Advancing New Computer-based Health Outcomes Regarding Sexual Behavior(ANCHORS) Study: UH2 Project
Phase: NA
Conditions: HIV-1-infection
Sponsor: University of Florida

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Protocol 
 
1. Project Title:  
 
Advancing New Computer-based Health Outreach Regarding Sexual behavior (ANCHORS) 
Study: UH2 Project 
 
2. Investigator(s):  
 
Robert Leeman, Ph.D. (PI) 
JeeWon Cheong, Ph.D. (Co-I) 
Robert Cook, M.D., M.P.H. (Co-I) 
Jalie Tucker, Ph.D. (Co-I)  
Benjamin Berey B.A. (Study Coordinator) 
Tessa Frohe, B.A. (Study Coordinator) 
Bonnie Rowland, B.S. (Study Coordinator) 
 
3. Abstract: 
 
Despite clinical and public health efforts, the rate of new HIV infections in the United States 
(U.S.) remains unacceptably high1 with an estimated 44,000 Americans diagnosed in 20141. 
About 1.2 million Americans are living with HIV2 leading to 23 billion dollars in annual public 
health costs3. The state of Florida (FL) carries an inordinate burden. As of 2013, FL ranked first 
in new HIV infections per year and second in total cases1.  
HIV has declined this past decade1, but not equally across groups. Men who have sex with men 
(MSM) remain the highest risk group and primary intervention target1,3. Black MSM were the 
most affected racial group, making up 2/3 of new diagnosesl1. In the past decade, new 
diagnoses have risen among Hispanic MSM as well. Young adults also suffer disproportionately 
with over 40% of new infections among 18-30 year olds4. Elevated rates are due in part to 
overlapping risk behaviors like heavy drinking that tend to reduce safer sex5.  
Prevention is critically important6. About 1 in 8 HIV-positive people are unaware of their 
diagnosis7, meaning they may infect others without their knowledge. This unaware population 
further increases prevention need. If more of these individuals could be reached for prevention 
pre-infection, the spread of HIV would be curbed8. 
New prevention efforts must address alcohol and HIV and be directed to the highest-risk 
groups3,9,10. While interventions have targeted MSM, few have targeted young MSM 
specifically11. Young people and MSM bring particular challenges5. Thus, it is important that 
prevention be targeted to them and developed with their input5. To that end, the goal of this 
project is to lay the groundwork for a synergistic, mobile intervention to reduce alcohol use and 
risky sex and prevent HIV among young adult MSM. This research study is made up of three 
related sub-projects: 1) a web-based survey; 2) a series of focus groups and 3) a small, 
preliminary acceptability and usability to study to test the mobile intervention. The proposed 
intervention to be tested on a preliminary basis in this study combines brief motivational 
intervention 24,46 with daily interactive voice response (IVR)61 monitoring including personalized 
feedback65. Ultimately, this combined intervention will also include pre-exposure prophylaxis 
(PrEP)47-49, however there will be no medication in this particular study. Each of these 
components has efficacy in enhancing treatment adherence, reducing alcohol and/or HIV risk 
but requires other interventions to maximize its potential benefit. Combining them will capitalize 
on the strength of each, leading to a higher impact alcohol and HIV preventive intervention. 

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4.  Background: 
Brief Interventions to Reduce Alcohol Use and Risky Sexual Behavior 
Computer and web-based brief intervention based on motivational interviewing tenets have 
efficacy in reducing young adult alcohol use comparable to in-person interventions23,24. 
Computer/web-based interventions offer convenience and privacy26,27 and young adults prefer 
them28,29. Recently, evidence has shown very brief (10 minute or less) web-based interventions, 
a subset of computer-based interventions, have efficacy and high dissemination potential30. 
Tertiary Health Research Intervention via Email (THRIVE), developed by Consultants Kypri and 
Hallet31-33 is a very brief web-based alcohol intervention with efficacy based on multiple large 
trials overseas. These were followed by a study to develop and test an American version (US-
THRIVE), which also yielded evidence for its efficacy34 (see Preliminary Studies). Despite their 
efficacy, no studies have tested brief, web-based intervention in heavy drinking MSM, or 
evaluated how such interventions may reduce HIV risk. 
Personalized normative feedback35-37 is a key part of brief motivational intervention24. Evidence 
supports added utility of normative data that pertains closely to the study population38. This 
requires survey data to ascertain alcohol use and risky sex in a relevant sample, in this case 
young adult MSM. Protective behavioral strategies (PBS; cognitive behavioral techniques to 
reduce alcohol use and related harms) are also valuable intervention components39-42. Leeman 
et al.34 showed that the type of PBS presented as part of US-THRIVE mattered as a version 
including only indirect PBS targeting behaviors ancillary to drinking (e.g., carrying a 
condom/protection while drinking) was associated with greater efficacy than control (see 
Preliminary Studies). Brief intervention for young MSM may be enhanced by including indirect 
PBS pertinent to drinking in relation to risky sex.  
Brief motivational interventions have efficacy in reducing sexual risk including concurrent 
alcohol use and risky sex. In HIV-positive MSM, in-person motivational interviewing had efficacy 
in reducing concurrent alcohol use and unprotected sex43. A brief variant of the RESPECT 
counseling modality related to significant increases in condom use and reductions in sexually 
transmitted diseases (STDs) compared to control44. The HIV preventive component of the 
present intervention will be based partly on RESPECT. A multiple-module web intervention was 
linked to greater risky sex reduction among MSM45. Consultant Lewis46 found web-based 
personalized normative feedback on alcohol-related risky sex related to reductions in this 
behavior in college students.  
Pre-exposure Prophylaxis (PrEP): An Under-Utilized Intervention Strategy that Requires Strong 
Adherence 
Evidence supports the efficacy of pre-exposure prophylaxis (PrEP) via once per day oral 
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) to prevent HIV in high-risk groups like 
MSM47-49,82. In 2012, the FDA approved FTC/TDF for HIV prevention. Despite strong evidence; 
data indicating physician openness to prescribing10; and evidence of acceptability in MSM47,50, 
uptake has been poor51. In a recent large survey, 1% of young adult MSM reported lifetime 
PrEP use54. Uptake in minority MSM has been particularly slow53. Rather than more placebo-
controlled trials, research is needed to enhance PrEP uptake and adherence among 
MSM10,54,55.  
Findings with PrEP have shown regular adherence is needed with trials having lower adherence 
producing null results10,57. Daily assessment via interactive voice response (IVR) has been 
related to greater medication adherence57,89 and drinking reduction60,64, including in HIV/risky 

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sexual behavior studies. However, positive changes are typically associated with a combination 
of daily assessment and other intervention elements to enhance motivation to change58 and/or 
with longer assessment periods59-61 than the short-term (30-day) period in the proposed 
study62,63. In a study by Consultant Hasin, IVR data were used to create personalized feedback 
on alcohol use, which when combined with motivational interviewing showed greater decreases 
in alcohol use at longer-term follow-up than motivational interviewing only in alcohol dependent, 
HIV-positive patients64.  
IVR has pragmatic advantages including convenience, accessibility to anyone with phone 
access and cost-effectiveness61,64 plus research advantages in enhancing data accuracy20,64. 
While cell/smartphones are common, some rural and lower socioeconomic people may not have 
one or be restricted in data use or texting. Further, text messaging adherence interventions in a 
recent review were not efficacious57. Though it has been used with young MSM52, IVR has not 
been used for intervention or to enhance adherence in PrEP research.  
An ultimate goal of this line of research is to develop a multi-component intervention one goal of 
which will be to enhance uptake and adherence to PrEP. Accordingly, several of the questions 
posed in this study will concern participants’ views and knowledge regarding PrEP. However, 
there will be no medication taking in this particular study. 
Barriers to medication adherence 
Youth, risk perception, motivation and alcohol/substance use are barriers to uptake and 
adherence addressed in the proposed study. Younger age has been the most common factor 
tied to weaker PrEP adherence5,10,65. Thus, we opted to target young adults using web and 
mobile intervention components they prefer29,52. Daily IVR monitoring will provide additional help 
to enhance adherence given young adults’ difficulties in this area.  
Low perceived risk and motivation to change make young adults a challenging intervention 
population18. Relatedly, low perceived infection risk has been identified as a barrier to PrEP 
uptake and adherence10. Thus, along with intervention for PrEP adherence, an intervention 
component is needed to increase perceived risk and enhance motivation to initiate and continue 
medication use and decrease risky sex. Alcohol/substance use is another factor limiting 
adherence to PrEP65 and antiretroviral treatment (ART)67,68. Along with effects on adherence, 
alcohol increases unprotected sex69 in MSM70. Likewise, alcohol (especially heavy use) 
increases HIV risk71 in MSM72. Thus, substance interventions can be considered primary HIV 
prevention for MSM73.  
The Proposed Study 
According to the National HIV/AIDS Strategy3, MSM, young adults, Black and Latino men and 
people in the Southern U.S. are at highest HIV risk and should be targeted with cost-effective, 
scalable interventions. We propose a synergistic mobile intervention to reduce alcohol and HIV 
risk in young adult MSM that combines 3 efficacious approaches. Brief interventions enhance 
motivation and risk perception but effect sizes are small to medium24. IVR has strengths in 
medication adherence57,89 but daily monitoring typically requires additional intervention to 
observe behavior change in a short time period58. PrEP is highly efficacious, but uptake has 
been poor57 suggesting a need for enhanced motivation and risk perception. High adherence 
PrEP is required10,57, supporting a need for daily monitoring. An intervention including these 
elements will offer the strengths of all 3 while compensating for the limitations of each, yielding a 
combined intervention with great potential impact. This intervention will be readily accessible 
and amendable to use in clinical practice.  

