Clinical trial NCT05729256: Alcohol and "Heat of the Moment" Sexual Decision Making
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Sex, Unsafe
Hiv
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Syracuse University
name: University of South Dakota
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-02-15
Enrollment: 354
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomly assigned to either intervention or control
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
timeFrame: Past 90 days
measure: Heavy Drinking Episodes from the Quick Drinking Screen
timeFrame: Past 90 days
measure: Average number of drinks per week from the Quick Drinking Screen
timeFrame: Past 90 days
measure: Condomless Anal Intercourse: Experience Sampling
timeFrame: ESM assessments over a 3 week period
measure: Alcohol Use: Experience Sampling
timeFrame: ESM assessments over 3 week period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Department of Psychological and Brain Sciences
state: Massachusetts
Study officials:
affiliation: Boston University
name: Tibor Palfai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.