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临床试验/NCT02709759
NCT02709759已完成不适用

Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care

Brown University3 个研究点 分布在 1 个国家目标入组 210 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
210
试验地点
3
主要终点
Average Number of Drinks Per Week at 6 Months

研究概览

简要总结

The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months.

详细描述

Heavy drinking in HIV-infected patients can lead to low antiretroviral therapy adherence and poor virologic control, greater sexual risk taking, increased risk of liver disease, and decreased cognitive function. Therefore, reductions in drinking may have particularly positive and widespread effects in HIV-infected patients. Men who have sex with men (MSM) continue to represent the majority of new HIV infections, and HIV-infected MSM have rates of hazardous drinking as high as 33%. Therefore, developing and testing interventions to reduce heavy drinking in HIV-infected MSM is a very high public health priority. There have been relatively few alcohol interventions tested that focus on MSM, and only two have addressed drinking in HIV-infected MSM. Although recent studies indicate that behavioral interventions can reduce heavy drinking in HIV-infected patients, much remains unknown about the efficacy of different approaches to behavioral intervention and their unique and combined effects. The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months. BA and MI will be delivered by a core set of interventionists from a central location using a webcam-enabled telemedicine system, which can facilitate larger-scale implementation. The design will allow us to test the hypothesis that MI compared to BA, ITM compared to no ITM, and EI compared to no EI, will result in significantly greater reductions in number of alcoholic drinks consumed and number of heavy drinking days at 6- and 12-month follow-ups. Secondary outcomes include engagement in unprotected anal intercourse, ART adherence and viral suppression, CD4 cell count, liver function tests, and neurocognitive function. We also will test the hypothesis that the effects of MI, ITM, and EI on drinking will be moderated by alcohol use disorder status and readiness to change drinking such that these interventions will be relatively more efficacious in those with a current disorder and those with low readiness. The study will provide crucial evidence regarding which intervention approaches, alone or in combination, are likely to be most efficient to implement on a large scale in HIV care settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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 have drunk more than 14 drinks per week over the past 3 months
  • have a confirmed diagnosis of HIV
  • be a biological male who identifies as male
  • report having had sex (oral or anal) with a male partner in the past 12 months and/or, identify as gay or bisexual.
  • For those on ART, they must be stabilized on their current regimen for at least 3 months prior to study enrollment.

排除标准

  • report past 3 month intravenous drug use
  • are currently psychotic, suicidal, or manic
  • 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.

结局指标

主要结局

Average Number of Drinks Per Week at 6 Months

时间窗: Past 30 days

Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment.

Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months

时间窗: Past 30 days

Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment.

Number of Heavy Drinking Days at 6 Months

时间窗: Past 30 days

Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months

Number of Heavy Drinking Days at 12 Months

时间窗: Past 30 days

Number of days drinking 5 or more alcoholic drinks

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

Christopher W. Kahler

Professor

Brown University

研究点 (3)

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