Mobile-Based Application "MyChoices" to Increase Uptake of HIV Testing, Detection of New HIV Infections, and Linkage to Care and Prevention Services by Young Men Who Have Sex With Men
Phase: NA
Conditions: HIV, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
Sponsor: Fenway Community Health

Behavioral Template_Final_R2_200807 
 
 
 
Version 3.2 
February 8, 2019 
 
 
ATN 141 - MyChoices:  
Mobile-Based Application to Increase Uptake of HIV Testing, Detection of New HIV Infections, 
and Linkage to Care and Prevention Services by Young Men who have Sex with Men 
 
 
Sponsored by: 
The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD) 
 
 
with co-funding from: 
 
The National Institute on Drug Abuse (NIDA) 
 
The National Institute of Mental Health (NIMH) 
 
 
 
 
 
 
 
 
Protocol Co-Chair: 
Katie Biello, PhD, MPH 
 
Assistant Professor 
Departments of Behavioral & Social 
Sciences and Epidemiology 
 
Center for Health Equity Research (CHER) 
 
Brown University School of Public Health  
Box G-S121-8 
Providence, RI 02912 
 
katie_biello@brown.edu 
 
Protocol Co-Chair: 
Kenneth Mayer, MD 
Medical Research Director 
Fenway Health 
Co-Director 
The Fenway Institute 
1340 Boylston Street 
Boston, MA 02215 
kmayer@fenwayhealth.org 
 

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ATN 141 - MyChoices:  
Mobile-Based Application to Increase Uptake of HIV Testing, Detection of New HIV Infections, 
and Linkage to Care and Prevention Services by Young Men who have Sex with Men 
 
 
 
 
 
SIGNATURE PAGE 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable U.S. Food and Drug 
Administration regulations; standards of the International Conference on Harmonization Guideline 
for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee determinations; all 
applicable in-country, state, and local laws and regulations; and other applicable requirements 
(e.g., US National Institutes of Health, Division of AIDS) and institutional policies. 
 
 
Investigator of Record: _______________________________________________ 
Print/Type 
 
 
 
 
 
Signed: ___________________________________ Date: ____________________ 
 
 
Title: _____________________________________ 
 
 

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PROTOCOL TEAM ROSTER 
Matthew Mimiaga, ScD, MPH 
Co-Investigator 
Center for Health Equity Research (CHER) 
Brown University School of Public Health  
Box G-S121-8 
Providence, RI 02912 
matthew_mimiaga@brown.edu 
 
Julian Dormitzer, RN 
Project Manager 
The Fenway Institute 
1340 Boylston St. 
Boston, MA 02215 
jdormitzer@fenwayhealth.org 
 
Donna Futterman, MD 
Site PI 
Montefiore Medical Center 
111 East 210th Street 
Bronx, NY 10467 
dfutterman@adolescentaids.org 
 
 
 

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Table of Contents 
 
 
PROTOCOL TEAM ROSTER .................................................................................................... 3 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................... 6 
STUDY ABSTRACT ................................................................................................................... 7 
1.0 Introduction .......................................................................................................................... 9 
1.1  
Background.................................................................................................................. 9 
1.2  
Rationale ..................................................................................................................... 9 
2.0  
Study Objectives ............................................................................................................10 
2.1  
Primary Objectives ......................................................................................................10 
2.2  
Study Hypotheses/Research Questions ......................................................................11 
Primary Objectives: ................................................................................................................11 
Aim 3 Secondary Objectives: .................................................................................................12 
Study Hypotheses/Research Questions .................................................................................12 
3.0 
Study Design ..................................................................................................................12 
3.1  
Study Population .........................................................................................................15 
3.2 
Sample Size................................................................................................................15 
4.0  
Selection And Enrollment Of Study Participants .............................................................16 
4.1 
Inclusion Criteria .........................................................................................................16 
4.2 
Exclusion Criteria ........................................................................................................16 
4.3 
Recruitment ................................................................................................................17 
4.4 
Informed Consent .......................................................................................................17 
4.5 
Screening ...................................................................................................................19 
5.0 
 Study Procedures ..........................................................................................................20 
5.1 Enrollment .......................................................................................................................20 
5.2 
Locator/Contact Information ........................................................................................20 
5.3 
Randomization Procedures .........................................................................................21 
5.4 
Intervention/Investigation Procedures .........................................................................21 
6.0 
Evaluations and Measures .............................................................................................24 
6.1 
Aim 1: Focus groups ...................................................................................................24 
6.2 
Aims 2 and 3: Open technical pilot and pilot RCT .......................................................25 
7.0  
Data Collection And Site Monitoring ...............................................................................28 