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The present study represents the first phase (UH2) of what we anticipate to be a two phase  
project, building toward a randomized controlled trial in the next phase (UH3). Again, the goal of 
this, the UH2 phase study is to lay the groundwork for this combined intervention, one focus of 
which will be to enhance uptake and adherence to PrEP. However, there will be no medication 
taking in this particular study. 
To that end, the UH2 phase study will be made up of three related sub-projects: 1) a web-based 
survey; 2) a series of focus groups and 3) a small, preliminary acceptability and usability to 
study to test the mobile intervention. The web survey will yield normative data to be included in 
the intervention. Focus group participants will be provided the web-based component of the 
combined preventive intervention and offer suggestions to tailor it to be culturally appropriate to 
MSM. Based on this input, the web-based intervention will be finalized and tested with IVR daily 
monitoring for usability in preparation for a follow-up randomized controlled trial (UH3), which 
will be proposed at a later date if the UH2 project is completed successfully. 
The UH2 studies are innovative in that they address a lack of data regarding PBS use in young, 
heavy drinking MSM and a lack of focus group data regarding young MSM views on mobile 
prevention. Most importantly, the studies will provide critical data to inform the combined 
intervention to be tested in UH3, which is highly innovative.  
Preliminary Studies 
Preliminary Study 1: Initial US-THRIVE study. We tested the feasibility and preliminary efficacy 
of THRIVE31-33 in U.S. college students. We modified THRIVE by changing Australian slang, 
standard drink units, normative data, web links, referrals and relevant laws (see Appendix) and 
compared this adaptation to an electronic brochure/assessment control. In addition to testing a 
Full/Replication variant with all protective behavioral strategies (PBS) from the original THRIVE, 
we tested variants containing short, focused lists of only Direct or Indirect PBS. Direct PBS focus 
on manner of drinking itself (e.g., slowing the pace of drinking). We predicted Direct PBS use 
would be too difficult to change based on a very brief intervention and thus Indirect PBS would be 
a more appropriate target. This was the first study to systematically vary types of PBS in a brief 
intervention.  
Methods: Undergraduates reporting >1 heavy drinking day in the past 30 days were 
randomized. Those who completed the initial assessment/intervention were followed up 1- and 
6 mos. later.  
Results: The sample (N=208) was 36% Male, 68% White. There were significant condition x 
time effects for drinks per week (Fig. 2a) and peak drinks in a day (Fig. 2b). After 1-mo., the 
Indirect PBS-only condition had about a 25% decline in peak drinking and drinks per week 
compared to no decrease in Control. The difference between Indirect-only and Control for peak 
drinking was significant (d=.56) with a trend for drinks per week (d=.26). At 6-mos., both were 
significant (d=.45-.57). The Direct PBS-only condition did not differ from Control. 
 
 

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Conclusions: Results suggest efficacy for our U.S. adaptation. As predicted, the Indirect-only  
 
 
 variant showed significant decreases in alcohol use, but the Direct-only variant did not. Based 
on our findings we incorporated US-THRIVE as part of the intervention in the proposed study 
and opted to focus on provision of Indirect PBS. 
Preliminary Study 2: PrEP knowledge, acceptability and alcohol use among MSM in 
Florida. We used recent data from an ongoing NIAAA-funded cohort study led by Co-
Investigator Dr. Cook (U24AA022002) to address PrEP awareness and attitudes. These 
participants differ from the proposed study in that they are HIV-positive, but research has shown 
myriad similarities between HIV-positive and high-risk HIV negative individuals in demographics 
including race/ethnicity, risky sexual behaviors and alcohol use76.  
Methods: Data were from baseline and follow-up for the ongoing Florida Cohort study on 
relationships among substance use, mental health, health services use and HIV. Participants 
have been enrolled in-person from clinics and community settings in 7 Florida locations 
including rural and lower socio-economic sites. 
Results: To date, 867 participants have enrolled (47% MSM). Among them, 71 (18%) were 18-
30 years old (48% non-Hispanic Black, 27% Hispanic, 17% non-Hispanic White, 8% Other). 
Among MSM older than 30, non-Hispanic Whites were more common (41%) and non-Hispanic 
Black less common (41%). Among young adult MSM, 36% reported at least one past-month 
heavy drinking day, with 47% reporting non-heavy drinking. PrEP questions are in an ongoing 
follow-up including 133 MSM (n=22 ages 18-30). Among young adult MSM, 77% had heard of 
PrEP compared to 55% older MSM. Given small numbers thus far, we examined attitudes 
among all MSM who had heard of PrEP (n=76). Of these, 74% rated it at least “somewhat safe”; 
61% stated they were at least “somewhat confident” it would reduce HIV and 63% reported they 
were at least “somewhat likely” to recommend PrEP. Most (61%) believed daily PrEP taking 
would be “not” or “somewhat” not difficult.  
Conclusions: Enrollment of 405 MSM supports the recruitment capability of Dr. Cook’s group. 
Given a minority were young adults, we considered all data in projecting racial/ethnic 
breakdown. A considerable percentage of young MSM reported heavy drinking, but there was a 
range. The results support our ability to recruit racially diverse, young MSM with varied drinking 
for the UH2 web survey and heavier drinking for UH3. Young MSM tended to have heard of 
PrEP with positive attitudes. About 40% expressed uncertainty with ease of daily use. 
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Figure 2a. Overall Weekly Alcohol Consumption 
Figure 2b. Peak Alcohol Consumption in a Day 

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Preliminary Study 3: IVR in HIV-positive rural Southerners. Co-investigator Tucker led 
research with daily substance use, sex and ART use reports from HIV-positive people in the 
rural South (R21-DA021524)20,61,63. 
Methods: Using IVR, they assessed the prior day’s substance use in a 5-minute assessment. 
Participants accrued points for completing assessments in a timely manner, which were 
modestly reimbursed77.   
Results: Over 70 days, the primarily low-income sample (N=44, 65% male, 43% African 
American) used the system to a similar extent as higher-SES populations78-80. Compared to 
non-callers, IVR callers were younger and less likely to be heterosexual. Baseline risk 
behaviors, including substance use, and sexual practices, did not predict IVR use. Odds of 
reporting risky sex and illicit drug use decreased by 3.0% (OR = 0.970, p < 0.0001), and 1.3% 
per IVR call day, respectively (OR = 0.987, p = 0.014). Odds of reporting alcohol use were not 
significantly altered as number of IVR call days increased (OR = 0.998, p = 0.63).  
Conclusions: Findings support the utility of IVR as a way of obtaining valid, daily data and a 
means to deliver interventions to hard-to-reach populations living with or at risk for HIV. 
Younger, non-heterosexuals as in the proposed study were likely to access the system. IVR 
monitoring alone did not affect reports of alcohol use.  
Summary and relevance. These studies demonstrate our group’s skill and expertise pertinent 
to the proposed study, in web-based survey and brief intervention in alcohol; recruitment of 
young adults including young MSM; assessment of alcohol, sexual behavior and PrEP-related 
attitudes; including IVR-based assessment. 
 
