Alcohol & Men's Sexual Risk Behaviors

Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors (Extension)

This project extends the investigators' previous research regarding the intersecting risks of alcohol, sexual risk behavior (SRB), and sexual aggression (SA) in male drinkers who have sex with women by examining the mediating and moderating roles of both intrapersonal and interpersonal emotional factors. While independent streams of research consistently document alcohol's role in SRB and SA, the investigators' work has demonstrated that these behaviors are related, and that alcohol exacerbates their likelihood both independently and synergistically. The researchers' investigations focus on a particular type of SRB: men's resistance to condom use with female partners who want to have protected sex. Condom use resistance (CUR) is common and normative among young male drinkers, with up to 80% of men reporting engaging in CUR. Of particular concern, research demonstrates that up to 42% of men report using coercive CUR tactics such as emotional manipulation, deception, condom sabotage, and force to obtain unprotected sex. Investigators will evaluate hypotheses that distal and proximal emotional and alcohol factors influence in-the-moment SRB/CUR intentions as well as daily alcohol use and SRB/CUR. The investigators will also examine whether the relationships among assessed variables are similar across experimental and naturalistic settings. That is, investigate the extent to which men's responses in the lab parallel their real-world drinking and SRB/CUR behaviors, particularly regarding self and partner emotions, empathy, and interpersonal stress.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Drinking; Sexual Behavior; Emotions; Sexual Aggression
• Intervention / Treatment: Behavioral: Alcoholic Beverage; Behavioral: Non-alcoholic Beverage; Behavioral: Partner Negative Mood Manipulation; Behavioral: Partner Positive Mood Manipulation

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Davis, PhD; Phone Number: 6024963217; Email: Kelly.Cue.Davis@asu.edu
• Study Contact Backup: Name: Nolan Eldridge; Email: neldrid2@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Single
• Male
• Ages 21-30
• Engagement in unprotected intercourse with a woman at least once in the past year
• Consumed alcohol at least 2 times per week in the past 30 days
• Had sex with a woman at least 2 times in the past 30 days

Exclusion Criteria:

• A history of alcohol problems
• A medical condition and/or medications which contraindicate alcohol consumption
• In a relationship that is monogamous and has lasted longer than 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcoholic beverage; Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%.	Behavioral: Alcoholic Beverage; Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight.
Active Comparator: Non-alcoholic beverage; Participants will receive a beverage that does not contain alcohol (fruit juice only).	Behavioral: Non-alcoholic Beverage; Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Experimental: Partner Negative Mood Manipulation; Participants receive an experimental manipulation describing negative emotions in a hypothetical sexual partner.	Behavioral: Partner Negative Mood Manipulation; Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.
Active Comparator: Partner Positive Mood Manipulation; Participants receive an experimental manipulation describing positive emotions in a hypothetical sexual partner.	Behavioral: Partner Positive Mood Manipulation; Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean score of sexual risk intentions	Self-reported ratings of unprotected sex likelihood in a hypothetical scenario Scale range: 1 (not at all likely) to 7 (very likely). A higher value is a worse outcome. This is one total scale (no subscales). Items are averaged to compute a mean score.	within one hour of receiving the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual risk behavior	Number of unprotected sexual intercourse events	6 months

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Georgia State University
• Investigators: Principal Investigator: Kelly Davis, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Emotion dysregulation; Condom use resistance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Drinking Behavior; Aggression; Alcohol Drinking
• Other Study ID Numbers: STUDY00018369; 4R37AA025212 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make available individual, de-identified participant data that underlie disseminated results.
• IPD Sharing Time Frame: Immediately following publication and ending 3 years following publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal for the use of the data. Data will also be made available through the NIAAA Data Archive.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No