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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900650
• Other study ID #: STUDY00008097
• Secondary ID: 5R37AA025212
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: July 5, 2023

Study information

• Verified date: November 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Alcohol Drinking
• Emotions
• Sexual Aggression
• Sexual Behavior

Intervention

Behavioral:
• High provocation manipulation
Participants will engage in a laboratory task and will then report their emotions following the task.
• Low provocation manipulation
Participants will engage in a laboratory task and will then report their emotions following the task.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Georgia State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Score of Sexual Risk Intentions	Scale name: Intentions to have unprotected sex Construct: 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
Primary	Sexual Risk Behavior	Number of unprotected sexual intercourse events	30 days