Effects of Acute Alcohol on Sex-Specific Delay Discounting and Subsequent Sexual Decision Making Among MSM
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Condomless Anal Sex Intentions
研究概览
简要总结
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.
详细描述
Significance and Specific Aims of Project
Men who have sex with men (MSM) continue to be disproportionately affected by the HIV epidemic in the United States. However, the experimental research designed to advance our knowledge of the causal link between alcohol use and risky sex has disproportionately focused on heterosexual men and women. Experimental studies are needed to test established theories and explore new mechanisms linking alcohol to HIV risk among MSM. This proposed project will experimentally test if sex-specific delay discounting (SSDD) is a mechanism of action underlying the association between alcohol and risky sexual behavior among MSM. More specifically stated, the aims are to:
- Examine the pharmacological effect of alcohol on sex-specific delay discounting in MSM, with the prediction that individuals who consume alcohol will display greater sexual impulsivity
- Examine the expectancy effect of alcohol on sex-specific delay discounting in MSM, with the prediction that those who receive placebo will evince greater sexual impulsivity than true controls
- Test whether sex-specific delay discounting mediates the effects of alcohol on risky sexual decision making in MSM, using the CMM as a theoretical base for hypothesis testing
Participant Population
The participant population will consist of males age 21 to 35 years who are able to read and communicate in English. Eligible participants are: 1) single (i.e., not in a mutually monogamous relationship for at least 3 months); 2) sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months; and 3) have had condomless anal sex with a male partner in their lifetime; 4) have had at least one sexual encounter with a male partner met online in their lifetime; 5) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Masking only applies to those participants who are randomly assigned to the placebo condition, which is described in detail above.
入排标准
- 年龄范围
- 21 Years 至 35 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Alcohol
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.
干预措施: Alcohol Administration (Other)
Placebo
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.
干预措施: Placebo Alcohol Administration (Other)
True Control
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.
干预措施: No Alcohol Administration (Other)
结局指标
主要结局
Condomless Anal Sex Intentions
时间窗: Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol.
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?"
Sexual Partner Delay Discounting Task
时间窗: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
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.
Sex Discounting Task
时间窗: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
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.
次要结局
- Online Sexual Communication(Approximately 45 minutes after beverage administration within our single-session, lab-based protocol.)
- 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.)
研究者
Mark Celio
Assistant Professor (Research)
Brown University
