Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
Phase: NA
Conditions: Alcohol; Harmful Use, Sex, Unsafe
Sponsor: Boston University Charles River Campus

 
 
 
 
 
 
NCT 03755661  
 
 
 
 
updated April 17, 2019 
 
 
Alcohol and Implicit Process in Sexual Risk Behavior in MSM-Supplement 
 
 
Study Procedures Protocol 
 
 

Study Protocol Procedures NCT 03755661 updated April 17, 2019  
 
The study was approved by the Boston University Institutional Review Board. Informed consent 
was obtained from all individuals before completion of the baseline assessment. Participants 
were men recruited through various digital media outlets (e.g., Facebook, Grindr). Individuals 
between the ages of 21-50 who reported at (1) at least one heavy drinking episode in the past 
thirty-days (defined in screening as 5 or more drinks on a single occasion) more than 14 drinks 
per week on average in the past month, (2) had one episode of condomless anal intercourse 
(CAI) with a man in the past ninety-days, and had a score of 3 or greater on the Kinsey scale 
were recruited to participate in the study.  Those who were currently in an exclusive, 
monogamous relationship, had alcohol treatment in the past 3 years, or had treatment for 
schizophrenia or bipolar disorder were excluded.   Participants were screened by phone for 
eligibility which was confirmed at an in-person screening. Following baseline assessments, 
participants were randomized to either the intervention or assessment only condition.  Those 
assigned to the intervention condition engaged in a brief in-person intervention session (up to 
50 minutes) regarding their alcohol use and sexual risk behaviors.  They were then enrolled in 
the mobile application which supported the subsequent messaging component of the 
intervention. Mobile messages were sent over the following six- weeks to support the brief 
intervention content. Six weeks after baseline, participants completed the first follow up 
assessment, then again at 3-months, and finally at 6-months.  Assessments were conducted by 
a research assistant who was blind to intervention condition.  Measures of heavy drinking 
frequency in the past month, average drinks per week in the past month, and frequency of 
condomless anal intercourse (CAI) in the past 90-days assessed at the 3-month outcome were 
the primary outcomes of interest.  
 
 

NCT 03755661 
 
 
 
 
updated April 17, 2019 
 
 
Alcohol and Implicit Process in Sexual Risk Behavior in MSM-Supplement 
 
 
Data Analytic Procedures 
 
 

 
 
Data Analytic Strategy NCT 03755661 
 
This is a small scale pilot study to provide preliminary effect sizes regarding intervention 
efficacy.  The main outcome point was at the 3-month assessment.  The three primary 
measures were as follows (1) frequency of heavy drinking days in the past 30, average number 
of drinks per week in the past 30 days, and number of condomless anal intercourse (CAI) 
episode in the past 90 days.  Each of these outcomes were also are assessed at baseline. 
 
All analyses were conducted using hierarchical multiple regression with the corresponding 
baseline value as a covariate entered in the first step.  Condition (i.e., Intervention vs. 
Assessment) was dummy coded.  The effect size value used in these analyses was f2.  For 
interpretation we used standard guidelines, of .02 as small effect, .15, medium effect, .35 large 
effect.  We have also provided statistics for r-square change and the p-value for completeness. 
The primary outcome variable was f2 at the 3-month outcome. 
 
Secondary outcomes (i.e., alcohol-related consequences, 6-wk, CAI were analyzed using the 
same procedures).