Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
2 other identifiers
interventional
420
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedResults Posted
Study results publicly available
November 29, 2023
CompletedNovember 29, 2023
November 1, 2023
4.3 years
March 28, 2019
October 3, 2023
November 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Sexual Risk Behavior
Number of unprotected sexual intercourse events
30 days
Study Arms (4)
Alcoholic beverage, High Provocation Manipulation
EXPERIMENTALParticipants 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.
Non-alcoholic beverage, High Provocation Manipulation
EXPERIMENTALParticipants 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.
Alcoholic beverage, Low provocation manipulation
EXPERIMENTALParticipants 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.
Non-alcoholic beverage, Low provocation manipulation
EXPERIMENTALParticipants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions.
Interventions
Participants will engage in a laboratory task and will then report their emotions following the task.
Participants will engage in a laboratory task and will then report their emotions following the task.
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.
Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arizona State Universitylead
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- Georgia State Universitycollaborator
Study Sites (1)
Arizona State University
Phoenix, Arizona, 85004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data collection was paused for approximately 11 months due to COVID-19 safety protocols.
Results Point of Contact
- Title
- Kelly Cue Davis
- Organization
- Arizona State University
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Davis, PhD
Arizona State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 3, 2019
Study Start
March 7, 2019
Primary Completion
July 5, 2023
Study Completion
July 5, 2023
Last Updated
November 29, 2023
Results First Posted
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Immediately following publication and ending 3 years following publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal for the use of the data.
We will make available individual, de-identified participant data that underlie disseminated results.