5. Specific Aims: 
Aim 1. Collect alcohol and sexual activity data via web survey from 683 young MSM to yield 
normative data for the alcohol and HIV preventive intervention in a follow-up study (UH3). The 
survey will also help to establish feasibility.  
Aim 2. Conduct focus groups (N=30) with young MSM who drink regularly to inform the content 
of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the 
intervention is culturally appropriate for MSM.  
Aim 3. The combined alcohol/HIV preventive intervention will be finalized based on the web 
survey and focus groups. Preliminary testing (N=10) will establish usability, acceptability and 
correct any functionality issues. 
 
6. Research Plan: 
 
Figure 1. Overview of steps in UH2 Phase Project 
 
Overview 
For the UH2 phase project, we will screen a total of 1093 individuals in order to ultimately recruit 
683 MSM for a brief web survey to yield data for personalized normative feedback included in the 

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intervention to be tested in a future study. The web survey will also allow us to demonstrate 
feasibility by inclusion of sufficient numbers of higher risk MSM from our geographic area. Thirty 
survey completers will be chosen for a focus group to provide opinions and suggestions to 
enhance the cultural appropriateness of the web-based intervention component for MSM. With 
data from the web surveys and focus groups, the brief web-based component will be finalized. A 
small sample will be enrolled to test usability and acceptability of the combined intervention and 
correct any technical flaws. With these steps completed, we will move to a separate study that 
recruits higher-risk MSM (UH3 Phase).  
Procedures 
This study (UH2) will be made up of three components. At the outset, an initial version of the 
brief, web-based alcohol and HIV intervention component will be developed based on existing 
interventions33,34,44,46,64. This will enable us to provide it to focus group participants subsequently 
for their input. Recruitment of respondents for the web survey will also begin at this time. The 
IVR system will be implemented in a REDCap system using REDCap’s native IVR services. The 
REDCap IVR service uses the telephony service, Twilio Inc., to initiate phone calls to the 
participants, read survey questions, relay touch-tone responses back to the REDCap survey. 
This service will configured and tested internally over the first 6 months of UH2. This will enable 
us to test the IVR system combined with the brief web-based alcohol and HIV intervention 
component, revised based on web survey and focus group results, in a usability study in the last 
few months of UH2.  
Web survey. Respondents will be recruited 3 ways: 1) at bars, clubs, clinics and community 
events and organizations (e.g., GatorWell) attended by MSM using flyers, palm cards and 
promotional items (e.g., pens, adhesive wristbands) with the study web address and QR code, 
which will be left at these locations; 2) ads on social media and other sites used by MSM (e.g., 
Grindr). Similar in-person methods have been used in the Florida Cohort study (Preliminary 
Study 2) and similar online approaches are used in studies of MSM45,53,54; 3) the study will be 
posted on Amazon M-Turk to recruit respondents through the M-Turk worker pool; and 4) the 
study will be posted on ResearchMatch.org to recruit ResearchMatch volunteers. 
Those visiting the study web page can read an overview and complete electronic consent, 
followed by a pre-screener for eligibility.  Before starting the pre-screener, participants will 
review a brief message to emphasize the goals of the research and its importance, along with 
the related importance of honest survey responses. The goal is to deter people from completing 
the survey multiple times and/or providing invalid contact information. Participants will be told 
that some respondents to the brief survey will be chosen for a 30-minute survey with possible 
invitation to a focus group. IP addresses will be recorded and only one pre-screen will be 
allowed per address. Respondents meeting inclusion criteria will be informed they were selected 
for the longer survey and continue to the survey. Upon completion, the survey will generate a 
study ID that respondents will provide to study staff with additional contact information via 
phone, text or email to be compensated. Participants who complete the 30-minute survey have 
the option to select whether or not they are interested in additional participation in the study.  
Those individuals who expressed interest will be contacted through email and given the 
opportunity to recruit peers to participate in the study.  Interested individuals will be provided 
unique referral codes to distribute to peers “like yourself”.  We have based these procedures 
on approved protocol # 201601365 with Dr. Jalie Tucker (who is a Co-Investigator and PI 
Proxy on this protocol) as PI.  The recruits who complete the screener survey will insert a 
unique referral code on the 1-minute screener survey.  Current participants will be compensated 
based on the number of unique individuals who submit a screener survey with their referral 
code. Compensation will not be based on the referred individual’s eligibility for the 30-minute 

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survey, or completion of the 30-minute web survey. Therefore, referral compensation will be 
based on referral only, not eligibility.  Participant referrals will be entirely voluntary.  In addition, 
those individuals referred to the survey may also elect (or not) to participate in the web survey.   
Focus groups. After the first 50 respondents complete the survey, participants will be chosen 
randomly for the first of 4 focus groups. Randomly selected participants will be informed they 
are invited to give opinions on an alcohol and HIV preventive intervention for young MSM in a 
small group of peers. On the date of each group, after informed consent, participants will 
complete the web-based intervention component. Afterward, participants will be engaged by an 
experienced facilitator in a discussion of aspects of the intervention they liked and disliked and 
suggestions they have for enhancing its cultural appropriateness to young MSM. Local 
participants will also have the opportunity to participate in focus groups without first being 
recruited through the web survey.  Flyers and advertisements will be posted in the Gainesville, 
FL area.  Advertisements will direct participants to call, text, or email to learn more about the 
focus group participation. 
Usability study. In the final 4 months of UH2, a small study will be conducted to test usability 
and acceptability of the combined alcohol and HIV preventive intervention including IVR-based 
monitoring and personalized feedback. Key goals will be to identify any issues and learn what 
aspects of it participants find more and less beneficial. PrEP will not be included and there will 
be no control condition. Participants (N=10) will be recruited from survey completers.  
Participants will be invited to the office to complete the web-based alcohol and HIV intervention 
component and for IVR training. Participants will give convenient times and the best phone 
number to reach them and the IVR system will call up to 3 times/day until successful. 
Participants can also call back at a dedicated phone number using a personalized code. The 5-
min. assessment will include items on alcohol, sex and medication taking. Given PrEP is not 
included, participants will report on another medication or health activity. Staff will remind 
participants by phone or text message if they miss a day. Participants will return 30 days later to 
give input and suggestions. 
Participants 
HIV-negative men ages 18-30 who report no lifetime PrEP use and past-3-month sexual activity 
with another man will be enrolled for a 30-minute web survey. Open criteria are needed to 
ensure the survey produces normative data with a range of alcohol use and sexual activity and 
mean scores reflecting moderate drinking and sexual activity. Efforts will be made to ensure the 
sample is representative in terms of age and race/ethnicity. Of those completing the survey, 
randomly selected participants will be invited for a focus group (N=30) each including up to 7-8 
participants.  Individuals who have prior experience taking PrEP can be enrolled directly in a 
focus group even though they are not eligible for the web survey or usability study. Similarly, a 
broader age range of 18-35 will be implemented for the focus groups. After the combined web-
based alcohol and HIV preventive intervention is finalized with information from the survey and 
focus groups, 10 higher-risk MSM will be recruited to test the combined web-based intervention 
and IVR monitoring system to establish usability. 
Participants will meet the following inclusion and exclusion criteria: 
Inclusion 
Web-survey: 
1) Male sex at birth 
2) Ages 18-30 

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3) Ability to read and write English 
4) 1 or more instances of sexual activity with another man in the past 3 months 
5) HIV-negative  
Focus group:  
1) 18-35 
2) All other inclusion criteria will be the same as the web survey 
Usability phase: 
Along with inclusion criteria above (#1-5), the usability study will have more specific self-
reported criteria, to recruit a higher-risk sample:  
1) 5 or more drinks in a day in the past month  
2) Past-month intercourse with another man without a condom 
3) Willingness to try PrEP, but have never tried it before 
 
Exclusion 
Web Screen: 
No subject may have lifetime use of PrEP 
Focus group:  
1) A current undergraduate or graduate student at any level in one of the 3 departments 
that make up the College of Health and Human Performance (HHP) at the University of 
Florida (UF), where Dr. Leeman’s faculty appointment is.  
2) Do not want to engage in open discussion regarding substance use or sexual 
activity/orientation in a group setting. It will be possible for participants to contribute to focus 
group discussions without providing detailed information about their own substance use or 
sexual activity, however focus group participants must have a degree of openness to 
discussing these topics with others. These groups will take place with 6-7 other people and 
some people may be made uncomfortable by the discussions that may take place with 
regard to participants’ drinking, substance use or sexual behavior.  
3) Not willing to be recorded via an electronic recording device 
Usability phase: 
In addition to #1 under web screen, those who do not wish to provide a phone number 
where they can be reached reliably will be excluded 
Sample size estimation. In the UH2 phase, we will recruit men ages 18-35 who report HIV-
negative status and sex with another man for focus groups (N=30).  Additionally, we will recruit 
men ages 18-30 who report HIV-negative status and sex with another man for a web survey 
(N=683) to yield normative data for the personalized feedback component of the intervention, 
which will then be modified, IRB approved and tested initially for usability (N=10). Completion of 
each aim is a benchmark of the UH2 phase’s success and feasibility of the UH3 phase.  
Statistical power. The survey sample size was identified based on Hulley et al.96. A sample 
of 683 is needed to estimate with high precision 95% confidence intervals for mean 
endorsement levels of alcohol use and risky sex, thereby yielding accurate normative data 
for the personalized normative feedback. Another goal of analyses in this study is to add 
items regarding protective behavioral strategies to avoid alcohol-related sexual risk to the 
existing Protective Strategies Questionnaire. One key part of this process is to conduct 

