Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage
Phase: NA
Conditions: HIV
Sponsor: Florida State University

STUDY00002534: Project Engage: A Wrist Biosensor-based mHealth Suite to Support 
Alcohol Intervention in Young People Living With HIV 
NCT05431855 
Study Protocol 
October 28, 2024 

PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Page 1 of 38
Revised: October 15, 2023
PROTOCOL TITLE:
A wrist biosensor-based mHealth suite to support alcohol intervention in young 
people living with HIV 
PRINCIPAL INVESTIGATOR:
Sylvie Naar, PhD, SHARE Program MPI
Center for Translational Behavioral Science
Behavioral Sciences and Social Medicine, College of Medicine
850.644.2334
Sylvie.naar@med.fsu.edu 
Yan Wang, PhD –Project Principal Investigator
Assistant Professor, Department of Epidemiology
College of Public Health and Health Professions and College of Medicine
University of Florida
352.294.5942
ywang48@ufl.edu 
VERSION NUMBER/DATE: 6.0 / 10/15/2023
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
2.1
5.13.2022
Section 6: Updated Engage measures to remove 
measures that were previously submitted in error and 
additional details regarding the recruitment and 
enrollment process per IRB reviewer feedback. 
Section 7: Details were provided on how data from 
both the Skyn biosensor and the mEMA app will be 
deidentified from the study participant as well as 
how the data will be stored and managed securely 
and language pertaining to the manufacturer not 
using study data to support adoption/change 
indication for the device. 
Section 8: Provided explanation as to why alcohol 
levels measured by the Skyn biosensor will not be 
provided to the subjects
Section 10: Added the inclusion criteria of being 
diagnosed as HIV+
Section 13: Additional details regarding recruitment 
to be conducted by the CEC
Section 18: Addition of DSMB members and 
qualifications
Yes
MOD00005379
FSU IRB Approved
28 October 2024

PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Page 2 of 38
Revised: October 15, 2023
Section 22: Contact information for participants who 
have questions throughout the study was provided
Section 26: Additional description of core and site 
activities as they pertain the SHARE Program 
overall and the Engage project.
2.2 
6.29.2022
Section 6: Other related studies are now included 
(e.g. inclusion of STUDY00002535, SHARE P01: 
DEFINE); Confirmation that the zoom meetings will 
not be recorded; Updated language surrounding the 
viral load test results, including information related 
to email encryption. Participants will not be emailing 
their viral load results. Rather, if participants opt to 
provide their viral load results as an attachment, that 
attachment will be uploaded to the secure REDCap 
platform and will not be sent by the participant via 
email; Removed language related to reasons for 
refusal as these are not currently programmed into 
REDCap. Should we add this back, we will do so 
with an IRB modification.
Section 8: Language added that only encrypted 
email communications will be used to convey VL 
results. We will not provide VL results via 
telephone. Instructions for encryption are built into 
the study personnel’s standard operating procedure.
Section 11: Removed language related to minimal 
risk
Section 17: Updated language to state that zoom 
meetings will not be recorded.
Section 18: Updated the description related to the 
DSMB to include that only aggregate data will be 
shared. No personally identifiable information will 
be shared or connected to the aggregate data 
discussed in the meeting.
Section 20: Removed language related to minimal 
risk
Section 22: Removed language related to reasons for 
refusal as these are not currently programmed into 
REDCap. Should we add this back, we will do so 
with an IRB modification.
Yes
2.3
07.08.2022
Section 6: The SHARE screening process has been 
updated to include language relevant to the three 
options for eligible participants to enroll, description 
of process to retain screener information for 
enrollment purposes only, clarification of the triage 
process (randomization) for Define or Engage, and 
redirection to the SIU Connect repository. 
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PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Page 3 of 38
Revised: October 15, 2023
Section 10: Inclusion and exclusion criteria is 
consistent related to pregnancy 
Section 15: We have removed the language related 
to violation of confidentiality is considered minimal 
2.4
10.05.2022
Section 6: We have added details about prorating 
participants’ compensation for the EMA assessments 
if they respond to less than 80% of the assessments. 
Info about the tutorial videos for the EMA and Skyn 
apps was included. 
Section 22: We have added information regarding a 
video that will accompany the informed consent 
form
Yes
3.0
02.01.2023
We have modified the following protocol sections:
Section 1.0: study sample size from 222 to 160
Section 3.0: study sample size from 222 to 160, with 
15% attrition anticipated
Section 6.0: participant incentive schedule to reflect 
reduced sample size.
Section 9.0: Study timeline to reflect new sample 
size
Section 12: Total sample size
Section 13: Total sample size
We have also updated the consent form to include 
the sample size change.
Yes
4.0
06.06.2023
Section 13: We have modified Section 13 of the 
protocol to include information related to the use of 
the BuildClinical platform for social media 
recruitment. Attached to this modification please 
find the accompanying materials for IRB review 
(advertisements, study landing page, pre-screener 
form, ad copy).
No
5.0
08.25.2023
Section 6: We have updated the measures table to 
include the addition of the Sexual Sensation Seeking 
Scale
No
6.0
10.15.2023
Section 1: Added information on the inclusion of the 
eWrapper app 
Section 5:  Added the eWrapper app 
Section 6: Details on the eWrapper app intervention 
were added. Information regarding how incentives 
are delivered following completion of baseline and 
follow up surveys was added. The incentive structure 
was adjusted to accommodate for the inclusion of the 
eWrapper app
Section 19: Details concerning the security of the 
eWrapper app were added
Yes
MOD00005379
FSU IRB Approved
28 October 2024

PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Page 4 of 38
Revised: October 15, 2023
Section 22: Added that an agreement to send back 
study materials will be included in the consent 
process
7.0
04.29.2024
Section 6: We have updated the incentives for EMA 
assessments to increase retention and to prevent 
device loss. 
Yes
8.0
10.21.2024
Section 18: 
•
Modified language to include the addition of 
the University of South Florida as the 
primary Data Science Core site due to Dr. 
Sam Wu’s transition from UF to USF.
Section 19:
•
Added additional language related to the 
transfer to FDOH data to include USF.
Section 24: 
•
Modified language to include USF Data 
Science Core activities.
Section 26: 
•
We have added the Northeastern University 
and the University of South Florida as they 
are new sites to the SHARE program and 
removed Nova Southeastern University.
No
MOD00005379
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PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
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Revised: October 15, 2023
Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................6
3.0
Background*.............................................................................................................6
4.0
Study Endpoints*......................................................................................................7
5.0
Study Intervention/Investigational Agent.................................................................7
6.0
Procedures Involved* ...............................................................................................8
7.0
Data and Specimen Banking*.................................................................................14
8.0
Sharing of Results with Subjects* ..........................................................................19
9.0
Study Timelines*....................................................................................................16
10.0
Inclusion and Exclusion Criteria* ..........................................................................17
11.0
Vulnerable Populations*:........................................................................................17
12.0
Local Number of Subjects ......................................................................................18
13.0
Recruitment Methods..............................................................................................18
14.0
Withdrawal of Subjects*.........................................................................................18
15.0
Risks to Subjects*...................................................................................................19
16.0
Potential Benefits to Subjects* ...............................................................................21
17.0
Data Management* and Confidentiality.................................................................21
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*.........................24
19.0
Provisions to Protect the Privacy Interests of Subjects ..........................................26
20.0
Compensation for Research-Related Injury............................................................27
21.0
Economic Burden to Subjects.................................................................................27
22.0
Consent Process......................................................................................................27
23.0
Process to Document Consent in Writing...............................................................28
24.0
Setting.....................................................................................................................29
25.0
Resources Available ...............................................................................................20
26.0
Multi-Site Research* ..............................................................................................30
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Revised: October 15, 2023
1.0
Study Summary
Study Title
A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Study Design
Overview: Young people living with HIV (YPLWH) will be 
asked to wear a wrist alcohol biosensor (BACtrack Skyn) for 30 
days and report their alcohol use using daily ecological 
momentary assessment (EMA). Data from the 30-day period will 
be used to develop and validate the algorithm for alcohol 
detection based on Skyn data. We will also collect alcohol 
biomarker (i.e., PEth) at 1-month follow up. 
Primary 
Objective
Health Services Research: to develop a mHealth suite based on 
the Skyn biosensor to help self-management of alcohol use 
among YPLWH.
Secondary 
Objective(s)
N/A
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
Behavioral Intervention: Single Group, Randomized
eWrapper-Engagement strategies to facilitate alcohol 
biosensor wearing 
We will conduct a 30-day micro-randomized trial (MRT)--a 
clinical trial design for developing and optimizing mHealth 
interventions to test which engagement strategy works better, for 
who, and under what condition. Participants will be micro-
randomized in the morning and in the evening, to either a prompt 
delivering non-contingent small reward (reciprocity); or a prompt 
containing feedback on self-monitoring progress based on 
dynamic self-regulation theories (personalized feedback); or no 
prompt. Up to 60 Engage participants will engage with the 
eWrapper application.
IND/IDE # 
Study Population
This study will only recruit participants who are 18 to 29 years of 
age due to focus on YPLWH. Targeted enrollment of women and 
minorities is summarized in the accompanying Planned 
Enrollment Table. The distribution by gender and ethnicity is 
expected to be similar to that of the people living with HIV 
(PLWH) in the state of Florida, given that we will be recruiting 
across the state.  
