Individual and Contextual Factors That Influence Sexual Decisions
NCT03224416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2017-07-21
Summary
For decades, men who have sex with men (MSM) have carried the heaviest burden associated with the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately 4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV infections among males. Furthermore, the estimated number of new HIV infections attributed to male-to-male sexual contact is currently rising. In order to improve interventions to decrease transmission of HIV among MSM, it is important to have a better understanding of predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have mainly relied on survey-based methods that cannot advance our understanding of the causal mechanisms linking acute alcohol use to HIV risk behavior.
This study will utilize an "alcohol/placebo/nonalcohol" design to examine the mechanisms underlying the association between the acute effects of alcohol (i.e., pharmacological and expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. This 3-group design will enable us to test the pharmacological effects of alcohol while accounting for potential expectancy effects. Participants (Target N = 150-180) will be randomly assigned to one condition; all will undergo the same protocol, which will be completed within one experimental session. The study protocol consists of baseline assessment, followed by beverage administration, followed by post-drinking assessment of SSDD and sexual decision making, followed by debriefing.
Conditions
- Binge Drinking
- Unsafe Sex
- HIV/AIDS
- Sexually Transmitted Diseases
Interventions
- OTHER
-
Alcohol Administration
In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence.
- OTHER
-
Placebo Alcohol Administration
In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims.
- OTHER
-
No Alcohol Administration
In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
Sponsors & Collaborators
-
Brown University
lead OTHER
Principal Investigators
-
Mark A Celio, PhD · 1979
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 35 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2019-02-28
- Completion
- 2019-02-28
Countries
- United States
Study Locations
More Related Trials
-
Young Men and Media Study
NCT04109443 ·Status: COMPLETED ·Phase: NA
-
Game Plan: Efficacy of a Brief, Web-based Intervention on Alcohol Use and Sexually-transmitted Infections
NCT04552171 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
NCT03409328 ·Status: COMPLETED ·Phase: NA
-
MI-based PrEP Intervention
NCT03313765 ·Status: COMPLETED ·Phase: NA
-
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
NCT00691496 ·Status: COMPLETED ·Phase: NA
-
Alcohol Use and Sexual Risk: An Intervention
NCT00914719 ·Status: WITHDRAWN ·Phase: NA
-
Risk Reduction Intervention for Vulnerable Young Adult Males
NCT01118416 ·Status: COMPLETED ·Phase: NA
-
Game Plan for PrEP
NCT04973267 ·Status: COMPLETED ·Phase: NA
-
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
NCT00741975 ·Status: COMPLETED ·Phase: PHASE1
-
Development of a Methamphetamine Early Intervention
NCT01174654 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Understanding Substance Use and Incident HIV/STI Among Young Black MSM
NCT02503618 ·Status: COMPLETED
-
Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
NCT03175159 ·Status: COMPLETED ·Phase: NA
-
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
NCT01573065 ·Status: COMPLETED ·Phase: NA
-
Being Responsible for Ourselves HIV Risk Reduction for Black MSM
NCT02561286 ·Status: COMPLETED ·Phase: NA
-
Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
NCT02116049 ·Status: COMPLETED ·Phase: NA
-
Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
NCT00432926 ·Status: COMPLETED ·Phase: PHASE2
-
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
NCT03488914 ·Status: COMPLETED ·Phase: NA
-
HIV Prevention Counseling for Men Who Have Sex With Men
NCT00000931 ·Status: COMPLETED ·Phase: PHASE3
-
Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
NCT03899220 ·Status: COMPLETED ·Phase: NA
-
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
NCT03823209 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
NCT02045225 ·Status: COMPLETED ·Phase: PHASE1
-
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
NCT01279044 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
NCT01395979 ·Status: COMPLETED ·Phase: NA
-
Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
NCT01327898 ·Status: COMPLETED ·Phase: PHASE2
-
Addressing Young Men's Substance Use and HIV Risk
NCT00325702 ·Status: COMPLETED ·Phase: NA