研究者

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

Deborah Hasin

Professor of Epidemiology

Columbia University

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