Sample Size
N = 160
Study Duration 
for individual 
participants
Approximately 2 calendar months
Study Specific 
Abbreviations/ 
Definitions 
ART: Antiretroviral Therapy
ARV(S): Antiretroviral
ASSIST: Alcohol, Smoking and Substance Involvement 
Screening Test
CITI: Collaborative IRB Training Initiative
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Revised: October 15, 2023
CoM: College of Medicine
DBS: Dried Blood Spot
DSC: Data Science Core
eHARS: Enhanced HIV/AIDS Reporting System 
EHR: Electronic Health Record
EMA: Ecological momentary analysis
FDOH: Florida Department of Health
FDOH HSP: Florida Department of Health HIV/AIDS 
Surveillance Program 
GLMM: Generalized Linear Mixed Model
GUID: Globally Unique IDentifier
HIV: Human Immunodeficiency Virus
NIAAA: National Institute on Alcohol Abuse and Alcoholism
NIAAADA: National Institute on Alcohol Abuse and Alcoholism 
Data Archive 
NLP: Natural Language Processing
REDCap®: Research Electronic Data Capture
RERAC: Recruitment, Engagement, Retention, and Assessment 
Center
SHARC: Southern HIV and Alcohol Research Consortium
SHARE: Self-management of HIV and Alcohol Reaching 
Emerging adults
SEM: Structural Equation Models
SMC: Study Monitoring Committee
TLFB: Timeline Follow-back
USF: University of South Florida
VL: Viral Load
YAC: Youth Advisory Council
YPLWH: Young People Living with HIV
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2.0
Objectives*
This project aims to (1) develop and validate machine learning algorithm 
for proximal and distal drinking detection based on biosensor-derived 
transdermal alcohol concentration (TAC) data. (a) Drinking reported in the 
EMA (proximal drinking) will be used to develop and optimize machine 
learning algorithm for detecting drinking episodes based on TAC. (b) PEth 
level at 1 month (distal drinking) will be used to further validate the 
algorithm; (2) explore whether wearing the biosensor (thus self-
monitoring) for 30 days is associated with reduced alcohol use; and (3) 
pilot test the feasibility of using the eWrapper app as engagement 
strategies to increase Skyn sensor wearing time. 
3.0
Background*
Despite the high prevalence of alcohol use and its detrimental 
consequences in YPLWH, developmentally-tailored intervention 
targeting alcohol use in YPLWH is rare. 
In Dr. Wang’s current R21 project (data collection still ongoing), we 
collected data from 28 adult drinkers (21 HIV-, 7 HIV+, 61% male, Mean 
age=32.8, SD=15.2) to test feasibility, acceptability and preliminary 
validity of the Skyn biosensor in both laboratory and field settings. 
During two lab sessions, participants wore the sensor while they 
consumed 3 standard drinks (15min for each) in succession with a break 
(15min) in between. Breathalyzer was used to obtain breath alcohol 
concentration (BrAC) readings at set intervals (30min during drinking 
and 15min after drinking period). The correlation between peak TAC and 
BrAC was r =.23 (N=22) for session 1, and r =.60 (N=16) for session 2. It 
should be noted that TAC and BrAC are not linearly translatable. The 
correlations here are similar or higher than what was reported in prior 
research using the same lab administration paradigm for SCRAM 
biosensor (r =.24), which is considered gold standard for TAC.127 Also, 
we speculate the lower correlation for session 1 were due to less stable 
data quality at earlier stage (2019) where we used an early production 
version of Skyn. The current version of Skyn is more stable (updated 
hardware and software), so we expect TAC and BrAC readings in the 
proposed study will be closely related like that for session 2. Participants 
also wore the wrist sensor for 2 weeks in their daily lives at all times 
besides bathing/showering/swimming and when charging the device. 
Participants were incentivized to wear the biosensor at least 80% of the 
time and to complete at least 80% EMA. Participants have had good 
adherence, wearing it 87% of the time on average, and completing 76% 
of EMAs. The Skyn TAC readings showed a visible drinking curve 
(coded by two independent coders) for 99 out of 114 drinking episodes 
(86.8%) reported in the EMA from 27 participants who completed the 
two-week field test. The episodes that were not detected by the Skyn 
were mostly 1-2 drinks (80%). The spearman correlation between peak 
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TAC and self-reported number of drinks was .63, indicating good 
agreement. At the end of 2 weeks, participants completed a 
usability/acceptability survey, where they rated Skyn as easy to learn 
(M=4.22, SD=0.95) and easy to use (M=3.96, SD=1.29) on a scale from 
1 = “strongly disagree” to 5 = “strongly agree”.  
Despite the overall decline in new HIV infections in U.S., adolescents 
and emerging adults aged 13 to 29 remain disproportionately affected by 
HIV who account for 37% of all new HIV diagnoses. Alcohol use is more 
common among YPLWH than other age groups, creating a significant 
barrier for mitigating transmission, achieving viral suppression, and 
reducing comorbidities. Despite the high prevalence of alcohol use and 
its detrimental consequences in this population, developmentally-tailored 
intervention targeting alcohol use in YPLWH is rare. Self-management 
emerged as an important strategy in the context of medical adherence and 
chronic disease management, with self-monitoring and personalized 
feedback being two key elements to improve health outcomes including 
alcohol use. Recent development of wrist alcohol sensors provides a 
promising tool for self-monitoring and feedback based on objective data. 
Our current R21 project (N=28) showed acceptability and initial validity 
of a wrist-worn biosensor (BACtrack Skyn) in both laboratory and field 
settings. However, without existing analysis software, accurate detection 
of alcohol use (e.g., start time, consumption level) based wrist sensor data 
remains a significant barrier. Some literature also suggests that HIV may 
impact blood alcohol concentration, so a detection algorithm specific to 
this population is needed. 
To address these challenges and achieve the overall P01 goal to improve 
self-management of alcohol use and HIV care among YPLWH, we 
propose to develop the first wrist biosensor-based mHealth suite for 
alcohol self-monitoring with validated alcohol detection algorithm 
tailored for YPLWH. YPLWH (N = 160, 136 after 15% attrition,18-29 
years) will wear the Skyn biosensor for 30 days and report alcohol use 
via smartphone-based ecological momentary assessment (EMA). Data 
from the 30-day period will be used to (a) develop and validate machine 
learning algorithm for alcohol detection in YPLWH based on Skyn data. 
We will collect alcohol biomarker (i.e., PEth) at 1-month follow up to 
explore whether wearing the sensor for 30 days impacts alcohol use.
4.0
Study Endpoints*
By the end of this study, we will develop a mHealth suite based on the 
Skyn biosensor to help self-management of alcohol use among YPLWH. 
5.0
Study Intervention/Investigational Agent
eWrapper-Engagement strategies to facilitate alcohol biosensor 
wearing: We will conduct a 30-day micro-randomized trial (MRT)--a 
clinical trial design for developing and optimizing mHealth interventions 
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intervention in young people living with HIV
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to test which engagement strategy works better, for who, and under what 
condition among a subset of participants (up to 60). Participants will be 
micro-randomized in the morning and in the evening, to either a prompt 
delivering non-contingent small reward (reciprocity); or a prompt 
containing feedback on self-monitoring progress based on dynamic self-
regulation theories (personalized feedback); or no prompt. The eWrapper 
app will also collect paradata about participants’ usage of the app (e.g., 
how often message notifications were clicked, how often the application 
was opened). Additionally, information on how long participants wore 
the Skyn biosensor will be calculated based on downloaded Skyn sensor 
data from its web portal using an algorithm based on motion and 
temperature. None of these data will involve any personal identifier. The 
eWrapper app security has been evaluated by the University of Florida IT 
risk assessment and deemed acceptable if only used on the study iPhones. 
6.0
Procedures Involved*
The SHARE Program’s Community Engagement Core (CEC), Administrative 
Core (AC), and Data Science Core (DSC) are charged with the identification of 
participants for the SHARE Program’s studies (inclusive of Engage). 
Recruitment materials will include different electronic and printed materials (e.g. 
insta-stories; flyers, brochures, and palm-cards) and be distributed via social 
media sites, smartphone applications, email, as well as at community venues, 
clinics, and agencies as recommended by the Youth Advisory Committee (YAC) 
and stakeholders. Promotional materials (both virtual and physical) will include a 
brief description of the study and a rapid way to access the screening 
questionnaire – a hyperlink or QR code. In the unlikely event that we do not 
accrue participants at the rate proposed with these time-tested procedures, we will 
pivot to more traditional venue and clinic-based recruitment approaches while 
adhering to COVID-19 safety recommendations. Participants will be self-
identified through contact with (electronic or printed) recruitment materials.
After completing the eligibility screener, those deemed eligible will be asked if 
they are interested in participating in the SHARE Program. If they are not 
eligible, they will be routed to a page with a link to the SIU Connect repository 
(IRB approved STUDY00002871), which gives them the option to complete the 
consent and enrollment process for SIU Connect if they meet the eligibility 
criteria. This is a separate and independent process from the SHARE Program. 
If they are eligible, participants will be notified that should they choose to 
participate, they will be invited to enroll in either DEFINE or ENGAGE, and 
which they are invited to is by chance. They will then be given three options 
(please refer to the SHARE Program Screening Forms attachment): 
•
Option 1 - Yes: The participant will be automatically triaged by the DSC to the 
DEFINE (STUDY00002535) or ENGAGE studies where they will complete the 
consent and enrollment process. 
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•
Option 2 – No but want to join later: If this option is selected, participants will 
be directed to provide their email address and click submit. As indicated on the 
REDCap form, by clicking “submit” they are giving permission for the SHARE 
DSC to retain their information to follow-up via email that will include a link to 
return to this page and select “Yes” to complete the enrollment process, and they 
are informed that this data retained will not be linked with any data collected as 
part of their potential enrollment in any of the SHARE studies. The participant 
will receive up to 3 emails to prompt them to complete the enrollment process. If 
they ignore all prompts, they will no longer be contacted and will be deemed 
ineligible, and their email address will be removed from our database.