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7.1 
Development of Protocol and Case Report Forms ......................................................28 
7.2 
Data Records ..............................................................................................................28 
7.3  
Data Collection ...........................................................................................................28 
7.4 
Data Submission .........................................................................................................30 
7.5 
Data Quality Assurance ..............................................................................................33 
7.6 
Role of Data Management ..........................................................................................33 
7.7 
Study Site Monitoring and Record Availability .............................................................33 
8.0 
Participant Management .................................................................................................33 
8.1 
Tracking Participants / Follow-up ................................................................................33 
8.2 
Compensation .............................................................................................................34 
8.3 
Intervening on “Social Harms" .....................................................................................34 
8.4 
Criteria for Premature Study Discontinuation ..............................................................35 
9.0  
Monitoring Untoward Effects Associated With Or Resulting From Study .........................35 
10.0  Statistical/Analytic Considerations ..................................................................................36 
10.1 
Introduction .................................................................................................................36 
10.2 
Power Estimates .........................................................................................................37 
10.3  
Statistical Analysis Plan ...........................................................................................37 
10.4 
Missing Data ...............................................................................................................39 
11.0  Human Subjects .............................................................................................................40 
11.1 
Participants’ Confidentiality .........................................................................................40 
11.2 
Certificate of Confidentiality ........................................................................................41 
11.3 
Risks and Benefits ......................................................................................................41 
11.4 
Institutional Review Board (IRB) Review and Informed Consent .................................43 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances ..........43 
11.6 
Waiver of the Requirement for Signed Consent Form .................................................44 
11.7  
Prisoner Participation ..............................................................................................45 
11.8 
45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health 
Information ("Privacy Rule" Pursuant to the Health Insurance Portability and Accountability Act 
- HIPAA) ................................................................................................................................45 
11.9 Repository Policies (if applicable) ..................................................................................45 
11.10 
Study Discontinuation ..............................................................................................45 
12.0  Publication of Research Findings ...................................................................................46 
13.0  Biohazard Containment ..................................................................................................46 
14.0  References .....................................................................................................................47 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
AC 
 
 
Analytic Core 
AE 
 
 
Adverse Event  
AIDS  
 
Acquired Immunodeficiency Syndrome 
ATN 
 
 
Adolescent Medicine Trials Network for HIV/AIDS Interventions 
ARBA  
 
AIDS Risk Behavior Assessment 
BAA 
 
 
Business Associate Agreement 
CASI  
 
Computer Assisted Self-Interview 
CFR 
 
 
Code of Federal Regulations 
CRF 
 
 
Case Report Form 
DHHS  
 
U.S. Department of Health and Human Services 
EC 
 
 
Ethics Committee 
GCP 
 
 
Good Clinical Practices 
HIPAA  
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IRB 
 
 
Institutional Review Board 
LGBT  
 
Lesbian, Gay, Bisexual, and Transgender 
MC 
 
 
Management Core 
NICHD  
 
National Institute of Child Health and Development 
NIDA  
 
National Institute on Drug Abuse  
NIH 
 
 
National Institutes of Health 
PI 
 
 
Principal Investigator 
PrEP  
 
Pre-Exposure Prophylaxis   
OHRP  
 
Office of Human Research Protection 
QNS 
 
 
Query and Notification System 
QR 
 
 
Quick Response (Code) 
QA 
 
 
Quality Assurance 
RCT 
 
 
Randomized Controlled Trial 
RDC 
 
 
Remote Data Capture 
SAE 
 
 
Serious Adverse Event 
SCT 
 
 
Social Cognitive Theory 
SID 
 
 
Study Identification Number 
SMART 
 
Study Management and Retention Tool 
SMS 
 
 
Short Message Service 
SOC 
 
 
Standard of Care 
SRV 
 
 
Subject Recruitment Venue 
SUS 
 
 
System Usability Scale 
TC 
 
 
Technology Core 
UAE 
 
 
Unanticipated Adverse Event 
UNC- CH 
 
The University of North Carolina at Chapel Hill 
YMSM  
 
Young Men who have Sex with Men  
 

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STUDY ABSTRACT 
 
 
DESIGN:  
“MyChoices”, an app developed using iterative feedback 
from youth, will be refined through theater testing in focus 
groups (Aim 1) and an open technical pilot (Aim 2) with 
young men who have sex with men (YMSM) at iTech 
SRVs in Boston, MA, Bronx, NY, Chapel Hill, NC, and/or 
Atlanta, GA. To plan for an R01 efficacy trial proposed for 
years 3-5 of the current iTech project, we will conduct a 
pilot randomized controlled trial (Aim 3) to assess 
acceptability, feasibility, and preliminary efficacy of 
MyChoices. 
 
 
DURATION: 
Aim 1: single study visit (focus group) for theater testing  
 
Aim 2: 2 months 
 
Aim 3: 6 months 
 
 
SAMPLE SIZE: 
Aim 1:  Up to 40 YMSM across two iTech SRVs 
 
Aim 2:  Up to 15 YMSM across two iTech SRVs 
 
Aim 3:  Up to 60 YMSM across two to four iTech SRVs 
(~15 to 30 per SRV) 
 
 
POPULATION:  
● Between 15 and 24 years of age 
● HIV uninfected (or HIV status unknown) 
● Assigned male sex at birth and identifies as male 
● Have not had an HIV test within past 3 months (for 
Aims 2 and 3) 
● Not currently on PrEP regimen (for Aims 2 and 3) 
● High-risk for acquiring HIV via sexual transmission 
● Own or lease Android mobile phone (for Aims 2 and 
3) 
● Able to understand, read, and speak English 
 
 
STRATIFICATION:  
Participants in Aim 3 will be randomized 2:1 to receive the 
MyChoices app vs. Standard of Care 
 
 
DATA 
COLLECTION: 
Aim 1: Focus groups will be audio-recorded and 
participants will complete a brief demographic 
questionnaire. 
 

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Aim 2: At enrollment and study completion, participants will 
complete a brief quantitative assessment (in person at 
baseline and online at follow-up); online qualitative exit 
interviews will be conducted; and app usage patterns will 
be assessed. 
 
Aim 3: At Month 3 and Month 6 after enrollment/baseline, 
all participants will 
complete a brief quantitative 
assessment (in person at baseline and online at follow-up) 
and app usage patterns will be assessed. An online 
qualitative exit interview will be conducted for up to 20 
participants.   
 
 
OBJECTIVES 
1) To refine a mobile phone app, “MyChoices,” to promote 
HIV/STI testing and PrEP uptake among YMSM by 
conducting theater testing with up to 40 YMSM. Data will 
be used to make final app refinements. 
 
2) To conduct a technical pilot with up to 15 YMSM to 
optimize 
MyChoices 
app 
functionality, 
technical 
performance, and user satisfaction. Data will be used to 
finalize the pilot study methods, the mobile app 
functionalities, and measures for the pilot trial (Aim 3). 
 
3) To conduct a pilot randomized controlled trial (RCT) with 
up to 60 YMSM to evaluate the feasibility and acceptability 
of MyChoices to increase HIV/STI testing and PrEP uptake 
among YMSM. 
 
 
 
 

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1.0 INTRODUCTION 
1.1  
Background 
HIV incidence is growing most rapidly among young men who have sex with men 
(YMSM) in the United States (US). Moreover, among all MSM, YMSM account for 15% of new 
infections.1 Awareness of HIV status through routine HIV testing is essential for reducing the 
population burden of disease, as well as for improving health outcomes for those who are 
infected.3-5 However, it is estimated that, compared to the general population, a higher proportion 
of YMSM (13% vs. 44%, respectively) living with HIV do not know that they are infected. HIV-
infected black YMSM are 33% less likely to be aware of their HIV status.6, 7 
HIV testing among young adults is suboptimal. Data suggest that approximately 60% 
of YMSM do not get annual HIV tests.19 The normal developmental trajectory of adolescence and 
young adulthood involves behavioral experimenting, risk taking, and confronting a host of difficult 
choices with regard to identity formation.20 These age-appropriate behaviors, beliefs of 
invincibility, and still developing cognitive processes21 may play a role in increasing HIV risk-taking 
behaviors and placing a low priority on HIV testing.  
The ongoing and growing HIV risk for YMSM highlights the need to reach younger 
individuals using developmentally appropriate, innovative methods and modalities. In 
addition to expanding access to effective prevention modalities, innovative methods to reach 
YMSM “where they are” must be developed. Smartphone use is nearly universal among youth in 
the US.15 Younger adults, racial and ethnic minorities, and socioeconomically disadvantaged 
populations have been identified as having high rates of smartphone use, reducing concerns of 
inequitable access to the technology.16 The use of mobile phone applications (“apps”) is 
ubiquitous, and is a common way in which youth interact, get information, and meet sex partners. 
As such, mobile apps offer unique opportunities for public health interventions, including efforts 
to increase HIV testing, particularly for YMSM, who may be open to receiving information in a 
familiar and discreet environment. 
Although the popularity of mobile health apps (mHealth) is growing, there are 
limited data on the efficacy of app-based interventions to enhance HIV prevention and 
increase HIV testing among MSM, particularly YMSM. However, formative research suggests 
that online, mobile, or social media outlets are acceptable and feasible means to increase uptake 
of prevention services and HIV testing among MSM.10-14 Informed by extensive formative 
research, Dr. Patrick Sullivan of Emory University, with app developers from Keymind, developed 
and tested an HIV testing promotion app for adult MSM (“HealthMindr”). Our initial formative 
research with YMSM suggested interest in an HIV testing app, like HealthMindr, but the youth 
agreed that it had to be adapted to be more culturally and developmentally appropriate for their 
peers. 
 
1.2  
Rationale 
Advances in mobile phone technologies have enabled YMSM to have immediate access 
to broad social and sexual networks. The proposed project responds to the increasingly 
widespread use of mobile technology in the US. A recent review of the literature demonstrated 
that most mobile phone apps for HIV prevention are designed by non-academic, non-public 
health developers and are not guided by behavior change theories.24 Moreover, only a small 

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proportion of available HIV prevention mobile apps specifically address MSM populations, and 
none was developed specifically for YMSM.24  
Using HealthMindr as a starting point, our interdisciplinary team of HIV clinicians, 
epidemiologists, behavioral scientists, and app developers designed the “MyChoices” app by 
conducting formative work with YMSM in Boston, Chicago, and Los Angeles. MyChoices is 
informed by the Social Cognitive Theory (SCT) which specifies a core set of factors that 
influence health behavior with an emphasis on goal setting, self-efficacy, and self-regulation.22, 
23 SCT holds that cognition, behavior, and environmental influences interact and are reinforcing. 
For example, self-regulatory functions (e.g., self-monitoring one’s HIV testing) and self-efficacy 
(e.g., belief that one can attain the goal to test regularly) are enhanced by facilitative 
environmental conditions,22, 23 such as reminder systems. “MyChoices” uses interactive 
capabilities and environmental influences to support self-regulation and self-efficacy by 
enhancing the feeling of control over one’s ability to get tested regularly for HIV. For example, 
the app allows users to create an individualized HIV testing plan where youth are encouraged to 
select predetermined built in reminders which will alert them when it is time to get tested. The 
geofencing technology allows a user to be notified when they are near a testing location and 
when they are due for HIV testing. These techniques are expected to help overcome key 
barriers to HIV testing (e.g., being perceived as inconvenient), which we anticipate will increase 
self-efficacy and self-regulation, and consequently, change behavior. 
This study will provide the necessary data to make final refinements to the intervention in 
preparation for a multi-city, RCT of this app and another youth-optimized app (“LYNX”) versus 
standard of care among YMSM in Years 3-5 of the proposed iTech award period. If shown to be 
efficacious, to our knowledge, “MyChoices” will be the first comprehensive HIV prevention app 
designed specifically for YMSM. We anticipate that MyChoices will increase HIV testing and 
linkage to prevention services because it is developmentally appropriate and meets YMSM 
where they are, in an environment that is familiar and discreet.  
 
