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Clinical Trials/NCT03900650
NCT03900650CompletedNot Applicable

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

Arizona State University1 site in 1 country420 target enrollmentStarted: March 7, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
420
Locations
1
Primary Endpoint
Sexual Risk Behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to 30 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

Non-alcoholic beverage, High Provocation Manipulation

Experimental

Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration.

Intervention: High provocation manipulation (Behavioral)

Alcoholic beverage, High Provocation Manipulation

Experimental

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration.

Intervention: High provocation manipulation (Behavioral)

Alcoholic beverage, High Provocation Manipulation

Experimental

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration.

Intervention: Alcoholic beverage (Behavioral)

Non-alcoholic beverage, High Provocation Manipulation

Experimental

Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration.

Intervention: Non-alcoholic beverage (Behavioral)

Alcoholic beverage, Low provocation manipulation

Experimental

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions.

Intervention: Low provocation manipulation (Behavioral)

Alcoholic beverage, Low provocation manipulation

Experimental

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions.

Intervention: Alcoholic beverage (Behavioral)

Non-alcoholic beverage, Low provocation manipulation

Experimental

Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions.

Intervention: Low provocation manipulation (Behavioral)

Non-alcoholic beverage, Low provocation manipulation

Experimental

Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions.

Intervention: Non-alcoholic beverage (Behavioral)

Outcomes

Primary Outcomes

Sexual Risk Behavior

Time Frame: 30 days

Number of unprotected sexual intercourse events

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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