•
Option 3 – Not interested: If individuals are eligible but not interested, they will 
be directed to a page in REDCap where a link to the SIU Connect repository 
where they can choose to navigate to the repository screening page. 
Participants will not enroll in SHARE as an overarching protocol, rather, they will 
enroll in a specific study that is within the umbrella of the overall SHARE 
program. Screening data will not be linked to any enrolled participants in any of 
the SHARE Studies and the screening data is not capturing any identifiable data 
unless participants selection option 2 and provide their email address and phone 
number (where we have inserted an additional statement to this effect). 
Once a participant consents and is enrolled, a member of the CEC will contact 
participants to confirm their HIV and Florida residency status, giving the 
participants the option to upload documents to the secure REDCap platform or 
schedule a virtual conference via HIPAA compliant zoom with CEC relationships 
specialists. These zoom sessions will not be recorded, they will simply be 
conducted to confirm HIV status for eligibility purposes, if the zoom session is 
the preference of the participant. If the preference of the participant is to upload 
proof of HIV status, these documents will not be stored in the DSC participant 
database; rather, their participant record will be verified by the CEC coordinator 
and documentation will be removed unless the documentation also serves as the 
participants viral load as required for study enrollment. Once verification of HIV 
status, age, and Florida residency is complete, the CEC will confirm the 
participants method for providing HIV viral load results if not already provided 
(DBS test kit, release of information, or document upload), and confirm the 
selection and information in the DSC participant database and notify the AC of 
any DBS test kits that must be shipped to participants. Only authorized CEC staff 
and research assistants will directly interact with participants throughout the 
study.
Engagement and retention efforts: We will maintain regular contact 
with participants through the contact information provided by them at the 
time of consent. Reminders will be sent to participants before each 
assessment. 
SHARE Recruitment and Enrollment process:
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Study Procedures: Once enrolled, participants will be asked to wear a 
wrist alcohol biosensor (BACtrack Skyn) for 30 days, report their alcohol 
use using daily ecological momentary assessment (EMA), and use the 
eWrapper app where randomized messages will be delivered to the 
participant. We will also collect alcohol biomarker (i.e., PEth) at 1-month 
follow up. 
Materials: 
1. Online survey including questions on demographic 
characteristics, alcohol use (including Timeline follow back) 
and substance use, mental health symptoms, ART adherence, 
and acceptability & usability of the wrist worn biosensor. 
2. An alcohol biomarker Phosphatidylethanol (PEth) will be 
collected from participants after they complete the 30-day 
period.
3. Transdermal alcohol concentration readings collected by the 
Skyn wrist biosensor. Data will be downloaded regularly by the 
Data Science core to secure UF drives.
4. Self-reported alcohol use and related factors assessed by 
ecological momentary assessment App (mEMA). Data will be 
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uploaded to a secure encrypted cloud storage which researcher 
can have real time access and will be downloaded regularly by 
the Data Science core to secure UF drives. 
5. The eWrapper app, developed by our team and the Florida 
Center for Interactive Media (FCIM). The app is an animal 
raising game which includes engagement strategies to promote 
engagement in terms of wearing the Skyn biosensor. Data will 
be downloaded regularly by the Data Science core to secure UF 
drives.
6. Viral load abstracted from participants’ health record or via 
dried blood spots (DBS) test. 
Baseline/follow up assessments:  Online survey (baseline and follow up): 
At baseline and 1-month follow up, participants will be asked to complete 
online surveys programmed in REDCap; completion will take about 30 
minutes. Baseline survey will include questions such as demographics 
(e.g., age, race/ethnicity, biological sex, sexual/gender identity, mode of 
transmission), alcohol (AUDIT) and other substance use (ASSIST), 
mental health symptoms (DSM-5 Self-rated Level 1 cross-cutting 
symptom measure - adult), ART adherence (Visual Analogue Scale), and 
sexual risk behaviors. The same survey questions minus demographics 
will be used at follow up. Additionally, we will assess usability and 
acceptability of the biosensor at follow up using established measures such 
as System Usability Scale and the Mobile App Rating Scale, with some 
open-ended questions about user-desired features. Survey links will be 
sent to each participant at each assessment point and can be completed at 
his/her convenience. Completion of the baseline survey will result in a $25 
compensation for the participant, which will be provided to the participant 
once the 30-day study trial begins. Completion of the follow up survey 
will result in a $35 compensation for the participant, which will be 
provided to the participant after they have returned their study materials.
Timeline follow back (TLFB) (baseline and follow up): We will use an 
online version of TLFB provided by the University of Washington, which 
has shown comparable validity to the in-person interview-based TLFB, 
and is more amiable for remote data collection. Participants will receive 
$25 for complete the baseline online assessments (survey and TLFB), and 
$35 for the follow up online assessments to increase retention. 
Phosphatidylethanol (PEth) (follow up only): We will collect dried 
blood spots (DBS) to test for PEth level at 1-month follow up. Research 
staff will mail the DBS collection kit and an illustrated instruction sheet to 
participant’s preferrable address, with a prepaid pre-addressed envelope 
for participants to return the sample. The DBS collection kit will be 
provided by the United States Drug Testing Laboratories (USDTL Inc.), 
which is a reputable lab for PEth test. The collection kit includes DBS 
collection supplies (e.g., sterile safety lancet, collection card with five 
circles for blood drops) and a drying box. Participants will be encouraged 
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to watch a video on YouTube produced by USDTL which walks through 
the DBS collection process to make sure they perform each step properly. 
After collection is complete, participants will mail back the DBS sample 
to our research team. The DBS is stable for at least 9 months at ambient 
temperature. After receiving kits, research staff will store samples to be 
sent to USDTL for testing PEth in batches. Participants will receive $10 
for providing PEth biomarker. 
Viral load (follow up only): As a common measure across projects, HIV 
viral load will be abstracted from the Florida Department of Health 
(FDOH) surveillance data at follow up (detail see Data Science Core). 
Participants have several options for how they would like this data 
submitted. VL measurements collected during follow-up or after may be 
used, as long as they are collected no later than 1 month from the follow-
up survey date (exceptions to this must be approved by the REC). 
Participants may submit VL test results from their standard care providers 
as long as they were measured using a level of detection of within the 
required window period. Clinical care VL measurements can be used as 
long as they were measured using a level of detection of <200 copies/mL 
or below. VL measurements using a level of detection >200mL will not be 
accepted. If participants decide to obtain a copy of their standard care VL 
test results, they may take a picture of their newly obtained standard care 
VL test result using their personal cell phone and submit the picture 
through a secure REDCap online submission form as a file attachment.
Participants who cannot or do not wish to visit a medical provider may be 
referred to their local health department for free VL testing or they may 
request HemaSpot™ Blood Sampling Kit.  The participant will indicate 
this as the preferred option for providing VL upon enrollment/baseline and 
the Data Science Core will communicate the information to the Admin 
Core, who will mail the Spot*On Sciences HemaSpot™ blood sampling 
kit to the address provided by the participant. This kit includes the 
HemaSpot™ device, 2 lancets, 2 alcohol pads, 2 sterile gauze pads, and 2 
adhesive bandages. The kit also contains printed instructions, as well as a 
link to an instructional video, from the manufacturer on how to collect and 
handle your blood with the items provided. The kit requires about 2-3 
drops of blood and takes less than 5 minutes to complete. The participant 
will then mail the completed kit to Florida State University, Center for 
Translational Behavioral Sciences, 2010 Levy Avenue, Suite B0266, 
Tallahassee, FL 32310. The research team will provide the participants 
with a mailing kit and pay for the postage. Participants will complete this 
process only once for ENGAGE by the 30-day follow-up; however, 
participants may be requested to resubmit another kit in the event there 
was an error in the collection, handling, and/or mailing of the original kit. 
Upon receipt of the specimen, Admin Core personnel will ensure the 
specimen is properly and securely stored at the Center for Translational 
Behavioral Science until the next scheduled specimen batch will be 
shipped to the analyzing laboratory. Specimens are anticipated to be stored 
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on site for no more than 90 days prior to shipping for analysis. The Admin 
Core personnel are responsible for ensuring that all specimens are de-
identified and tracked only by the participant’s GUID. Specimens will be 
destroyed by the analyzing laboratory upon completion of viral load 
analysis and transmittal of viral load results to the Data Science Core. 
Participants will receive $10 for providing VL data. 
Alcohol biosensor and EMA: After participants are enrolled, we will 
mail the Skyn biosensor to their preferred address along with the 
instructions for each study related app. We will also mail a study iPhone 
with data plan to the participant to facilitate data collection if they don’t 
own one, because the Skyn app is currently only compatible with iOS 
system. Research staff will instruct participants on downloading the apps 
on their own smartphone (if they use the study iPhone, all apps will be 
preinstalled), and train participants on how to use the Skyn biosensor and 
its associated app (Skyn app) and the EMA app (mEMA) remotely via 
videoconferencing, until participants demonstrate efficiency with using 
these technologies. The research staff will send tutorial videos 
corresponding to the Skyn app and the EMA app, allowing for the 
participants to have a point of reference if they have questions about the 
materials for the study. Likewise, research staff will also be available to 
help the participants with troubleshooting if any issues occur during the 
30-day period. 
Biosensor: Participants will be asked to wear the Skyn biosensor at all 
times during the 30-day period. They will be allowed to take it off for 
bath, swimming, charging the device, or when their activities may cause 
damage to the biosensor. Since the biosensor also has motion and 
temperature sensors, it’s possible to determine whether participants take it 
off. At the end of the 30-day trial, participants will mail back the Skyn 
biosensor (and the study iPhone if applicable) using a pre-paid and pre-
labeled box back to us in order to get their compensation. Participants will 
not be compensated for the study activities during the 30-day period and 
follow-up if they do not return the study devices or the device/s get lost. 