2.0  
STUDY OBJECTIVES 
2.1  
Primary Objectives 
Aim 1, Qualitative research for final app refinement (Months 1-9). To refine and enhance 
“MyChoices” components and to include additional components to increase PrEP uptake among 
YMSM, we will conduct qualitative research based on interactions with the current app (i.e., 
“theater testing”) with up to 40 YMSM in 2 SRV sites (~2 groups at each SRV). YMSM of color 
will be oversampled in order to reach a target enrollment of approximately 50% and ensure 
sufficient representation in the population with the most need. We will demonstrate the current 
mobile app to participants and elicit feedback on:  the overall appearance and functionality of 
the interface, appeal, and usability; ways to maximize acceptability; components that they like 
and/or dislike; and areas for improvement. Guided by the SCT model, we will elicit feedback on 
the following areas designed to increase PrEP uptake among YMSM:  1) potential content to 
address PrEP-related self-regulation (e.g., recommendations to speak with a provider about 
PrEP if their risk assessment indicates potential eligibility, and how their risk may be impacted if 
they take PrEP); 2) content and functionalities to improve PrEP use self-efficacy [e.g., videos 
showing couples discussing PrEP, GPS-enabled provision of links to local PrEP providers which 
allows them to manage their own PrEP care, and guidance on questions to ask providers about 
PrEP (e.g., dosing, side effects, necessary follow-up]); 3) potential content to address 

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environmental influences on PrEP uptake (e.g, information on insurance and other payment 
options for PrEP). We will ask participants about attitudes regarding documenting their testing 
practices and results through signed medical releases, sending photos of test results, and/or 
scanning a Quick Response (QR) code (i.e., barcode that is scanned at a testing site to “check 
in”) to document completed testing, for feasibility testing in the pilot RCT. Theater testing groups 
will last 60-90 minutes, and discussions will be audio recorded and transcribed verbatim. 
Facilitators will also take notes and complete standardized debriefing forms immediately 
following the visit so that data can be used in real-time to refine the app. 
 
Aim 2, Technical Pilot (Months 10-12). After refinement according to Aim 1 findings, the 
“MyChoices” app and intervention procedures will be evaluated and revised during a 2-month 
technical pilot with a small group of YMSM participants (up to 15 YMSM at two iTech sites). All 
participants will be given brief instructions on the purpose of the “MyChoices” app and an 
overview of how to use it. They will complete a brief online assessment (see Measures) at 
baseline and at the end of the 2-month follow up period. Participants will also be asked to 
provide feedback during exit interviews conducted by study staff online using VSee technology 
(described fully below) on functionality, technical performance, errors and bugs encountered, 
overall experiences using the app, and feedback for further refinement. These data will be used 
to refine the app, intervention protocol, and instruments to be tested in the pilot RCT (Aim 3). 
 
Aim 3, Pilot RCT (Months 13-24). We will conduct a feasibility and acceptability study of the 
app and evaluation of the app and its components for preliminary efficacy. This information will 
determine whether MyChoices moves forward to be tested in an efficacy trial in years 3-5 of the 
current iTech. We will enroll up to 60 YMSM across two to four iTech SRVs and randomize 
them to receive either 1) the “MyChoices” app and provision of referrals to local HIV/STI testing 
and PrEP resources (n=40); or 2) provision of referrals to local HIV/STI testing and PrEP 
resources (i.e., SOC) (n=20). Participants will be followed for 6 months and will complete a brief 
online assessment every 3 months. At 3 months post enrollment, all participants who 
seroconvert and up to 20 participants randomized to the intervention arm will also be asked to 
provide feedback during qualitative interviews conducted by study staff online using VSee 
technology (described fully below) on functionality, technical performance, errors and bugs 
encountered, overall experiences using the app, and feedback for further refinement. 
 
