Alcohol and Heat of the Moment Sexual Decision Making

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Alcohol Drinking, Sex, Unsafe

Intervention / Treatment
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* Behavioral: Self-Regulation Intervention
* Behavioral: Brief Advice and Information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomly assigned to either intervention or control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Regulation Intervention<br>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: Self-Regulation Intervention<br>* 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<br>|
| Active Comparator: Brief Advice and Information<br>Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) | Behavioral: Brief Advice and Information<br>* Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Heavy Drinking Episodes from the Quick Drinking Screen | Self-reported number of days consumed 5 or more standard drinks | Past 90 days | 
| 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 | 
| Condomless Anal Intercourse: Experience Sampling | Self-reported frequency of CAI from experience sampling questions | ESM assessments over a 3 week period | 
| Alcohol Use: Experience Sampling | Self-reported number of drinks and perceived intoxication (composite variable) | ESM assessments over 3 week period |