Returning the study devices late (not within two weeks after the 30-day 
study period is completed) or damage of the biosensor/iPhone will result 
in deduction ($100) in compensation to encourage careful handling of the 
device/s. EMA: Participants will be instructed to enter information on 
their drinking behaviors using an EMA app called mEMA (ilumivu, Inc.). 
This app is developed for mobile-based EMA to collect real-time data in 
daily life. Participants will be asked to initiate an on-demand survey in the 
app whenever they start a drinking episode. This survey will include 
questions on the drinking episode such as the starting and ending times of 
their drinking, type and number of drinks, 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 
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include reminders to check the battery life of the biosensor and report 
issues they had with the sensor. Once a survey is completed, the app 
automatically pushes data into its cloud-based data portal and researchers 
can access data in real time. Troubleshooting and noncompliance 
procedures: We will contact participants via phone call if we notice any 
issues (e.g., missing daily prompt, reported biosensor malfunction) so that 
these issues can be resolved in time. Drinking data will be obtained via 
phone call if both daily and self-initiated surveys are missing. Participants 
will receive $60 for completing the EMA assessments over the whole 30-
day period, if they respond to more than 80% of the EMA assessments. If 
the participant’s response rate is lower than 80%, then the $60 
compensation will be prorated as follows: 60-79% EMA assessment 
response rate = $50, 50-59% EMA assessment response rate = $40, 40-
49% EMA assessment response rate = $30, 20-39% EMA assessment 
response rate = $20, 0-20% EMA assessment response rate = $10. There 
will be bonus for participants to complete 80% or more EMA assessments. 
Bonus will increase each week and accumulate to up to $100 total if they 
complete 80% or more each week on a continuous basis (Week 1: $10, 
Week 2: $20, Week 3: $30, Week 4: $40). If their completion rate falls 
below 80%, they will not get bonus that week, and the bonus amount 
resets at $10 again. Participants will be notified by the study RA during 
the middle of the 30-day period if their response rate is below the targeted 
80%, encouraging them to increase their response rate to be over 80%. For 
those who also use eWrapper as part of their 30-day trial, they will be 
expected to receive $10 from playing the eWrapper game, so their EMA 
compensation will be reduced by $10 from the original EMA payment 
scheme.
eWrapper: The eWrapper app was developed by our team and the Florida 
Center for Interactive Media (FCIM). The app is an animal raising game 
which includes engagement strategies to promote engagement in terms of 
wearing the Skyn biosensor. Engagement will be reinforced via a point 
system and a virtual environment, which starts with a giraffe, but allows 
the user to unlock new environments, animals, and accessories for their 
animals. The more the participant wears the Skyn sensor, the more points 
they will receive as a reward. Also, participants will be micro-randomized 
in the morning and in the evening, to either a prompt delivering non-
contingent small reward (either $1 cash reward or free points for the 
game); or a prompt containing feedback on self-monitoring progress based 
on dynamic self-regulation theories (personalized feedback); or no 
prompt. During the 30-day period, the number of times the participant will 
receive these $1 reciprocity messages will total around 10, accounting for 
$10 of their compensation. The eWrapper app will collect paradata as 
participants use it. Specifically, the following information will be 
recorded:
•
App Usage: when the app is opened and game scenes are loaded
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•
Skyn Data Source Connections: whenever the eWrapper succeeds 
or fails to connect to the Skyn wearing time summary database (a Json 
file). 
•
Gameplay Interactions: whenever the player purchases from the 
shop, completes the tutorial, interacts with any of the popups or animals, 
daily reward collections, etc.
Additionally, information on how long participants wore the Skyn 
biosensor will be calculated based on downloaded Skyn sensor data from 
its web portal using an algorithm based on motion and temperature. None 
of these data will involve any personal identifier.
The participant incentive schedule is as follows:
Timepoint
Year 1
Year 2
TOTAL Participants
Baseline
70 participants x $25 per 
participant
90 participants x $25 per 
participant
160
PEth Analysis
70 participants x $10 per 
participant
90 participants x $10 per 
participant
160
Viral Load
70 participants x $10 per 
participant
90 participants x $10 per 
participant
160
EMA and 
eWrapper if 
applicable
70 participants x $160
90 participants x $160
160
1-month follow up
60 participants x $35 per 
participant
100 participants x $35 
per participant
160
7.0
Data and Specimen Banking*
T1
T2
Screening
√
Consent
√
HIPAA Authorization
√
Demographics(survey)
√
√
HIV Viral Load Submission
√
ART Adherence
√
√
√
Sex Risk
√
√
√
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure—Adult
√
√
√
Alcohol-Smoking-Substance Screening Test (ASSIST)
√
√
√
Timeline Followback 
√
√
√
Berger's Scale Revised for Adolescents (HIV Stigma)
√
√
Sexual Sensation Seeking Scale 
√
√
Perceived Stress Scale (PSS)
√
√
Pittsburgh Sleep Quality Index (PSQI)
√
√
Usability Acceptability Survey
√
Biosensor Wearing Status
Ecological Momentary Assessment Questionnaire (EMA) 
Eligibility Verification
√
√ (not in REDCap)
√ (not in REDCap)
Measures (Short Name)
ENGAGE**
Required common 
measure
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 Data Banking: We will link information collected from this study with 
information abstracted from electronic medical records (EMR) and state 
surveillance including the Enhanced HIV/AIDS Reporting System 
(eHARS). These data will be updated first at baseline, from 1 year prior to 
study enrollment until 2 years after the 1-month follow-up.  We have 
already established this procedure of data linkage and management with 
eHARS in our previous studies approved by the University of Florida IRB. 
To link the data, a single research team member, who does not have access 
to research data, will generate a list of individuals with their identifying 
information who have enrolled in the study. This list, together with the 
SHARE_ID number, will be sent securely to a single contact at the FDOH 
in Tallahassee. There, the DOH contacts will use the identifying 
information to obtain the latest HIV surveillance data for that individual, 
add the SHARE_ID number to the surveillance data, remove all other 
identifying information, and send the data back securely to our Research 
Data Manager. Our team has used this process multiple times over the past 
4 years, and we have never had any type of data security issue.
 
Biological samples collected for the purposes of this study will not be used 
to conduct any future research. They will be destroyed after analysis is 
completed. The utilization of at-home Dried Blood Spot (DBS) test kits  
with study participants will be centralized within the administrative and 
community engagement cores. This centralization will allow for 
identifiable participant data to be properly secured and accessible only by 
those key personnel identified in the approved IRB protocol within the 
Admin Core at the contact site and will minimize the risk of breach of 
participant confidentiality. All biological samples collected will be 
securely stored upon receipt from the participants in the Center for 
Translational Behavioral Science, accessed only by authorized study 
personnel, before sending to the vendor for analysis. The Admin Core will 
oversee all aspects of at home test kits by facilitating transport from the 
vendor to the Admin Core, shipment of test kits to study participants, 
receipt of collected samples, de-identification of samples and preparation 
of samples for transport to the vendor laboratory for analysis and maintain 
secure access to the vendor’s web-based portal for sample analysis results. 
Participants will be provided with unidentifiable shipping materials in 
order to confidentially return specimens to the study team. Only 
participant ID number and date may be associated with DBS specimens. 
Specimens obtained will be de-identified and sent securely via postal mail 
to the processing laboratory on a monthly basis. All results will be 
communicated to the study team via HIPAA compliant email or fax 
communication. The processing laboratory will destroy the specimens 
upon completion of analysis and transmittal of results to the project team. 
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Data collected during the research study from the Skyn biosensor and the 
EMA app (mEMA) will not contain any personal identifier. To use the app 
needed for data collection with the Skyn biosensor, the participants will 
receive a premade study email address and password to log into the app. 
Therefore, no personal information will be collected via the app. The 
mEMA app will use a unique eight-digit code for each participant, so there 
will also be no personal identifier with the data collected from the app. All 
data collected from the Skyn biosensor and mEMA app will first go to a 
secure cloud storage hosted by the respective company. The researchers 
will then have a secure download (password protected login for the 
research account) to access the participant’s data. All downloaded data 
will be stored on a secure UF drive managed by the data science core 
team. The device manufacturer will not use study data to support 
adoption/change indication for the device.
 
Survey data will be available to the research team and authorized staff. 
Data collected during this research study may be used for future research 
purposes. The data stored will be de-identified. Data that cannot be linked 
to participants (i.e., de-identified data) will be kept indefinitely; these data 
will be saved for future use and may be shared with other researchers. At 
the end of the study data collected will be made available, in accordance 
with the NIH Data Sharing Policy 
(http://grants.nih.gov/grants/policy/data_sharing). These data will be saved 
for future use and may be shared with other researchers. By participating 
in this study, participants are agreeing to allow us to save and share their 
data anonymously. Publications and/or presentations that result from this 
study will not include any identifying data.
8.0
Sharing of Results with Subjects*
Results from the self-report surveys will not be shared with subjects or 
others. 
Results of HIV viral load DBS will be made available to participants upon 
request.  The research team will not share these results with any other 
individuals. Participants who request their results will receive their results 
via encrypted email only. The protocol team will develop email templates 
for sharing both detectable and undetectable VL results. The templates 
will include a brief introduction of the research staff delivering the results 
followed by either detectable or undetectable VL results and the meaning 
of those results, as well as information regarding available resources. For 
those who had undetectable VL, no further step is needed. For those who 
had detectable VL, any necessary referrals will be provided. Participants 
will also be recommended to follow up with health care provider.
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Data measured by the Skyn biosensor pertaining to the participant’s 
alcohol level will not be provided to the participant. The app associated 
with the Skyn biosensor does not display active alcohol levels on its 
interface and the Skyn biosensor has not been FDA-approved to give up-
to-date readings for current alcohol levels. 
