Individual and Contextual Factors That Influence Sexual Decisions

NCT03224416 | Unknown

• 1 other identifier: Project Now (Phase II)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alcohol; Delay Discounting; Risky Sexual Behavior; Decision Making; MSM

Outcome Measures

Primary Outcomes (3)

• Sexual Partner Delay Discounting Task

  This delay discounting task measures hypothetical choice preference for immediately available sexual partners versus delayed but more attractive sexual partners. Data collected across 35 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate sexual activity.

  Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.

• Sex Discounting Task

  This discounting task measures the degree to which the value of hypothetical condom-protected sex decreases as a product of the amount of time one would have to wait for a condom to be available. Data collected across 32 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate and condomless sexual activity.

  Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.

• Condomless Anal Sex Intentions

  In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Intention to have condomless anal sex with this partner is assessed in the middle and at the end of this scenario. Intention is rates as "yes" or "no" in response to the question "In this situation, do you have anal sex with \[this partner\] without a condom?"

  Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol.

Secondary Outcomes (3)

• Perceived Sex Potential

  Approximately 35 minutes after beverage administration within our single-session, lab-based protocol.

• Perceived Sexual Risks and Benefits Scale

  Approximately 40 minutes after beverage administration within our single-session, lab-based protocol.

• Online Sexual Communication

  Approximately 45 minutes after beverage administration within our single-session, lab-based protocol.

Study Arms (3)

Alcohol

EXPERIMENTAL

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: Alcohol Administration

Placebo

PLACEBO COMPARATOR

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: Placebo Alcohol Administration

True Control

SHAM COMPARATOR

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.

Other: No Alcohol Administration

Interventions

Alcohol Administration OTHER

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.

Alcohol

Placebo Alcohol Administration OTHER

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.

Placebo

No Alcohol Administration OTHER

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.

True Control

Eligibility Criteria

• Age: 21 Years - 35 Years
• Gender Eligibility Details: Cisgender males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• single (i.e., not in a mutually monogamous relationship for at least 3 months)
• sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months
• have had condomless anal sex with a male partner in their lifetime
• have had at least one sexual encounter with a male partner met online in their lifetime
• characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.

You may not qualify if:

• Non-drinkers and light to moderate drinkers
• Individuals with current alcohol problems (as indexed by an AUDIT score ≥16)
• Individuals with current drug problems (as indexed by a DAST score ≥6)
• Females (as this is a study of men who have sex with men).

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Binge Drinking; Unsafe Sex; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Interventions

Ethanol; Organization and Administration

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders; Sexual Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Health Services Administration

Study Officials

• Mark A Celio, PhD

  1979

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Celio, PhD

CONTACT

401-863-6662; mark_celio@brown.edu

Jamie Hendrickson

CONTACT

401-863-6665; jamie_hendickson@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking only applies to those participants who are randomly assigned to the placebo condition, which is described in detail above.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: July 21, 2017
• Study Start: May 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)