Recruiting

Observational StudyAlcohol and "Heat of the Moment" Sexual Decision Making

Sponsor:

Boston University Charles River Campus

Code:

NCT05729256

Conditions

Alcohol Drinking

Sex, Unsafe

Hiv

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Self-Regulation Intervention

Brief Advice and Information

Study Details

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.

Conditions

Alcohol Drinking

Sex, Unsafe

Hiv

Study ID

NCT05729256

Start date

Nov 2, 2023

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

354 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Self-Regulation Intervention

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

active comparator: Brief Advice and Information

Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

Interventions

Self-Regulation Intervention

Brief Advice and Information

Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

Primary outcome measure

Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey [ Time Frame: Past 90 days ]
Heavy Drinking Episodes from the Quick Drinking Screen [ Time Frame: Past 90 days ]
Average number of drinks per week from the Quick Drinking Screen [ Time Frame: Past 90 days ]
Condomless Anal Intercourse: Experience Sampling [ Time Frame: ESM assessments over a 3 week period ]
Alcohol Use: Experience Sampling [ Time Frame: ESM assessments over 3 week period ]

Central Contacts and Locations

Central contacts

Tibor Palfai, PhD

6173539345 palfai@bu.edu

Maya Kratzer

mkratzer@bu.edu

Locations

Boston University Department of Psychological and Brain Sciences

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Tibor P. Palfai, PhD

617-353-9345 palfai@bu.edu

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-07-20.