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临床试验/NCT01351389
NCT01351389已完成不适用

Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk

Brown University6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年5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
400
试验地点
6
主要终点
Number of Alcoholic Drinks Consumed Per Week

研究概览

简要总结

This brief alcohol and sexual risk taking intervention has the potential to influence the public health by reducing alcohol use and sexual risk taking behavior in individuals who are seeking treatment in an Emergency Department.

详细描述

Linkages between alcohol use and HIV/sexual risk behaviors have been observed in multiple groups and each behavior has been successfully treated individually. Indeed, some studies suggest these behaviors can be successfully treated together. The Emergency Department (ED) provides a venue through which many patients with multiple risks are treated. Yet, to date no study has addressed these behaviors together in an ED, where admission may represent an opportunistic moment when patients are particularly willing to discuss these risky behaviors. Motivational Interviewing (MI) has demonstrated promise with alcohol risk in the ED in several of our previous studies, and has shown promise with sexual risk populations as well. Accordingly, this study (N=302) will address whether a one session multiple risk MI can more effectively decrease and maintain reduction in alcohol use, alcohol related problems, and sexual risk taking following discharge from the ED than Brief Advice (BA). Baseline, MI Session 1 and BA will be administered in the ED. Follow-ups will be conducted at 3, 6 and 9 months. This project will allow us to address the next phase of our program of research that has been designed to develop easily disseminable treatments for high-risk populations in medical settings. This study will also address potential mediators (motivation to change risk taking, self-efficacy) of MI effects. We will also examine whether reductions in sexual risk associated with MI compared to BA are accounted for by reduced drinking. A tertiary aim will examine the moderating effect of co-occurring substance use on outcomes. The cost-effectiveness of the interventions will also be addressed. Thus, this study will address two significant Public Health problems and provide significant information about MI mechanisms that may be relevant to the treatment community.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients older than 18 who receive medical care in the ED *score positive (> 8 for males; > 6 for females) for harmful alcohol use on the AUDIT screening questionnaire and report past 3-month binge drinking
  • be sexually active (past 6 months)
  • endorse any past-year sex-risk behavior criterion, including:
  • having more than one sexual partner
  • having sexual intercourse without a condom
  • consuming alcohol prior to or during sex
  • sing illicit drugs (or using licit drugs to get high) prior to or during sex.

排除标准

  • Patients under the age of 18; Patients in a mutually monogamous relationship for longer than 1 year will be excluded unless either the patient or his/her partner are HIV+ or has unknown HIV status. Other exclusion criteria include:
  • scoring below 18 on a mini-mental status exam
  • no verifiable address
  • plans to move outside a 45-mile radius within the follow-up period.

结局指标

主要结局

Number of Alcoholic Drinks Consumed Per Week

时间窗: 3 month

Number of standard alcoholic drinks consumed in the past month

Number of Alcoholic Drinks Consumed Past Month

时间窗: 9-months

Number of standard alcoholic drinks consumed in the past month

Number of Days Engaged in Risky Sex in the Past Month

时间窗: 3-months

Number of days engaged in risky sex during the past month (condomless sex)

Number of Days Engaged in Condomless Sex in the Past Month

时间窗: 9-months

Number of days engaged in condomless sex during 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

Brown University

研究点 (6)

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