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confirmatory factor analysis (CFA) of the measure including the new items. For CFA, the 
sample needed to evaluate model fit depends on model degrees of freedom (df). Models 
with 100 df need a sample of 132 for testing close model fit with power over .80. Power 
increases with df97. We will include up to 16 items in the revised PSQ loaded on 2 factors, in 
which case df will be 103. Thus, 683 respondents will yield excellent power to test the PSQ 
measurement model. Model fit will be evaluated with the Comparative Fit Index ( >.95), 
Root Mean Square Error of Approximation (<.06) and Chi-square98. Thirty is a common 
minimum initial sample size for a focus group study66,75. Ten has been identified as an 
appropriate usability study sample size for technological tools with Faulkner99 reporting a 
sample this size uncovered an average of 95% of problems. 
Procedures 
Milestones and timelines 
Mos. 
Task 
1-3 
Reword brief web-based preventive intervention component to make appropriate for 
MSM 
1-6 
Develop IVR system based on prior work by Drs. Tucker and Hasin, test among study 
staff 
1-12 
Set up, then begin web-survey to obtain normative data. Our benchmark is 450 
respondents in Year 1. Recruitment will focus initially on FL. If 50% of the goal is not 
reached after 6 mos., recruitment will be expanded to other states in the 
Southeastern U.S. If after 6 mos., the sample is not representative in terms of 
younger/older age, targeted web ads will be focused on the needed age. If the 
sample is not suitably diverse, ads will be oriented to include more actors of the 
needed race. Identifiers other than study ID and IP address will be destroyed once 
individuals’ study participation is complete. IP addresses will be retained only until the 
conclusion of the study, at which point this information will be destroyed as well. 
4-12 
Conduct focus groups to get opinions on intervention. Four focus groups are planned 
but if thematic saturation (no new themes discussed) is not reached66, additional 
groups will be scheduled.  
13-18 Continue web-survey to obtain normative data with a benchmark of 233 respondents. 
Over the 18 mos., recruitment of 80 MSM from the area who will likely be eligible for 
the subsequent UH3 study (i.e., report past-month heavy drinking and unprotected 
sex, openness to PrEP) is a feasibility benchmark. 
13-18 Analyze focus group data, synthesize suggestions for changes to web-based 
intervention component and present to collaborators, then make any final decisions 
on changes 
19-20 Analyze survey data to obtain normative data and conduct CFA to evaluate new PSQ 
items on avoiding sexual harms, revise web intervention to include normative data 
and focus group input  
21-24 Conduct usability study (N=10), then make further changes to web intervention and 
IVR accordingly 
 
Screening. 
Preliminary screening via web screen: Respondents will be recruited 3 ways: 1) at bars, clubs, 
clinics and community events and organization (e.g., GatorWell) attended by men who have sex 
with men (MSM) using flyers, palm cards and promotional items (e.g., pens, adhesive 
wristbands) with the study web address and QR code that will be left at these locations; 2) ads 

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on social media and other websites used by MSM (e.g., Grindr). Some of the same in-person 
methods have been used in the Florida Cohort study (Preliminary Study 2) and similar online 
approaches are often used in studies recruiting MSM; 3) the study will be posted on Amazon M-
Turk to recruit respondents through the M-Turk worker pool; and 4) the study will be posted on 
ResearchMatch.org to recruit ResearchMatch volunteers. Registered ResearchMatch 
volunteers between the ages of 18-30 that live in the Southeastern United States will be sent a 
brief message about the web survey.  If volunteers indicate interest, they will be sent the 
screener survey link via the UF email server.  At that point, they can voluntarily visit the link and 
complete the survey as described next.  Those visiting the study web page can read an 
overview and provide electronic informed consent. As part of the consent process, respondents 
will be informed of efforts to protect their confidentiality including a Certificate of Confidentiality 
and that they may decline to participate or refuse to answer any questions without explanation. 
Individuals will be informed that some survey respondents will be chosen for a 30-minute survey 
with possible invitation to a subsequent study if they so choose. Should respondents omit on the 
pre-screener a response that is needed to determine eligibility, they will be informed that they 
were not selected for the full survey. IP addresses will be recorded as part of the survey. No 
identifiers other than IP address will be retained for individuals who complete the pre-screener 
but are not eligible to complete the 30-minute web survey. For those who complete the 30-
minute survey, identifiers other than study ID and IP address will be retained only for those who 
want to be considered for participation in a subsequent study and are within a 50-mile radius of 
Gainesville. IP addresses will be retained only until the conclusion of the study in order to 
prevent individuals from completing multiple web surveys. At the conclusion of the study, IP 
address information for all participants will be destroyed as well. Identifiers will be recorded on 
paper forms including the paper-based master list including both study ID and identifiers. At the 
conclusion of the study, these paper records containing identifiers will be shredded.  
Screening for focus groups: Those invited to take part in focus groups will be selected randomly 
from among web survey completers or from participants recruited locally.  Prospective 
participants will initially be contacted by phone, text or email but the focus group process will be 
explained to them in some detail by phone. Upon initial phone contact and again during 
informed consent procedures on the day of the session, they will be informed that the goal of 
the focus groups is to get theirs and their peers’ opinions on a web-based alcohol and HIV 
preventive intervention for men who have sex with men. The format of the focus group session 
will be detailed with prospective participants, first on the phone and then as part of informed 
consent. They will first complete the web-based intervention, which includes questions 
regarding their alcohol and other substance use along with their sexual behavior and that they 
will receive some information about these behaviors based on their responses. They will then be 
asked to discuss the opinions and suggestions regarding the intervention with a particular focus 
on ways in which the intervention can be made appropriate for men who have sex with men. It 
will be explained that they may know other participants in the focus group but that since the goal 
of the focus group is to get their opinion on an intervention, they need not discuss personal 
information during the focus groups. They may also opt not to respond to any particular 
discussion question during the focus group. They may also decline to continue should they 
recognize another participant and opt not to continue for this or any other reason. In order to 
participate, participants must agree to being part of an audio recording of the focus group, but 
study staff will not use their name or any other identifiable information during the recording, 
which will only be made available to investigators working on the study. Instead, participants will 
be referred do during focus group meetings and on the audio recordings by participant number. 
Participants are informed that if they are not comfortable with any aspect of the focus group 
process, that they should decline to participate. They will also be informed that they are allowed 
to omit any question they are uncomfortable answering. 

