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临床试验/NCT01328743
NCT01328743已完成不适用

Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

Brown University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2011年5月最近更新:
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
180
试验地点
2
主要终点
Number of Heavy Drinking Days

研究概览

简要总结

This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.

详细描述

This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • be at least 18 years of age
  • drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week
  • have a confirmed diagnosis of HIV/AIDS
  • be a male who has had sex (oral or anal) with a male partner in the past 3 months.

排除标准

  • current intravenous drug use
  • currently psychotic, suicidal, or manic
  • are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
  • currently receiving treatment for an alcohol or drug problem

研究组 & 干预措施

Treatment as usual

No Intervention

Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.

Brief Alcohol Intervention

Experimental

Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls

干预措施: Brief alcohol intervention (Behavioral)

结局指标

主要结局

Number of Heavy Drinking Days

时间窗: 3 months

Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

Number of Alcoholic Drinks Consumed

时间窗: 6 months

Number of standard alcoholic drinks consumed per week in the past month

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

Peter Monti

Professor of Behavioral and Social Sciences

Brown University

研究点 (2)

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