Alcohol DrinkingNCT05729256
Alcohol and "Heat of the Moment" Sexual Decision Making
A study testing Self-Regulation Intervention and Brief Advice and Information in people with Alcohol Drinking and Sex, Unsafe, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Sex, Unsafe, Hiv
- What is being tested?
- Self-Regulation Intervention and Brief Advice and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maya Kratzer contact
United States1 site, 1 recruiting
- Recruiting
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215
Tibor P. Palfai, PhD, 617-353-9345, palfai@bu.edu
About this study
Official title: Alcohol and "Heat of the Moment" Sexual Decision Making Among MSM: Identifying Mechanisms of Sexual Risk and Promoting Behavior Change Through Brief Intervention
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.
Read the detailed description
Despite prevention efforts over the past two decades, HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Approximately 65% of new HIV diagnoses in the United States are due to male-to-male sexual contact. 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 risk factors that underlie HIV acquisition and transmission and develop behavioral strategies that modify them directly or reduce the influence of these factors on behavior. Alcohol use, particularly heavy episodic drinking, is a central modifiable risk factor that may increase CAI in conjunction with other contextual variables. Although there have been a limited number of HIV prevention interventions that incorporate alcohol in sexual risk reduction efforts, relatively little is known about how such interventions impact sexual decision-making in "heat-of the-moment", particularly while intoxicated and in high arousal states that commonly are proximal to sexual behavior.
The goals of this study are to: (1) better understand the within-person mechanisms linking alcohol and arousal with CAI and (2) test the efficacy of an HIV prevention intervention approach that both reduces alcohol consumption and mitigate the influence of intoxication and arousal on CAI. These complementary objectives are addressed through an experience sampling method study (ESM) that examines the impact of an HIV prevention intervention that targets sexual risk and alcohol use. This study will examine whether mechanisms that underlie sexual risk in the natural environment and can be modified by intervention.
In the proposed study, non-monogamous adult MSM who engage in heavy drinking and CAI will be randomly assigned to an intervention condition that addresses alcohol use and sexual decision-making in "heat-of-the-moment" situations. The intervention will be preceded and followed by 3-week ESM bursts of intensive longitudinal assessment of alcohol use, arousal, sexual delay discounting, working memory, and CAI. 4-month follow-up data will be collected. Results will contribute to the long-term goal of enhancing effectiveness of behavioral HIV prevention interventions that address alcohol use.
- Conditions
- Alcohol Drinking, Sex, Unsafe, Hiv
- Being tested
- Self-Regulation Intervention, Brief Advice and Information
- Medical subject headings
- Alcohol Drinking, Unsafe Sex, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Regulation InterventionBehavioural
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
Brief Advice and InformationBehavioural
Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
| Study group | Role | What they receive |
|---|---|---|
| Self-Regulation Intervention | Experimental | 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 Receives: Behavioral: Self-Regulation Intervention |
| Brief Advice and Information | Active comparator | Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) Receives: Behavioral: Brief Advice and Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Self-reported number of times engaged in CAI
Measured: Past 90 days
Heavy Drinking Episodes from the Quick Drinking Screen
Self-reported number of days consumed 5 or more standard drinks
Measured: 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
Measured: Past 90 days
Condomless Anal Intercourse: Experience Sampling
Self-reported frequency of CAI from experience sampling questions
Measured: ESM assessments over a 3 week period
Alcohol Use: Experience Sampling
Self-reported number of drinks and perceived intoxication (composite variable)
Measured: ESM assessments over 3 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start2 Nov 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to either intervention or control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Syracuse University, University of South Dakota, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Tibor Palfai, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729256
- Sponsor's protocol ID
- 6603e
- Other IDs
- R01AA030461-01
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
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.
PubMed 14743950Gordon 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.
PubMed 9302547
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and "Heat of the Moment" Sexual Decision Making Among MSM: Identifying Mechanisms of Sexual Risk and Promoting Behavior Change Through Brief Intervention
- ClinicalTrials.gov ID
- NCT05729256
- Acronym / sponsor ID
- 6603e
- Conditions
- Alcohol Drinking, Sex, Unsafe, Hiv
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Syracuse University, University of South Dakota, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite prevention efforts over the past two decades, HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Approximately 65% of new HIV diagnoses in the United States are due to male-to-male sexual contact. 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 risk factors that underlie HIV acquisition and transmission and develop behavioral strategies that modify them directly or reduce the influence of these factors on behavior. Alcohol use, particularly heavy episodic drinking, is a central modifiable risk factor that may increase CAI in conjunction with other contextual variables. Although there have been a limited number of HIV prevention interventions that incorporate alcohol in sexual risk reduction efforts, relatively little is known about how such interventions impact sexual decision-making in "heat-of the-moment", particularly while intoxicated and in high arousal states that commonly are proximal to sexual behavior.
The goals of this study are to: (1) better understand the within-person mechanisms linking alcohol and arousal with CAI and (2) test the efficacy of an HIV prevention intervention approach that both reduces alcohol consumption and mitigate the influence of intoxication and arousal on CAI. These complementary objectives are addressed through an experience sampling method study (ESM) that examines the impact of an HIV prevention intervention that targets sexual risk and alcohol use. This study will examine whether mechanisms that underlie sexual risk in the natural environment and can be modified by intervention.
In the proposed study, non-monogamous adult MSM who engage in heavy drinking and CAI will be randomly assigned to an intervention condition that addresses alcohol use and sexual decision-making in "heat-of-the-moment" situations. The intervention will be preceded and followed by 3-week ESM bursts of intensive longitudinal assessment of alcohol use, arousal, sexual delay discounting, working memory, and CAI. 4-month follow-up data will be collected. Results will contribute to the long-term goal of enhancing effectiveness of behavioral HIV prevention interventions that address alcohol use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomly assigned to either intervention or control
| Arm | Type | Receives |
|---|---|---|
| Self-Regulation Intervention | Experimental | Behavioral: Self-Regulation InterventionSingle 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 comparator | Behavioral: Brief Advice and InformationSingle session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Regulation InterventionSingle 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 | Behavioural | Self-Regulation Intervention |
| Brief Advice and InformationPsychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) | Behavioural | Brief Advice and Information |
Primary outcome
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Time frame: Past 90 days
Self-reported number of times engaged in CAI
Heavy Drinking Episodes from the Quick Drinking Screen
Time frame: Past 90 days
Self-reported number of days consumed 5 or more standard drinks
Average number of drinks per week from the Quick Drinking Screen
Time frame: Past 90 days
Self-reported average number of drinks per week multiplied by frequency of drinking per week
Condomless Anal Intercourse: Experience Sampling
Time frame: ESM assessments over a 3 week period
Self-reported frequency of CAI from experience sampling questions
Alcohol Use: Experience Sampling
Time frame: ESM assessments over 3 week period
Self-reported number of drinks and perceived intoxication (composite variable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 14743950Sobell 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.
- Background: PubMed 9302547Gordon 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.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya Kratzer contact
Tibor Palfai, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Regulation Intervention and Brief Advice and Information in people with Alcohol Drinking and Sex, Unsafe, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tibor Palfai, PhD (6173539345, palfai@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey (time frame: Past 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729256, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.