- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900650
Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
November 8, 2023 updated by: Arizona State University
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
420
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcoholic beverage, High Provocation Manipulation
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.
|
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 engage in a laboratory task and will then report their emotions following the task.
|
Experimental: Non-alcoholic beverage, High Provocation Manipulation
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.
|
Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Participants will engage in a laboratory task and will then report their emotions following the task.
|
Experimental: Alcoholic beverage, Low provocation manipulation
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.
|
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 engage in a laboratory task and will then report their emotions following the task.
|
Experimental: Non-alcoholic beverage, Low provocation manipulation
Participants will receive a beverage that does not contain alcohol (fruit juice only).
Participants then receive an experimental manipulation designed to evoke positive emotions.
|
Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Participants will engage in a laboratory task and will then report their emotions following the task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within one hour of receiving the intervention
|
Sexual Risk Behavior
Time Frame: 30 days
|
Number of unprotected sexual intercourse events
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelly Davis, PhD, Arizona State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2019
Primary Completion (Actual)
July 5, 2023
Study Completion (Actual)
July 5, 2023
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
April 1, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008097
- 5R37AA025212 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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