跳至主要内容
临床试验/NCT05729256
NCT05729256招募中不适用

Alcohol and "Heat of the Moment" Sexual Decision Making Among MSM: Identifying Mechanisms of Sexual Risk and Promoting Behavior Change Through Brief Intervention

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
354
试验地点
2
主要终点
Heavy Drinking Episodes from the Quick Drinking Screen

研究概览

简要总结

HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking.

详细描述

Despite prevention efforts over the past two decades, HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Approximately 65% of new HIV diagnoses in the United States are due to male-to-male sexual contact. Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify risk factors that underlie HIV acquisition and transmission and develop behavioral strategies that modify them directly or reduce the influence of these factors on behavior. Alcohol use, particularly heavy episodic drinking, is a central modifiable risk factor that may increase CAI in conjunction with other contextual variables. Although there have been a limited number of HIV prevention interventions that incorporate alcohol in sexual risk reduction efforts, relatively little is known about how such interventions impact sexual decision-making in "heat-of the-moment", particularly while intoxicated and in high arousal states that commonly are proximal to sexual behavior.

The goals of this study are to: (1) better understand the within-person mechanisms linking alcohol and arousal with CAI and (2) test the efficacy of an HIV prevention intervention approach that both reduces alcohol consumption and mitigate the influence of intoxication and arousal on CAI. These complementary objectives are addressed through an experience sampling method study (ESM) that examines the impact of an HIV prevention intervention that targets sexual risk and alcohol use. This study will examine whether mechanisms that underlie sexual risk in the natural environment and can be modified by intervention.

In the proposed study, non-monogamous adult MSM who engage in heavy drinking and CAI will be randomly assigned to an intervention condition that addresses alcohol use and sexual decision-making in "heat-of-the-moment" situations. The intervention will be preceded and followed by 3-week ESM bursts of intensive longitudinal assessment of alcohol use, arousal, sexual delay discounting, working memory, and CAI. 4-month follow-up data will be collected. Results will contribute to the long-term goal of enhancing effectiveness of behavioral HIV prevention interventions that address 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
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Trial procedures designed so that the post-intervention assessor is blind to condition

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

  • At least 18 years of age
  • Cisgender man who has had condomless anal intercourse with another man in the past 3 months
  • Engaged in heavy drinking (assessed by either weekly National Institute on Alcohol Abuse and Alcoholism guidelines [> 14 for men], and/or a heavy drinking episode in the past month [> 4 drinks on an occasion])
  • Has a smartphone

排除标准

  • HIV-infection
  • Currently using PrEP
  • In an exclusive monogamous sexual relationship
  • History of bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent
  • Current treatment for alcohol use disorder or substance use disorder
  • Unable to provide one or more individuals who can serve as an alternate contact

研究组 & 干预措施

Self-Regulation Intervention

Experimental

Single session motivational intervention on reducing heavy drinking and sexual risk behavior, encouraging consideration of pre-exposure prophylaxis (PrEP), followed by 4 weeks of text messages on content relevant to drinking goals and support for healthy sexual choices

干预措施: Self-Regulation Intervention (Behavioral)

Brief Advice and Information

Active Comparator

Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

干预措施: Brief Advice and Information (Behavioral)

结局指标

主要结局

Heavy Drinking Episodes from the Quick Drinking Screen

时间窗: Past 90 days

Self-reported number of days consumed 5 or more standard drinks

Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey

时间窗: Past 90 days

Self-reported number of times engaged in CAI

Alcohol Use: Experience Sampling

时间窗: ESM assessments over 3 week period

Self-reported number of drinks and perceived intoxication (composite variable)

Average number of drinks per week from the Quick Drinking Screen

时间窗: Past 90 days

Self-reported average number of drinks per week multiplied by frequency of drinking per week

Condomless Anal Intercourse: Experience Sampling

时间窗: ESM assessments over a 3 week period

Self-reported frequency of CAI from experience sampling questions

次要结局

未报告次要终点

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor

研究点 (2)

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