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Screening for usability phase: Prospective participants will be selected randomly from among 
web survey completers and individuates recruited locally outside of the web survey. These 
individuals will invited to take part in a 30-day usability study with a goal of obtaining their 
opinions and suggestions regarding a combined mobile alcohol and HIV preventive intervention. 
In addition to the minimal risk that was associated with completing the web survey, the IVR daily 
assessment system will be explained to participants along with the need to provide a phone 
number so that they can be reached by the system. Participants will be informed that they are 
free to refuse participation, to stop participating entirely at any time or to omit any question they 
do not feel comfortable answering. 
Intervention during focus group and usability phase. The intervention that will be developed 
initially and tested in this initial UH2 phase will include a brief web-based alcohol and HIV 
preventive intervention, then daily monitoring via IVR with personalized feedback for 30 days.  
Alcohol intervention: US-THRIVE34 with wording changes to make it more appropriate for young 
adult MSM. US-THRIVE begins with an introductory screen, then assessments of 
demographics; past-month drinking; hazardous use (Alcohol Use Disorders Identification Test 
[AUDIT]83; height and weight to calculate estimated blood alcohol content [eBAC]). Immediately 
after assessments, US-THRIVE gives personalized feedback on 1) risk level based on AUDIT 
score; 2) eBAC from their peak past month drinking day; 3) a comparison between their typical 
alcohol use and normative data from age-matched MSM; and 4) estimated money spent on 
alcohol. For the initial version to be used in the focus groups, normative data will be estimated 
based on results in the literature, but for the small usability study and subsequent UH3 phase, 
these estimates will be replaced with normative data from the US2 web survey. Tabs at the top 
of the screen and clickable arrows will direct them to 3 other pages: “Tips,” “Facts,” and 
“Support.”  
PBS will be in the “Tips” tab. In Leeman et al.34, 96% accessed this tab. We will provide indirect 
PBS only, based on prior findings that provision of indirect PBS only was associated with similar 
outcomes as a full list of PBS. Each PBS will have a title in bold (e.g., “flock together,”) and brief 
description. The same 4 indirect PBS from Leeman et al.34 will be included in the version 
provided to focus groups (Appendix). For the usability study and subsequent UH3 phase, 
additional PBS to avoid alcohol-related sexual risk will be added from among new items in the 
web survey (see measures below). Additional PBS will be added based on psychometric 
analysis and participant acknowledgment of openness to using each of these PBS (see data 
analytic section below). 
The “Facts” screen contains standard alcohol-related information including local alcohol related 
laws. The “Support” screen contains standard web-based resources and local referrals for 
treatment options.  
The original Australian THRIVE took 9 minutes to complete, on average31,84, thus, the alcohol 
portion of the intervention should take less than 10 minutes on average.  
HIV prevention:  The web-based HIV preventive component will contain intervention material 
pertaining to risk for HIV and overlap between alcohol and risky sex. The HIV part will be a 
combination of web-based material from the single session version of the efficacious RESPECT 
intervention44, followed by personalized normative feedback on alcohol-related sexual risk 
based on an intervention developed by Consultant Dr. Lewis46.  
Similar to US-THRIVE, the HIV preventive intervention will begin with a brief assessment of 
past-30-day sexual behavior including sex after alcohol use, Perceived Risk of HIV Scale 
(PRHS)85 and Penn Risk Assessment Battery (RAB)86. The participant will be taken to material 

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adapted from RESPECT based on the intervention’s 3 goals: 1) determine what behaviors put 
the participant at HIV risk; 2) use a “teachable moment” to enhance risk perception: and 3) 
develop risk-reduction strategies. Participants scoring over normative mean on the PRHS will 
get feedback that their perceived HIV risk is likely accurate but contrasts with their recent 
experiences of unprotected sex. Those with PRHS scores below the mean will get feedback that 
their risk perception may not be accurate. On the next page, participants will describe briefly a 
recent sexual encounter that may have put them at risk. On the page after, they will think back 
to prior sexual situations and steps they took to reduce risk. There will be several options given 
(e.g., wore a condom) and they will be able to give their own responses. Next, participants will 
be given their RAB score and an interpretation, in relation to a benchmark associated with 
elevated HIV risk55. Lastly, participants will return to their recent high-risk situation and think of 
one aspect of it that could have been changed to reduce risk (see Appendix). Based on the skill 
of IT professionals from the Clinical and Translational Science Institute (CTSI) who will program 
the web-based version of RESPECT; evidence supporting RESPECT’s efficacy44, and 
comparable efficacy between in-person and web-based interventions23,24 we have confidence in 
the efficacy of this web version. 
After RESPECT, based on Lewis et al.46, participants will be presented personalized normative 
feedback summarizing 4 types of information on separate screens with a combination of text 
and graphs comparing the participant’s responses with normative results from MSM of a similar 
age: 1) number of sexual partners; 2) number of instances of unprotected sex; 3) number of 
times having drank alcohol before sex; and 4) number of drinks typically consumed before sex 
(see Appendix). For the initial version in focus groups, normative data will be estimated.  
Assessments contributing to personalized feedback should require a few minutes and 
participants in Dr. Lewis’ study needed less than 1.5 minutes on average to view their feedback. 
The initial RESPECT session requires about 20 minutes, thus the web version should require 
this time or less. Thus, the HIV part should entail 25 minutes or less, with the combined 
alcohol/HIV intervention requiring no more than 35 minutes. 
IVR: Cumulative personalized normative feedback will be generated weekly based on IVR 
responses. Similar to the web component, participants will get feedback with text and graphs on 
1) drinks per week compared to normative data; 2) days with protected/unprotected sex 
compared to normative data; 3) number of days taking medication/completing other health 
activity; 4) comparisons between instances of sex (protected/unprotected) following alcohol 
versus not; and 5) medication taking/other health activity on drinking vs. non-drinking days. 
Feedback will be mailed to a postal address or posted to a secure, password-protected 
webpage.  
Focus Group. 
Sources of materials: Research data are derived from the on-line questionnaires as in the web 
survey and from discussion about the web-based alcohol and HIV intervention component 
during the focus groups. Discussion will be recorded using an electronic recording device and 
later transcribed verbatim, hard copies of which will be reviewed by study staff. All data are 
obtained strictly for research purposes and with the informed consent of subject participants, 
and are confidential.  
In-person focus group: Participants who are selected randomly from among web-survey 
completers in the Gainesville area or recruited locally will be invited to take part in a focus 
group. These sessions will take place either in Yon Hall North or Florida Gymnasium on the UF 
campus. The Florida Gym and Yon Hall North facilities are centrally located on campus, both 

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connected to Ben Hill Griffin Stadium. These research facilities have dedicated, free parking for 
research participants. With the convenient location and parking, the research facilities are also 
readily accessible by emergency personnel in the unlikely event of an emergency. Focus group 
sessions will last about two hours. Compensation will be $35. Written informed consent will be 
obtained at the outset of the appointment.  
Transportation will be provided via Uber, Lyft, or a taxi service for participants who would like to 
participate in an in-person focus group, but are limited by transportation.  Individuals invited to 
participate in a focus group but are unable to attend in person will be given the opportunity to 
participate remotely via Zoom PHI.  For those individuals who are interested in participating in a 
focus group but have limited availability or feel uncertain about taking part in a focus group with 
other participants, we will offer the opportunity for them to participate in an in-person one-on-
one interview in place of the focus group.   
Usability Study. 
Sources of materials: Research data are derived from the on-line questionnaires and from 
responses provided to the interactive voice response system (IVR), which will also be 
developed and maintained using the same REDCap system as the web-based surveys. All data 
are obtained strictly for research purposes and with the informed consent of subject participants, 
and are confidential.  
Procedures for identifying participants: Participants will be selected randomly from among 
web survey completers from a 50 mile radius of Gainesville, FL.  Participants who 
completed a focus group may also be eligible for the usability portion should they be 
interested. Participants may also be recruited directly from this geographic area, outside of 
the web survey. Those selected will be invited to complete another preliminary web 
screener including items on frequency of any alcohol use; frequency of consumption of 5 or 
more drinks in a day in the past month; past-month intercourse with same and opposite sex 
partners; past month intercourse with same and opposite sex partners without a condom; 
HIV-negative status; no lifetime PrEP use; willingness to try PrEP.  
Initial appointment: Eligible participants will be invited to the office to provide informed 
consent, to complete the web-based alcohol and HIV intervention component along with 
baseline assessments and for training in how to use the IVR system. Participants will give 
convenient times and the best phone number to reach them for the daily IVR assessments.  
30-day intervention period: Participants will be asked to complete assessments using the IVR 
system daily for a 30-day period. The IVR system will call up to 3 times/day using the number 
provided by the participant until successful. Participants can also call back at a dedicated 
phone number using a personalized code. The 5-minute assessment will include items on 
alcohol, sex and medication taking. Given PrEP is not included, participants will report on 
another medication or health activity. Staff will remind by phone or text message if they miss 
a day. Based on the participant’s IVR responses, study staff will produce a cumulative 
personalized feedback document that will be posted to a secure site on the web to which 
only that study participant will have access, or it will be mailed to the participant’s postal 
address, based on their preference.  
Follow-up appointment: After the end of the 30 day IVR field period, participants will return for a 
follow-up appointment. At this appointment, they will complete another web-based TLFB 
assessment and repeat the rest of the measures from baseline. They will also be asked to give 
their views on each component of the intervention including how much they liked using it; how 