9.0
Study Timelines*
The table below lays out the planned research tasks and the corresponding 
timeline. The first 6 months will be preparatory to the recruitment, such as 
staff hiring/training, IRB approval, manual of procedures, and database 
development. Once recruitment is started (planned N = 160), we anticipate 
on average recruiting 10 participants per month into this project. This 
means we can finish recruitment at the beginning of Month 30. We will 
start data analysis at Month 24 when we have at least 70% of the data 
collected on the Skyn biosensor for machine learning models and continue 
to analyze data and writing papers through the study period.  
Study Timeline
Research tasks 
Y1
Y2
Y3
Y4
Y5
IRB, staff hiring/training, protocol/database building 
Recruitment and assessments, data monitoring 
Data merge/analysis and result dissemination 
Integrate biosensor and/or app into Project Sustain  
10.0
Inclusion and Exclusion Criteria*
Inclusion Criteria: To be considered eligible for the study an individual 
must meet the following criteria: 1) be 18 years and 0 months to 29 years 
and 11 months; 2) currently reside in Florida; 3) report having had at least 
1 alcoholic drink in the last 30 days; 4) able to read and understand 
English; 5) have internet access via smartphone, tablet or computer; 6) be 
diagnosed as HIV+ and 7) willing to provide informed consent; 8) Are not 
pregnant at the time of enrollment.
The population specifically targeted are YPLWH between the ages of 18 
and 29 who are currently living in Florida. Given that only 0.4% of 
YPLWH in Florida are between 13 to 18, we elected not to include those 
younger than 18. Those who report being pregnant at time of screening 
will be excluded from the study.
The following categories will be excluded from eligibility for 
participation:
•
Adults unable to consent
•
Individuals who are not yet adults
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•
Individuals who are not diagnosed as HIV+
•
Incidental recruitment of pregnant women may occur, but 
pregnancy is not part of the study’s exclusion criteria
•
Prisoners
•
Pregnant women
11.0
Vulnerable Populations*: 
2019 HIV prevalence data for Florida revealed that approximately 75% of 
persons living with HIV in that state belong to racial/ethnic minority 
populations (38% Black, 36% Hispanic/Latinx, and 2% American Indian, 
Asian, and mixed race) compared to 24% White. Seventy-three percent 
identify as male, 26% as female, and less than 1% as transgender (male to 
female and female to male). We anticipate that young people who enroll in 
Project Engage will reflect the gender and race/ethnicity characteristics of 
the broader Florida population of individuals with HIV.  
•
Minority Group(s)/Non-English Speakers – This project will 
include individuals who meet the inclusion criteria, 
regardless of race or ethnicity. - Subjects will be English 
speakers. 
•
Elderly (65+) – This project will not include those over age 29.
•
Gender imbalance – It is expected that there will be more male 
than female individuals who participate. 
•
Pregnant women – Participants who report to be pregnant will be 
excluded from the study. 
•
Minors – No minors will be directly recruited for the purposes 
of this project.
12.0
Local Number of Subjects
160 total participants will be recruited across the state of Florida.
13.0
Recruitment Methods
The goal is to recruit 160 young people living with HIV (YPLWH) (N = 
136 after 15% attrition, 18-29 years of age, estimated to include 73% 
male, 26% female, 1% transgender, 70% racial and ethnic minorities) into 
the study. 
Recruitment for the study will be conducted by the CEC. Recruitment materials 
will include different electronic and printed materials (e.g. insta-stories; flyers, 
brochures, and palm-cards) and be distributed via social media sites, smartphone 
applications, email, as well as at community venues, clinics, and agencies as 
recommended by the Youth Advisory Committee (YAC) and stakeholders. 
Promotional materials (both virtual and physical) will include a brief description 
of the study and a rapid way to access the screening questionnaire – a hyperlink or 
QR code. 
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In the unlikely event that we do not accrue participants at the rate proposed with 
these time-tested procedures, we will pivot to more traditional venue and clinic-
based recruitment approaches while adhering to COVID-19 safety 
recommendations. Participants will be self-identified through contact with 
(electronic or printed) recruitment materials. Additionally, we plan to utilize 
BuildClinical for an online recruitment campaign. The addition of BuildClinical is 
intended to address recruitment challenges for the study. BuildClinical is a data-
driven platform that helps academic researchers recruit participants for research 
studies more efficiently using social media, software, and machine learning. 
BuildClinical has a long-standing history of working IRBs in the US to ensure 
they adhere to all the appropriate guidelines and procedures. BuildClinical utilizes 
study-specific advertisements to engage participants on digital platforms such as 
Facebook, Google, WebMD, etc. and redirect them to a study-specific landing 
page should they click it. On the landing page, the person can complete an online 
pre-screen questionnaire that gets routed into BuildClinical's platform. 
BuildClinical's Secure Socket Layer (SSL) software encrypts all inputted 
information and keeps information private and HIPAA compliant. The 
BuildClinical backend servers are stored in the United States at some of the most 
secure data centers in the world. All data collected from the BuildClinical 
screener is intended to inform the machine learning approach to tailoring the 
recruitment campaign and allows members of the CEC team to contact interested 
participants, who may then be directed to the SHARE study screener in REDCap. 
No data collected in the BuildClinical screener will be linked to any study 
data and the CEC will request that BuildClinical delete of all data collected as 
part of the pre-screener process upon conclusion of the campaign. 
14.0
Withdrawal of Subjects*
A participant meets the criteria for “premature discontinuation” if they withdraw 
from the study before completion. Completion represents completing all 
interviews and surveys (pre and post). Participants meeting the criteria for 
premature discontinuation will be reported to the study team. Participants may 
choose to leave the study at any point. Participants may be removed from the 
study based on changes in eligibility and/or safety concerns after careful review 
and consideration by the study team as appropriate.
Participants will not be tracked after they withdraw and all data collection will be 
stopped at that time; however, the research team will keep track of which 
participants have withdrawn and the timepoint at which they were withdrawn 
from the study. If a participant withdraws before the completion of the study 
activities, the participant’s responses will remain a part of the study data corpus. 
Participant data will be included, unless a participant requests that their data is 
removed. In such cases, the participant’s data will be deleted. Participants will be 
informed of the ability to request their data is removed in the consent process.
15.0
Risks to Subjects*
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Every effort will be made to ensure that study participants are protected 
from risks. The risks are as follows: 1) breach of confidentiality, 2) 
emotional discomfort when completing surveys and/or while using the 
mobile app, 3) medical complications from PEth biomarker collection or 
viral load test, and 4) concerns about data security associated with apps. 
The protection against each risk is described in detail below.
Breach of Confidentiality: A potential risk to participants is violation of 
confidentiality.. We will take the utmost caution to protect the 
confidentiality of all participant responses. We will minimize this risk by 
maintaining confidentiality and discretion in all study activities. Study 
data files will not have any identifying information about the study 
participants and will be tracked through a unique numerical identifier 
(study ID). This research specifically targets a vulnerable population, 
YPLWH. We will take every step to minimize the risk of 
identifying/linking data being successfully subpoenaed, stolen, or 
inadvertently released. The study will safeguard against the risk of the 
linking information being stolen by keeping such information in an 
encrypted, password protected file on FSU’s secure server to which only 
the MPI (Naar) and study Project Coordinator have access. These 
individuals will have completed CITI certification for human subject’s 
research ethics training (http://citiprogram.org). Furthermore, a certificate 
of confidentiality (CoC) will be in place. 
Emotional discomfort: It is possible that participants may experience 
emotional discomfort when completing surveys and/or while using the 
mobile app. The study may precipitate discomfort and/or an emotional 
response when YPLWH provide information about their lives and HIV 
status. Further, participants may feel embarrassed about discussing 
sensitive issues. To minimize harm, participants are not required to answer 
any questions or provide any information that they do not wish to provide. 
They are also not required to use any features of the app that they do not 
wish to use, and they will have the freedom to uninstall the app from their 
phone at any time. All participants will be told during the informed 
consent/assent process that their participation is voluntary and that they 
can chose to stop participating at any time without any consequences. 
Medical complications/discomfort from finger prick for PEth 
biomarker: The measurements that are involved in this study require 
finger prick to collect blood samples. This procedure may cause local 
discomfort, bleeding, or bruising; rarely infection can occur at the blood 
draw site. This measurement should not be considered greater than 
minimal risk in and of itself given its routine use in general health care 
delivery.
Medical complications/discomfort from VL DBS collection: The 
measurements that are involved in this study require dried blood spot 
(DBS) samples. The HemaSpot® sampling kit will be used for DBS 
collection.  A disposable lancet provided in the kit will be used to prick 
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the finger for the collection of 2-3 drops of blood. This procedure may 
cause local discomfort, bleeding, or bruising; rarely small clot or infection 
can occur at the blood site. This measurement should not be considered 
greater than minimal risk in and of itself given its routine use in general 
health care delivery.
Concerns about app data security: Participants may be concerned about 
the security of their data, particularly since it is collected and stored 
electronically. Our study team has significant experience developing 
security protocols for Internet-based studies, and we will take a variety of 
steps to ensure participant security, including using a dedicated server 
behind a firewall, encryption of data, separation of identifiers from 
responses, and password-protected access to data. Therefore, we believe 
that this risk will be minimal.
Crisis Mitigation: Some of the measures we are using contain sensitive 
information and may be triggering to some participants.  As we have done 
in previous studies, we have put in place procedures to protect 
participants’ safety and well-being.  During the programming of our 
assessments, sensitive questions such as suicide attempts, trauma 
experiences, and sexual abuse will be flagged.  When responses reach a 
predetermined critical level, the system will send an automated 
notification to the Project Director who will initiate our crisis management 
and safety protocols directed by clinical psychologists, Drs. Ennis and 
Naar. Remote interviewers (e.g. guiding participants through the assisted 
survey) will also be given the ability to activate this system during Zoom 
meetings with participants. The clinician on call will contact the 
participant to initiate a crisis intervention counseling session using a 
HIPAA compliant telehealth platform. In the case of bandwidth or 
technology failure, the clinician will make standard telephone call. During 
the session, the clinician will assess the specific nature of the participant’s 
situation and develop a plan to connect the participant needed community 
resources. In cases of acute emergencies, the clinician will call 911 and 
follow-up with wellness checks. Standard case notes will be used to 
document all crisis intervention sessions.
No information about the study’s actual purpose with be withheld from 
study subjects. We do not anticipate unforeseeable risks.
16.0
Potential Benefits to Subjects*
The risk to individual participants is small and the potential benefit to 
society is substantial. There are no direct benefits to participants, although 
some persons enjoy participating in studies that can provide information to 
help others. 
17.0
Data Management* and Confidentiality
Confidentiality: Prior to involvement, all study personnel will complete 
the required web-based Collaborative IRB Training Initiative (CITI) 
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course. All study personnel facilitating enrollment will adhere to the study 
protocols for obtaining informed consent from participants. Further, 
confidentiality will be protected through the use of unique participant 
identifiers, and all study data (quantitative, qualitative, recordings, etc.) 
will be securely stored at the Center for Translational Behavioral Science 
under lock and key, or on Florida State University password-protected 
secure servers, with access granted only to authorized study personnel. To 
further protect the privacy of the study participants, the study will obtain a 
Certificate of Confidentiality from the U.S. Department of Health and 
Human (DHHS). With this Certificate in place, researchers cannot be 
forced to turn over identifying information about a study participant in any 
Federal, State, or local criminal, administrative, legislative, or other 
proceedings. This Certificate does not prevent a study participant from 
volunteering to turn over their research information, nor does it prevent 
researchers from providing research-related information to others when 
requested by the study participant. 
Data Management: All study data will be kept confidential in accordance 
with Florida state laws and Federal law. When study activities with 
participants are conducted virtually, the Zoom HIPAA compliant platform 
will be utilized to ensure participant confidentiality. Zoom meetings will 
not be recorded. Participants will be assigned a unique ID and all other 
identifiable participant data will be redacted from study records. 
Information collected from this study will be linked with information 
abstracted from electronic medical records (EMR) and state surveillance 
including the Enhanced HIV/AIDS Reporting System (eHARS). We will 
obtain your data 1 year prior to your baseline assessment and 2 years post 
your follow-up assessment.  DSC has already established this procedure of 
data linkage and management with eHARS in previous IRB-approved 
Study Enrollment/Consent to Data Linkage
Data collection through 
surveys/medical records
Linked Data De-
Identified
Continued follow-up data collection
Updated Data De-Identified
Surveillance updated every year
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studies. We will use the NIH Global Unique ID (GUID) to conduct data 
linkage. Specifically, we will collect each participant’s legal name at birth, 
date of birth, sex, and city/municipality of birth. A single research team 
member supervised by Dr. Wu, and who does not have access to research 
data, will access GUID tool to perform bulk GUID generation for 
participants enrolled in the study. The GUID list will be sent securely to a 
single contact at the Florida Department of Health (FDOH) in Tallahassee. 
There, the contact will use the GUID list to obtain the latest HIV, and 
mental health and substance use surveillance data for these individuals, 
remove all other identifying information, and send the data back securely 
to our data science core. For this specific study, the data linkage process 
will also be approved by the FDOH IRB and accompanied by a Data 
Sharing Agreement between the research team and FDOH. For subjects 
reported no clinical visit, viral load will be collected using DBS procedure 
to supplement FDOH data. This process has been used multiple times over 
the past 4 years, and no data security issues have occurred. 
To enable linkage of subjects who have incomplete Personally Identifiable 
Information (PII) to generate GUID, we will employ a second 
cryptographic hash function that is based on less PII to generate 
SHARE_ID. In other words, we will send GUID and SHARE_ID lists to 
FDOH. Because cryptographic hash is a one-way function, it is practically 
impossible to recover PHI from the GUID or SHARE_ID. The requested 
disclosure of PHI is the minimum necessary for research purposes. 
In addition, the Data Science Core will utilize clinical natural language 
processing methods for extracting social determinants of health and 
behavioral determinants of health behaviors (e.g., smoking, substance 
abuse, alcohol use) utilizing the Florida Department of Health, HIV/AIDS 
Surveillance Program (FDOH HSP), the OneFlorida Data Trust, and the 
University of South Florida Policy and Services Research Data Center 
(USF PSRDC).
Brief summary of the assessment schedule for data that will eventually be 
shared with the NIAAADA (via executed DUA00000137):
The core staff will link information collected from this study with public health 
surveillance data including the Enhanced HIV/AIDS Reporting System (eHARS). 
We will use the NIH GUID to conduct data linkage, which should be an improved 
procedure of data linkage and management with eHARS in our previous Florida 
Cohort study approved by the UF IRB (IRB #201500849). Specifically, we will 
collect each participant’s legal name at birth, date of birth, sex, and 
city/municipality of birth. A single research team member supervised by Dr. Wu, 
and who does not have access to research data, will access GUID tool to perform 
bulk GUID generation for participants enrolled in the study. The GUID list will 
be sent securely to a single contact at the Florida Department of Health (FDOH) 
in Tallahassee. There, the contact will use the GUID list to obtain the latest HIV, 
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and mental health and substance use surveillance data for these individuals, 
remove all other identifying information, and send the data back securely to our 
data science core. For this specific study, the data linkage process will also be 
approved by the FDOH IRB and accompanied by a Data Sharing Agreement 
between the research team and FDOH. For subjects reported no clinical visit, viral 
load will be collected using DBS procedure to supplement FDOH data.
In addition to active participant data, the SHARE P01 Data Science Core 
will utilize clinical natural language processing (NLP) methods for 
extracting social determinants of health (SDOH) and behavioral 
determinants of health behaviors (BDOH, e.g., smoking, substance abuse, 
alcohol use) utilizing the Florida Department of Health, HIV/AIDS 
Surveillance Program (FDOH HSP), the OneFlorida Data Trust, the 
University of South Florida Policy and Services Research Data Center 
(USF PSRDC) (see Data Science Core Research Strategy for full list of 
available databases). The data integration activities will be performed 
during the first three years of this project.
Listing of proposed data collection instruments (assessments) that do not currently 
exist in the NDA (if applicable):
All measures have been previously utilized by the MPIs in preliminary studies and 
across the NIH Adolescent Trials Network for HIV/AIDS Interventions or are 
accepted in the literature. For further synergy, all three projects will test age, 
ethnicity, biological sex and gender, other substance use and mental health as 
moderators.
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
Data Storage and Sharing: Participant data will be de-identified and 
stored in a centralized location within the Data Science Core at the 
University Florida. Additionally, Data Science Core personnel at the 
University of South Florida will access data stored at the University of 
Florida and Florida State University in line with the DSC aims and 
associated tasks. Only approved study personnel will have the ability to 
access identifiable data, which will be stored and disposed of according 
to applicable federal and state statutes and institutional rules/regulations. 
The associated project core leads at the contact institution will utilize the 
confidential and secure transfer and acquisition of relevant study between 
the Data Science Core and research projects as described in the approved 
IRB protocol and associated agreements.
Monitoring Data Quality: The Admin Core will provide regulatory 
support and monitoring for the study team. This will include the 
development of protocols, Standard Operating Procedures (SOPs), and 
will assist the project leads with the finalization of measures. Quantitative 
study data will be entered into RedCap by the Data Science Core PI and 
study personnel as applicable, for all study timepoints within each 
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project. All Electronic Health Record (EHR) data utilized from respective 
study sites will be securely submitted every six months or upon data 
download as applicable. The MPIs and project leads will be responsible 
for continual monitoring of the database, data structure, and data quality 
and report these efforts at bi-annual SMC meetings.
Data Safety and Monitoring Board: In order to comply with the NIH 
policy related to a single institutional review board, it is the 
recommendation of the study team to utilize an independent study 
monitoring committee (SMC). Members selected as part of the SMC will 
possess the relevant expertise (e.g., HIV-related research and prevention, 
adolescent health and medicine, and adolescent and emerging adult 
sexual health and substance use).  A committee of individuals, 
coordinated by the contact MPI and project manager, will at minimum 
participate in bi-annual tele-conference meetings to:
1. Review the study’s ongoing compliance with data safety 
standards, required IRB monitoring and approvals, recruitment, 
accrual and retention, risks vs. benefits, protocol and timeline 
changes, and study progress toward the achieving the overall 
study aims. 
2. Review unanticipated study problems and all adverse events, 
and report concerns to the appropriate governing bodies should 
a risk to participant safety require such reporting.
3. Assess participating sites and provide feedback and/or make 
ethical recommendations for necessity of external site 
participation in the achievement of study aims. 
Members of the Monitoring Board will be required to:
1. Have no direct contact with study MPIs and key personnel 
outside of relevant study monitoring activities.
2. Sign a Conflict-of-Interest statement, and disclose all 
relationships and affiliations related to the study and/or 
associated interests relevant to the aims and objectives of the 
study that could present or be perceived as a conflict of 
interest. 
