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NCT Number: NCT05729256

Alcohol and "Heat of the Moment" Sexual Decision Making

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Department of Psychological and Brain Sciences

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Tibor P. Palfai, PhD

CONTACT

[email protected]

617-353-9345

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Self-regulation intervention

Behavioral

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

Brief Advice and Information

Behavioral

Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

Primary outcomes

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

    Time frame: Past 90 days

    Self-reported number of times engaged in CAI

  2. Heavy Drinking Episodes from the Quick Drinking Screen

    Time frame: Past 90 days

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

  3. Average number of drinks per week from the Quick Drinking Screen

    Time frame: Past 90 days

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

  4. Condomless Anal Intercourse: Experience Sampling

    Time frame: ESM assessments over a 3 week period

    Self-reported frequency of CAI from experience sampling questions

  5. Alcohol Use: Experience Sampling

    Time frame: ESM assessments over 3 week period

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Kratzer

CONTACT

[email protected]

Tibor Palfai, PhD

CONTACT

[email protected]

6173539345

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Syracuse University
  • University of South Dakota

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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