Alcohol and "Heat of the Moment" Sexual Decision Making
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBoston University Charles River Campus
About this trial
HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years of age
Cisgender man who has had condomless anal intercourse with another man in the past 3 months
Engaged in heavy drinking (assessed by either weekly National Institute on Alcohol Abuse and Alcoholism guidelines [> 14 for men], and/or a heavy drinking episode in the past month [> 4 drinks on an occasion])
Has a smartphone
Disqualifiers
HIV-infection
Currently using PrEP
In an exclusive monogamous sexual relationship
History of bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Regulation Intervention
BehavioralSingle session motivational intervention on reducing heavy drinking and sexual risk behavior, encouraging consideration of pre-exposure prophylaxis (PrEP), followed by 4 weeks of text messages on content relevant to drinking goals and support for healthy sexual choices
Brief Advice and Information
BehavioralPsychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Treatment groups
354 Participants
are divided into 2 treatment groupsGroup A: Self-Regulation InterventionExperimental treatment 1 intervention
Group B: Brief Advice and InformationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Self-reported number of times engaged in CAI
Time frame
Past 90 days2
Heavy Drinking Episodes from the Quick Drinking Screen
Self-reported number of days consumed 5 or more standard drinks
Time frame
Past 90 days3
Average number of drinks per week from the Quick Drinking Screen
Self-reported average number of drinks per week multiplied by frequency of drinking per week
Time frame
Past 90 days4
Condomless Anal Intercourse: Experience Sampling
Self-reported frequency of CAI from experience sampling questions
Time frame
ESM assessments over a 3 week periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University Charles River Campus
Lead sponsor
Syracuse University
Collaborator
University of South Dakota
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov