Theoretically Based Mobile App to Increase PrEP Uptake Among MSM
Phase: NA
Conditions: HIV Infections
Sponsor: Emory University

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Theoretically based mobile App to increase PrEP 
uptake among MSM
Short Title:
HealthMindr
Principal Investigator:  
Patrick Sullivan, DVM PhD
Lead Investigator: 
Jeb Jones, PhD
Co-Investigators:
Amanda Castel, MD MPH
Rob Stephenson, PhD
Joanne Stekler, MD MPH
Samuel Jenness, PhD
Aaron Siegler, PhD
Sponsor: 
NIH National Institute on Drug Abuse
Version Number:  1.4
August 28, 2020

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i
STATEMENT OF COMPLIANCE
The study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and the NIDA Clinical Terms of Award. All 
personnel involved in the conduct of this study have completed human subjects protection 
training.

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SIGNATURE PAGE
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
Name: 
Title:

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TABLE OF CONTENTS
STATEMENT OF COMPLIANCE ...................................................................................................I
SIGNATURE PAGE.......................................................................................................................II
TABLE OF CONTENTS ...............................................................................................................III
LIST OF ABBREVIATIONS AND ACRONYMS ............................................................................V
PROTOCOL SUMMARY..............................................................................................................VI
1
KEY ROLES AND CONTACT INFORMATION ....................................................................8
2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .........9
2.1
Background Information............................................................................................9
2.2
Rationale.................................................................................................................11
3
OBJECTIVES .....................................................................................................................11
3.1
Study Objectives.....................................................................................................11
3.1.1
Primary Objective........................................................................................11
3.1.2
Secondary...................................................................................................11
3.2
Study Outcome Measures ......................................................................................11
3.2.1
Primary........................................................................................................11
3.2.2
Secondary...................................................................................................11
4
STUDY DESIGN.................................................................................................................12
4.1
Study Population.....................................................................................................13
5
STUDY ENROLLMENT AND WITHDRAWAL....................................................................14
5.1
Subject Eligibility Criteria ........................................................................................14
5.1.1
Inclusion Criteria .........................................................................................14
5.1.2
Exclusion Criteria ........................................................................................14
5.2
Strategies for Recruitment and Retention...............................................................14
5.2.1
Recruitment.................................................................................................14
5.2.2
Retention.....................................................................................................15
5.2.3
Participant Incentive....................................................................................16
5.3
Treatment Assignment Procedures ........................................................................16
5.3.1
Randomization Procedures.........................................................................16
5.4
Subject Withdrawal .................................................................................................17
6
STUDY INTERVENTION....................................................................................................17
6.1
Study Product Description ......................................................................................17
6.1.1
Acquisition...................................................................................................18
7
STUDY SCHEDULE...........................................................................................................18
7.1
Screening................................................................................................................18
7.2
Enrollment/Baseline................................................................................................18
7.3
Follow-up Visits.......................................................................................................19
7.4
Withdrawal Visit ......................................................................................................19
7.5
Unscheduled Visit ...................................................................................................19
7.6
In-depth Interviews..................................................................................................19
8
STUDY PROCEDURES/EVALUATIONS...........................................................................20
8.1
Study Procedures/Evaluations................................................................................20
8.2
Laboratory Procedures/Evaluations........................................................................20

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8.2.1
Specimen Shipment....................................................................................21
9
ASSESSMENT OF SAFETY ..............................................................................................21
9.1
Specification of Safety Parameters.........................................................................21
9.1.1
Adverse Events...........................................................................................22
9.1.2
Serious Adverse Events..............................................................................22
9.1.3
Relationship to Study Intervention ..............................................................22
9.1.4
Severity of Event.........................................................................................22
9.2
Reporting Procedures.............................................................................................23
9.2.1
Serious Adverse Event Reporting...............................................................23
10
STUDY OVERSIGHT .........................................................................................................23
11
CLINICAL SITE MONITORING ..........................................................................................24
12
STATISTICAL CONSIDERATIONS....................................................................................24
12.1
Study Hypotheses...................................................................................................24
12.2
Sample Size Considerations...................................................................................24
12.2.1 Efficacy Review...........................................................................................24
12.3
Final Analysis Plan..................................................................................................25
13
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS...................26
14
QUALITY CONTROL AND QUALITY ASSURANCE .........................................................26
         14.1 Recontacting Previous Participants………………………………………………………26
15
ETHICS/PROTECTION OF HUMAN SUBJECTS..............................................................27
15.1
Potential Risks and Benefits ...................................................................................27
15.1.1 Potential Risks ............................................................................................27
15.1.2 Potential Benefits ........................................................................................27
15.2
Ethical Standard......................................................................................................27
15.3
Institutional Review Board ......................................................................................27
15.4
Informed Consent Process .....................................................................................28
15.5
Exclusion of Women, Minorities, and Children (Special Populations) ....................28
15.6
Subject Confidentiality ............................................................................................28
15.7
Future Use of Stored Specimens and Other Identifiable Data................................29
15.8
Training...................................................................................................................29
16
DATA HANDLING AND RECORD KEEPING ....................................................................30
16.1
Data Management ..................................................................................................30
16.2
Procedures for Prevention and Addressing Breaches of Confidentiality ................30
16.3
Data Capture Methods............................................................................................31
16.4
Types of Data..........................................................................................................31
16.5
Protocol Deviations.................................................................................................34
17
PUBLICATION/DATA SHARING POLICY..........................................................................34
18
LITERATURE REFERENCES............................................................................................35
SUPPLEMENTAL MATERIALS ..................................................................................................39
APPENDICES .............................................................................................................................40
APPENDIX A: SCREENING INFORMED CONSENT FORM .....................................................41
APPENDIX B: ENROLLMENT INFORMED CONSENT FORM ..................................................42
APPENDIX C: PREP AND HIV TESTING RESOURCES...........................................................43

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LIST OF ABBREVIATIONS AND ACRONYMS
AE
Adverse Event/Adverse Experience
CDC
Centers for Disease Control and Prevention
CFR
US Code of Federal Regulations
CITI
Collaborative Institutional Training Initiative
CLIA
Clinical Laboratory Improvement Amendments
DBS
Dried Blood Spot
DHHS
Department of Health and Human Services
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
HSP
Human Subjects Protection
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
IDI
In-depth Interview
IRB
Institutional Review Board
LGBT
Lesbian, Gay, Bisexual, Transgender
MSA
Metropolitan Statistical Area
MSM
Men who have sex with men
NIH
National Institutes of Health
OHRP
Office for Human Research Protections
OSHA
Occupational Safety and Health Administration
PEP
Post-Exposure Prophylaxis
PrEP
Pre-Exposure Prophylaxis
SAE
Serious Adverse Event/Serious Adverse Experience
SAMHSA
Substance Abuse and Mental Health Services Administration
STI
Sexually Transmitted Infection
TFV-DP
Tenofovir diphosphate
USAID
United States Agency for International Development

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PROTOCOL SUMMARY
Title:
HealthMindr: Theoretically based mobile app to increase PrEP 
uptake among MSM
Précis:
The study is based on the premise that providing, through a mobile 
phone app, self-directed PrEP information; periodic PrEP eligibility 
screenings to identify risk and eligibility objectively; referral to PrEP 
providers with directions; and related prevention services will 
increase the uptake of PrEP among at risk, HIV-negative MSM to a 
greater extent than standard of care referrals to existing resources.
Objectives:
Aim 1: Test an HIV prevention mobile app versus a standard of care 
condition with outcome of rate of PrEP uptake among MSM.  
Aim 2: Quantify the behavioral, social, and clinical factors that 
mediate and moderate the efficacy of the HealthMindr app on the 
rate of PrEP uptake.
Aim 3: Conduct individual in-depth interviews (IDIs) to assess how 
the app promoted PrEP uptake, unmet needs of men who did not 
start PrEP, and how repeated app interactions might further PrEP 
uptake.
Population:
680 MSM, aged 18-34 
Sites:
Atlanta, GA; Jackson, MS; and Washington, DC
Intervention:
HIV prevention mobile app with basic prevention services including 
HIV test planning and test locators; risk assessment; HIV treatment 
locators; and condom, HIV test kit, and at-home STI specimen 
collection kit distribution plus monthly PrEP eligibility assessments, 
PrEP provider locator, enhanced information about PREP, and 
referrals to local PrEP navigators.
Study Duration:
60 months
Subject Participation 
Duration:
12 months
Estimated Time to 
Complete 
Enrollment:
18 months

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Schematic of Study Design:
Figure 1. Study Schema

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1
KEY ROLES AND CONTACT INFORMATION
Patrick Sullivan, DVM, PhD
Principal Investigator
Department of Epidemiology
Rollins School of Public Health
  
Amanda D. Castel, MD, MPH, AAHIVS
Site PI, Co-Investigator
Department of Epidemiology and Biostatistics
George Washington University
 
Jeb Jones, PhD
Lead Investigator
Department of Epidemiology
Rollins School of Public Health
Aaron Siegler, PhD
Co-Investigator
Department of Epidemiology
Rollins School of Public Health
Phone: 
Samuel Jenness, PhD
Co-Investigator
Department of Epidemiology
Rollins School of Public Health
 
Joanne Stekler, MD MPH
Co-Investigator
University of Washington
Harborview Medical Center
 
Rob Stephenson, PhD
Co-Investigator
Center for Sexuality and Health Disparities
Department of Health Behavior and Biological 
Sciences
School of Nursing
University of Michigan
Sponsor
Richard Jenkins
NIDA Program Official
Phone: 
Edith Davis
Grants Management Specialist
Phone: 

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2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1
Background Information
In the United States (US) HIV epidemic, MSM are disproportionately impacted in terms of HIV 
prevalence1-4 and incidence.5-7 MSM are the only US risk group for whom HIV incidence 
increased after 20006; increases are especially alarming among young MSM5 and MSM of 
color.8 MSM aged 13-24 and 25-34 are the only MSM age groups among whom new diagnoses 
increased after 2009.9 Profound health disparities exist for both MSM relative to other adult men 
and within the MSM community, with a burden of HIV infection that is a staggering 67 times 
greater than for other men in the US population.10  There are estimated to be more than 
4,700,000 MSM in the US10 and as many as 500,000 of these men might be current candidates 
for pre-exposure prophylaxis (PrEP).11
The landscape of HIV prevention for HIV-negative MSM is changing. There is broad agreement 
that reducing new HIV infections will require a package of HIV prevention strategies.  Multiple 
studies of PrEP12-14 suggest that PrEP will be an efficacious tool in reducing HIV acquisition risk 
among MSM.  However, other data suggest that we cannot abandon basic prevention services 
for MSM to focus solely on PrEP: in an agent-based modeling study of HIV incidence in MSM, 
Brookmeyer et al demonstrated that, even in the setting of PrEP coverage varying up to 50% of 
eligible men, HIV testing and condom promotion still provided 5-21% marginal benefits in terms 
of reductions in HIV incidence.15  Thus, HIV testing, condom uptake, and biomedical prevention 
strategies must be promoted together, in a way that makes connections between negative HIV 
tests, screening for PrEP eligibility, and information and referrals for PrEP-interested and PrEP-
eligible men. Rather than being presented with prevention alternatives, MSM need to be able to 
see the synergy between prevention options: to understand the need for HIV testing and to view 
testing as a stepping stone to their next prevention option.  This must be accomplished in the 
setting of stagnant or shrinking Federal and local resources for HIV prevention.16  
Models suggest that uptake of multiple prevention tools needs to be high to reduce HIV 
incidence in MSM, but current uptake is low.  Multiple models of HIV incidence in MSM suggest 
that, to decrease HIV incidence in MSM, we will need to achieve 40-50% coverage of multiple 
prevention services and interventions (e.g., condom promotion, HIV testing, PrEP, treatment as 
prevention) in at-risk MSM.15,17-19   Currently, uptake of even basic prevention services among 
MSM is low.  HIV testing within the past 12 months, as recommended by some health 
jurisdictions20 and CDC21, is reported by 71% of men in 21 NHBS cities22, and by 58% of 
respondents in American Men’s Internet Survey (AMIS)23, a national survey which includes 
more rural men and men from smaller cities.  In Atlanta, Jackson and Washington, DC, AMIS 
data indicate that there are significant deficits in annual HIV testing and PrEP knowledge and 
uptake. Data from the 2016-2017 AMIS survey indicate substantial unmet need for PrEP: 42%, 
35% and 43% of HIV-negative MSM in Atlanta, Jackson and Washington are behaviorally 
eligible for PrEP, but have never taken it.  Accounting for the number of HIV-negative MSM per 
city,24 we estimate that the unmet need for PrEP among MSM in these cities totals 62,160 MSM.
Electronic tools provide an opportunity to increase capacity for supporting certain HIV 
prevention services.   A recent summary of electronic tools for HIV prevention in MSM noted 
that certain types of prevention services are most amenable to provision through new 
technologies. Services for which eligibility can be determined through an algorithm are good 
candidates to bring to scale with technologies.25 For example, behavioral eligibility for PrEP has 
well-described criteria and eligibility algorithms.26,27 Furthermore, using technology to administer 
PrEP eligibility screening would also eventually make services more accessible to rural MSM.25 
The need to make better use of technology to scale up PrEP is a story told in the numbers of 

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prevention service encounters that would be needed to bring a comprehensive package of HIV 
prevention tools to scale in MSM in the US.  Based on CDC estimates, there are approximately 
4.7 million US MSM, of whom about 4.1 million are HIV-negative.10  Of those, approximately 
500,000 are estimated by CDC to be eligible for PrEP.28  However, men’s indications for PrEP 
change over time29,30, so to determine which of those 4.1 million MSM might be PrEP eligible 
will require periodic screening against PrEP eligibility criteria.  Assuming 6-monthly PrEP 
eligibility screenings for HIV-negative MSM, approximately 8 million PrEP eligibility screenings 
would be needed annually to identify PrEP-eligible MSM.  To reduce healthcare system burden, 
this process must be assisted by technologies that let men conduct periodic self-screenings and 
opt into clinical screening when indicated.
Electronically delivered or supported prevention services are effective, are acceptable to MSM, 
and will likely reach heavily impacted men. Across prevention disciplines, there is a substantial 
body of research indicating that electronically delivered prevention services are as effective as 
traditionally-delivered services. A meta-analysis indicated that computer-delivered HIV 
prevention interventions had similar efficacy to human-delivered interventions.31 In a 
randomized trial, the addition of a mobile application to a standard weight loss program was 
found to significantly increase weight loss.32 A systematic review documented that mobile phone 
and text message-based interventions to support adherence increased client satisfaction and 
improved biological markers of diabetes control (A1c).33 Despite this evidence that apps can be 
efficacious for prevention, a 2015 inventory of all HIV-related Apple and Android apps found that 
less than 7% focused on MSM and none provided PrEP information34; a second, independent 
review found that <4% of HIV-related apps were tailored for MSM, and only 6 apps covered 
multiple key areas of HIV prevention (but not PrEP).35
Further, using technologies to support HIV prevention is acceptable to MSM. Before the 
proliferation of Smartphone apps, we asked a large geographically diverse sample of MSM 
about their willingness to use mobile phones as part of an HIV prevention study. About half of 
men were willing to use their mobile phones for HIV prevention; younger MSM and MSM of 
color were more likely to be willing.36 In another study, gay and lesbian youth were much more 
likely than their heterosexual peers to engage in sexual health information provided using their 
mobile phones.37 Smartphones are widely accessible to MSM who are most at risk: among 
Americans, smartphone ownership in 2015 was 85% among those 18-24 (higher than among 
older Americans), and was 70% among African Americans (higher than among white 
Americans).38 
In 2015, we published a conceptual framework for promoting PrEP uptake among MSM taking a 
continuum perspective.39 The framework is intended to facilitate categorization of interventions 
and conceptualization of systems-based approaches to enhance PrEP uptake and articulates 
several domains on the pathway to PrEP uptake: Awareness and Willingness; Access to 
Healthcare; Likelihood of receiving a prescription; and Adherence and Efficacy.39  Some 
elements, like awareness, are necessary but not sufficient alone to lead to PrEP initiation.  
Further, other basic prevention services, like HIV testing, are necessary elements of PrEP 
uptake, both because PrEP is a serostatus-dependent intervention, and because post-test 
counseling sessions for HIV-negative MSM should include discussion of PrEP.40  Access to 
healthcare is critical to support costs of PrEP and monitoring tests.40  Our proposal addresses 
these domains through the materials and components of the HealthMindr mobile app.

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2.2
Rationale
The premise is that providing, through a mobile phone app, self-directed PrEP information; 
periodic PrEP eligibility screenings to identify risk and eligibility objectively; referral to PrEP 
providers with directions; and related prevention services will increase the uptake of PrEP 
among at risk, HIV-negative MSM to a greater extent than standard of care referrals to existing 
resources.
3
OBJECTIVES
3.1
Study Objectives
3.1.1
Primary Objective
Compare the uptake of PrEP among men provided the HealthMindr app to men provided 
standard of care among MSM the Southern United States.
3.1.2
Secondary
Quantify the behavioral, social, and clinical factors that mediate and moderate the efficacy of the 
HealthMindr app on the rate of PrEP uptake.
Conduct in-depth interviews to assess how the app promoted PrEP uptake, unmet needs of 
men who did not start PrEP, and how repeated app interactions might further PrEP uptake.
3.2
Study Outcome Measures
3.2.1
Primary
The rate of PrEP uptake will be assessed during follow-up by self-report at months 3, 6, 9, and 
12.  Self-report will be confirmed by laboratory testing for the presence of tenofovir diphosphate 
(TFV-DP) and/or photograph of PrEP prescription or bottle.
3.2.2
Secondary
Mediation Analysis: This analysis will examine how study arm assignment may lead to 
intermediate effects, such as greater access to HIV testing or decreased risk behavior, which 
themselves are associated with the primary effect of PrEP initiation. Using the difference 
method for a set of Cox proportional hazards models, log coefficients for the indirect effects will 
be subtracted from log coefficients for the direct effect to estimate the size of the mediation.41 
Mediators will be selected on the variables known to be associated with the 4 domains of the 
PrEP continuum (including awareness, access, and engagement with HIV prevention services), 
and changes in risk behaviors resulting from app utilization.
Moderation Analysis: This analysis will examine how attitudes and beliefs about PrEP, as well 
as individual, social, and community characteristics can moderate the effect of the app on PrEP 
initiation. Examples of moderators include perceived benefits of PrEP use, self-assessed 
vulnerability to HIV, perceived advantages to meeting partners if currently taking PrEP, and 
social support for PrEP use within one’s social network.

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Demographic factors including age, race/ethnicity, and geographic setting will also be critical 
moderators. Although the distribution of these factors will be balanced across study arm with 
randomization, they may have effects on the level of engagement in the app (i.e., post-
randomization treatment adherence) that itself will influence the rate of PrEP initiation. Given 
this causal model, we will use instrumental variable analyses to estimate the effect of optimal 
app use on PrEP initiation given measured and unmeasured moderators.42
In-depth Interviews (IDI): IDIs will assess the extent to which app components facilitated or 
inhibited PrEP uptake. Central to the IDI will be understanding the participants’ use of the app. 
The IDI will begin by asking the participant to walk the interviewer through a “typical use 
session” of the app, during which the interviewer will probe around key decisions (e.g. why one 
function was used over other functions). The interview will examine the participant’s views on 
the positive and negative elements of the app. The interview will focus on the use of PrEP 
components: participants will be asked to walk through the PrEP knowledge, screening and 
locating functions with the interviewer and describe why they did or did not use them. 
Participants who started PrEP will be asked to describe the role that the app played in their 
decision and which app components were most integral to their decision. They will be asked to 
demonstrate which components of the app were useful in adopting PrEP, and areas of the app 
where further support might be useful. Participants who did not start PrEP will be asked if there 
are additional components (e.g., better linkage to providers, other information) that could be 
added to the app that might lead them to change their mind about starting PrEP. Participants 
who did not adopt PrEP will be asked to demonstrate how they used the app and which 
components of the app were not used. These data will provide insight into how the app is used 
in PrEP decision making, and identify areas of opportunity to promote PrEP adoption for future 
app versions.
4
STUDY DESIGN
We will conduct a randomized controlled trial (RCT) with two arms. Participants in the 
intervention arm will receive access to the HealthMindr app with basic prevention services (HIV 
test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test 
kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility 
assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local 
PrEP navigators. The app also provides links to health insurance exchanges, where men can 
seek health insurance (all cities) or payment assistance programs. The control arm will be 
standard of care (receive baseline survey, followed by referral to existing online PrEP and HIV 
prevention information; with a mobile-phone administered attention control survey about diet 
and exercise (and PrEP initiation) of the same length as the monthly PrEP assessment given to 
the intervention arm, to maintain the same monthly frequency of contact with control 
participants. Control arm participants will not have access to the active app.
Study participants are followed for 12 months with outcome measurements occurring in both 
arms at 3-month intervals and monthly brief surveys to assess PrEP uptake and reassess PrEP 
eligibility (intervention arm) or assess diet and exercise (control arm).  Surveys will be 
distributed to all participants through the mobile app at baseline and quarterly. Participants will 
specify their preference for communication media in the baseline survey. Quarterly surveys will 
last approximately 30 minutes; to limit survey duration, some non-labile survey elements will not 
be assessed at each time point. Quarterly surveys are identical for men in both arms, except the 
final survey includes questions on acceptability only for men who used the app. Surveys are 
smartphone-optimized so that they may be completed on participants’ phones. The survey 

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measures represent a comprehensive set of previously validated measures that will 
characterize the population, allow for assessment of adequacy of randomization, document 
important outcomes, and allow for exploration of possible moderating factors.  A summary of 
measures is included in Figure 2.
Figure 2. Measures to be assessed in participant surveys.
4.1
Study Population
The study population will be men who have sex with men age 18-34 years (inclusive) who 
reside in one of the study MSAs - Atlanta, Georgia, Jackson, Mississippi, or Washington, DC. 
Additional recruitment locations may be added to meet recruitment targets, including Houston, 
Texas, Dallas, Texas, New Orleans, Louisiana, Nashville, TN or Miami, Florida. The total 
sample size will be 680, with a goal of at least 50% racial / ethnic minority participants. Full 
inclusion and exclusion criteria are specified below.    
Outcomes
Community & Network Characteristics
PrEP Awareness/Use/Efficacy
Health Care Environment
Participant has heard of PrEP
Payer source: insurance coverage, out-of-pocket
Current/past use of PrEP
Delivery source: private provider, demonstration 
Perceptions about partner PrEP current/past use
project, black market
Attitudes about safety and utility of PrEP
Decision-Making Opportunity Scale: between patient
Perceptions of side effects and toxicity
and provider
Perceptions of antiretroviral drug resistance
Personal knowledge by provider, e.g., knows patient
Perceived Benefits of PrEP Use*
as a person
Perceptions of increased sexual intimacy, pleasure
Local availability of PrEP (PrEPLocator.org)
Individual-Level Characteristics
 •Comfort in disclosing behaviors to provider
Demographic and Personal Characteristics
Social Environment
Race/ethnicity, age, education, marital/partnership status
Enacted experience of stigma and discrimination
Socioeconomic status; income, employment status
Internalized homo-negativity
Sexual identity
Anticipated stigma around sexuality
Vulnerability to HIV
Media
Recent sexual behavior with main and other partners
Formal: information about sexual health, HIV prevention 
Substance use: recent use, use during or before sex
and PrEP from television, newspapers, radio, online
Depression – CES-D
media, medical journals
Recent incarceration
Social: usage, frequency, purpose (e.g., for information, 
to 
Perceived severity and risk of HIV infection
communicate)
Knowledge of HIV Prevention
Websites: sites that host discussions on sex and HIV 
HIV risks: types of sexual acts, virological factors, STI co-
Prevention
Infection
Perceptions of Local HIV Prevalence
Behavioral methods: sero-adaptation, sexual negotiation
Perceived prevalence among sex partners, friends, MSM 
Knowledge of emerging HIV prevention technologies
in city of residence
Healthcare Attitudes and Values
Social Network Composition
Adherence self-efficacy: confident in ability to adhere to PrEP
Proportion of social network: MSM/LGBT, using PrEP, 
PrEP stigma: e.g., perceived as promiscuous, “Truvada whore”
perceived supportive of PrEP, discussed PrEP

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5
STUDY ENROLLMENT AND WITHDRAWAL
5.1
Subject Eligibility Criteria
Men will be eligible to participate in the study if they: (1) are cis-gender male (male at birth and 
currently identify as male gender) ; (2) are 18-34 years of age (inclusive); (3) report residing in 
one of the study MSAs with intent to remain for the duration of the trial; (4) have an Android or 
iOS phone with active service and are willing to download study app; (5) are an English 
speaker; (6) report having anal sex with a man in the past 6 months; and (7) report being HIV-
negative, or never having been tested for HIV. Men who report currently being on PrEP will be 
ineligible, but prior PrEP use will not be exclusionary.
5.1.1
Inclusion Criteria

Cis-gender male

18-34 years of age (inclusive)

Resides in one of the  study MSAs

Intends to remain in study area for duration of the trial

Owns an Android or iOS smartphone and willing to download study app

Able to read and understand English without assistance

Reports having anal sex with a man in the past 6 months

Reports being HIV negative or never tested for HIV
5.1.2
Exclusion Criteria

Cisgender female, transgender male, transgender female, gender non-conforming

Currently on PrEP

< 18 or >34 years of age

Reports being HIV positive 

Resides outside of the  MSAs or plans to move outside study MSA within 12 months

Current participant in an HIV prevention study

Unable to download study app
5.2
Strategies for Recruitment and Retention
5.2.1
Recruitment
Recruitment strategies will aim to recruit MSM who are diverse in terms of race/ethnicity 
and to minimize recruitment biases and maintain comparability across sites. Black and 
Hispanic MSM will be oversampled with a goal of enrolling at least 50% of the study 
population in these disparately impacted groups. 
Online recruiting: The primary method of recruitment will include online recruitment 
activities. Although online venues are constantly evolving, in the past, major categories of 

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recruitment have included social network sites (e.g., Facebook, Instagram, Twitter); online 
sexual networking apps (e.g., Grindr, Scruff); and banner advertisements on other websites 
frequented by MSM (e.g., Queerty, Towleroad, Adam for Adam). Examples of the online 
recruitment types and procedures for each type follow. We will target men at least 18 years 
old who live in or work near the Atlanta, GA, Jackson, MS, or Washington, D.C. MSA. 
Additional MSAs may be added if needed to meet recruitment targets, including New 
Orleans, LA; Houston, TX;  Miami, FL; Dallas, TX;  Nashville, TN; Austin, TX; Tampa, FL; 
Orlando, FL; Birmingham, AL; Memphis, TN; Louisville, KY; Baltimore, MD; Detroit, MI; 
Charlotte, NC; Raleigh, NC; and Columbus, OH.. When men click on a banner 
advertisement, they will be taken to a page containing basic study information that includes 
a short description of study activities. If they click on a button to advance, they will be taken 
to the study screening consent form, and if they consent they will be directed to a short 
eligibility screener to determine whether they meet the eligibility criteria.
Facebook: Targeted online recruitment will be conducted via Facebook. This involves 
targeting advertisements to all adults in the three study cities based on several factors, 
including interests expressed in profiles and through expressed "likes" of other posts or 
pages with gay themes. Those who click on the Facebook ads will be referred to a brief 
introduction script and a self-administered online screening form with questions identical to 
those to be administered in venues. 
Grindr: Recruitment through Grindr uses banner advertisements and targeted email blasts 
that target MSM in the three cities. Those who click on the banner ad or who receive an 
email will be directed to the brief online consent and screener to determine eligibility. 
Offline recruiting: Participants may be recruited through posting flyers and promoting the 
study through community partners (e.g., community-based organizations, drop-in centers). 
Those recruited through these flyers will be directed to an online web location for eligibility 
screening. 
The data collected from screening will be stored in the secure, HIPAA-compliant servers of 
SurveyGizmo.
5.2.2
Retention 
The study retention plan will incorporate multiple interventions to achieve a retention rate 
greater than 70%.  Contact information will be collected from each participant, including 
email and mobile phone number verification. The study will allow participants to schedule 
their preference for when (e.g., afternoon, evening) they would like to receive prompts to 
complete electronic follow-up surveys. Participants are more likely to complete surveys if 
they are alerted about them at a time they can complete the survey. At enrollment, study 
staff will ask permission for several means of contacting participants and ask for updated 
information on each follow-up survey. Retention contacts will be customized based on 
participants’ contact preferences (email, text, call, US mail) and organized on a database 
platform called Study Management and Retention Tool (SMART), a secure system 
accessible only to designated study staff. Participants will be asked about any changes in 
their contact information or plans to move during each follow-up survey, conducted at 3-
month intervals.
Follow-up methods include sending electronic notification reminders to the participant up to 
3 times if a survey remains uncompleted.  If after the 3rd notification, the assessment has 

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still not been completed, then the retention activities will escalate to a staff member. 
Depending on the participant’s preferences provided upon registration, contacts will be 
made initially with the preferred mode of re-contact (for example, SMS); if still 
unresponsive, other available modes (e.g., phone call, private social media messages) will 
be used. Each contact is logged in an electronic retention system developed by Emory. The 
system maintains electronic lists of each participant’s retention status and automatically 
creates notification lists for retention staff to ensure that a systematic process is followed 
and documented for retention.
If contact with participants is lost (missed surveys or appointments and non-responsive to 
contact requests), we will have obtained consent to use public-use databases (e.g., Lexis-
Nexis) to locate participants. Study staff will check for entry into a jail or prison in the 
jurisdiction from which the participant was recruited (i.e., Atlanta, GA, Jackson, MS, or 
Washington, D. C.). For participants who cannot be contacted, after IRB approval staff will 
attempt to link the identities of participants to registries of known decedents using a 
statewide dataset (vital records) and a nationwide dataset (National Death Index).  
5.2.3
Participant Compensation
Compensation for survey completion will be graduated ($50 baseline, $40 months 3 and 6, 
$50 month 9, $60 month 12). Study incentives for the baseline will be sent 48-72 hours 
after completion of the baseline survey to allow for review of data and identification of 
possible fraudulent or duplicate enrollments. Incentives for IDIs and quarterly follow-up 
surveys will be processed electronically at the time of interview or survey completion (see 
Fraud Deterrence). Men in both arms will be asked monthly if they have initiated PrEP; men 
who report initiating PrEP in either arm will be mailed a dried blood spot collection kit with 
instructions and a prepaid return mailing envelope, and will be directed to collect and mail a 
dried blood spot specimen for tenofovir diphosphate detection. Those who return a DBS 
specimen will be provided with an additional compensation of $40. Participants will also be 
asked to take a picture of their prescription or PrEP label; those who provide a photograph 
will be provided with an additional compensation of $15. A maximum compensation of $295 
could be provided for completing all of the study visits ($240), DBS specimen ($40), and 
PrEP prescription photo verification ($15).
5.3.4 Fraud deterrence and detection
Fraudulent responses in research are of concern in all settings, and there are particular 
vulnerabilities in online research. In order to avert fraudulent registrations details of 
eligibility criteria will not be reported before screening, IP addresses will be tracked to block 
duplicate screening attempts, and Captcha will be used to avoid bots. Payment of initial 
baseline incentives will be delayed for 48-72 hours to allow us to perform automated scans 
for duplicate IP addresses, names, duplicate email addresses, or phone numbers. In these 
cases, study staff will attempt to resolve concerns by contacting participants and clarifying 
how the situation arose. If duplicate registrations are detected, records will be inactivated 
and deemed to be invalid. 

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5.3
Treatment Assignment Procedures
5.3.1
Randomization Procedures 
After providing informed consent, downloading the study application, and passing the fraud 
check, participants will be randomized to study arms in a 2:1 ratio of intervention to control arms 
(rationale: to allow sufficient data on app users to allow for analysis of efficacy by level of app 
usage), stratified by MSA to ensure balance of the study arms across the three study sites.43 
Within each city stratum, a computer program will randomly assign each participant to the next 
treatment allocation from a random-permuted block randomized sequence. Once participants 
are randomized, they will be kept in and analyzed according to their original assignment (i.e., 
intent-to-treat). Participants who are not verified as legitimate or are unable to download the app 
will not be randomized into the study.
5.4
Subject Withdrawal 
Participants may voluntarily withdraw from the study for any reason at any time. The study 
investigators also may withdraw participants from the study in order to protect participant or staff 
safety. Study staff will record the reasons for all withdrawals or holds from the study on a Study 
Stop Form in the participants’ study records. 
Participants who seroconvert will be asked to participate in in-depth interviews (IDI).  All of the 
participants will be followed per standard protocol for linkage to care. Participant will then be 
withdrawn from study activities. 
6
STUDY INTERVENTION
6.1
Study Product Description
HealthMindr is a mobile app with HIV prevention information and links to services developed 
specifically for MSM. A summary of the key features of the app is provided below.
Functions included in the HealthMindr app:  

HIV testing: learn more about testing options; make a plan to test 2-4 times in the 
coming year; locate possible places for those tests; and schedule reminders (goal 
setting). 

Behavioral risk assessment: short behavioral risk assessment (e.g., HIV risk behaviors: 
sex while drunk or high, condomless anal intercourse with a positive or unknown HIV 
status partner, total number of sex partners, recent STI diagnosis, use of 
methamphetamine or poppers) and protective behaviors (HIV testing, STI testing, 
consistent condom use; feedback/self-regulation).  

Non-occupational post-exposure prophylaxis (nPEP): information about nPEP; nPEP 
self-assessment27; nPEP locator44; referral to PrEP for men who evaluate multiple 
exposures for nPEP indication (goal setting and outcome expectation). 45

Product ordering: Via the app, users can order condoms, condom-compatible lubricant, 
and at-home STI specimen collection kits (urethral and rectal gonorrhea and chlamydia, 
syphilis) and at-home HIV test kits (OraQuick; goal setting). Orders are filled 
automatically through Amazon fulfillment services.  

Pre-exposure prophylaxis: PrEP self-assessment at first app use; monthly rescreening 
for PrEP eligibility; recommendation for PrEP based on CDC criteria; PrEP provider 

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locator; transport or driving directions to providers, and PrEP FAQ. The PrEP self-
screener assesses certain key elements of behavioral eligibility (potential indicators of 
“ongoing, high risk for HIV acquisition”), and recommends potentially eligible MSM visit a 
PrEP provider for further clinical assessment, with help locating nearby providers and 
transport directions (self-efficacy, goal setting and outcome expectations). 

Substance Use Directory: a list of local resources available for treatment, rehab, and 
counselling options will be accessible through the app. 
6.1.1
Acquisition
After completing the eligibility screener and informed consent (Appendix B), participants will be 
directed to a link to authenticate their smartphone and download the HealthMindr App from 
either Google Play or Apple App Store. All participants will view the same app shell and 
complete the baseline survey in the app. However, once randomized, the app for those marked 
as intervention will open up to show all HealthMindr app capabilities. The app information will 
cover the importance of testing, links to HIV prevention resources, resources to locate HIV 
testing and PrEP services, the SAMHSA substance abuse treatment resource locator, and other 
prevention information specific to their area.  The app for the control arm will allow study staff to 
interact with them via the SMART system. The control-arm app will display a study event 
timeline but none of the HIV prevention information contained in HealthMindr app.
The HealthMindr application will prompt the intervention participants to complete a brief PrEP 
assessment (monthly). Any notifications directed to a phone’s lock screen or to a participant’s 
SMS/text message account can be partially viewed by unauthorized users of the phone and will 
be generic text (e.g., “You have a message waiting for you.”). To ensure that app notifications 
protect the privacy and discretion of participants, all app and text notifications will be stated 
generally, with no reference to the content of the message, the nature of the message, the 
content of the app in general, the name of the study, or any reference to HIV, STI or MSM. The 
lock screen banner notification will indicate only that the notification is for the HealthMindr app. 
SMS/text message notifications will similarly alert participants that a new message is available 
in HealthMindr. Absolutely no content referring to sensitive topics will be exposed without 
directly entering the app. The same notification format will be used for both intervention and 
control groups.
Every three months, participants will be asked to complete a follow-up survey similar to the 
initial baseline survey. The follow-up survey will include questions on demographic 
characteristics, HIV and STI testing history and status, and condom use, PrEP use and 
adherence, knowledge, perceptions, beliefs, intents, communication with sex partners, 
substance use, mobile phone and data usage, access to internet and information, as well as 
psychosocial cofactors. If the participant has any questions regarding study activities, they will 
be connected with study staff. Study staff will handle any research related questions or issues 
with the participant.
7
STUDY SCHEDULE
7.1
Screening
After a potential participant is determined to be eligible and agrees to participate, they will be 
asked to provide their contact information including name, primary phone number and primary 
email address. The phone number and email address will be used as a measure against 

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participant fraud. If a participant does not provide valid and unique contact information, they will 
not be able to sign in to the app until they have provided it. If a participant provides contact 
information that matches that of another registrant, they will be rejected administratively.
7.2
Enrollment/Baseline
All participants will download the app, complete the Baseline survey through the app via 
SurveyGizmo API, and provide contact information for a friend or relative.  Intervention 
participants will also receive access through the app to basic prevention services (HIV test 
planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, 
and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, 
PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. 
The app also provides links to health insurance exchanges, where men can seek health 
insurance (all cities) or payment assistance programs. The control arm will be referred to 
existing online PrEP and HIV prevention information (Appendix C). Participants who do not 
download the app or have problems downloading the app will be ineligible to participate in the 
study.
7.3
Follow-up Visits
All participants will be asked to complete quarterly surveys through the app for follow-up visits at 
Month 3, 6, 9 and 12.  Participants who have indicated starting PrEP will be asked to upload a 
picture of their prescription and/or be asked to self-collect DBS using a home test kit. 
Both groups will also receive a monthly assessment. The intervention group will receive a 
monthly PrEP assessment and the Control group will receive a survey about diet and exercise 
of similar length. All participants will also be asked questions to ascertain whether they started 
PrEP within the past month. Generic questions about new medication prescriptions will be used 
in the control arm so that PrEP is not mentioned specifically. Intervention arm participants will 
be asked if they have initiated PrEP prior to starting the monthly PrEP assessment. Participants 
reporting PrEP initiation will then complete a PrEP adherence assessment.
The intervention group will be able to use the resources in the app throughout the study, 
including placing orders for home test kits, condoms and lubricant.
7.4
Withdrawal Visit
Participants may withdraw at any time during the study.  If they indicate they wish to withdraw, 
they will be asked to complete a short survey to identify reasons for wanting to withdraw.  
7.5
Unscheduled Visit
Any interaction with participants between scheduled visits will be considered unscheduled visits 
and will be tracked in SMART.
7.6
In-depth Interviews
In-depth interviews: Up to 30 IDIs (approximately 10 per site) will be conducted within one 
month of PrEP initiation with men in the intervention arm who start PrEP. Up to 20 additional 
IDIs will be conducted within one month of study completion among men who fit the following 
criteria (N = maximum of 5 each): PrEP starters, PrEP non-starters, PrEP stoppers, and men 
that cycled on and off PrEP. IDI participants will be purposively sampled to ensure 

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representation of men who accessed the app at least one time during follow-up and received a 
PrEP recommendation. PrEP starters interviewed after one month of follow-up will not be re-
interviewed at the end of study. The IDIs will be conducted by trained qualitative interviewers. 
We will develop semi-structured interview guides. Interviewers will receive training on the 
interview guides to ensure standardization across study sites. IDIs will assess the extent to 
which app components facilitated or inhibited PrEP uptake. Central to the IDI will be 
understanding the participants’ use of the app. The IDI will begin by asking the participant to 
walk the interviewer through a “typical use session” of the app, during which the interviewer will 
probe around key decisions (e.g. why one function was used over other functions). The 
interview will examine the participant’s views on the positive and negative elements of the app. 
The interview will focus on the use of PrEP components: participants will be asked to walk 
through the PrEP knowledge, screening and locating functions with the interviewer and describe 
why they did or did not use them. Participants who started PrEP will be asked to describe the 
role that the app played in their decision and which app components were most integral to their 
decision. They will be asked to demonstrate which components of the app were useful in 
adopting PrEP, and areas of the app where further support might be useful. Participants who did 
not start PrEP will be asked if there are additional components (e.g., better linkage to providers, 
other information) that could be added to the app that might lead them to change their mind 
about starting PrEP. Participants who did not adopt PrEP will be asked to demonstrate how they 
used the app and which components of the app were not used. These data will provide insight 
into how the app is used in PrEP decision making, and identify areas of opportunity to promote 
PrEP adoption for future app versions.
Additional IDIs will be conducted with any participant who seroconverts during follow-up. These 
IDIs will follow a structure similar to those described above. Additional questions will be added 
to explore factors related to PrEP and seroconversion. Participants who were not on PrEP at the 
time of seroconversion will be asked why they did not initiate PrEP or why they discontinued 
PrEP if they had previously taken it. Patients who report being on PrEP at the time of 
seroconversion will be asked about adherence to the dosing regimen. 
8
STUDY PROCEDURES/EVALUATIONS
8.1
Study Procedures/Evaluations
Per-Protocol and Dose-Response Analyses: The primary efficacy analysis will be an intent-to-
treat analysis. Because randomization to the intervention arm will not guarantee engagement 
with the HealthMindr app, we will use two types of secondary analysis to estimate the potential 
effects of the app under conditions of optimal adherence. First, a per-protocol analysis will 
estimate the effect of the app on rates of PrEP initiation under assumptions of substantial 
adherence using principal stratification methods to estimate the causal effects given 
associations between measured confounders and adherence profiles.47 Study subjects who 
participate in the baseline assessment and at least 3 subsequent monthly PrEP screeners 
during the year will be categorized as substantially adherent for this purpose. Second, level of 
engagement with the app, including number of times the app is opened per month or number of 
app features accessed per use, may vary strongly across participants. Under the hypothesis 
that greater engagement with the app will lead to faster initiation into PrEP, we will model the 
dose-response relationship between a continuous gradient of app engagement and rate of PrEP 
initiation among app users in the study.

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8.2
Laboratory Procedures/Evaluations
HIV Testing: Participants in the intervention arm will be offered at-home HIV test kits up to 2 
times during their 12 months of participation through the Emory CFAR.  HIV is tested using 
FDA-approved OraQuick test using a mouth swab. Results can be verified through self-report. 
STI Testing: Participants in the intervention arm will be offered at-home STI test kits up to two 
times during their 12 months of participation; through the Emory CFAR. Diagnosis of an STI is 
an indication for PrEP.40  The presence of C. trachomatis (CT) and N. gonorrhea (NG) in self-
collected urethral, throat, and rectal specimens will be determined by using the Aptima Combo 2 
CT/NG assay or Abbott Real Time CT/NG assay, an FDA-cleared real-time polymerase chain 
reaction (PCR) assay for direct, qualitative detection of a region of the cryptic plasmid DNA of 
CT and the Opa gene of NG.48 Syphilis screening will be conducted  using the TREP-SURE EIA 
assay with reflexive rapid plasma reagin (RPR) test for reactive results49; participants with a 
reactive result will be referred to a local provider for treatment and follow-up. Positive STI test 
results will be provided to participants over the phone by a study staff member who can refer 
participants to treatment. Upon request, copies of results may also be sent to the study 
participant. 
Alcohol and Substance Use Screening: Residual urine from STI testing will be screened for 
alcohol and substance use. This will be done as a confirmation of self-report for substance use 
for research purposes only and results will not be reported back to participants. Participants who 
wish to receive referrals for assistance with substance use will be assisted with navigation 
services by study staff.
Tenofovir detection: Dried blood spot specimens from men who report initiating PrEP will be 
analyzed for intracellular concentrations of tenofovir diphosphate (TFV-DP) in the laboratory of 
Dr. Angela Kashuba, who directs the University of North Carolina CFAR Clinical Pharmacology 
Core.  DBS cards are used to obtain a 3 mm “punch” which is eluted in a micro-centrifuge tube. 
The eluate is analyzed by liquid chromatography/tandem mass spectrometry. Tenofovir 
concentration is reported as fmol/106 RBCs; the lower limit of quantification is 2.5 ng/mL. 
Intracellular TFV-DP is commonly used as method of assessing adherence to PrEP; we will 
consider a positive result solely to corroborate self-report of PrEP initiation and photographic 
evidence of prescription. This will not be used to monitor adherence and results will not be 
returned to participants, as disclosed in the informed consent process. 
8.2.1
Specimen Shipment
Shipping CareKits to Participants
1.
After the order is placed through the app, staff will place the kit order with the lab. 
2.
Kits will be mailed directly to the participant with instructions on how to register their kit 
online. This will allow staff to link the kit with the participant. 
Shipping Specimen
After collecting specimen(s) for testing, participants will indicate the  date of collection  and 
place  specimens collected in the provided packaging, which meets all federal regulations for 
shipment of Biological Substances. Participants will ship their collected specimen(s) via USPS  

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to the designated laboratory via the provided pre-labeled  mailer.  Instructions on how to mail 
kits are included on an instructional sheet provided within the kit.
9
ASSESSMENT OF SAFETY
9.1
Specification of Safety Parameters
All adverse events reported will be assessed by the PI for the study site in which the participant 
was enrolled for the severity, expectedness and relatedness, using the criteria listed below.
9.1.1
Adverse Events
1.
Participant report of loss of confidentiality through the app or its functions
2.
Participant report of loss of confidentiality through delivery of prevention supplies or 
commodities
3.
Participant report of access by others to protected health information through the app or 
study procedures.
4.
Participant report of disclosure of status as a research participant due to study-related 
reminders (from app, phone calls, emails, or text messages).
5.
Participant report of discomfort or injury due to use of provided specimen collection 
materials (e.g., finger stick for syphilis testing, self-administered rectal swab or 
pharyngeal swab).
6.
Disclosure of personal information about health, sexuality or sexual practices that results 
in physical violence or threat of violence.  
7.
Disclosure of personal information about health, sexuality or sexual practices that results 
in adverse effects on employment
9.1.2
Serious Adverse Events
1.
Suicidal behavior or intention, including but not limited to following learning the results of 
study-provided tests (e.g., HIV tests, STI tests)
2.
Any event that results in death, is life-threatening, results in persistent or significant 
disability/incapacity, or requires hospitalization or prolongation of existing hospitalization 
9.1.3
Relationship to Study Intervention
The potential event relationship to the study intervention and/or participation is assessed by the 
site investigator. A comprehensive scale in common use to categorize an event is:

Definitely Related:   The adverse event is clearly related to the investigational 
intervention – i.e. an event that follows a reasonable temporal sequence from first 
exposure to the app, follows as a known or expected consequence from using the 
intervention, and that could not be reasonably explained by the known characteristics 
of the subject’s normal activities.

Possibly Related:  An adverse event that follows a reasonable temporal sequence 
from exposure to the app, follows a known or expected consequence from use of the 
app, but that also could readily have been produced by a number of other factors.

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
Not Related:  The adverse event is clearly not related to use of the app - i.e. another 
cause of the event is most plausible; and/or a plausible temporal sequence is 
inconsistent with the onset of the event and the study intervention and/or a causal 
relationship is considered implausible. 
9.1.4
Severity of Event
Severity will be classified using the following standards: 

Mild: Awareness of the issue, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Incident did not require counseling or 
a medical evaluation; concern on the part of the participant or physical symptoms 
were transient.

Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved within a 
few days (social harms) or by simple therapeutic measures (injury due to specimen 
collection); moderate experiences may cause some interference with usual activities 
for a few days.

Severe:  Events interrupt the participant’s normal daily activities and require mental 
health assessment and treatment (social harms) or clinical treatment (injury due to 
specimen collection); they usually produce major disruptions in daily activities such 
as work, school, or family commitments.
9.2
Reporting Procedures
In all study sites, new confirmed STI infection, including HIV, is reportable to local health 
departments.  We will complete mandatory notification of positive STI results as required by law.  
Participants will be informed in the informed consent process and counseled when receiving 
positive STI results that results will be reported to the local or state health department as 
required by law, and that the health department might contact them to offer treatment or to 
assess possible onward exposures.  Abuse that comes to the attention of study staff will be 
required to be reported in all three jurisdictions if the abuse is perpetrated on a child (who would 
be ineligible to participate per the study age criteria), or if the abused person is a vulnerable 
adult (e.g., elderly person, person in a long-term care facility).  We do not anticipate having 
participants who would be considered to be vulnerable, but if we become aware of abuse to a 
person meeting this criterion, we will report to state/district authorities as required by law. 
9.2.1
Serious Adverse Event Reporting 
All SAEs require expedited reporting by the Principal Investigator to the Emory IRB. An 
expedited report of an SAE can be submitted by telephone, fax, or email and must be 
reported to the IRB and the NIDA project officer within 24 hours of the event being reported 
to the Investigator. 
The expedited report will be followed by a detailed, written SAE report of the event and its 
resolution as soon as possible but no longer than 72 hours after the study team learns of the 
event. Follow up information may be required and asked for by the IRB directly, or through 
the NIDA or its representative. A standardized SAE reporting form will be used.

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10 STUDY OVERSIGHT
A DSMB is not planned for this study.  Based on criteria included in the NIDA online guidance 
on safety monitoring (https://www.drugabuse.gov/funding/clinical-research/guidelines-
developing-data-safety-monitoring-plan), monitoring will be done by the Principal 
Investigator and the Institutional Review Board.  This level of monitoring is based on NIDA’s 
criteria that the study is a multicenter clinical trial, but does not propose blinded or high-risk 
interventions.  The intervention and the only medication involved is open label and is FDA 
approved for the indication to which we are referring men.  The study does not provide 
medication, but rather refers men to clinical providers.  Further, the centralized nature of the 
study data at Emory will facilitate routine monitoring.  
11 CLINICAL SITE MONITORING
The principal investigator will monitor data collection throughout the study, and will ensure that 
interview protocols are followed, all adverse event reports are reviewed (if any), confidentiality 
procedures are implemented, and the Emory University IRB is alerted if unexpected concerns 
arise.
12 STATISTICAL CONSIDERATIONS
12.1
Study Hypotheses
1) The rate of PrEP uptake will be higher among men provided with the HealthMindr app 
compared to men provided with standard of care.
2) Access to additional HIV prevention services available in the HealthMindr app will result in 
reductions in risk behaviors or greater access to HIV testing services, which are associated with 
PrEP uptake.
3) Individual, social, and community characteristics of participants will be associated with PrEP 
uptake among participants provided access to the HealthMindr app.
12.2
Sample Size Considerations
Power calculations were conducted for the main analysis of time to PrEP initiation comparing 
the intervention arm with the control condition. Current estimates of PrEP uptake in the most 
recent 4 quarters for which data are available are that 4,507 men started PrEP50. Assuming all 
of these men are MSM, which is an overestimate, and using as the denominator the number of 
MSM estimated by CDC to be eligible for PrEP22, only 4,507/492,000 = 0.9% of eligible MSM 
started PrEP between mid-2104 and mid-2015. Thus, our assumption that at most 2% of men in 
the control arm will initiate PrEP during the study period is conservative. Based on our 
preliminary pilot data, men using the app initiated at 9% per 4 month period; we conservatively 
estimate that men in the intervention period would initiate PrEP at 9% in a year. We propose a 
total sample size of 438 intervention arm and 219 control which will provide 91% power (α = 
0.05) to detect a 4.5 fold increase in the hazard of uptake in the intervention arm compared to 
the control arm. If our effect were less than our conservative estimates, we would retain 
reasonable power (4-fold: 80% power; 3.5-fold: 74% power). These power calculations assume 
20% annual attrition.

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12.2.1
Efficacy Review
The primary efficacy analysis will be an intent-to-treat analysis. Participants will be analyzed 
based on the study arm they were assigned to regardless of the level of engagement with the 
HealthMindr app among intervention arm participants. Because randomization to the 
intervention arm will not guarantee engagement with the HealthMindr app, we will use two types 
of secondary analysis to estimate the potential effects of the app under conditions of optimal 
adherence. First, a per-protocol analysis will estimate the effect of the app on rates of PrEP 
initiation under assumptions of substantial adherence using principal stratification methods to 
estimate the causal effects given associations between measured confounders and adherence 
profiles.47 Study subjects who participate in the baseline assessment and at least 3 subsequent 
monthly PrEP screeners during the year will be categorized as substantially adherent for this 
purpose. Second, level of engagement with the app, including number of times the app is 
opened per month or number of app features accessed per use, may vary strongly across 
participants. Under the hypothesis that greater engagement with the app will lead to faster 
initiation into PrEP, we will model the dose-response relationship between a continuous gradient 
of app engagement and rate of PrEP initiation among app users in the study.
12.3
Final Analysis Plan
The main analysis will use four standard survival analysis techniques to compare the rate of 
PrEP initiation by study arm and estimate the size and statistical significance for observed 
differences. This approach will account for loss-to-follow-up, study termination due to competing 
events (e.g., HIV seroconversion), and other forms of censoring.51 The first analysis will use 
Kaplan-Meier methods to characterize the empirical survival distribution, which here is the time-
dependent probability of remaining PrEP uninitiated over follow-up. This method will yield 
estimates of the median time to PrEP initiation and cumulative incidence with 95% confidence 
intervals. Second, log-rank or related (e.g., Harrington-Fleming) statistical tests will be used to 
test the null hypothesis of no difference in rates of PrEP initiation by study arm, with a cutoff p 
value of 0.05 used to determine significance.52 Third, a Cox proportional hazards model will be 
used to estimate the hazard ratio associated with study arm to characterize the strength of 
causal effect of use of the app. The primary model will only include an independent exposure 
variable for the study arm as randomized (i.e., standard intent-to-treat analysis), but secondary 
models may include covariates (including those related to the four domains along the PrEP 
continuum) for which there is descriptive evidence of residual imbalance after randomization.53 
Fourth, parametric survival models (e.g., under exponential or Weibull distributional 
assumptions) will be used to characterize the rate of PrEP initiation overall and by study arm. 
Mediation Analysis: This analysis will examine how study arm assignment may lead to 
intermediate effects, such as greater access to HIV testing or decreased risk behavior, which 
themselves are associated with the primary effect of PrEP initiation. Using the difference 
method for a set of Cox proportional hazards models similar to those in the Aim 2 analyses, log 
coefficients for the indirect effects will be subtracted from log coefficients for the direct effect to 
estimate the size of the mediation.41 Mediators will be selected on the variables known to be 
associated with the 4 domains of the PrEP continuum (including awareness, access, and 
engagement with HIV prevention services), and changes in risk behaviors resulting from app 
utilization.
Moderation Analysis: This analysis will examine how attitudes and beliefs about PrEP, as well 
as individual, social, and community characteristics can moderate the effect of the app on PrEP 
initiation. Examples of moderators include perceived benefits of PrEP use, self-assessed 

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vulnerability to HIV, perceived advantages to meeting partners if currently taking PrEP, and 
social support for PrEP use within one’s social network. Demographic factors such as age, 
race/ethnicity, and geographic setting will also be critical moderators. Although the distribution 
of these factors will be balanced across study arm with randomization, they may have effects on 
the level of engagement in the app (i.e., post-randomization treatment adherence) that itself will 
influence the rate of PrEP initiation. Given this causal model, we will use instrumental variable 
analyses to estimate the effect of optimal app use on PrEP initiation given measured and 
unmeasured moderators.42 
In-Depth Interview Data Analysis: All IDIs will be digitally recorded, transcribed verbatim, and 
de-identified. Transcripts will be entered into MAXQDA, which facilitates the processes of 
coding, annotating, and retrieving text such that analysts may note patterns in the textual data 
across themes. Data analyses will be conducted using a phenomenological inquiry 
framework.54,55 Phenomenology is focused on describing what a given group of people have in 
common as they experience a phenomenon, and is an inductive analytic approach that allows 
the patterns, themes, and categories of analysis to emerge from data.54,55 Data are then 
presented through textual phenomena descriptions based on summaries of experiences 
described by respondents. Composite descriptions offer explanation of underlying structures 
which exist across the respondents’ experiences.54,56
Our data analysis team will consist of lead analysts and trained analysts at Emory. Analysts will 
have had previous experience with thematic coding and will attend training on coding guidelines 
to ensure consistency. After close readings of the text, the lead analysts will create a preliminary 
codebook to capture emergent themes. We anticipate developing a codebook consisting of 12-
15 codes representing key project themes, including explicit domains from the interview guides 
and from the theoretical basis of our app (deductive themes) and pervasive, unanticipated 
themes that were emergent across various transcripts (inductive themes). Provisional definitions 
will be given to each code. The preliminary codebook will be presented to other analysts (per 
the phenomenological approach) and a group discussion will occur. After edits are made to the 
codebook, all analysts will apply the preliminary codebook to a single transcript. The coded 
transcripts will be merged for comparison and code definitions will be revised based on an 
examination of coding disagreement. This process will be repeated until consistent agreement is 
attained among all coders. A finalized codebook will be created and the trained analysts will 
start coding (from scratch) all of the textual data for the project. Coders will also develop brief 
summaries to describe individual participants in order to help contextualize the thematic 
analysis across individuals. MAXQDA’s search and retrieve functions will then be used to review 
coded data and identify patterns, including similarities and differences across study sites.
13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
Study staff will maintain appropriate medical and research records for this study, in compliance 
with ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of subjects.  Study staff will permit authorized representatives of NIDA and 
regulatory agencies to examine (and when required by applicable law, to copy) research 
records for the purposes of quality assurance reviews, audits, and evaluation of the study 
safety, progress and data validity.  

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14 QUALITY CONTROL AND QUALITY ASSURANCE
The main sources of possible data entry errors will lie with the matching of study ID numbers 
and participant identifying information and with capturing of participant information from mail in-
specimens.  This risk will be mitigated by identifying any mail-in specimen with a possible 
discrepancy in linking with study ID; such specimens will not be processed and participants will 
be requested to provide a new specimen. For app-based and survey-based data, the participant 
identifiers are associated with the electronic record automatically, so the chance of problems 
with attribution of responses to the incorrect participant is very small.
For study IDs, the files linking the study ID and identifying information will be generated through 
a SAS program that retrieves data entered by the participant at the time of enrollment.  
For mailed-in specimens, all specimen tubes will be labelled with a unique ID number, which will 
be the same for all tubes in one specimen collection kit, i.e. the box ID. Participants will be 
asked to register this box ID using a unique URL linked to their study ID. This will allow linkage 
of specimen test results back to the correct participant. 
14.1
Recontacting Past Participants
Participants who reported PrEP initiation on a monthly check-in survey but not a quarterly 
survey (primary study outcome) will be contacted for clarification. Only the participants who 
previously provided consent to be recontacted will receive a message. A $20 compensation in 
the form of electronic gift code will be given to those participants who respond.
Voicemail: Hi, this is [insert your name] calling from Emory with the HealthMindr study. You 
have reported starting PrEP during our research study, but you also reported that you have not 
started PrEP in surveys afterwards. I was hoping to verify some information from your time in 
the study. You are eligible to receive additional compensation for your response. You can call 
us back at [phone number]. Or feel free to text me and let me know what the best time is for a 
call. Thank you!
Phone Script: Hello, may I speak with [PARTICIPANT’S NAME]? My name is [insert your 
name]. I am with Emory working on the HealthMindr study. You have reported starting PrEP 
during our research study, but you also reported that you have not started PrEP in surveys 
afterwards. According to your survey, you reported PrEP usage in [MONTH/YEAR]. Is this 
correct? Did you stop taking PrEP any time after?Thank you for your clarification. Also for the 
compensation, we will send you a $20 gift code. Do you have a preferred store? We have gift 
codes from Amazon, Target and Walmart.That is all the questions I have and thank you for 
participating in our research study!
Text Message: Hello! This is [NAME] from the Emory HealthMindr study. We were hoping to get 
you on a call for a few minutes to to verify some information from your time in the study and you 
will be compensated for your time. What time works best for you for a short phone call?

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS
15.1
Potential Risks and Benefits
15.1.1
Potential Risks
The potential risks to participants are minimal.
Surveys: Some participants may be uncomfortable answering personal questions, or feel 
uncomfortable with the HIV prevention topics. Men will have the option for all questions to not 
answer.
Disclosure of participation in a research study: There is a possibility that someone participating 
in an online data collection could be identified as participating in research, but this is 
uncommon.  There is some risk that those who participate in online surveys could be observed 
if they complete the surveys in public, or that data could be at risk during transmission. We will 
mitigate this risk by reminding participants at the beginning of each survey to complete the 
survey in a private place, where their responses cannot be observed by others. We will also 
encourage participants to delete any emails or text messages received as part of the study to 
protect them from an unauthorized individual viewing the messages.
15.1.2
Potential Benefits
There are no direct benefits for participating in this study. The potential benefits to study 
participants in the intervention group include access to HIV and STI testing, knowledge about 
serostatus, access to pre-exposure prophylaxis for HIV prevention, access to free condoms, 
ordered by participants through the study app and delivered through a parcel shipping service 
(e.g., UPS or FedEx), and access to information to promote personal health. Control arm 
participants might benefit from access to information about HIV prevention services.
15.2
Ethical Standard
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46 and/or the ICH E6. 
15.3
Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the Emory University IRB for review and approval.  Approval of both the protocol 
and the consent form must be obtained before any subject is enrolled.  Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented in the 
study. IRB authorization agreements (IAA) will be used between Emory University and each 
site. 
15.4
Informed Consent Process
Consent will be administered through the online screening and registration portal. Because men 
will not be enrolled and consented at an “in person” visit, the consent process will be online. 

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Therefore, a video-based online consent will be used, and the participant will be provided a PDF 
of the complete informed consent document.
The consent will be done in two stages, for screening and study enrollment. Due to the sensitive 
nature of screening questions regarding participants’ sexual history, all potential participants 
must consent to be screened before they can access the eligibility survey. The consent to 
screen form (Appendix A) will describe the nature of the study, the need to collect sensitive 
sexual health information in the screener, and what safeguards are in place to ensure the 
security and confidentiality of the screening data collected. 
Those determined to be eligible will be directed to an electronic informed consent form 
(Appendix B) presented online. The electronic informed consent document will explain: (1) what 
is meant by consent; (2) why we need to obtain consent and (3) the purpose of the consent 
form. Participants will also have access to a video describing the components of the informed 
consent document. Participants will be required to view the informed consent document before 
indicating whether or not they consent; this will be enforced by requiring participants to scroll 
through the entire consent before they can choose to consent to participate. Consent or lack 
thereof will be documented in the electronic database by the stored variable indicating consent 
or lack of consent. A button to allow participants to print or email the consent form for their 
records will be located at the end of the consent form document. The consent process will take 
approximately 5 minutes per individual. Study staff will be available during business hours by 
phone or by email to answer any questions that participants have prior to consenting. The 
consent forms have a Flesch-Kinkaid Reading Level of <8.5.
15.5
Exclusion of Women, Minorities, and Children (Special Populations)
Women, including transgender women, are excluded from the study because (1) effective HIV 
preventive interventions for women are likely to differ markedly from those focusing on men 
(particularly men who have sex with men), both in content and presentation; (2) the individual, 
socio-cultural and developmental factors associated with HIV risk in MSM are different from 
those for women; (3) the research questions and issues of relevance for MSM are not relevant 
or appropriate for women; (4) several effective HIV prevention interventions for women have 
already been developed, evaluated, and disseminated. 
People under age 18 are excluded from the study because (1) effective HIV preventive 
interventions for teenagers are likely to differ markedly from those focusing on young adults and 
adults, both in content and presentation; (2) the individual, socio-cultural and developmental 
factors associated with HIV risk in MSM under 18 are different from those for MSM 18 and up; 
and (3) the research questions and issues of relevance for MSM aged 18 and up may not be 
relevant or appropriate for MSM under age 18.
15.6
Subject Confidentiality
Our efforts to protect privacy and confidentiality are evident in several areas: study procedures, 
training, and data management practices.
Study procedures
We will collect multiple means of contact with participants at the study visit. For each means of 
permitted contact, we will leave a generic message about participation in a health research 
survey at that phone/email/cell phone, etc. Standardized scripts for phone and email contact will 

