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OpenTrials
Completed

NCT Number: NCT03900650

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

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.

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Key information

Age range

21 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High provocation manipulation

Behavioral

Participants will engage in a laboratory task and will then report their emotions following the task.

Low provocation manipulation

Behavioral

Participants will engage in a laboratory task and will then report their emotions following the task.

Alcoholic beverage

Behavioral

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

Behavioral

Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.

Primary outcomes

  1. Mean Score of Sexual Risk Intentions

    Time frame: within one hour of receiving the intervention

    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.

  2. Sexual Risk Behavior

    Time frame: 30 days

    Number of unprotected sexual intercourse events

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Georgia State University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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