Trial Outcomes & Findings for Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors (NCT NCT03900650)

Last Updated: 2023-11-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

420 participants

Primary outcome timeframe

within one hour of receiving the intervention

Results posted on

2023-11-29

Participant Flow

Prior to assignment to an arm, 420 participants were enrolled, then completed an in-lab baseline session. They then completed 32 days of daily surveys. Participants then returned to the lab for a second session where they were assigned to a study arm.

Participant milestones

Participant milestones
Measure	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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, 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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Overall Study STARTED	74	75	74	70
Overall Study COMPLETED	72	74	74	70
Overall Study NOT COMPLETED	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, 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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study Withdrawn by staff	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcoholic Beverage, High Provocation Manipulation n=74 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, High Provocation Manipulation n=75 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	Alcoholic Beverage, Low Provocation Manipulation n=74 Participants 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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, Low Provocation Manipulation n=70 Participants Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	Total n=293 Participants Total of all reporting groups
Age, Continuous	24.96 years STANDARD_DEVIATION 74 • n=5 Participants	24.45 years STANDARD_DEVIATION 2.98 • n=7 Participants	24.27 years STANDARD_DEVIATION 2.76 • n=5 Participants	24.53 years STANDARD_DEVIATION 2.74 • n=4 Participants	24.39 years STANDARD_DEVIATION 2.81 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	75 Participants n=7 Participants	74 Participants n=5 Participants	70 Participants n=4 Participants	293 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	18 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants	59 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	56 Participants n=7 Participants	67 Participants n=5 Participants	55 Participants n=4 Participants	231 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	54 Participants n=7 Participants	58 Participants n=5 Participants	53 Participants n=4 Participants	217 Participants n=21 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment United States	74 participants n=5 Participants	75 participants n=7 Participants	74 participants n=5 Participants	70 participants n=4 Participants	293 participants n=21 Participants

PRIMARY outcome

Timeframe: within one hour of receiving the intervention

Population: Of the 293 participants, 3 withdrew before completing this measure. 6 participants had missing data on this measure. Thus, the analysis population for this outcome was 284.

Outcome measures

Outcome measures
Measure	Alcoholic Beverage, High Provocation Manipulation n=72 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, High Provocation Manipulation n=72 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	Alcoholic Beverage, Low Provocation Manipulation n=72 Participants 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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, Low Provocation Manipulation n=68 Participants Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Mean Score of Sexual Risk Intentions	2.35 score on a scale Standard Deviation 1.74	1.67 score on a scale Standard Deviation 1.26	2.15 score on a scale Standard Deviation 1.46	1.37 score on a scale Standard Deviation .91

PRIMARY outcome

Timeframe: 30 days

Number of unprotected sexual intercourse events

Outcome measures

Outcome measures
Measure	Alcoholic Beverage, High Provocation Manipulation n=74 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, High Provocation Manipulation n=75 Participants 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. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.	Alcoholic Beverage, Low Provocation Manipulation n=74 Participants 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. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: 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, Low Provocation Manipulation n=70 Participants Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
Sexual Risk Behavior	4.13 Unprotected sex events Standard Deviation 4.32	3.34 Unprotected sex events Standard Deviation 3.73	3.80 Unprotected sex events Standard Deviation 4.65	3.69 Unprotected sex events Standard Deviation 3.56

Adverse Events

Alcoholic Beverage, High Provocation Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-alcoholic Beverage, High Provocation Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alcoholic Beverage, Low Provocation Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-alcoholic Beverage, Low Provocation Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly Cue Davis

Arizona State University

Phone: 602-496-3217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place