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be used (uploaded in the eIRB system for review). Participants are offered the option to receive 
STI testing results by email or text message; for those who so choose, the results messages will 
not identify the type of testing, the nature of the study, or the specific test names. Scripts for the 
return of results by email or text message are included in the "Miscellaneous Documents" 
section of the eIRB forms. 
Training
All study staff will have a 1-hour training on patient privacy and confidentiality. (Section 15.7) 
Staff will sign a confidentiality agreement (uploaded to eIRB) before having access to any 
confidential data. 
Data management practices
As described above, personally identifying information will be stored in a separate dataset from 
case report form data, test results, survey answers, and interview transcripts. Access to the 
identifying information will be restricted, so that persons who are responsible for scheduling can 
view contact information and next study visit due date, but no other study data. Similarly, 
persons who can view study data will only be able to see the study data and the (non-
identifying) study ID.
15.7
Future Use of Stored Specimens and Other Identifiable Data
No specimens will be stored for future use. Specimens returned for STI testing or TFV-DP 
testing will be destroyed after laboratory analysis. 
Additional data analyses beyond those described in this protocol will be performed. Study staff 
will continue to only have access to identifiable data only as needed.
15.8
Training
All study staff are required to complete the CITI training course modules on human subjects 
research, socio-behavioral science, and GCP.  Annual refresher training on human subjects is 
required every 3 years.  These requirements are tracked by the Emory IRB, and are verified for 
all new staff being added to the IRB protocol.  Certificates will be retained by the PI and 
available for review on request by the IRB or NIH staff.  Study staff will also receive study-
specific training on delivering STI test results, and will have completed CDC’s Fundamentals of 
HIV Prevention Counseling course before providing any test results.  All staff sign a 
confidentiality agreement and receive annual refresher training on protecting human subject’s 
information, PII, and protected health information (PHI).
16 DATA HANDLING AND RECORD KEEPING
16.1
Data Management 
Data will be stored in password-protected, encrypted files on Rollins School of Public Health 
computers and on secure Rollins and SurveyGizmo servers, both HIPAA compliant. 
SurveyGizmo has a HIPAA Business Associate agreement with Emory University. Databases of 
participant identifying information (contact information such as names, emails, and phone 
numbers) will not be linked to databases with participant data. Participant identifying information 
will only be linked to whether the participant completes study procedures, needs to be re-

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contacted, or refuses to participate. The name, e-mail, and phone number of screened men who 
decline to be scheduled for participation will be removed from the study database after we have 
asked them questions about why they have a lack of interest in proceeding, unless they request 
to be contacted for future studies. Access to the identifying information will be on a role-based 
system: access to identifying information will be restricted to those who need access to perform 
their work function.  Thus, access to identifying information will be restricted to the Project 
Coordinator, study staff providing counseling/referral services, and 2-3 work study students 
charged with data entry and scheduling tasks.   
16.2
Procedures for Prevention and Addressing Breaches of Confidentiality 
The main approach to preventing breaches of confidentiality is to maintain identifying participant 
information in a single location at each site and to use a non-personally identifying study ID to 
store all other study data. 
The study will use a HIPAA-compliant web-based platform entitled Study Management and 
Retention Toolkit (SMART), which is a SaaS (Software as a Service) based mobile application 
aiding studies with various aspects of participant recruitment, study implementation, and 
retention. The application has the ability to securely manage participant information across 
multiple studies and customers simultaneously, stratifying participant information by study and 
site. SMART includes an admin web portal and a participant facing mobile app (optional), which 
allows for secure messaging, study calendar management, self-scheduling by participants, 
secure photo uploads, and longitudinal tracking of participants from screening to study 
completion. The ability to designate specific roles to all SMART users allows for greater control 
around permissions and accessibility to participant information. Users can even be limited to a 
reporting only role, which allows for study oversight through real time aggregate reporting, but 
no access to PHI. SMART is a licensed service of the Center for AIDS Research (CFAR) at 
Emory University, Prevention Science Core. Utilization of the mobile app is optional and the 
admin web portal will fully function without it. 
The following information outlines the security of the three SMART components: (1) the admin 
web portal, (2) the participant app, and (3) a web service that acts as a liaison between the 
mobile app and the study database. 
Admin Web Portal. The admin web portal is a web-based application developed using Microsoft 
.NET technologies. It uses SQL server as backend database. The application requires two 
servers to host: (1) Web server [Windows server with IIS] and (2) SQL server [Standard or 
Enterprise version]. Both these servers are to be placed behind a firewall. Web server will have 
a public IP to access the server using VPN. SSL certificate is to be installed on the web server. 
The admin website will be rendered over SSL (https). The application uses form authentication 
(no integrated authentication such as AD). All passwords are stored encrypted within the 
database. System will also be using database level encryption, which will prevent any copying 
of information from one database to another. Web application also uses an automatic logout 
feature after a certain period of inactivity. By default, the inactivity duration is set to three 
minutes. 
Study staff can only first gain access to the admin web portal if granted by a study or site 
administrator. Their assigned user role will determine their permissions to perform different 
actions and even view PHI. Email notifications are sent from the system (without the need to 
login) when: (1) a staff member requests to reset their password, (2) role assignments to a 
study are made, (3) an event/visit staff are scheduled to work is nearing, (4) a new task is 

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assigned to a staff member, or (5) they are designated as a staff member to receive alerts of 
positive test results. All participant communications are performed using secure messaging 
through the message center (inbox) implementation within the mobile app. If the mobile app is 
not utilized by a study, communications are sent as standard email or text messages to 
participants. 
Mobile App. The mobile app, developed natively for iOS and Android platforms and available for 
free in the App Store and Google Play Store, is an optional feature the study can utilize for self-
scheduling, communication, photo uploads, and updating contact information. The study will 
indicate during the initial setup within the admin web portal whether the participant mobile app is 
utilized or not. If the app is utilized, participants will receive download instructions after their 
information is entered into the admin web portal. Only participants listed in an active study who 
validate their email or phone number against the contact information listed in the admin web 
portal will be able to proceed into the app. For validation, the app uses both traditional form 
authentication as well as social login (Facebook and Google). The social login feature will only 
work if the email associated with either social account matches the contact information within 
the admin web portal. The app does not request anything other than basic information from 
these authentication services. Participants cannot “remember” their password on the mobile 
device for automatic logins to ensure privacy. All participant data and activity status is 
maintained within a secure and encrypted SQL Server database. To create the connection 
between the admin web portal and the mobile app, each participant is assigned a unique ID 
within the application, which is associated with their login credentials. When a participant has 
been successfully authenticated through the mobile app, the admin web portal will send their 
specific information to their phone through the established secure session (web APIs using 
SSL). The app will not store the information presented locally on the phone. Local data storage 
is used only for storing some minimal non-PHI information, such as app settings. The mobile 
app implements an automatic logout when there is inactivity for more than three minutes. If a 
participant should need to re-download the app on a new device, login and password 
authentication will be required again. 
The mobile app has push notifications that are primarily used for reminders and notifications of 
new messages. Push notifications displayed on the participant’s phone will be generic in nature 
and not contain any PHI. Reminders and notifications within the mobile app inbox will also be 
generic in nature, with any message containing sensitive information requiring a pin, established 
during registration as a secondary authentication, to open within the mobile app. Firebase cloud 
messaging service is used as a communication channel for these notifications. No PHI is 
passed through Firebase. Push notifications are customizable in the study setup, and samples 
of system notifications include: “You have a new message in your inbox,” “You have an 
upcoming event for March 7, 2018,” and “You have a pending task.” 
Web Service. A web service will also be hosted on the web server. This service is used by the 
mobile application to retrieve and store data. The service will utilize secure socket layer (SSL) 
for communication.
The HealthMindr app itself also has protections for breach of confidentiality. The app requires 
re-authentication through a user-selected password or proxy (e.g., fingerprint authentication) if 
the app has been navigated away from, or if more than 5 minutes pass without interaction.  This 
is similar to security functions that are in place for other apps with sensitive information (such as 
banking or apps allowing access to medical records).  

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To minimize risks to confidentiality, we will provide study data with all appropriate physical and 
operational security protections. Paper-based data will be stored in a locked cabinet in a locked 
office, and all data files will have encryption and strong password protection. Access to data will 
be on a role-based standard; only those study staff, such as principal and co-investigators, data 
managers, data analysts, study staff (public health program associates and assistant or 
associate directors of research), and graduate research assistants, who require access to 
identifying data to complete their study-related roles will be allowed access. Any photographs 
(i.e., PrEP prescriptions or bottle labels) will be sent to study staff securely through the app. 
SurveyGizmo, the electronic platform for self-interview, has a HIPAA business partner 
agreement with Emory. All study staff will complete CITI course modules on human subjects 
research ethics, socio-behavioral research, and good clinical practice (GCP), will be trained in 
security and confidentiality procedures, and will sign a confidentiality agreement before 
receiving access to any participant data. Any breaches in confidentiality will immediately be 
reported to the PI and to the IRB. Based on the PI and IRB’s recommendation, staff may be 
retrained or receive disciplinary action.
Study staff will follow procedures to minimize indirect disclosure that a participant is participating 
in an HIV-related research study, or a study that enrolls MSM. For each mode of contact 
information, including email, telephone, text, and voicemail, we will ask specifically whether 
anyone else potentially has access to that mode of communication, and if it is acceptable to 
leave a non-specific message about participation in a health study. No study-related messages 
to the participant will ever mention HIV prevention or the nature of the research study. 
Additionally, all scripts for email, text message, and telephone contact with participants will be 
reviewed and approved by the Emory IRB before being used for contact with participants.
16.3
Data Capture Methods
Data collected through the mobile app: Participants will use a mobile phone app to get 
information about HIV prevention and referrals to local services.  As participants use the app, 
data about which features they used are entered directly by the participant in the process of 
interacting with the study app or control app.  
Data collected through the online survey interface: Participants will also take surveys through an 
online survey portal.  Data are collected directly on the private server as participants respond to 
questions. Data will be identified in the system through a Study ID.  Surveys are conducted 
using a secure (https://) webpage, which means that data entered by participants are encrypted 
before they are sent through the internet, and are decrypted once received by the survey 
hosting site. The link between the participant and the participant contact information is held by 
Emory University research staff.
Data collected through mail in-specimens: Participants who request STI testing will mail in urine, 
rectal swab, throat swab, and blood specimens for testing. All mailed-in specimens will be 
labelled with a unique ID number, which will be the same for all tubes in one specimen 
collection kit, i.e. the box ID. Participants will be asked to register this box ID using a unique 
URL linked to their study ID. This will allow linkage of specimen test results back to the correct 
participant. 
Electronic CRFs through DFexplore will be used for any data collection unable to be completed 
through the surveys and HealthMindr database, such as study withdrawal or adverse events. 
Data entry will be conducted by IRB-approved staff. Forms are double checked, and 