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useful they believe each part was in prompting them to change their behaviors and to offer 
suggestions for improvement, particularly ways to enhance the appropriateness of the 
intervention components for young adult MSM. 
Assessments. On the pre-screen to indicate eligibility for the full survey, participants will be 
asked demographics (birth sex, age range); number of instances of intercourse in the past 3 
months with same and opposite sex partners; HIV status and whether have taken PrEP. The 
following will be included in the full survey: 
Demographics: The full survey includes questions on age, race, ethnicity, highest educational 
attainment, employment type, marital status, personal and household income. 
Alcohol/substance use & sexual activity: Participants will complete an online TLFB81 covering 
past-month alcohol and other substance use, adapted to include sexual activity20,87. Participants 
record memorable anchor events on calendars that serve as recall aids, then report daily 
drinking of beer, wine, and liquor and use of licit and illicit substances88. Participants report daily 
instances of sexual activity including whether day-to-day activity was with the same or different 
partners. On days when they indicate activity, they will be asked whether the partner was same 
or opposite sex, whether protection was used, and number of drinks before sex. 
Sexual risk behaviors: The reliable and valid sexual risk subscale of the RAB86 will be used, 
which contains 8 items each with 4 response options addressing sexual behaviors over the past 
6 months.  
Perceived HIV risk: The PRHS85 is a reliable and valid 8-item measure of perceived risk of HIV 
infection that captures likelihood estimates, intuitive judgments and salience of risk.  
HIV testing history. Participants will be asked to report the number of times they have taken any 
type of HIV test in the past 12 months and in their lifetimes. 
Sexually transmitted infection history items: Participants will be asked to report regarding 
whether they have been diagnosed with 4 types of STIs in the past 12 months or prior. 
Hazardous drinking: The Alcohol Use Disorders Identification Test* (AUDIT83) is an established, 
10-item scale including items on alcohol use and DSM-IV dependence criteria that has been 
used in college samples90,91. 
Protective behavioral strategy use: The revised Protective Strategies Questionnaire (PSQ) 
contains 11 direct and indirect protective behavioral strategies. Participants rate the extent to 
which they use each on a 7-point scale. Additional items will be added to extend measurement 
of protective strategies to avoid additional alcohol-related sexual harms. In addition to the 
aforementioned questions, additional questions also on 7-point scales will ask participants about 
their openness to using each of the 16 strategies in the future.  
PrEP knowledge and attitudes: These items will be taken from Co-Investigator Dr. Cook’s 
Florida Cohort study. Participants will report whether they have heard of PrEP and openness to 
future use. On 5-point scales, those who have heard of PrEP will report perceptions of its safety, 
effectiveness, and difficulty in taking it daily.  
Motivation: On 100-point visual analog scales, participants will report their interest in 
immediately making the following behavior changes: drinking less alcohol; quitting alcohol use 
altogether; having less sexual activity altogether; having less unprotected sexual activity; having 
sex less frequently following alcohol/substance use. 

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The UPPS Impulsive Behavior Scale92,93 is a reliable, valid 59-item measure that assesses 5 
subdimensions of impulsivity (premeditation, positive urgency, negative urgency, sensation 
seeking and perseverance).  
 
Measures for usability study: The same assessments will be administered at baseline and 
conclusion of the 1-month usability study. In addition, usability study participants will be asked 
their liking of the intervention and agreement t is useful on 7-point scales and there will be an 
open-ended item where they can provide written input. Usability study participants will also 
complete the following assessments via the IVR system: 
IVR assessment: Questions will concern behaviors the preceding day. Similar to Tucker et al. 
20,61, participants will report number of drinks; whether they used a substance other than alcohol 
to get high; and whether they had sexual activity. If they reply “yes,” follow-up questions will ask 
whether it was with a same or opposite sex partner; with their main, non-main or anonymous 
partner; type of activity (anal, oral, vaginal); whether or not protection was used; and whether or 
not a transaction for money or goods was involved. For those reporting alcohol or other 
substance use and sexual activity, a follow-up question will ask if substance use occurred 
before or after sex. The IVR system will include a question on PrEP use though usability study 
participants will respond according to another medication or health behavior. TLFB81 will provide 
data for missing IVR days. 
Compensation. Web survey compensation will be $25 in an electronic gift card.  Participants 
will receive $10 in an electronic gift card per completed referral for the 1-minute screener 
survey. Participants will receive $35 for a focus group in a gift/cash card. Usability study 
participants will receive $30 at the first appointment. The IVR compensation strategy will be 
taken from Searles et al.77 and implemented by Co-Investigator Tucker20,21. Participants receive 
$1 per day, banked in an electronic account plus an extra 10 bonus “points” ($2 value each) for 
completing 7 of 7 days in a week. If participants miss a day, they lose bonus points for the week 
but can recover 7 lost points for weeks with missing data if they do not miss more than 2 
consecutive days. Should participants miss a day, they can call a separate number and leave 
the prior day’s responses in a voicemail. Participants receive daily payment for “makeup” calls 
but are not figured into bonus eligibility. The system rewards consistent reporting while limiting 
punishment for missing minimal days. Maximum compensation for completing IVR assessments 
is $110. Participants are compensated $35 for the interview at the end, making maximum 
compensation $175.  
 
7. Possible Discomforts and Risks: 
Web Screen 
Web-based assessments. The assessments in this study deal with some sensitive issues 
including participants’ experiences of alcohol-related problems and risky sexual behavior. Potential 
disadvantages of these assessments are the time taken to complete them and possible breach of 
confidentiality. There is a slight possibility that completion of these measures may cause 
participants to experience stress or anxiety regarding their drinking, substance use or sexual 
behavior. 
Possible breach of confidentiality. The chief risk to participants in the study is that their 
responses regarding alcohol/other substance use and sexual behaviors and/or their identities as 
research participants will be compromised, however extensive steps will be taken to avoid such 
breaches (see below).  

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Stress or anxiety. There is a slight chance of participant stress or anxiety stemming from 
answering questions regarding their substance use and sexual behavior. Steps will be taken to 
mitigate these risks (see below). 
Focus Group 
Web-based assessments and intervention materials. Risk associated with web-based 
assessments is the same as in the web survey with the exception that focus group participants 
will also complete the web-based alcohol and HIV intervention component being developed for 
the subsequent UH3 phase intervention study, based on existing intervention components. 
There is a possibility that completion of the intervention may cause participants to experience 
stress or anxiety regarding their drinking, substance use or sexual behavior. 
Possible breach of confidentiality. In addition to a slight risk that their data collected via the web 
may be compromised, which is the same as in the web survey, there is an additional breach of 
confidentiality risk due to participants’ completion of the focus group with 6-7 other participants. 
Efforts will be taken to avoid scheduling participants who reside close to each other, based on web 
survey respondents’ postal addresses provided to study staff for compensation purposes, however 
study staff do not have any additional material they can use to avoid scheduling people who know 
each other for the same focus group. Web survey completers who are selected randomly for a 
focus group will be apprised of this risk when they are contacted initially by study staff and again as 
part of informed consent procedures. Also as part of informed consent procedures, participants will 
be asked to respect the confidentiality of their fellow participants’ identities (to the extent that 
participants will be made aware of other participants’ identities since they will not be required to 
provide their name or other personal details during the focus group discussions), responses and 
opinions stated during the focus group sessions.  
Stress or anxiety. Participants may experience a degree of stress or anxiety due to the sensitive 
nature of some survey items or due to realization that their alcohol use and/or sexual behavior is 
problematic based on information presented in the personalized feedback portion of the web-based 
intervention. Participating in the focus group with other participants may also cause a degree of 
stress or anxiety. Steps will be taken to mitigate these risks (see below). 
Usability Phase 
Web-based surveys, IVR system and intervention materials. Risk is the same as in the other 
studies with the exception that usability study participants will also provide daily responses 
regarding alcohol and other substance use, sexual behavior and medication use or another health-
related activity given that there is no medication involved with the usability study. The potential 
sensitivity of the IVR items is the same as in the prior web surveys. Use of the IVR system brings 
with it a slight increase in risk of confidentiality breach. The IVR calls will be managed through a 
cloud-based telephony services provider, Twilio Inc. Twilio’s systems will initiate phone calls to the 
participants, read survey questions, relay touch-tone responses back to the REDCap survey. 
This process exposes the participant’s phone number, the content of the survey questions, and 
the participant’s responses to the Twilio’s systems. Twilio does not maintain a record of these 
details. Twilio does record a log of what numbers where called when, but REDCap mitigates 
that risk by deleting the call log from the Twilio moments after completion using Twilio’s own 
software interface libraries.  
Possible breach of confidentiality. The chief risk to participants in the study is that their 
responses regarding alcohol/other substance use and sexual behaviors and/or their identities as 
research participants will be compromised. Similar steps will be taken as in the other studies, 
however the usability study also entails use of the IVR system. In order to be called by the 

