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

Primary Purpose

Sexual Behavior, Alcohol Drinking, Sexual Aggression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High provocation manipulation
Low provocation manipulation
Alcoholic beverage
Non-alcoholic beverage
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sexual Behavior focused on measuring Condom use resistance, Emotion dysregulation

Eligibility Criteria

21 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Alcoholic beverage

Non-alcoholic beverage

High provocation manipulation

Low provocation manipulation

Arm Description

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%.

Participants will receive a beverage that does not contain alcohol (fruit juice only).

Participants receive an experimental manipulation designed to evoke negative emotions such as frustration.

Participants receive an experimental manipulation that is designed to evoke neither positive or negative emotions.

Outcomes

Primary Outcome Measures

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.
Sexual risk behavior
Number of unprotected sexual intercourse events

Secondary Outcome Measures

Full Information

First Posted
March 28, 2019
Last Updated
August 2, 2023
Sponsor
Arizona State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT03900650
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Behavior, Alcohol Drinking, Sexual Aggression, Emotions
Keywords
Condom use resistance, Emotion dysregulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcoholic beverage
Arm Type
Experimental
Arm Description
Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%.
Arm Title
Non-alcoholic beverage
Arm Type
Active Comparator
Arm Description
Participants will receive a beverage that does not contain alcohol (fruit juice only).
Arm Title
High provocation manipulation
Arm Type
Experimental
Arm Description
Participants receive an experimental manipulation designed to evoke negative emotions such as frustration.
Arm Title
Low provocation manipulation
Arm Type
Active Comparator
Arm Description
Participants receive an experimental manipulation that is designed to evoke neither positive or negative emotions.
Intervention Type
Behavioral
Intervention Name(s)
High provocation manipulation
Intervention Description
Participants will engage in a laboratory task and will then report their emotions following the task.
Intervention Type
Behavioral
Intervention Name(s)
Low provocation manipulation
Intervention Description
Participants will engage in a laboratory task and will then report their emotions following the task.
Intervention Type
Behavioral
Intervention Name(s)
Alcoholic beverage
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-alcoholic beverage
Intervention Description
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 Outcome Measure Information:
Title
Mean score of sexual risk intentions
Description
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.
Time Frame
within one hour of receiving the intervention
Title
Sexual risk behavior
Description
Number of unprotected sexual intercourse events
Time Frame
30 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-defined as male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Davis, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will make available individual, de-identified participant data that underlie disseminated results.
IPD Sharing Time Frame
Immediately following publication and ending 3 years following publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal for the use of the data.

Learn more about this trial

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

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