Alcohol and "Heat of the Moment" Sexual Decision Making
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-Regulation Intervention, Brief Advice and Information.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Sex, Unsafe, Hiv. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 - Behavioral Brief Advice and Information
Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Primary outcome measures
- Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey [Time frame: Past 90 days]
- Heavy Drinking Episodes from the Quick Drinking Screen [Time frame: Past 90 days]
- Average number of drinks per week from the Quick Drinking Screen [Time frame: Past 90 days]
- Condomless Anal Intercourse: Experience Sampling [Time frame: ESM assessments over a 3 week period]
- Alcohol Use: Experience Sampling [Time frame: ESM assessments over 3 week period]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Boston University Department of Psychological and Brain Sciences — Boston
Publications
- 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. PMID 14743950
- 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. PMID 9302547
Identifiers
NCT: NCT05729256 · 6603e · R01AA030461-01