Clinical trial NCT03900650: Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
Official title: Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Alcohol Drinking
Sexual Aggression
Emotions
Keywords: Condom use resistance
Emotion dysregulation
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Georgia State University
First posted: 2019-04-03
Enrollment: 420
Sex: MALE
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Score of Sexual Risk Intentions
timeFrame: within one hour of receiving the intervention
measure: Sexual Risk Behavior
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Kelly Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References: