Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
Phase: NA
Conditions: Sexual Behavior, Alcohol Drinking, Sexual Aggression, Emotions
Sponsor: Arizona State University

Men’s Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors 
 
NCT: Not Yet Assigned 
 
Date: March 18, 2019 
 

 
Study Protocol and Statistical Analysis Plan 
 
Study Protocol 
The objectives of the protocol are to examine men’s sexual risk intentions and sexual risk 
behaviors, with a focus on the contributing roles of sexual aggression propensity, alcohol 
intoxication, and emotions. The study will involve 3 phases: 1) a baseline survey; 2) a 30-day 
daily diary assessment of emotions, drinking and sex coping motives, and drinking and sexual 
behavior; and 3) a laboratory experiment assessing the effects of alcohol intoxication and 
provocation on in-the-moment emotional state and sexual risk behavior/condom use resistance 
likelihood.  
 
 
Recruitment. Participants will be recruited from the community through advertisements 
placed in online classifieds, social networking websites, community newspapers, and local 
venues that target the young adult population. Ads will state that single men 21-30 years old are 
needed for an Arizona State University study of alcohol and male-female relationships. We will 
also use flyers, brochures, and postcards in locations likely to reach young single men, such as 
local community colleges, coffee shops, and bars. All advertising materials will include a URL 
for a website that will provide limited information about the study with particular emphasis on 
information about the PI and research at Arizona State University. If they are interested in 
proceeding, potential participants will need to call our offices for more detailed information, 
screening, and scheduling.  
 
Retention. We will take multiple steps to retain participants throughout the project. First, 
we will reduce the time span between the three study phases as much as possible during 
scheduling such that all three phases of the study will take less than 6 weeks total. Second, we 
will make participation as convenient as possible by using online data collection for the baseline 
and daily diary surveys. We will also offer transportation assistance (e.g., bus passes, taxi rides 
home) for the in-lab experiment. Third, we will give reminders to participants if more than 2 days 
have passed without completion of the baseline survey or if they miss more than 2 consecutive 
daily assessments. Finally, we will structure our payment and incentive schedule to encourage 
full completion. Similar procedures and incentives have yielded retention rates of 87-92% over 
3-month periods in our prior studies. 
 
Study Design. All participants will compete an online baseline survey that will assess 
information about sexual risk behavior, drinking behavior, sexual aggression, and emotion 
regulation skills. The online daily diary study will require participants to answer questions once a 
day during a 30-day period assessing their emotions, sexual risk behaviors, and drinking 
behaviors. During the in-lab experiment, two factors will be manipulated between subjects: 
alcohol intoxication and provocation condition. We will use a randomized block design to assign 
participants to experimental conditions based on their sexual aggression history so that 
aggression backgrounds are evenly distributed across the cells. Participants will receive either 
no alcohol (control beverage) or a high alcohol dose (target peak BAC = .08%), will experience 
a standard experimental provocation manipulation (high vs. none), and then will read a sexual 
risk analogue and rate their sexual risk intentions while on the ascending limb of the BAC curve.  
 
 
 

 
Statistical Analysis Plan 
 
 
Sexual Risk Behavior. For the sexual risk behavior outcome, we plan to enroll 420 
subjects. Sexual risk behavior will be assessed in multiple ways: having unprotected vaginal or 
anal sex (yes/no), condom use resistance (yes/no), and partner type (casual vs. steady). 
GLMMs with a negative binomial distribution and log link function will be used to examine the 
daily influence of emotions on alcohol consumption, and a binomial distribution and logit link 
function will be used to examine the daily influence of emotions on the binary indicators of 
sexual risk behavior. Multilevel mediation (MLM) will be conducted to examine the potential 
mediating effects of drink- and sex-to-cope motives on the relation between emotions and 
subsequent alcohol use and sexual risk behavior. The moderating effects of sexual aggression 
propensity and emotion dysregulation will be examined by creating interaction terms with daily 
emotions and will be entered in the GLMM models described above.  
 
 
Sexual Risk Intentions. For the sexual risk intentions outcome, we plan to enroll 420 
subjects. The sexual risk intentions variables will include unprotected sex and CUR intentions, 
and the between-subjects factors will be intoxication and manipulated provocation. Direct and 
indirect effects of alcohol intoxication (.08% vs. control) and provocation (high v. none) will be 
tested utilizing path analysis within a structural equation modeling (SEM) framework, which 
provides significance tests and confidence intervals for total indirect effects and specific indirect 
effects. A path analysis will be conducted to test whether alcohol intoxication directly increases 
sexual risk intentions and whether emotional state mediates the effects of provocation and 
alcohol intoxication on sexual risk intentions. To test the hypothesis that the effects of 
intoxication and provocation on negative emotional states will be greater among those with 
stronger sexual aggression perpetration propensities, SEM analyses that include that interaction 
term will be conducted. Additional SEM analyses will be conducted to test the moderating 
effects of emotion dysregulation on the negative emotion-sexual risk intentions relationship. 
 
Power and Sample Size. The study was powered to detect the mediational effects of 
negative emotional state and on the relationship between provocation and alcohol intoxication 
on unprotected sex likelihood, as this hypothesis serves as a test of the overarching conceptual 
model and requires participants be randomized to one of four experimental conditions, thereby 
decreasing power. Monte Carlo simulations indicate that a sample size of 350 yields power .79 - 
.96 to detect small to medium effects. Based on an estimated 20% attrition rate, the final sample 
recruited will comprise 420 men. This sample size also yields sufficient power to detect small to 
medium effects in the within-subject GLMM analyses examining men’s daily sexual risk 
behavior.