SMC Meeting Format: The format for all SMC meetings will be an 
open and closed session, followed open session (if needed) where 
the MPIs will be informed of recommendations of the SMC. The 
open sessions will include the MPIs and applicable study personnel 
(project manager, project coordinators), wherein issues will be 
discussed related to study conduct and progress of the study, 
including accrual, compliance with overall study design, 
compliance with regulatory functions and oversight, adverse 
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events, and will review aggregate study data. No personally 
identifiable information will be shared or connected to the 
aggregate data discussed in the meeting.   The closed session will 
allow for SMC members to participate in confidential and 
independent discussion related to study recommendations. Any 
suggestions related to early termination of a study component will 
require a vote of the SMC members. 
NAME
ROLE
EXPERTISE
Marvin Belzer, MD
Director, Division of Adolescent and 
Young Adult Medicine; Attending 
Physician, Children’s Hospital of Los 
Angeles
Professor of Pediatrics and Medicine, 
Keck School of Medicine of USC
mbelzer@chla.usc.edu 
323.361.2153
Adolescent and Young Adult 
Medicine & Behavioral Health, 
HIV
Larry Brown, MD
Director of the Division of Child and 
Adolescent Psychiatry 
Vice Chair of the Department of 
Psychiatry and Human Behavior, Brown 
University
larry_brown@brown.edu 
40l.444.8539
HIV and risk behaviors among 
adolescents and young adults, HIV 
biobehavioral clinical trial 
research, substance use and 
depression among PLWH, mHealth
Ken Resnicow, PhD
Professor of Health Behavior and Health 
Education
University of Michigan, School of 
Public Health
kresnic@umich.edu
734.647.0212
Health behavior, e-Health 
technology, Health messaging, 
Substance Use, Minority and 
Health Disparity Research
Samantha Chahin, MPH
SHARE Study Coordinator
Florida State University
Samantha.chahin@med.fsu.edu
Designee
19.0
Provisions to Protect the Privacy Interests of Subjects
Privacy Interests – Interactions. In order to protect the privacy interests 
of study participants, recruitment, consent, enrollment, and retention 
activities will be centralized to the greatest extent possible. 
Privacy Interests – Data. All data transferred from FDOH to the study 
team will transferred through the secure FSU Dropbox portal or FDOH 
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MoveIT data transfer system, as a password protected and/or encrypted 
file accessed through login/password. The study team will then store the 
received data as an encrypted file on the secure FSU Network server and 
the USF Health Informatics Data Management System. Data will be stored 
and disposed of per prevailing record retention regulations and sponsor 
requirements where applicable. The requested disclosure of PHI is the 
minimum necessary for research purposes.
Privacy Interests – Access. Only those members included on this study 
protocol as engaged personnel will have access to study data. Prior to 
upload to any shared file storage/management system, all participant data 
will be fully de-identified and stored as encrypted, password protected 
files to ensure data security and fidelity. 
Breach of Confidentiality: We will take every precaution to minimize 
risks to study participants. All research staff members are required to 
complete ethical clearance certification regarding protection of human 
subjects. We also have a strong data and safety monitoring plan in place to 
protect participants. Adverse events will be reported to FSU using the 
Adverse Event Reporting Forms as well as to the NIH. Reports will be 
sent within 24 hours of notification by the MPIs. Annual updates on 
enrollment and retention will also be sent to the FSU IRB and reported to 
the NIH. 
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.
Alcohol monitoring using wrist biosensor: The risk for breach of 
confidentiality associated with the biosensor is very low. Participants will 
be given a study account for them to use to log into the Skyn app, so no 
personal information (e.g., email address) will be collected from the Skyn 
sensor or app. The data will be uploaded to its encrypted cloud-based 
storage and will be downloaded to secure drives managed by the Data 
Science core. Only study ID will be used to link the data. Login to the data 
portal for data downloading is password protected. Only the study PI and 
key personnel will have the login information for downloading the data. 
The Skyn biosensor and its associated app and database have been 
evaluated by the University of Florida IT Risk Assessment team and 
deemed low risk. 
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. Additionally, the App 
will use an 8-digit code generated by its system for participants to use as 
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the unique identifier to collect data, so no personal information (e.g., 
phone number) will be collected. Login to the data portal for data 
downloading is password protected. Only the study PI and key personnel 
will have the login information for downloading the data. The EMA app 
and its database have been evaluated by the University of Florida Risk 
Assessment team and deemed low risk.
eWrapper app specific security: We have included numerous features to 
ensure app security and privacy. All relevant app communications (e.g., 
those between users or between users and study staff) will be secured via 
industry standard encrypted Secure Socket Layer (SSL) communications 
links. These connections will ensure that all communications are 
inaccessible to unauthorized third parties. Furthermore, the app can be 
updated regularly to address any unforeseen security updates to the 
software libraries underlying the secured communication links. Beyond 
encrypting communication, the app itself requires users to set up a 
password as part of their onboarding procedures. This adds a layer of 
security to protect privacy and confidentiality and allows the user to share 
their phone generally with others without granting access to the app. The 
app is designed to be non-stigmatizing and un-interpretable by anyone 
seeing the app on a participant’s phone. Additionally, the app icon and 
reminders are discrete and do not utilize HIV-related language or imagery. 
Moreover, mobile phone screens themselves are also constructed to 
prevent surreptitious observation. Within the app, participants set up a 
profile and choose a username. Participants are required to choose a 
username that is different from any names they may use as part of their 
personal email address or social media accounts. Consent documents will 
also encourage participants to activate their phone’s native locking feature 
for a further layer of security. These software security solutions will 
provide the layers of both communications’ security and physical access 
security to ensure that only authorized users have access to the 
information stored on the phone as well as the information being shared 
over communications links. Finally, the app platform is engineered to keep 
PHI safe and secure and is HIPAA compliant.
20.0
Compensation for Research-Related Injury
Due to the nature of the study, no research-related injury is expected, and 
no funds are available for research-related injury
21.0
Economic Burden to Subjects
The research does not anticipate any costs that subjects may be 
responsible for because of participation in the research.
22.0
Consent Process
 Informed consent will be automated. The consent process will provide an 
interactive multimedia experience that will enable potential participants 
to make informed decisions using a point-and-click interface and allows 
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the research team to assess whether the potential participant has fully 
understood the parameters for participation via a series of interactive 
questions and answers. Those who click on the “yes” button will be 
redirected to a secure database to read and provide informed consent. For 
those who would like, there will be an additional consent video that will 
provide an overview of the information in the informed consent. 
Participants who watch this video will be directed to the written copy of 
the informed consent following the video’s completion. Those who 
provide consent will receive a link to complete the baseline assessment 
and instructed that a research team member will contact them to schedule 
a session to complete an assisted survey. With guidance from our YAC 
and stakeholders, we will use an electronic consent platform such as 
REDCap’s Cloud’s flexible eConsent solution to develop an engaging 
informed consent for each study. As part of this process, participants will 
be asked if they are willing to enroll or are already enrolled in a mobile 
payment service such as CashApp for distribution of the incentive. We 
will send e-gift cards for incentives to participants who chose not to 
enroll in the mobile payment service. Upon approval of the HIPAA 
Authorization form contents from the Florida Department of Health 
(FDOH), participants will be asked to complete the HIPAA authorization 
form to authorize accessing viral load information from their electronic 
health records or from the FDOH database. Recruitment of study subjects 
will not occur until FDOH approves the HIPAA authorization, as the 
covered entity. Moreover, the participant will be asked to sign an 
agreement in which they agree to send back study materials to the 
ENGAGE study team in Gainesville, Florida. After providing this  
information, the participant will be redirected via secure hyperlink to a 
separate database to complete the baseline assessment.  
The risk of potential coercion will be minimized by following standard 
procedures for obtaining informed consent from participants. During the 
e-consent process, study procedures, risks, benefits, and alternatives to 
participate will be explained to participants. Participants will be told that 
they do not have to answer any questions if they do not wish to and can 
drop out of the study at any time without affecting their medical care or 
the cost of their care. They will be told that they may not benefit directly 
from the study, and that all information will be kept strictly confidential, 
except as required by law. Participants will also be reminded that study 
participation is voluntary and that refusing to participate or withdrawing 
from the study at any time will not result in any negative consequences.
Any participants who have questions or concerns that arise during the 
consent process can contact the SHARE Program’s Community 
Engagement Core personnel at SHARE.CEC@med.fsu.edu and/or Dr. 
Sylvie Naar and/or Dr. Yan Wang at sylvie.naar@med.fsu.edu and/or 
ywang48@phhp.ufl.edu. 
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23.0
Process to Document Consent in Writing
The study team will obtain consent via REDCap enrollment form. 
Clicking on “Yes” and providing their electronic signature on the 
REDCap form will be considered consent to participate.
24.0
Setting
All data will be gathered and analyzed by IRB approved personnel within 
the Data Science Core at the University of Florida, the University of South 
Florida, at the University of Michigan, and at Florida State University’s 
Center for Translational Behavioral Science. This is a virtual study, which 
means that all study assessments and activities will take place online or 
virtually. There will be no face-to-face interactions with participants for 
this study.
25.0
Resources Available
Feasibility of Recruitment and Study Completion. Dr. Sylvie Naar 
(SHARE Program MPI) has spent two years developing active 
partnerships with state and community level stakeholders in Florida, 
toward the goals of the federal End the HIV Epidemic initiative. These 
collaborations have been developed through her ongoing projects within 
her Scale It Up – Florida research program that houses the NIH funded 
Scale It Up project, the FDOH funded FLEX Peer Navigation service 
program, as well as her iREP community needs assessment, all of which 
focus on adolescents and young adults living with or at-risk for HIV. The 
effort to establish community-based connections with individuals and 
organizations to that end has facilitated a far-reaching state-wide network 
of engaged stakeholders within community-based organizations, HIV 
treatment clinics, testing service providers, and members of the target 
population. Further, these connections have created a large state-wide 
participant recruitment audience who are members of the study’s target 
population. Additionally, the support of NIH funding toward the success 
of this project will allow for adequate personnel, supplies, infrastructure, 
technology, and other necessary means to be utilized to ensure study 
completion. 
