Alcohol and "Heat of the Moment" Sexual Decision Making (NCT05729256) | Clinical Trial Compass
RecruitingNot Applicable
Alcohol and "Heat of the Moment" Sexual Decision Making
United States354 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Timeframe: Past 90 days
2
Heavy Drinking Episodes from the Quick Drinking Screen
Timeframe: Past 90 days
3
Average number of drinks per week from the Quick Drinking Screen