Alcohol and "Heat of the Moment" Sexual Decision Making

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729256
• Other study ID #: 6603e
• Secondary ID: R01AA030461-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: Boston University Charles River Campus
• Contact: Tibor Palfai, PhD
• Phone: 6173539345
• Email: palfai[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: November 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Hiv
• Sex, Unsafe

Intervention

Behavioral:
• Self-Regulation Intervention
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
Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

Locations

Country	Name	City	State
United States	Boston University Department of Psychological and Brain Sciences	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Syracuse University, University of South Dakota

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gordon CM, Carey MP, Carey KB. Effects of a drinking event on behavioral skills and condom attitudes in men: implications for HIV risk from a controlled experiment. Health Psychol. 1997 Sep;16(5):490-5. doi: 10.1037//0278-6133.16.5.490. — View Citation

Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey	Self-reported number of times engaged in CAI	Past 90 days
Primary	Heavy Drinking Episodes from the Quick Drinking Screen	Self-reported number of days consumed 5 or more standard drinks	Past 90 days
Primary	Average number of drinks per week from the Quick Drinking Screen	Self-reported average number of drinks per week multiplied by frequency of drinking per week	Past 90 days
Primary	Condomless Anal Intercourse: Experience Sampling	Self-reported frequency of CAI from experience sampling questions	ESM assessments over a 3 week period
Primary	Alcohol Use: Experience Sampling	Self-reported number of drinks and perceived intoxication (composite variable)	ESM assessments over 3 week period