A summary of the recruitment and assessment activities the entire SHARE 
program is found in Table 1. Our projected yearly accrual rate is reasonable 
given that there are 8,000 YPLWH in Florida in our target age group.  
Furthermore, in 2019, 8% of the 4,584 newly diagnosed HIV cases in the state 
were between 18 and 29.  The RERAC will manage the distribution and 
processing of the biomarker self-assessment kits and all of the participant 
engagement, tracking and retention functions. 
     
                      Table 1: RERAC Schedule of Recruitment and Assessments
Activity
Year 1
Year 2
Year 3
Year 4
Year 5
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Screen
1,152
2,304
2,304
384
Recruitment
144
288
288
48
13
Baseline 
144
288
288
48
13
Follow-ups
72
500
900
611
118
Resources available. As mentioned above, the Scale It Up Florida program 
has developed program specific services and resources to aid individuals 
within the target population of this study. The FLEX Peer Navigation 
program is designed specifically to address the needs of YPLWH by 
providing a peer-level navigation resource providing information and 
referrals to resources that are specific to the unique needs of YPLWH 
through the use of a need’s assessment, partnership with Ryan White case 
managers in all 67 Florida counties. 
Facilities. The Center for Translational Behavioral Science (CTBScience) is a 
university center, affiliated with the FSU College of Medicine. This facility 
provides 6 faculty offices, 4 research core offices, a program manager office, 
two shared postdoc offices, offices for a research coordinator and research 
assistants, and a shared space for students and staff working with faculty. The 
center also houses 4 multifunctional participant spaces, 2 of which can function 
as working sleep laboratories equipped with state-of-the-art sleep diagnostic 
equipment, video monitoring / recording capability and 2 of which have the 
ability to be used as both assessment rooms and therapy rooms. Further, the 
center houses a conference room with video conferencing capabilities and a 
community space that functions as a group meeting room and/or classroom. 
Within its three cores (Management Core, Methods Core, and Community
Engagement), the Center has a dedicated clinical trials coordinator,
administrative coordinator, grants contracts administrator, data manager, 
biostatisticians, and a communications expert as well as access to FSU’s IT, 
library, and other administrative resources. CTBScience also hosts the 
Adolescent Trials Network (ATN) Scale It Up Center’s Analytic Core, 
Implementation Science Core, and Management Core, with dedicated faculty 
members assisting with protocol development, recruitment and retention, 
sustainment, study management, data management and analysis, and 
dissemination. There is a Youth Community Advisory Board (YCAB) 
nationwide for the ATN, and an ATN Bioethics Working Group, which is made 
up of a team of national ethics experts. The Management core, along with the 
study team will maintain responsibility for the overall conduct and 
implementation of the study. The study team is responsible for data 
management, analysis and reporting. The Protocol Leads are responsible for 
scientific leadership and dissemination. 
Required CITI Training. All study team members will be adequately 
trained in the responsible conduct of research, and the study team will 
continue weekly meetings to discuss project status, address concerns, and 
ensure protocol compliance. Study participants will be fully informed of 
the study team members roles and functions, and provided information 
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related to reporting of concerns. If serious or unexpected adverse events 
occur during the study, the PI will report these occurrences within the 
specified time frames to the IRB.
26.0
Multi-Site Research*
All information included in this section is relevant to SHARE Program as 
a whole. Those below specific to the Engage study are identified as 
such (see tables). 
Selection of the sIRB
The Florida State University (FSU) has been selected to serve as the 
single IRB of record (sIRB) for the proposed study. All participating 
domestic institutions engaged in human subjects research have agreed 
to rely on the FSU IRB, and any domestic sites added after the award 
will be required to complete a reliance agreement unless they meet 
exclusion criteria related to engagement in human subjects research.
Exceptions: There are no sites meeting the criteria for an exception to the 
single IRB requirement.
FSU IRB Compliance and Qualifications
The FSU IRB currently oversees a multitude of human subjects 
research studies including behavioral clinical trials. Further, the FSU 
IRB currently oversees Dr. Naar’s multi-site project (Scale It Up, 
U19), and maintains oversight of each study component and 
collaborates with 20 external domestic sites.
FSU’s IRB operates in compliance with all relevant federal and local 
regulations and is registered with FDA and OHRP. FSU maintains an 
active Federal Wide Assurance (FWA) with the Office for Human 
Research Protections (FWA00000168).
The FSU IRB has appropriate membership, including the professional 
competence necessary to review the proposed research, and is 
supported by the FSU Office for Human Subjects Protection (OHSP)..
Reliance Agreements
Before initiating any engaged study activities, each participating site 
will fully execute a reliance agreement with the sIRB. This agreement 
will clarify the roles and responsibilities of both the sIRB and each 
participating site. Further, FSU is a signatory to the SMART IRB 
Agreement and will facilitate the SMART IRB agreement with all 
applicable external domestic sites.
Communication Plan
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The FSU IRB utilizes an online protocol submission system that is 
accessible by FSU faculty and staff members, with the ability to allow 
external access as requested for external site investigators 
collaborating on multi-site projects. All protocol materials will be 
submitted to the sIRB through the online system and all external 
domestic sites will provide the necessary assurances to the FSU Admin 
Core team overseeing the regulatory components of the project. The 
FSU Admin Core team will provide each site with the necessary 
materials applicable to their sites as required and will communicate 
directly with each participating site’s IRBs and/or Human Research 
Protection Program offices/personnel. When necessary, the FSU 
OHSP in support of the sIRB will communicate directly with 
participating site Human Research Protection Program offices.
The Admin Core, under the supervision of the contact MPI and 
core/project leads, will provide coordination services by:
1. Coordinating communication with all external domestic sites
2. Request and receive information and required documentation for all 
participating sites
3. Develop template materials for review by the sIRB and assist external 
participating sites with modifications as necessary
4. Compile, review, and submit all protocol materials to the sIRB online 
system related to initial approvals, study modifications, continuing 
reviews, etc.
5. Provide all necessary documentation to all participating sites
Participating sites will follow local procedures in order to coordinate, 
collect, verify, and disseminate information for:
1. Local context
2. Site variations and/or necessary modifications related to recruiting, 
informed consent, HIPAA, and study populations
3. Conflict of interest and disclosure management 
4. Completion of ancillary reviews
5. Ensuring proper CITI training of all engaged study personnel and 
provide certifications to the Admin Core at FSU.
6. Complying with requirements of all Continuing Reviews or study 
closures
7. Monitoring and reporting adverse events All modifications have been 
communicated to sites and approved (including approval by the site’s 
IRB of record) before the modification is implemented.
A study query system will be developed by the SHARE Program AC 
and will allow for investigators and study personnel to submit queries 
related to study activities to the centralized study email address. This 
query system will be monitored by the SHARE Program AC and will 
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have automatic triage functions built into the query system to alert 
necessary study personnel based on responses entered. 
In line the proposal, the SHARE Program will utilize Microsoft 
Teams, housed on the Florida State University network, to conduct 
study team meetings, share de-identified study specific information 
and regulatory. In line with the existing agreement FSU Information 
Technology Services has with Microsoft, the study team will abide by 
the privacies and security set forth, wherein no identifiable participant 
data will be stored on Microsoft OneDrive unless encrypted and 
password protected. 
All direct recruitment activities for Define, Engage, and Sustain will be 
within the SHARE Program Cores as follows:
Core
Function
FSU - Admin 
Core
- Will order, distribute, and track PEth and DBS test kits and 
facilitate shipment of returned kits to laboratory for Define, 
Engage, and Sustain
- Will track, disburse, and reconcile participant incentives for 
Define, Engage, and Sustain
- Will oversee regulatory components of recruitment (e.g., 
social media marketing campaign development and 
oversight) for Define, Engage, and Sustain
FSU - 
Community 
Engagement 
Core
-
Will facilitate field-based recruitment efforts including 
organizational stakeholder and participant engagement, 
provide study related recruitment materials, and facilitate 
consent and enrollment for Define, Engage, and Sustain
-
Will manage social media and other digital recruitment 
activities, and facilitate Scientific and Youth Advisory 
Councils for Define, Engage, and Sustain
UF, USF & 
FSU– 
Data Science 
Core
-
Will develop and manage REDCap consent and survey 
tools/instruments for Define, Engage, and Sustain
-
Will manage all identifiable participant data and survey 
responses for Define, Engage, and Sustain
-
Will facilitate and manage FDOH Data for Define, Engage, 
and Sustain
-
Will integrate and oversee Data Sharing Plan requirements
The following external to FSU sites are involved in the SHARE Program and 
are considered engaged in human subject activities and will participate in the 
activities as described above. 
Site
Core/Project
Name/Role
University of Florida
ENGAGE Project
Admin Core
Yan Wang, PhD; Project PI
Bob Cooke, PhD; Co-I
MOD00005379
FSU IRB Approved
28 October 2024

PROTOCOL TITLE: A wrist biosensor-based mHealth suite to support alcohol 
intervention in young people living with HIV
Page 38 of 38
Revised: October 15, 2023
University of Central 
Florida
DEFINE Project
Karina Villalba, PhD; Site PI
University of Michigan
Data Science Core
SUSTAIN Project
Inbal Nahum-Shani, PhD; Site PI
University of 
California, San Diego
DEFINE Project
Sharon Nichols, PhD; Site PI
University of South 
Florida
Data Science Core
Samuel Wu, PhD; Site PI, DSC Lead
Northeastern 
University
SUSTAIN Project
Robert Leeman, PhD; Co-I
MOD00005379
FSU IRB Approved
28 October 2024