HIV/AIDS Clinical Trial
Official title:
Effects of Acute Alcohol on Sex-Specific Delay Discounting and Subsequent Sexual Decision Making Among MSM
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.
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:
1. 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
2. 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
3. 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.
Non-drinkers, light to moderate drinkers, and individuals with current alcohol problems (as
indexed by an AUDIT score ≥16) or drug problems (as indexed by a DAST score ≥6) will be
excluded. Given that this is a study of MSM, females will be excluded. Furthermore,
individuals who do not meet the relationship status and sexual activity criteria above will
be excluded. Lastly, individuals who participated in Phase 1 of this research program will be
excluded from Phase 2 Based on recruitment rates from studies at Brown, the investigators
estimate that one quarter of participants completing the screening consent will be eligible
for the study. As such, the investigators plan to obtain screening consent from approximately
600 to 800 individuals with the hope of yielding 150 to 180 participants eligible for the
experimental session.
Recruitment and Screening
Participants will be recruited using established and approved methods that have been applied
in our community, including online advertisement through the Brown CAAS and Brown Alcohol
Research Center on HIV (ARCH) websites, flyers posted at CAAS- and ARCH-affiliated clinical
and community centers, and flyers posted at public venues and organizations in the local
community. In addition to these direct recruitment strategies, this study will employ chain
referral sampling (i.e., "snowball sampling"), in which project staff will ask men who
respond to our advertisements if they would be willing to inform others about our study.
Project staff will also contact individuals who have completed the online survey for our
research participant pool. The participant pool survey provides an efficient means to
identify individuals who are interested in participating in research studies on sexual
minority men's health. The HRPP confirmed that the procedures necessary for creating and
managing this participant pool do not constitute human subjects research, and therefore do
not require IRB review. The participant pool survey includes items that are sufficient to
determine whether an individual meets preliminary screening criteria for the current study.
As with our other recruitment strategies, all individuals recruited through the participant
pool will be asked to complete the dedicated screening consent and survey to determine full
eligibility for this study.
Methodology and Procedures
Screening. Upon contact, potential participants will be given a brief description of the
study and will receive a link to our online screening consent form and screening survey. Upon
completion of the screening survey, those who do not meet the inclusion criteria will be
notified of their ineligibility online. Eligible participants will be contacted by a research
assistant to describe the experimental session further and confirm their interest in
participating. Eligible participants will be informed that the experimental session will last
2.5 hours, plus the time it takes for BrAC to fall to .02%. Participants will be told not to
drive to the session; public transportation or cab vouchers will be provided if necessary.
Participants will be asked to bring photo identification to their session, to avoid using
alcohol or drugs that are not prescribed (including over-the-counter drugs) for 24 hours
prior to their appointments, and to fast for 3 hours before their appointments. Participants
agreeing to these terms will be scheduled for the experimental session.
Informed Consent Procedure. All experimental sessions will be conducted at CAAS in
Providence, RI. Our labs are designed to facilitate studies involving alcohol administration.
When participants arrive to the lab, the research assistant will review photo identification
to verify the participant's age, then they will collect a BrAC to ensure that they are .000%.
Those with a BrAC above .000% will be rescheduled. Next, the research assistant will review
all sections of the informed consent document with the participant. The research assistant
will ask the participant if he understands the key component involved in participation, and
will answer any remaining questions before obtaining the participant's signature on the
appropriate documentation. After obtaining consent, the research assistant will review a
standard medical condition agreement, which asks participants to indicate whether they have
any medical conditions or are taking any medications for which alcohol use is
contraindicated. RAs will emphasize that questions are being asked of participants to ensure
their safety, and inquire about whether there are any safety reasons why they should not
participate. Lists of affected conditions and medications will be provided.
Experimental Session Protocol. Participants will be randomly assigned to one of three
potential conditions described above. The research assistant will collect measures of the
participant's weight and height for determining the volume of beverage to be administered.
This includes determining the appropriate dose of alcohol for those assigned to the alcohol
condition. Dose amounts will be calculated using a well-validated algorithm. Next
participants will be asked to complete a baseline assessment battery via computer-delivered
self-report questionnaire. Finally, the research assistant will encourage the participant to
use the restroom prior to initiating experimental procedures.
After completing the baseline measures, participants will undergo the beverage administration
protocol, which will be identical for all participants so as to avoid bias due to potential
timing effects. Duration and timing of beverage administration and post-drinking assessment
is based on pharmacokinetic assumptions that peak blood alcohol is approximately 60 minutes
after consumption. Participants in the alcohol condition will consume a volume of alcohol to
reach a peak BrAC of .080g%. The total volume will be divided into three drinks to be
consumed over the course of 15 minutes. Following consumption, BrAC will be measured every
5-minutes, and post-drinking assessment will be initiated when the participant's BrAC is
.035g%, as this corresponds with the initiation of stimulant effects of alcohol. The
estimated absorption period to reach this level is 10 to 20 minutes. Initiation of post-drink
assessment for placebo and true control participants will be determined using a yoked control
design, such that each control participant is assigned to undergo the same waiting period and
the same number of breath tests as a corresponding alcohol participant.
Upon reaching a BrAC of .035g% (or comparable time for placebo and control), participants
begin the post-drinking assessment protocol, comprising an arousal prime, two measures of
sex-specific delay discounting, followed by the MSM stimulus story. The instructions for each
of these tasks will be computer-delivered, and participant responses will be collected via
computer-based self-report questionnaires. Within the MSM scenario, participants are asked in
open-ended format to respond to other character in the story or to describe what happens
next. These responses will be audio recorded using a digital recording device set to
automatically record when the participant begins speaking. Throughout this protocol, which
will last approximately 35-45 minutes, BrAC will be measured every 10-15 minutes for all
participants independent of condition. To evaluate the success of the experimental
manipulation, subjective intoxication (e.g., "how intoxicated do you feel?") will be measured
every 10-15 minutes as well.
Following the assessment phase, participants in the placebo and control conditions will be
debriefed and provided with a taxi home. Participants in the alcohol condition will begin the
recovery period, in which they will be able to eat a snack, use the restroom, and wait
comfortably. BrAC will be assessed every 15-20 minutes until it is verified at .02g% or
below, at which point they will be debriefed and provided with a taxi or public
transportation home.
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