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electronically verified for possible discrepancies. Any possible discrepancies are resolved by re-
review by a third, more senior data manager.
16.4
Types of Data
Data collected through interactions with the app:
Data will be recorded as participants request certain app pages or functions. Each time the 
participant touches a button or navigation function in the app, that piece of data is stored in the 
administrative portal of the app.  Data are stored with a 16-digit alphanumeric string which is 
unique to the participant, and is not stored with identifying information for the participant.  The 
link between the alphanumeric string and the participant contact information is held by Emory 
University research staff.
Management and storage: 
Data within the study app: Data are stored in a secure, HIPAA compliant server in the cloud. 
Access to app data are password protected, and access is role-based. Access to participant 
data will be limited to study staff approved by IRB in each site, comprising principal and co-
investigators, data managers, data analysts, study staff, and graduate research assistants.  
Software developers will have access to administrative aspects of the management portal, but 
will not routinely have access to links to Study IDs or personally identifying information (PII).  In 
the case of a “need to know” for study related purposes (for example, duplicate or corrupted 
files, need to examine specific records to troubleshoot app or data functions) temporary access 
can be granted to developers, whose access will be limited to the specific records required to 
resolve the problem.  Any developer who needs such access will be required to complete CITI 
training, complete a PRISM data confidentiality form, and be added to the IRB protocol.  Access 
to participant-identifying information will be removed after the specific problem is resolved.
Security protections of identifying information:  Identifying information will be held in a secure 
study database at each study site.   Identifying data will be stored in the System for 
Management and Reporting of Trials (SMART), an IT solution provided by the Emory University 
CFAR and hosted on a secure cloud-based server at each of the three participating institutions.  
Access is role-based, and is protected through institutional firewalls and password procedures 
at Emory University, George Washington University, and the University of Mississippi Medical 
Center, respectively.
Data collection through Case Report Forms:
Collection: Data will be entered in DFexplore on electronic CRFs for enrollment, randomization, 
study stop, and reportable events. The records will be stored by Study ID and not include 
participant names.  
Management and storage: Data will be stored in a cloud-based LINUX Microsoft Azure server 
managed by DF/net, the company of that manages DFexplore. The data will then be 
downloaded onto secure Emory servers. Emory has BAA with DF/net and data will only be 
accessible to persons who have been provided with login and passwords. 
Data collection through online surveys:

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Collection: Data will be recorded as participants respond to questions in an online survey portal 
(SurveyGizmo) from a web browser, smartphone or tablet.  Data will be identified in the system 
through a Study ID.  Surveys are conducted using a secure (https://) webpage, which means 
that data entered by participants are encrypted before they are sent through the internet, and 
are decrypted once received by the survey hosting site. The link between the participant and the 
participant contact information is held by Emory University research staff.   For images of 
prescriptions or pill bottles, we will use a secure survey form to transmit the upload of the image 
file, and it will be treated under the same confidentiality protections as other study data (e.g., 
stored on a secure server).  The image data will be stored on the same server as the 
questionnaires data, subject to the same physical and procedural security measures described 
for the survey data.
Management and storage: Data at SurveyGizmo are stored in a secure, HIPAA compliant 
server in the physical facility in Boulder, Colorado.  Emory’s subscription to the SurveyGizmo 
service includes a private server so data are not co-mingled with other study data, and a HIPAA 
Business Partner Agreement is in place between Emory University and SurveyGizmo.  Access 
to participant data will be limited to study staff approved by IRB in each site. All survey and 
image data are maintained in a backup system.  First, all data are encrypted at three levels – at 
the row level, at the project level, and at the disk level.  Once data are encrypted, protected 
backups are stored in the cloud using Amazon Simple Storage Service (Amazon S3), which is 
designed to deliver 99.999999999% durability.  In addition to this, data is backed up using 
Amazon Elastic Block Store (EBS) snapshots, which are used as a primary storage device for 
data that require frequent and granular updates. Automated encrypted snapshots (differentials) 
of databases are performed daily, and all data storage is redundant.  Redundant databases 
reside in a private subnet that is only accessible via the SurveyGizmo application and web 
servers. Additionally, Amazon’s AWS security features to further “lock down” access to these 
systems. Data are only able to be transmitted through secure (https://) connections.
Security protections of identifying information:  Data are held on a private, physically-secured 
server in Boulder Colorado, and password-protected restrictions to access are in place for all 
study staff.
Data collected through mail-in specimens
Collection: Participants will collect a dried blood spot specimen at home, using a collection kit 
provided by the study.  Kits will be distributed with specimen collection tubes marked with a 
specimen ID .  Links between specimen ID and Study ID will be maintained  in a password 
protected database.  Links between specimen and Study IDs will be available only to staff who 
are responsible for linking study data (e.g., principal and co-investigators, data managers, data 
analysts, study staff , and graduate research assistants). An instructional video will be provided 
for participants and available through an online video facility.  Participants will be provided with 
instructions to prepare and mail the dried blood spot through US mail to Emory University or 
specified laboratory.
Management and storage: Specimens received through US mail  will be logged in and stored at 
-20 degrees. Specimens will be shipped in batches to the University of North Carolina CFAR 
lab, where testing for tenofovir will be conducted. Specimens will be identified by the participant 
study identifier and results will be reported from UNC to the Emory CFAR lab using the same 
specimen ID. Links between the study ID and participant identifying information will be held on a 
secure server .

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Security protections of identifying information: Identifying information will be held with Study IDs 
on a private, secure server at Emory University, and password-protected restrictions to access 
are in place for all study staff.  Dual-factor authentication is required for off-campus access.
Data collected through individual In-Depth interviews:
Collection: Interviews will be conducted through a HIPAA-compliant online platform, such as 
VSee or Zoom. Both platforms have end-to-end encryption to prevent 3rd party tampering. Data 
will be recorded as participants answer questions from a trained interviewer in a confidential 
space. Recorded files will be uploaded to a secure server at Emory University as mp3 files. The 
Study ID will be used in the file naming convention of the file, but no PII will be included in the 
file itself or in the naming convention.
Management and storage: Study forms and audio recorders will be kept in locked file cabinets 
at the project sites for the duration of the study. After each interview, the audio file will be 
uploaded to a secure server at Emory University and deleted from the recording device. All 
study data will reside in a secure SQL server file behind Emory’s IT firewall.  Dual-factor 
authentication is required for access off the University campus. Access to participant data will 
be limited to study staff approved by IRB in each site. Data will be transmitted via a secure 
(https://) web connection to a 3rd-party, licensed HIPAA-compliant transcription service. Data 
files will never be on a physical device, such as a flash drive, which would be lost or stolen.  
Data security protocols at the 3-rd party transcription service are governed by their organization 
policies and procedures, but must be HIPPA compliant.  Transcripts will be returned to Emory 
via a secure, password protected file transfer protocol.  The transcription service will be 
instructed to destroy all recordings upon completing each transcript. Upon receipt and 
confirmation of each transcript’s quality and accuracy, the study staff will destroy all backup 
copies of the original recording files. Transcripts and file names will not contain any identifying 
information, referring to interviews by participant study ID. Links between study ID and 
participant identifying information will be held in separate electronic files at Emory University, 
consisting of a database file that contains both the Study ID and the participant name and 
contact information.  This will allow most study data to be stored using on the Study ID, 
minimizing the impact of any breach of security for data files in which records are identified only 
by the study ID.
Security protections of identifying information: Audio recordings and transcribed data will be 
held on secure services with role-based access and password-protected restrictions to access. 
Only study staff approved by the IRB will be able to access the recordings or data. Once 
transcriptions are verified, audio recordings will be destroyed.
Combined data sets: Data from different modes of collection (app, lab, surveys) will be merged 
into a study data file which will be kept on the secure network drive at Emory.  Access will be 
limited to the PI, Public Health Program Associates, Data managers, and Graduate Research 
Assistants who work in data entry or management.  Backup copies are made daily and stored 
behind Emory’s institutional firewall.  Access to the combined study data file can only be gained 
either by being in an Emory building and accessing through an account with permission to read 
the data, or from off campus through a permitted account and with dual-factor authentication.

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16.5
Protocol Deviations
All protocol deviations and violations will be reported to NIDA at the time of submission to the 
Emory IRB, and at the time of disposition from the Emory IRB.  The latter reports will include 
any required actions specified by the IRB.
17 PUBLICATION/DATA SHARING POLICY
Any presentation, abstract or manuscript will be made available for review by the study 
sponsors prior to submission.  

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J.F. Rooney, H.S. Jaffe, A.I. Martinez, D.N. Burns, and D.V. Glidden, Preexposure 
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Holtgrave, D.R., When “heightened” means “lessened”: the case of HIV prevention 
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prevention in men who have sex with men. Lancet, 2012. 380(9839): p. 388-99.
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Khanna, A., S.M. Goodreau, D. Wohlfeiler, E. Daar, S. Little, and P.M. Gorbach, 
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Valleroy, D. Mackellar, S. Behel, and G. Paz-Bailey, Trends in HIV Prevalence and HIV 
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SUPPLEMENTAL MATERIALS
These documents are relevant to the protocol, but they are not considered part of the protocol.  
They are stored and modified separately. As such, modifications to these documents do not 
require protocol amendments.

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APPENDICES

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APPENDIX A: Screening Informed Consent Form

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APPENDIX B: Enrollment Informed Consent Form

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APPENDIX C: PrEP and HIV Testing Resources
A list of existing resources that might be included on the resources page can be found below.
PrEP Resources

Centers for Disease Control PrEP Resources,
https://www.cdc.gov/actagainstaids/campaigns/starttalking/materials/prepresources.html

The Fenway Institute: What is PrEP?, http://thefenwayinstitute.org/prepinfo/

PrEP Locator, https://preplocator.org/

AIDS.gov PrEP Information Page, https://www.aids.gov/hiv-aids-
basics/prevention/reduce-yourrisk/pre-exposure-prophylaxis/
HIV Testing Resources

Centers for Disease Control HIV Testing Locator, https://gettested.cdc.gov/

Centers for Disease Control HIV Testing Information Page, 
https://www.cdc.gov/hiv/testing/

AIDS.gov HIV Testing Locator, https://www.aids.gov/hiv-aids-basics/prevention/hiv-
testing/hiv-testlocations/

AIDSvu HIV Testing Locator, https://aidsvu.org/locators/testing-sites/