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system, participants will be required to provide a phone number where they can be reached 
reliably. This identifier must be shared with the IVR provider, Twilio Inc., to deliver IVR portion of 
the usability study. 
Stress or anxiety. Slight risk of stress or anxiety is the same as in the other UH2 phase studies. 
Steps will be taken to mitigate these risks (see below). 
Procedures to Protect against or Minimize Potential Discomforts and Risks 
Web-survey protections against risk. 
Participant rights and minimizing burden from web-based surveys: While items in these surveys 
cover some sensitive topics, our past experience with these measures indicates that they are 
acceptable to participants. As part of informed consent, participants are advised that their 
participation is voluntary and that they are free to decline participation. They will also be informed 
that they are allowed to omit any question they are uncomfortable answering. In order to minimize 
participant burden, we have made an effort to limit the length of the survey. The full survey should 
not require more than 30 minutes to complete. 
Ensuring confidentiality: Several steps will be taken to ensure participants’ confidentiality. The 
web survey will be created and managed using the REDCap secure web application. Data 
transmission will be encrypted and all data will be stored on a secure web-based research 
server. Identifiers entered into the survey will be minimal: randomly selected study ID number 
and the IP address of the computer used by the respondent will be entered into the survey in 
order to minimize submission of multiple surveys by the same individual. When respondents 
complete the survey, the study ID number will be generated automatically by the survey. 
Respondents will then be instructed to make separate contact with study staff by email, or 
telephone to provide the study ID number and additional information (name, postal address) so 
that they may be compensated for completing the survey. This separate correspondence will not 
be linked to respondents’ survey data at any point, though it is necessary to maintain a paper-
based master list matching participant names and study ID numbers in order to maintain 
payment records; to ensure there are no duplicate or other inappropriate study enrollments; and 
to contact randomly selected participants for focus groups or the usability study. Respondent 
information will be entered separately into the University of Florida’s (UF) secure online 
payment system, however this system is in no way connected to the research data. The Project 
Coordinator will keep a running paper record of study ID numbers and participant contact 
information, however this paper record will be stored in a locked cabinet in a locked room that is 
part of Dr. Leeman’s research space in Yon Hall and will only be accessible to Dr. Leeman and 
senior study staff.  
Web survey data collected via REDCap at UF are backed by UF Health’s computing and data 
center facilities, which has a powerful, reliable, and secure computer environment for 
researching, storing, analyzing and securing large sets of data. The data center is housed in a 
dedicated, climate controlled, and secure facility with guard patrolled physical security and 
electronically controlled access. Power is conditioned and provided with dedicated battery and 
generator backup for high availability. Servers run on enterprise operating systems with modern 
network infrastructure.  The UF Data Center employs the latest security technology including the 
most current enterprise class virus scanning software and network firewall to monitor and 
protect all network activity.  
Minimizing stress or anxiety: A secondary risk is stress or anxiety regarding one’s drinking, other 
substance use or sexual behavior that may occur as a result of responding to questions on the 
web survey. As part of the informed consent process, participants will be informed that they can 

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contact research staff including the Principal Investigator for clinical referrals should they be 
concerned and want to pursue treatment.  
Focus group protections against risk. 
Participant rights and minimizing burden: While items in these surveys cover some sensitive 
topics, our past experience with these measures indicates that they are acceptable to participants. 
As part of informed consent, participants are advised that their participation is voluntary and that 
they are free to decline participation. They will also be informed that they are allowed to omit any 
question they are uncomfortable answering. In order to minimize participant burden, we have made 
an effort to limit the length of the web-based intervention, which should not require more than 35 
minutes to complete. The focus group discussion should require no more than 1 hour. 
Ensuring confidentiality: Similar steps will be taken to ensure confidentiality of participants’ data 
collected via the web. Several steps taken to ensure participants’ confidentiality during the focus 
group were described above as part of the informed consent procedures. Before the focus group 
begins, participants will be asked to keep all information shared as part of the focus group 
confidential. Participants will not be referred to by their name or any other identifiable information 
during the focus group and in the transcript created from focus group discussions, any names or 
other personally identifiable information will be redacted and participants will instead be referred to 
by study ID only. Use of a trained, experienced focus group facilitator will enhance the quality of 
discussion, the resulting data and further minimize any threats to confidentiality. Audio recordings 
from focus group sessions will be transcribed verbatim. Once a printed record is created, which will 
be absent any identifiers other than study ID, the audio recordings will be destroyed.  
Minimizing stress or anxiety: A secondary risk is stress or anxiety regarding one’s drinking, other 
substance use or sexual behavior that may occur as a result of responding to questions on the 
assessment portion of the web-based intervention or from the personalized feedback and other 
intervention materials. Participants will receive treatment referrals as part of the intervention 
should participation raise concerns that lead them want to change their substance use or sexual 
behaviors. In terms of stress or anxiety stemming from focus group participation, participants 
are ensured that any statements they make will be kept confidential. They will be informed 
about the nature of the focus group, which involves discussion with a small group of peers and a 
trained focus group leader and that they need not provide personal information during the focus 
group and they can opt not to participate should they recognize another participant or feel 
uncomfortable with any aspect of the process.  
Usability study protections against risk. 
Participant rights and minimizing burden: Participant rights and the manner in which we inform 
them of these rights will be the same as in the other UH2 phase studies. Participant burden will 
be minimized by keeping appointments and assessments as short as possible. The IVR 
assessment will only require about 5 minutes per day. 
Ensuring confidentiality:  In addition to similar steps taken in the other UH2 phase studies, 
identifiers recorded in the IVR system (participant phone number and study ID) will be stored 
securely with the REDCap web application. Phone numbers are solely for the purpose of the 
system contacting participants on a daily basis to complete their assessment.  Phone numbers will 
be deleted from the IVR provider’s system logs upon completion of each call. At the conclusion of 
the study, the telephone numbers will be removed from the data. Consequently, participant phone 
number will not appear as part of any data set that will be analyzed by any study collaborator. 
HIPAA principles will be in place as in the other UH2 phase studies and a Certificate of 
Confidentiality has been obtained. 

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Minimizing stress or anxiety: Similar steps will be taken to minimize participant stress or anxiety  
Confidentiality (overall). In order to be compensated, participants’ identifiable information will 
be entered into a secure, online system maintained by the University of Florida. Participants’ 
names, street addresses and social security numbers will be entered into this system, however 
no study data will be entered and study id will not be included either thus preventing study data 
from being linked to the identifiers stored in this system. Use of this system enables us to 
compensate participants via a debit or gift card to which funds can be added as participants 
complete different stages of the study. Social security numbers will be collected only for the 
purpose of providing payment. 
In order to facilitate data analysis, electronic data sets not containing any identifiers other than 
study ID will be stored on the P.I.’s desktop computer in his office at Florida Gym, on computers 
in the research facility in Yon Hall North and on space in a secure server maintained by the 
University of Florida College of Health and Human Performance. At the conclusion of each of 
the three individual studies, data will be deidentified. Any data from this study that is shared with 
collaborators or other qualified individuals from institutions outside the University of Florida will 
first be de-identified. Thus, no investigators outside the University of Florida will have access to 
any protected health information collected in this study. 
With participants’ consent, the focus group will be recorded using a portable recording device. 
Participants’ will not be referred to by name on these recordings and it will not typically be 
necessary to discuss protected health information in the course of this discussion. Recordings 
will be transferred from the recording device to a secure server maintained by the UF College of 
Health and Human Performance and to the P.I. Dr. Leeman’s desktop computer and desktop 
computers in Dr. Leeman’s laboratory space. A study staff member will subsequently transcribe 
each focus group session verbatim for subsequent thematic analysis. After audio recordings are 
transcribed, they will be destroyed. 
A Certificate of Confidentiality has been obtained from NIH/NIAAA. 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.  
In case of injury. If a participant is injured as a direct result of participation in this study and is 
clearly in need of immediate emergency treatment, 911 will be called right away. Efforts will be 
made to assist participants in obtaining any necessary treatment. If injury is a direct result of 
study participation, healthcare will be provided at the University of Florida Health Science 
Center at no charge. The participant and/or his or her insurance carrier will be expected to pay 
the costs of any further treatment, including any treatment at Shands Hospital. No additional 
financial compensation for injury or lost wages is available. Participants will not waive their legal 
rights by participating in this study. Participants will be provided with this information as part of 
the informed consent process.  
 
