Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement
Phase: NA
Conditions: Heavy Drinking and Sexual Risk Behavior
Sponsor: Boston University Charles River Campus

 
 
 
 
 
 
NCT 03522948  
 
 
 
 
updated January 24 2021 
 
 
Alcohol and Implicit Process in Sexual Risk Behavior in MSM-Supplement 
 
 
Study Procedures Protocol 
 
 

Study Protocol Procedures NCT 03522948 updated January 21. 2021  
 
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 
are recruited through various digital media outlets (e.g., Facebook, Grindr). Individuals between 
the age of 21-50 who report at least one heavy drinking episode in the past thirty-days (defined 
in screening as 5 or more drinks on a single occasion), one episode of CAI in the past ninety-
days, and no involvement in an exclusive, monogamous relationship are recruited to participate 
in the study. Participants are screened by phone for eligibility which is confirmed at an in-
person screening. Following baseline assessments, participants engage in a brief in-person 
intervention session regarding their alcohol use and sexual risk behaviors and are then enrolled 
in the mobile messaging component. Mobile messages are sent over the following four weeks 
to support intervention content. Five to six weeks after baseline, participants return to the lab 
to complete a follow up assessment and engage in a discussion regarding the acceptability of 
the mobile messages and satisfaction with the intervention approach. Measures of heavy 
drinking frequency, condomless anal intercourse (CAI) were collected as secondary outcomes at 
baseline and at follow-up. Cognitive- motivational processes related to condom use and 
reduction of drinking are also collected at each time point for descriptive purposes.. 
 

NCT 03522948  
 
 
 
 
updated January 21, 2021 
 
 
Alcohol and Implicit Process in Sexual Risk Behavior in MSM-Supplement 
 
 
Data Analytic Procedures 
 
 

 
 
Data Analytic Strategy NCT 03522948  
 
This is a small scale pilot study to assess the acceptability of the intervention.  The primary 
outcome is descriptive, namely the mean and median score on the intervention satisfaction 
scale. Specifically, the index of acceptability for the mhealth approach consists of the mean and 
median scores of the Likert-scale CSQ satisfaction score at follow-up.  
 
Frequency of heavy drinking days and condomless anal intercourse (CAI) are assessed at 
baseline and follow-up. For analyses, frequency of heavy drinking days was assessed with item 
#3 of the Alcohol Use Disorders Identification Test (AUDIT).  This item has 5 response options 
ranging from “never” to “daily, almost daily” The baseline measure of past ninety-day CAI 
frequency will be divided by 3 to derive an average past thirty-day CAI frequency to parallel the 
time-period measured at follow up (past 30-day CAI). Secondary analyses consist of a series of 
paired sample t-tests which are used to measure differences in secondary outcomes between 
baseline and follow up. Given the small sample, effect size estimates are also provided to 
provide initial information about the potential impact of the intervention on outcomes. A series 
of self-regulation processes related to heavy drinking reduction and condom use are also 
assessed at these two time-points with the Goal Systems Assessment Battery.  These ratings are 
used for descriptive purposes to identify potentially important mediators in subsequent work.