Alcohol and "Heat of the Moment" Sexual Decision Making
2 other identifiers
interventional
354
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 7, 2025
February 1, 2025
2.8 years
February 6, 2023
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Self-reported number of times engaged in CAI
Past 90 days
Heavy Drinking Episodes from the Quick Drinking Screen
Self-reported number of days consumed 5 or more standard drinks
Past 90 days
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
Past 90 days
Condomless Anal Intercourse: Experience Sampling
Self-reported frequency of CAI from experience sampling questions
ESM assessments over a 3 week period
Alcohol Use: Experience Sampling
Self-reported number of drinks and perceived intoxication (composite variable)
ESM assessments over 3 week period
Study Arms (2)
Self-Regulation Intervention
EXPERIMENTALSingle 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
ACTIVE COMPARATORSingle session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Interventions
Single 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
Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- HIV-infection
- Currently using PrEP
- In an exclusive monogamous sexual relationship
- History of bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent
- Current treatment for alcohol use disorder or substance use disorder
- Unable to provide one or more individuals who can serve as an alternate contact
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston University Charles River Campuslead
- Syracuse Universitycollaborator
- University of South Dakotacollaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (1)
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215, United States
Related Publications (2)
Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858.
PMID: 14743950BACKGROUNDGordon CM, Carey MP, Carey KB. Effects of a drinking event on behavioral skills and condom attitudes in men: implications for HIV risk from a controlled experiment. Health Psychol. 1997 Sep;16(5):490-5. doi: 10.1037//0278-6133.16.5.490.
PMID: 9302547BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tibor Palfai, PhD
Boston University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Trial procedures designed so that the post-intervention assessor is blind to condition
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 15, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available one year after the end of the study. Support will be provided for data access for up to 5 years.
- Access Criteria
- Based on review of data plan from the Multiple Principal Investigators of the study
Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review. In addition, data will be shared according to the guidelines for the National Institute of Mental Health Data Archive (NDA)