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Alcohol and "Heat of the Moment" Sexual Decision Making

Primary Purpose

Alcohol Drinking, Sex, Unsafe, Hiv

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Regulation Intervention
Brief Advice and Information
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University Department of Psychological and Brain Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Regulation Intervention

Brief Advice and Information

Arm Description

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

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

Outcomes

Primary Outcome Measures

Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Self-reported number of times engaged in CAI
Heavy Drinking Episodes from the Quick Drinking Screen
Self-reported number of days consumed 5 or more standard drinks
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
Condomless Anal Intercourse: Experience Sampling
Self-reported frequency of CAI from experience sampling questions
Alcohol Use: Experience Sampling
Self-reported number of drinks and perceived intoxication (composite variable)

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
August 24, 2023
Sponsor
Boston University Charles River Campus
Collaborators
Syracuse University, University of South Dakota, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05729256
Brief Title
Alcohol and "Heat of the Moment" Sexual Decision Making
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
Syracuse University, University of South Dakota, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Sex, Unsafe, Hiv

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomly assigned to either intervention or control
Masking
Outcomes Assessor
Masking Description
Trial procedures designed so that the post-intervention assessor is blind to condition
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Regulation Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Brief Advice and Information
Arm Type
Active Comparator
Arm Description
Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Intervention Type
Behavioral
Intervention Name(s)
Self-Regulation Intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice and Information
Intervention Description
Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)
Primary Outcome Measure Information:
Title
Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey
Description
Self-reported number of times engaged in CAI
Time Frame
Past 90 days
Title
Heavy Drinking Episodes from the Quick Drinking Screen
Description
Self-reported number of days consumed 5 or more standard drinks
Time Frame
Past 90 days
Title
Average number of drinks per week from the Quick Drinking Screen
Description
Self-reported average number of drinks per week multiplied by frequency of drinking per week
Time Frame
Past 90 days
Title
Condomless Anal Intercourse: Experience Sampling
Description
Self-reported frequency of CAI from experience sampling questions
Time Frame
ESM assessments over a 3 week period
Title
Alcohol Use: Experience Sampling
Description
Self-reported number of drinks and perceived intoxication (composite variable)
Time Frame
ESM assessments over 3 week period

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tibor Palfai, PhD
Phone
6173539345
Email
palfai@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Kratzer
Email
mkratzer@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor Palfai, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Department of Psychological and Brain Sciences
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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)
IPD Sharing 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.
IPD Sharing Access Criteria
Based on review of data plan from the Multiple Principal Investigators of the study
Citations:
PubMed Identifier
14743950
Citation
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.
Results Reference
background
PubMed Identifier
9302547
Citation
Gordon 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.
Results Reference
background

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Alcohol and "Heat of the Moment" Sexual Decision Making

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