8. Possible Benefits: 
Web Survey 
The web survey was designed to yield data that will benefit science and society and inform 
personalized normative feedback that is part of the combined alcohol and HIV preventive 
intervention to be tested in the subsequent UH3 phase. The survey was not designed to have 

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individual benefit to research participants. However, survey completers may be selected to 
participate in a focus group or the usability study subsequently and they may benefit from this. 
Importance of the knowledge to be gained. The web survey will yield valuable data about 
correlates to heavy alcohol use and risky sexual behavior among MSM. Importantly, data from 
this survey will yield normative data to be incorporated in the subsequent intervention. 
Participants for the subsequent focus groups and usability study will be selected among survey 
completers and these studies will also yield valuable knowledge that will contribute to the 
intervention to be tested in the UH3 subsequent phase. Lastly, conduct of the web survey will 
support the feasibility of the UH3 phase intervention study. This is based on our expectation that 
at least 80 (the proposed sample size for the UH3 phase intervention study) of the 683 survey 
completers will be from a 50-mile radius surrounding UF and give responses indicative of 
eligibility for the subsequent UH3 phase intervention study. These include reporting at least one 
past-month heavy drinking day (i.e., 5 alcoholic drinks or more); unprotected sex with a man in 
the past month; and openness to trying PrEP. Participation in the web survey carries minimal 
risk, which is far outweighed by the potential benefit of the knowledge to be gained.  
Focus Group 
Participants may benefit from information about their alcohol and sexual risk behaviors from 
completing the web-based preventive intervention. They may also benefit from treatment 
referrals should they opt to change their drinking, other substance use or sexual risk behaviors. 
The focus groups offer great benefit to the project as they provide an opportunity to get input 
from the study population regarding what they liked and disliked about the web-based 
preventive intervention, along with their suggestions, particularly regarding how it can be made 
to be more culturally appropriate for men who have sex with men. Technical issues with the 
web-based intervention may also be detected as a result of focus group participants completing 
it.  
Importance of the knowledge to be gained. The focus groups will yield valuable data 
regarding MSM views on mobile interventions. They will also provide input and enable detection 
of any technical issues. Any needed changes to the web-based intervention can then be made 
in advance of the UH3 phase intervention study. 
Usability Phase  
As with the focus group study, participants have the opportunity to benefit from intervention 
material provided as part of the brief web-based alcohol and HIV preventive intervention. In 
addition, the participants will receive personalized feedback based on their IVR responses, thus 
there may be some additional benefit to participants in this study compared to the focus group 
study. 
Importance of the knowledge to be gained. This study will yield information valuable to this 
project. At the conclusion of 1-month, participants will inform study staff regarding what they 
liked and disliked about the combined intervention and any changes they recommend. The 
usability study will also provide an opportunity to uncover technical, legal, and regulatory issues 
with the web-based intervention component or the IVR monitoring system. 
 
9. Conflict of Interest: 
None. 
 
10.  Data Safety and Monitoring Plan: 

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Web Survey 
This study is not a Phase 3 clinical trial and does not require a data safety monitoring board. 
Given the minimal risk nature of this web survey, the likelihood of a serious adverse event is 
remote. Risk of breach of confidentiality is minimal given the preventive steps described. The 
Principal Investigator is responsible for monitoring the data and assuring protocol compliance.  
During the review process the Principal Investigator will evaluate whether the study should 
continue unchanged, require modification/amendment, continue or close to enrollment. Either 
the Principal Investigator or the UF IRB have the authority to stop or suspend the study or 
require modifications. Data quality will be ensured through making the questions in the web-
based surveys in the study as clear as possible, primarily through use of established measures 
that have been determined to be reliable and valid. This will increase the likelihood that 
participants will give valid responses. 
Focus Groups 
The focus group study is not a Phase 3 clinical trial and does not require a data safety 
monitoring board. Given the minimal risk nature of participation, the likelihood of a serious 
adverse event is slight. Risk of breach of confidentiality will be minimized through the preventive 
steps described. The Principal Investigator is responsible for monitoring the data and assuring 
protocol compliance.  During the review process the Principal Investigator will evaluate whether 
the study should continue unchanged, require modification/amendment, continue or close to 
enrollment. Either the Principal Investigator or the UF IRB have the authority to stop or suspend 
the study or require modifications. Data quality will be ensured through use of clearly worded 
discussion questions for use during the focus groups and through use of a trained, experienced 
facilitator. After focus group discussions are transcribed, they will be read carefully on multiple 
occasions, in part so that any errors can be corrected. Regarding data quality of the web-based 
alcohol and HIV preventive intervention, data quality is ensured by making the questions and 
instructions in the web-based forms as clear as possible. This will increase the likelihood that 
participants will give valid responses and benefit from the intervention material. 
Usability Study 
This study is not a Phase 3 clinical trial and does not require a data safety monitoring board. 
Given the minimal risk nature of this study, the likelihood of a serious adverse event is remote. 
Risk of breach of confidentiality is minimal given the preventive steps described. The Principal 
Investigator is responsible for monitoring the data and assuring protocol compliance.  During the 
review process the Principal Investigator will evaluate whether the study should continue 
unchanged, require modification/amendment, continue or close to enrollment. Either the 
Principal Investigator or the UF IRB have the authority to stop or suspend the study or require 
modifications. Data quality will be ensured through making the questions in the web-based 
surveys and the IVR assessment as clear as possible, primarily through use of established 
measures that have been determined to be reliable and valid. This will increase the likelihood 
that participants will give valid responses. 
Designation of serious adverse events. Dr. Robert Leeman, the PI, has primary responsibility 
for monitoring the data, assuring protocol compliance, and conducting regular safety reviews 
throughout the study. Dr. Leeman will be responsible for distinguishing serious from non-serious 
adverse events and has sufficient clinical research expertise to make this distinction. In addition 
to his own experience conducting clinical research for several years, Dr. Leeman will also base 
determination of serious adverse events on consultation with Co-investigators Dr. Tucker and 

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Dr. Cook who have extensive and varied clinical and research experience. Dr. Leeman will 
consult with Dr. Cook regarding any medical issues associated with a Serious Adverse Event.  
Reporting of serious adverse events. Should a serious adverse event occur, Dr. Leeman 
would report such events in writing within 48 hours to the NIAAA Project Officer as defined by 
NIAAA and to the UF IRB following their policies. The investigator will apprise fellow 
investigators and study personnel of all adverse events that occur during the conduct of this 
research project through regular weekly study meetings. An annual report will be submitted to 
the NIAAA Project Officer summarizing all adverse events. 
Procedures for data  quality assurance and confidentiality. The Principal Investigator is 
responsible for monitoring the data and assuring protocol compliance.  During the review 
process, the Principal Investigator will evaluate whether the study should continue unchanged, 
require modification/amendment, continue or close to enrollment. Either the Principal 
Investigator or the UF IRB have the authority to stop or suspend the study or require 
modifications. 
Data quality will be ensured through making the questions in the web-based surveys, IVR and 
clinical interviews in the study as clear as possible, primarily through use of established 
measures that have been determined to be reliable and valid.  On the web survey, respondents 
will review a brief summary emphasizing the importance of providing honest and valid 
responses while completing the survey.  They will also be encouraged to respond to the survey 
only once and discouraged from providing invalid contact information. This will increase the 
likelihood that participants will give valid responses. All research staff will be carefully trained by 
the Principal Investigator. Drs. Cheong and Leeman, who are experienced data analysts, will be 
primarily responsible for conducting the preliminary and final data analyses with advice from 
collaborators and with support from Ms. Jung.  
Right to privacy for participation in this research will be protected through coding of data using 
study-assigned identification numbers and proper storage of research records. Access will be 
limited to the P.I. and his designates involved in the study. Hard copy master lists linking study IDs 
to research participants’ contact information will be stored in locked cabinets at the Yon Hall 
research facility and in Dr. Leeman’s office in Florida Gymnasium. These lists will be stored 
separately from other study materials. Identifiers will be destroyed when the study is completed. All 
email contact with participants will occur with the use of secure UF email accounts only. Web-
based data collection will be encrypted and stored on secure servers, but will not contain any 
identifiers other than study ID and in the case of the web survey, IP address. A Certificate of 
Confidentiality has been obtained from NIAAA for this study. This certificate protects 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 and medical personnel will be trained on human subjects’ protection and 
HIPAA procedures. 
Clinicaltrials.gov requirements. This study will be registered on clinicaltrials.gov. 
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