Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Sponsor: University of Florida

Protocol #201801188 
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Title: Laboratory and field validation of a wrist-worn alcohol monitor 
 
 
 
Clinicaltrials.gov registration number: NCT03617705 
 
 
 
Protocol latest update date: 10.27.2022 
 
 

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Protocol 
1. Project Title 
Laboratory and field validation of a wrist-worn alcohol monitor 
2. Investigator(s): 
Yan Wang, PhD (Principal Investigator) 
Robert Cook, MD, MPH (Co-Investigator) 
Eric Porges, PhD (Co-Investigator) 
 
3. Abstract: 
Alcohol use among persons living with HIV remains a significant barrier for ending the HIV 
epidemic. The newest generation of wrist-worn alcohol monitor provides an unprecedented 
opportunity for improving alcohol intervention among this population. The proposed project 
will be the first study to validate the BACtrack Skyn wrist-worn alcohol monitor (Fig.1) in HIV+ 
drinkers with HIV- drinkers as comparison and evaluate its utility for research/clinical 
application.  
4.  Background: 
As HIV infection becomes a chronic condition with antiretroviral treatment, alcohol use 
remains a significant barrier for mitigating transmission,1 achieving viral suppression,2,3 and 
reducing comorbidities and all-cause mortality.4-9 In general, there are few effective alcohol 
interventions for persons living with HIV (PLWH).3,10 Traditional interventions also tend to 
have limited long-term benefit, partly due to the lack of individualized feedback and the 
absence of continuing care outside of the clinical setting.11 More cost-effective interventions 
(e.g., mHealth intervention) that can be individualized and implemented in daily life to sustain 
behavior change are urgently needed for PLWH.10,12  
Mobile technologies (e.g., smartphone applications) are rapidly changing the landscape of 
medical care and interventions,13-17 including for PLWH.18 Currently, smartphone-based 
intervention has shown some evidence of efficacy for alcohol use among PLWH.12,19 
However, accurately monitoring alcohol consumption remains a significant challenge.20,21 
According to the Integrated Theory of Health Behavior Change, self-monitoring is a key 
element of self-management to improve health outcomes.22 Recent developments in 
wearable alcohol monitors provide a potential powerful tool to monitor alcohol use in real-time 
with minimal participant burden.20,23-28   
Transdermal alcohol monitors can provide noninvasive, continuous monitoring of alcohol use 
by detecting ethanol diffused through the skin.27,31 Secure Continuous Remote Alcohol 
Monitor (SCRAM) anklet (Alcohol Monitoring Systems, Inc.) is the most widely used 
transdermal monitor but is designed to be used for law enforcement purposes.32 However, 
wider application of SCRAM anklet in clinical and intervention settings is limited by its 
shortcomings including its large size, high cost, and social stigma.20,25,29 The newest 
generation of wrist-worn alcohol monitor (BACtrack Skyn) is designed for consumer use and 

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addresses these limitations. The device looks like a fitness tracker, is inexpensive, samples 
up to every second, and transmits and shows data in real-time via a smartphone app. These 
advantages make this wrist-worn alcohol monitor a potentially ideal tool to be incorporated 
into smartphone-based intervention for alcohol use. However, prior to its application in 
research, thorough validation investigations of the monitor are needed. In this project, we will 
validate the Skyn monitor among 20 HIV+ drinkers and 20 HIV- drinkers (as comparison 
group) in both laboratory and field settings.   
 
Fig.1. BACtrack Skyn Alcohol Monitor 
5. Specific Aims: 
Aim 1: Assess the validity and reliability of the Skyn monitor through comparison with 
laboratory grade breathalyzer in two fixed-dose lab alcohol administration sessions (Sec. 4.3, 
4.5) 
Hypothesis 1a: The monitor will be able to detect alcohol use at a low threshold (e.g., one 
drink). 
Hypothesis 1b: The parameters of transdermal alcohol concentration (TAC) (e.g., peak, time-
to-peak, area under the curve) will be correlated with number of drinks and breath alcohol 
concentration (BrAC). 
Hypothesis 1c: The TAC readings in two lab sessions will show high correlation (test-retest 
reliability).  
Aim 2: Validate Skyn monitor in daily life using a 2-week ecological momentary assessment 
(EMA), and evaluate its acceptability and usability for daily alcohol monitoring (Sec.4.4)   
Hypothesis 2a: The monitor detected drinking episodes will correspond with self-reports in 
EMA.  
Hypothesis 2b: The TAC readings will correlate with number of drinks in each drinking 
episode.  

