Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
研究概览
简要总结
This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.
详细描述
This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is not provided with randomization information for the subjects
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month
- •At least 1 condomless anal sex episode in past 3 months
- •Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)
排除标准
- •Alcohol treatment currently or in past 3 years
- •Bipolar disorder or schizophrenia treatment
- •Exclusive monogamous relationship
结局指标
主要结局
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
时间窗: 30 days
Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion \[no scale\]. Higher score is a worse outcome, range 0-30
Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]
时间窗: 90 days
Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days \[no scale\] Range from 0-90
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
时间窗: 30 days
Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome
次要结局
- Young Adult Alcohol Consequences Questionnaire [Alcohol](30 days)
研究者
Tibor Palfai
Professor
Boston University Charles River Campus