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Exploratory Aim: Explore factors (e.g., gender, HIV status) that may be associated with 
individual differences in monitor readings (e.g., peak, time-to-peak, correlation with 
consumption level). 
6. Research Plan: 
Overview  
This study will include two parts: laboratory and field validation of the Skyn monitor(Fig. 2). 
We will need complete data from 20 HIV+ drinkers (~50% male) and 20 HIV- drinkers 
(~50% male), but we will screen to 160 participants to account for potential screen failure 
and drop out. Participants will be invited to complete all components of the study or only the 
field test portion given the COVID pandemic. The PI will decide who will complete all 
components and who will complete only the field testing. Participants will first complete an 
alcohol administration session (Lab Session 1) at the simulated bar lab, where they will 
consume 3 standard drinks (i.e., 3 12oz beers) at a determined consumption rate (30min). 
The transdermal alcohol concentration (TAC) readings collected from the Skyn monitor will 
be compared with breath alcohol concentration (BrAC) and may be compared with the 
Secure Continuous Remote Alcohol Monitor (SCRAM; Alcohol Monitoring Systems, Inc.) 
anklet. After completing Lab Session 1, during a two-week field test, participants will use the 
Skyn monitor and record drinking episodes using an EMA app. After the field test, 
participants will return to the bar lab to complete a second alcohol administration session 
using the same procedures as in Lab Session 1 to obtain test-retest reliability of the 
monitor. They will also complete a questionnaire on the acceptability and usability based on 
their experience with the Skyn monitor and its smartphone app.  
Of note, BACtrack Skyn monitor has been approved in our previous study (IRB201700455 
for laboratory alcohol administration study where participants wear the monitor while they 
self-administer alcohol in the bar lab).  
 
Participants  
Participants will be HIV+ and HIV- drinkers aged 21 - 64. HIV+ drinkers will be primarily 
recruited from the existing Florida Cohort registry managed by SHARC (Director: Dr. Cook). 
We will recruit from those who live in North-Central Florida area (n = 237, 60% male, 70% 
drank alcohol in past year) within 90 miles of the data collection site (not applicable to field 
only participants). We will also recruit participants from HealthStreet and Consent2Share 
through their referral service(s), the Center for Cognitive Aging and Memory (CAM) 
Registry, self-referrals from patients who see our flyers or social media advertising, and/or 
referrals from other UF HIV/alcohol studies (e.g., IRB201901192, IRB201702564). For 
referrals, research coordinators for the other studies will introduce this study to their 
participants at the end of their study procedures. Interested participants can choose to be 
screened onsite (if they are in another alcohol administration study like IRB201901192 and 
we have available study staff to do so), call us for further information, or leave their contact 

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information using the Contact Authorization Form. We will also send research staff to recruit 
from local community, such as local events (e.g., free HIV testing events) and 
clinics/organizations (e.g., Department of Health, Infectious Disease clinic within the UF 
Medical Plaza). For in-person recruitment, physicians at the clinic (e.g., Dr. Jennifer Janelle 
at UF infectious disease) will introduce our research staff after they meet with the patients 
for their appointment. If the patients agree, the physician will ask our research staff to go 
and talk with the patients in a private room (e.g., the exam room) about the study. They will 
either perform the preliminary screen on site for those who express interest and want to be 
screened right away, or use Contact Authorization Form to collect information from those 
who prefer to receive a phone call about the study later for preliminary screening. When our 
research staff are not present in the clinics, patients can also use the Contact Authorization 
Form to leave their contact information for the clinical staff to send the information to us. 
Our research staff will contact the patients and follow the same procedures.    
We will encourage each HIV+ drinker to refer up to 3 other drinkers, including persons that 
they suspect are HIV-, to participate. This will provide a comparison sample of HIV- drinkers 
who are likely to be of similar age and socio-economic status as the HIV+ participants. 
Additional inclusion criteria include self-reported ≥5 days with at least 1 alcoholic drink, and 
≥1days with at least 3 drinks (the level of alcohol consumption in lab sessions) in the past 
30 days. Exclusion criteria include recent addiction treatment or treatment seeking; urine 
positive for illegal drugs except THC (not applicable to those who are only invited to do field 
test); past & current alcohol withdrawal; severe alcohol use disorder (DSM-5); meeting 
criteria for current nicotine dependence(not applicable to field only participants) or current 
substance use disorder(excluding mild cannabis use disorder and mild/moderate alcohol 
use disorder) ; medical conditions (other than HIV) contraindicating alcohol; 
pregnancy/breastfeeding in women; psychosis or other severe psychiatric conditions. 
Current use of antidepressant medication will not be an exclusion criteria for participants 
who are only completing the field test portion of the study. 
Screening 
Potential participants will be contacted via phone call using their contact information in the 
Florida Cohort Registry, or they will contact our research staff if they are referred by others 
(i.e., HealthStreet, already enrolled participants) or self-referred (i.e., see our flyers in local 
HIV clinics). A trained research assistant (RA) will introduce the study and ask a few 
screening questions if the participant expresses interest. If the participant meets preliminary 
eligibility, the RA will schedule an in-person screen. For those who are asked to complete 
the field test only, portions of the in-person screening can be done remotely via phone call 
or password-protected UF zoom .If participants do not meet the preliminary eligibility, their 
data will be destroyed once their study status becomes clear. The in-person screen will 
include informed consent (can be signed in-person or as eICF through REDCap which will 
be sent via email), breath alcohol test (not applicable to field only participants), HIV test 
(only conducted on persons of unknown status to confirm HIV- status for the comparison 
group), drug and pregnancy test (women) (not applicable to field only participants), vital 
sign, height and weight collection, timeline followback (TLFB)49 for past 30-day alcohol use, 
and diagnostic interview for substance use disorder/withdrawal. The measures used at this 
step include the “Clinical interview measures” and “Timeline followback”. The CIWA (which 
is included in the “clinical interview measures”) may be waived for HIV+ participants who 
complete the screening remotely. The SCID-V will also be conducted at this time, to assess 

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for current and past substance use disorders. The screen will take approximately 2 hours, 
and participants will receive $20 for completing it. Participants who come to their in-person 
screen as originally scheduled will be provided an additional $10 payment. If screening is 
done remotely participants will receive $10 as compensation for using their phone minutes 
and $10 for completing the first set of questionnaires. They will receive $10 for coming in to 
pick up the skyn device and completing the second half of the in-person screen plus an 
extra $10 if they keep their originally scheduled appointment. HIV+ participants who 
complete the entire screening remotely will have the option of having the skyn device and 
other study materials mailed to them to their preferred address. For participants who are 
HIV+, we will ask them to bring in medical records of their most recent HIV lab values 
(CD4/Viral load) at any in-person appointment and will provide $20 compensation for doing 
so. If the participant shows up for the in-person screening but the appointment needs to be 
rescheduled due to reasons on our end (e.g., logistic issues), then they will still receive the 
$20 for this appointment. Those eligible will be scheduled for two drinking sessions. For 
those who screen out at the in-person screen, their data collected up to the point will be 
retained in the same way as those who are deemed eligible, because they sign the consent 
form before going through the in-person screen. However, like other participants they have 
the right to revoke authorization to use their data in writing. Screening documents will be 
assessed by Dr. Wang to confirm eligibility, a signature will be provided only if the 
participant is eligible. 
Participants will be given the option to receive an e-gift card, or receive the gift card via 
mail, if they do not want travel to UF campus to pick up a gift card. 
For those who are deemed eligible for the study after the in-person screen, they will also 
complete the baseline survey (can be sent via email), where they will answer questions on 
demographics, drinking history, alcohol use disorder, alcohol effects, drinking motives, other 
substance use, and HIV treatment/adherence (for HIV+ participants only). Information 
obtained from these questions will be used to explore factors contributing to interpersonal 
variations in transdermal alcohol concentration and how they impact participant compliance 
in the field test (as some preliminary findings for building a larger project on this exploratory 
R21).  
Lab Session 1. Participants will be asked not to eat for 3 hours pre-arrival, and arrive with a 
non-positive BrAC reading (.00%) detected by a laboratory degree breathalyzer (Alco-
Sensor VXL, Intoximeters). In the event that an individual registers a positive breath alcohol 
level, there will be two possibilities. If the individual’s breath alcohol level is likely to decline 
to 0.00% in a reasonable amount of time (i.e., 0.02% or lower), they will be offered the 
chance to remain at the research facility to be re-tested and take part in the appointment 
when their breath alcohol level reaches 0.00%. If it is not feasible for the participant to wait, 
they will be offered one opportunity to reschedule this appointment. Instruction/practice of 
the EMA app, Skyn monitor and its app will take place prior to the drinking session when 
participants are sober. The RA will help participants download the EMA app (Sec.4.4) on 
their smartphone, enter an 8-digit unique ID code for each participant, and show them how 
to enter a drinking session and answer the prompted questions. The RA will also help 
download the Skyn app and show participants how to pair the app with the monitor. The 
recording of data should automatically begin once the Skyn monitor is paired with the app. 
Instructions and demonstration of how to charge and operate the Skyn monitor will also be 
given. Procedures for the two-week field test will be explained. Participants will have time to 

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practice with the apps and monitor until they feel efficient with all. Further, participants may 
also be asked to wear the Secure Continuous Remote Alcohol Monitor (SCRAM; Alcohol 
Monitoring Systems, Inc.) anklet for the duration of the drinking session. The SCRAM anklet 
is similar to the Skyn device although it is worn around the ankle rather than the wrist. The 
SCRAM anklet will be used to evaluate whether transdermal alcohol concentration (TAC) 
readings obtained from each device converge, given that the SCRAM anklet is a validated 
TAC monitor. The SCRAM anklet has been approved and risk assessed in our previous 
study (IRB201700623). 
Once practice with apps and monitor is completed, vital signs (including blood pressure, 
pulse, height and weight) will be collected, urine drug and pregnancy screening will occur, 
and participants will be provided a light snack (150-200 calories). Next, participants will be 
asked to complete some questionnaires (e.g., Alcohol Urge Questionnaire (AUQ); Positive 
and Negative Affect Scale (PANAS);  Alcohol Purchase Task (APT);  real time impaired 
control scale (ICRT); and a single-item question asking how much one wants alcohol 
currently).   
Next, the drinking session will begin. We will provide several common beer brands with 
similar calorie (125-150) and alcohol level (~4.5% ABV) for the participants to choose from. 
Participants will be instructed to wear the Skyn monitor and SCRAM anklet and drink 3 
beers by completing each beer in 15 minutes50 with a 15-minute break in between (30min in 
total for each beer). During this time, the participant’s BrAC will be measured every 30 
minutes. Following the end of each beer during the 15-minute rest period, participants will 
also complete a brief packet of questionnaires very similar to the one they completed before 
drinking, plus the Biphasic Alcohol Effects Scale (BAES) and a single-item question asking 
how much one likes the effects of alcohol. Alcohol administration will be conducted per 
NIAAA guidelines51.  
At the end of the 90-minute drinking period, participants will give breath alcohol readings 
approximately every 15 minutes for the remainder of the session. Every hour participants 
will also complete the same brief packet of questionnaires they completed earlier in the 
session. At the end of the evening participants will remove the SCRAM anklet. All 
participants are required to remain in the simulated lab or research office for two hours after 
drinking and until the participant’s breath alcohol drops to the safe level of 0.00%. During 
this time, participants will be provided free Wi-Fi, TV, magazines, snacks and nonalcoholic 
beverages (e.g., water, juice).  
Once the participant’s breath alcohol level falls to a BrAC of 0.00%, they will be provided 
transportation back home. This transportation can only be taken directly home. 
Transportation will be by car unless the participant resides within a half mile of the research 
facility, in which case there will be an option for them to walk, along with a member of the 
study staff. For the participant’s safety, it will not be possible for them to drive themselves 
home or for them to have a friend or family member pick them up. 
The whole lab session is expected to last about 5-6 hours, and participants will receive 
$15/hour. Payment for drinking session is capped at $90 as we expect most people will 
reach .00% by then. Participants who come to their lab session as originally scheduled will 
be provided an additional $10 payment. 

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Field Test. After Lab Session 1 or when “field test only” participants come to the lab to pick 
up the device, participants will be instructed to wear the Skyn monitor in their daily life for a 
2-week period. They can see the readings from the Skyn app on their phone if they want, 
but not required for this study. They will be allowed to take it off for shower or bath, 
swimming, charging the device, or when their activities may cause damage to the monitor 
(e.g., exposure in the rain). Since the monitor also has a temperature sensor, it’s possible to 
determine whether participants take it off. We will ask participants to check the battery 
status every other day and charge it if needed. The RA will be available to answer questions 
over the phone to help troubleshoot remotely, or have the participant bring in the Skyn 
monitor if they really need in-person assistance with the device itself or the app.  
Due to the fact that the Skyn app is only compatible with iOS system, participants who do 
not own an iPhone will be provided with one to complete the two-week field test. The 
iPhone is to be used for research purposes only. Any personal use is not allowed except 
participants need to reach out to us about the study (e.g., they need help with the Skyn 
device). The iPhone must be returned intact at the end of this period, otherwise $200 will be 
deducted from participant payment.  
At the end of the 2-week period the RA will schedule a time with the participants who are 
doing the field test only to drop off the skyn device and study iPhone (if we loan them a 
phone). At this visit they will also complete a survey on the acceptability and usability of 
Skyn and its app as well as the TLFB. Payment for the 2-week period will occur after they 
complete these measures. If the participant is unable to return to the lab, we will conduct 
the usability/acceptability survey and the TLFB remotely. The participant will also have the 
option of mailing the study devices back to the lab. If mailing the devices, the study team 
will send a prepaid box or envelope to the participant’s preferred address. 
Of note, the procedures for field alcohol monitoring using transdermal alcohol monitor and 
EMA have been approved by IRB in our previous study (IRB201700623, where HIV+ and 
HIV- participants are asked to wear a transdermal alcohol monitor and use the EMA app 
described below for two weeks). 
EMA: Participants will be instructed to enter information on each drinking session using an 
EMA app called mEMA (ilumivu, Inc.). This app is developed for mobile-based ecological 
momentary assessment to collect real-time data in daily life (Fig. 4). Researchers can 
create questions and set up the prompt type for each question (e.g., scheduled, or on-
demand). In this study, participants will be asked to initiate an on-demand survey in the app 
whenever they start a drinking episode. This survey include questions regarding the 
drinking episode such as the starting and ending times of each drink, types of drinks, 
drinking amount, and food intake. To capture any potentially missed self-initiated entry at 
the time of drinking, the EMA app will also prompt questions at a fixed schedule every 
morning to ask about alcohol consumption in the past 24 hours. The morning prompts will 
also include reminders to check the battery life of the monitor and to upload EMA data, and 
report issues they had with the Skyn monitor. The app uses cloud storage and researchers 
can access data in real time once uploaded by the participants. We will contact participants 
via phone call if we notice any issues (e.g., missing daily prompt, reported monitor 
malfunction) so that these issues can be resolved in time. Participants will receive $70 
($5/day) and a bonus of $70 if they complete ≥80% of the EMA questions, wear the monitor 
≥80% of the time, and return it to the lab.52  

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Lab Session 2. For those who are asked to complete all study components, after 
completing the two-week field test, participants will return to the lab for a second drinking 
session. The procedures will be the same as in Lab Session 1 with only one exception: 
Instead of training/practice with the monitor and app, participants will be asked to complete 
a survey on the acceptability and usability of Skyn and its app. The survey will include 
questions adapted from established instruments such as the System Usability Scale53 and 
the Mobile App Rating Scale54, with some open-ended questions about user-desired 
features. Before dismissal, the RA will help uninstall the apps on the participant’s phone. 
Payment structure is the same as in Lab Session 1.  
Data sources and management. In the lab sessions, we will record information about the 
drinking episode (start and end times of each beer) and the BrAC data (time, reading). TAC 
readings from Skyn monitor and SCRAM anklet will later be downloaded from their 
respective web porter as a csv/Excel file and stored on a secured server at UF. In the field 
test, EMA data is cloud-based and will be downloaded to a secured server at UF on a daily 
basis when active data collection is in process. All data will be linked using the 8-digit ID 
code assigned to the participant.  
Analysis plan for Aim 1: Assess the validity and reliability of the Skyn monitor through 
comparison with laboratory grade breathalyzer in two fixed-dose lab alcohol administration 
sessions. H1a. Threshold of detection. We define the threshold of detection as the 
consumption level with a 60% or higher detection rate. Rate of successful detection at the 
end of 1 beer, 2 beers, and 3 beers will be calculated respectively. This will be done by 
observing the data series and curves from the monitor readings.45,48 Successful detection of 
consumed alcohol is defined by a TAC peak (e.g., ≥.02g/dL) with a reasonably visible 
elevation slope for absorption (i.e., TAC curve goes up at a reasonable pace) and a 
declination slope for elimination (i.e., TAC curve goes down at the reasonable pace). H1b1. 
Relationship between TAC and number of drinks. The means of peak TAC readings and the 
areas under the curve will be calculated for 1, 2, and 3 drinks respectively. We expect a 
linear increase of peak TAC and area under the curve as number of drinks increase from 1 
to 3. H1b2. Relationship between TAC and BrAC. We will examine the relationship between 
TAC and BrAC in three ways. First, a simple correlation will be calculated between recorded 
peak TAC and peak BrAC. A scatter plot will be produced to illustrate the bivariate 
correlation between these two readings. Second, the Bland-Altman method55,56 will be used 
to examine the magnitude of peak differences between TAC and BrAC. The average of 
paired TAC and BrAC peak values are plotted on x-axis, and the difference between them 
on y-axis. Stable TAC results across all BrAC levels will line up with a zero slope, which will 
suggest there is no systematic bias in estimating BrAC. Third, we will calculate the time-to-
peak based on recorded TAC and BrAC readings. Their differences will be calculated to 
determine time delays in BrAC to TAC peaks. All these analyses will be conducted for TAC 
and BrAC readings obtained after each beer respectively. H1c: Two-week test-retest 
reliability. Pearson correlational coefficients will be calculated to indicate test-retest 
reliability using TAC peak /time-to-peak for each participant in two lab sessions. A 
correlation ≥ .7 indicates good test-retest reliability.   
Analysis plan for Aim 2. Validate Skyn monitor in daily life using a 2-week ecological 
momentary assessment (EMA), and evaluate its acceptability and usability for daily use. 
H2a. Agreement between monitor and self-reports in EMA. Using the same definition of a 
successful detection and procedure of determining drinking episode in monitor data as in 

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H1a, we will calculate the detection rates by self-reported number of drinks. A receiver 
operating characteristic (ROC) curve will be plotted.  H2b: Relationship between TAC and 
number of drinks. First, simple correlations will be calculated to examine the association 
between TAC (peak, AUC) and self-reported number of drinks using all drinking episodes. 
Second, a multilevel analysis will be used to examine the association between TAC (peak, 
and AUC) and number of drinks accounting for nested data within person. Acceptability and 
Usability. Ratings of the Skyn monitor will be summarized on aspects such as wearability, 
ease to operate, satisfaction with the product, and willingness to wear.  
Analysis plan for Exploratory Aim. Explore factors that may be associated with individual 
differences in monitor readings. T-tests or Chi-square will be used to examine group 
differences (e.g., male vs. female, HIV+ vs. HIV-) in TAC parameters (i.e., peak, time-to-
peak) and their relationships with # of drinks and BrAC.  
Sample size and power. This is for how many participants need to complete the study. For 
Aim 1, the sample size was based on prior laboratory validation studies of transdermal 
alcohol monitors.36,45,57 Also, power analysis shows that a sample size of 40 will give us 
80% power to detect a correlation ≥.60. For Aim 2, power analysis shows that n = 40 will 
give us 90% power (α = .05) to detect an effect size ≥.13 in a multilevel analysis with r = .60 
between measures.58,59 For Exploratory Aim, n = 20 in each group can give us 80% power 
to detect a large difference (d ≥ .80).  
7. Possible Discomforts and Risks: 
Potential risks in this study include: 
1. Breach of confidentiality: Our study will collect data on alcohol use from persons living with 
HIV. HIV infection is a very sensitive health condition. Breach of confidentiality could occur via 
communications with participants, loss of research data, and transfer of data. Consequently, 
procedures have been established to ensure the protection of this information, described in 
the Adequacy of Protection against Risks section. 
2. Alcohol consumption: Potential risks in this study were identified in accordance with the 
recommended guidelines on ethyl alcohol administration in human experimentation put forth 
by the National Advisory Council on Alcohol Abuse and Alcoholism (2005). Steps taken to 
minimize these risks were also developed in accordance with these documents. 
A number of medical conditions could potentially be worsened by acute alcohol 
administration (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological 
problems, and gastrointestinal disorders). As a result, participants with such medical 
problems or who currently take medications contraindicating alcohol consumption at the 
level in this study will be excluded. 
Alcohol self-administration in a research study by individuals who are severely alcohol 
dependent as evidenced by current withdrawal, a history of withdrawal or diagnosis of 
current severe alcohol use disorder may pose a risk to their health and safety. Alcohol self-
administration in a research study by individuals who are seeking treatment for alcohol 
dependence or who have recently engaged in intensive treatment for alcohol dependence 
may compromise their efforts to reach or to maintain abstinence or moderate levels of 
alcohol use.  

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Alcohol may cause nausea in high doses, however, nausea is not expected at the doses 
that will be consumed in this sample of frequent heavy drinkers. Only current drinkers who 
had at least 1 drinking day with 3 or more drinks in the past month are selected for the 
study, thus ensuring that any amount of alcohol consumed during an alcohol administration 
session is less than or equal to an amount of alcohol they consume on their own.  
Another area of potential risk to participants under the influence of alcohol involves their 
safety during the experimental procedures. Although impairment of gross motor 
coordination in drinkers is rare at the alcohol doses to be consumed in this study, all 
participants will be under the close supervision of the experimenters to prevent possible 
accidents such as falls. Alcohol is a reinforcing agent, which may cause changes in 
behavior including repetitive or excessive alcohol consumption.  
3. Breath screening, urine tests and HIV oral swabs testing: Breath screening and urine 
collections are performed primarily as safeguards and should add no risks other than those 
normally associated with these procedures.  Oral swab is noninvasive and performed only 
to obtain HIV status of the participant (mainly for confirming HIV- status for the comparison 
group). It is possible that persons may receive a test result that was unexpected (e.g. a 
positive pregnancy test, a positive HIV test), and this could result in emotional distress. Our 
staff will be trained to assist as described in Adequacy of Protection against Risks section. 
4. Questionnaires and interview: The assessments used in this study deal with some 
sensitive issues including participants’ alcohol-related problems and other psychiatric 
conditions. The major disadvantages of these assessments are the time taken to complete 
them and possible breach of confidentiality. Our past experience with these measures 
indicates that they are acceptable to participants.  
5. Alcohol monitoring using wrist and ankle monitor: The wristband and ankle monitors are 
noninvasive and adjustable for different wrist and ankle sizes, respectively. It’s very unlikely 
to cause any discomfort based on our experience.  
6. Ecological momentary assessment (EMA) of self-reported drinking: The EMA involves 
minimal risk as it only collects self-reported drinking data and issues related to the monitor. 
The major disadvantage of this assessment is the time taken to complete daily reports. The 
possibility of confidentiality breach is very low, because the data collected from the mobile 
app will be encrypted and pushed to the cloud-based storage database. No data are ever 
stored on the server's file server but always in the database. Access to the database is 
gated so entry is only permitted to users entering through the approved route (i.e. you can't 
hack your way into the database by guessing at the url). 
Protection against Risks 
Recruitment: The HIV+ drinkers will be recruited from the existing Florida Cohort registry (a 
database of PLWH who are consented to be contacted for research) managed by the 
Southern HIV and Alcohol Research Consortium and from the Consent2Share registry. We 
will focus on recruiting participants living in North Florida (n = 237, 60% male, 70% drank 
alcohol in past year) within 50 miles of the data collection site. The racial distribution of 
these participants is 40% white, 53% black, 3% Latino, and 4% other (primarily mixed race). 
We expect to get a similar distribution in our sample. We expect similar racial distribution of 
the HIV- drinkers, and some additional HIV-positive drinkers, as we will use participant 
referrals to recruit HIV- drinkers. They are likely to come from similar demographic 
background. 

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Screening: Potential participants will be contacted via phone call using their contact 
information in the registry or call our research staff if referred by other participants. A trained 
research assistant (RA) will introduce the study and ask a few screening questions (e.g., 
past 30 day use of alcohol) if the participant expresses interest. If the participant meets 
preliminary eligibility, the RA will schedule an in-person screen. At the outset of the in-
person screening appointment, picture identification (i.e., passport, driver’s license or state-
issued identification card) is examined in order to verify the participant’s identity and to 
ensure that they are 21 years or older. This ensures that no alcohol consumption on the 
part of individuals under age 21 will take place in this study. The in-person screen will 
include breath alcohol test, drug and pregnancy test (women), HIV test if HIV status 
unknown, timeline follow back (TLFB) for past 30-day alcohol use, medical history, and 
diagnostic interview for substance use disorder/withdrawal. The screen will take 
approximately 2 hour, and participants will receive $20 for completing the screen. 
Participants who come to their in-person screen as originally scheduled will be provided an 
additional $10 payment. For participants who are HIV+, we will ask them to bring in medical 
records of their most recent HIV lab values (CD4/Viral load) at any in-person appointment 
and will provide $20 compensation for doing so. 
Informed consent: At the in-person screen appointment, the entire consent form will be 
reviewed in detail with the participant in a private, one-on-one setting at one of our research 
offices. If using eICF, the RA will go over the consent form with the participant over the 
phone and have them sign electronically. Participants will be told that the purpose of this 
study is to evaluate a new wrist worn alcohol monitor in lab alcohol drinking sessions and 2-
week field use. Potential risks will be described. Any questions the participant may have will 
be addressed. If the participant wishes, he/she may take the consent form home and 
consider it further before signing. They may also request to speak to anyone on the 
research team about questions they have. Once the participant has signed the consent, 
they may withdraw consent at any time. This informed consent form will serve as 
documentation of the major aspects of the consent process. The informed consent form will 
be signed and dated by the participant, and countersigned and dated by the staff member 
obtaining consent. A copy of the signed informed consent form will be given to the 
participant. Informed consent will be obtained prior to performance of any protocol specified 
procedures at the in-person screening with the exception of initial breath alcohol screening, 
which will take place at the outset. Determination must be made that participants’ breath 
alcohol concentration = 0.00% so that they can provide informed consent to participate. 
1. Breach of confidentiality. Precautions are taken to ensure that all research materials are 
inaccessible to anyone other than the investigators. Whenever possible, research 
participants will be referred to by study-assigned ID numbers rather than by their name or 
other personal information. Accordingly, results of interviews and questionnaires, breath 
alcohol concentration, and urine drug/pregnancy screening are recorded by staff members 
on paper forms using study IDs only. Urine testing and HIV test will take place only at our 
research offices. Urine samples will be used for the purposes of this testing only and will be 
discarded after tests are completed. HIV test will be conducted by research staff who has 
HIV 500/501 certification, which is a certification required for anyone who will perform HIV 
oral test, granted by the Florida Department of Health. Standard procedure outlined by the 
DOH will be followed if anyone is tested positive in the oral test. 

Protocol #201801188 
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Some private identifiable information about individuals will be collected to enroll and contact 
participants. This information will be collected primarily via paper forms, which will be stored 
in locked filing cabinets at the research facility and only be accessible by study staff and 
other authorized individuals (e.g., members of the University of Florida Institutional Review 
Board). This includes a master list connecting participant study identification numbers to 
participant names. 
Research data will be entered and stored on a secure server at the University of Florida, 
with no identifying information. Lab data (including monitor readings, breathalyzer readings, 
and information related to drinking such as timing and number of beer) and field data 
(including monitor readings and self-reports using EMA) will be linked using study ID. None 
of the study documents or communications with participants will directly identify the study as 
related to HIV. HIV status will be coded with the code key stored separately in a protected 
file on UF server. The code key will be destroyed after the study conclusion. No results will 
be published in a personally identifiable manner. 
All NIH-funded studies collecting sensitive data are now considered to be granted a 
Certificate of confidentiality.  
This certificate will protect the confidentiality of all research records generated by this study. 
Individually identifiable health information will be protected in accordance with the Health 
Insurance Portability and Accountability Act of 1996. All research personnel will be trained 
on human subjects’ protection and HIPAA procedures.  
Florida law requires reporting of newly discovered HIV cases. If participants test positive for 
HIV, we will do the following: 
•   Refer each participant to the Alachua county Health Department for another 
confirmatory test. 
•   Provide information on medical and support services available to the participant; 
and 
•   Discuss information on the importance of notifying previous and current sexual 
partners that they may have been exposed to HIV and how to prevent HIV 
transmission. 
2. Alcohol consumption: Participants will only be enrolled in the study if they self-report 
consuming the requisite level of alcohol use. This minimum level of alcohol consumption 
greatly decreases the likelihood that any individual in this study will consume alcohol at a 
level greater than to which they are accustomed. Participants will also be excluded should 
they self-report any condition that contraindicates alcohol consumption (e.g., a history of 
clinically significant withdrawal detected at the in-person screening). Females will be 
screened for pregnancy at the in-person screening, as well as during the pre-session 
appointment on the day of the alcohol drinking session. Also, considering the health 
consequences of alcohol use on persons living with HIV, we only administered 3 beers to 
remain below the binge drinking limit. 
Alcohol drinking sessions will be conducted by research staff who are experienced with 
these methods and have been carefully trained. As described above, all participants will be 
under supervision to prevent possible accidents. Several steps will be taken to ensure that 
alcohol consumption in this study occurs in a safe manner, in accordance with the 

Protocol #201801188 
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recommended guidelines on ethyl alcohol administration in human experimentation, set 
forth by the National Advisory Council on Alcohol Abuse and Alcoholism (2005).  
Participants will not be permitted to drive themselves to alcohol drinking sessions, which will 
decrease the likelihood that individuals will attempt to drive after consuming alcohol as part 
of this study. Participants will not leave the laboratory facility on the University of Florida 
campus where the study will be taking place during the self-administration procedure. Given 
that smoking is not allowed on the University of Florida campus, this necessitates exclusion 
of individuals who are currently nicotine dependent as we will not be able to allow them 
smoking breaks during the alcohol drinking period and nicotine deprivation may present a 
confound to the results of this study. Participants will be asked to remain at the research 
facility until their breath alcohol concentration drops to the safe level of 0.00%. When it is 
time for dismissal, participants will be provided transportation (either university shuttle, 
Uber, or Taxi service) directly home by the study.  
Several protocol features diminish the chance that study participants will leave the bar lab 
before dismissal by study staff and we have plans in place in case this occurs. As part of 
the informed consent process, we advise all participants of study requirements, including 
the requirement to stay until their BrAC falls to a safe level. We reiterate these requirements 
verbally before the alcohol drinking session. Thus, participants are made aware multiple 
times of the requirement to remain in the facility for at least two hours after the end of the 
alcohol drinking period and until they reach a safe BrAC. The pay structure of the study also 
discourages early departure. We pay participants $15/hour for the alcohol drinking session, 
so participants will receive only a prorated portion of the payment should they end the 
session early.  
Administration of alcohol to individuals in treatment for addictive behaviors could potentially 
impede the progress of their recovery. As a result, we will not enroll individuals who have 
taken part in inpatient or intensive outpatient treatment for alcohol use or other addictive 
behaviors in the past 12 months. Further, we will not enroll individuals with a lifetime history 
of clinically significant withdrawal from alcohol; a lifetime history of medical intervention for 
withdrawal or who currently present in a manner suggestive of withdrawal, based on the 
Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). These steps regarding 
withdrawal will also have the benefit of excluding individuals who are severely dependent on 
alcohol, for whom alcohol consumption in this study may not be safe.  
3. Breath screening, urine tests and HIV oral swabs testing: All these noninvasive tests 
were performed as safeguards or for confirming eligibility, so there is minimal risk. If 
participants become emotionally distressed by the test results (e.g. unexpected positive 
result for pregnancy or HIV), our staff will receive basic training to help calm them down but 
will refer them to a clinical psychologist at UF (e.g., Dr. Nicole Ennis who is also part of the 
SHARC team) if necessary. Persons become newly aware of their HIV+ status will also be 
referred for care linkage at the Department of Health or UF Infectious Disease department.  
4. Questionnaires and interview: The major risk of the assessments is potential loss of 
confidentiality, which we have addressed above. To minimize any discomfort associated 
with reporting sensitive behaviors, participants will be informed that they may refuse to 
respond to questions that they are not comfortable answering. Questions related to eligibility 
determination and monitoring of safety and treatment response are not optional. If a person 

Protocol #201801188 
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declines to answer these questions, we will advise them that they will not be able to 
participate. 
5. Alcohol monitoring using wrist and ankle monitors: The risk for breach of confidentiality 
associated with these monitors is very low. The data will be stored in the monitor’s data 
porter and will be downloaded to secure UF drives after each lab session and the field test. 
Only study ID will be used to link the data.  
6. Ecological momentary assessment (EMA) of self-reported drinking: The risk for breach of 
confidentiality associated with the EMA app is very low because of its encrypted cloud-
based storage (described above). Additionally, the App will need the study ID to collect 
data, with no requirement of other personal information (e.g., phone number). To encourage 
participants to take time every day to complete the assessment, they will receive a bonus 
($70 additional to the base payment of $70) for completing at least 80% of the EMA 
assessments.  
8. Possible Benefits: 
There are no direct benefits to participants, although some persons enjoy participating in 
studies that can provide information to help others.  
9. Conflict of Interest: 
N/A 
 
 

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