2.2  
Study Hypotheses/Research Questions   
Primary Objectives: 
Aim 1: To conduct qualitative, formative work to refine a mobile phone app, MyChoices, 
to promote HIV/STI testing and PrEP uptake among YMSM 
 
Aim 2: To conduct a technical pilot to optimize MyChoices app functionality, technical 
performance, and user satisfaction 
 
Aim 3: To conduct a pilot RCT to evaluate the feasibility and acceptability of MyChoices 
to increase HIV/STI testing and PrEP uptake among YMSM 
 

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Aim 3 Secondary Objectives: 
To compare the rate of HIV/STI testing in the MyChoices intervention 
vs. control arms  
To compare the rate of PrEP uptake in the MyChoices intervention vs. 
control arms 
To compare changes in sexual risk behaviors among YMSM in the 
MyChoices intervention vs. control arms 
 
Study Hypotheses/Research Questions 
Aim 1: Is the MyChoices app appealing to YMSM? What changes should be made to 
make it more acceptable to YMSM? 
 
Aim 2: Are the MyChoices app and study procedures and documents primed to be 
tested in a pilot trial? 
 
Aim 3: Is the MyChoices app a feasible and acceptable method to increase HIV testing 
and PrEP uptake among YMSM? Are there differences in HIV/STI testing and PrEP 
uptake among participants who receive MyChoices vs. the standard of care? 
 
The MyChoices app will be highly feasible and acceptable among 
YMSM aged 15-24. 
 
The MyChoices app will have preliminary efficacy in increasing 
HIV/STI testing and PrEP uptake.(secondary objective) 
 
3.0 
STUDY DESIGN 
MyChoices app was developed through an iterative process of app development. In the current 
study, “MyChoices” will be further refined through theater testing with ~ 4 focus groups with up 
to 40 YMSM (Aim 1) and an open technical pilot (Aim 2) with up to 15 YMSM at two iTech SRVs 
(Boston and Bronx). To plan for an R01 efficacy trial proposed within the current iTech project, 
we will conduct a pilot RCT with up to 60 YMSM (Aim 3) to assess acceptability, feasibility, and 
preliminary efficacy of MyChoices at iTech SRVs at Boston, Bronx, Chapel Hill, and/or Atlanta. 
 
Aim 1: Theater Testing Focus Groups 
To refine the “MyChoices” app and enhance components designed to increase PrEP uptake 
among YMSM, study staff at each SRV will conduct theater testing with up to 40 YMSM in up to 
four focus groups (~2 groups and up to 10 YMSM per group at each SRV). We will demonstrate 
the mobile app to participants and elicit feedback on the app. Theater testing focus groups will 
last 60-90 minutes, and discussions will be audio recorded and transcribed verbatim by the 
Analytic Core (AC).  
Aim 2: Open Technical Pilot 

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After refinement according to Aim 1 findings, the “MyChoices” app and intervention procedures 
will be evaluated and revised during a 2-month open technical pilot with a small group of YMSM 
participants (up to 15 YMSM at 2 iTech sites). All participants will be given brief instructions on 
the purpose of the “MyChoices” app, how to access it and an overview of how to use it, 
including reviewing privacy settings, completing an initial risk assessment as well as an initial 
HIV testing plan. Participants will be encouraged to explore all components of the app and to 
use it routinely. They will complete a brief online assessment (see below) at baseline and at the 
end of the 2-month follow-up period. Participants will also be asked to provide extensive 
feedback during exit interviews conducted online by study staff at Fenway Health using VSee 
technology (described fully below) on functionality, technical performance, errors and bugs 
encountered, overall experiences using the app, and feedback for further refinement. 
Two quantitative assessments will be conducted with each participant at baseline and 2-months 
follow-up. The participant will complete a Computer Assisted Self-Interview (CASI) survey, 
which includes questions and feedback pertaining to the acceptability and utility of the app, and 
assess how the app and intervention components could be strengthened, identifying areas 
needing improvement for future iterations. Participant feedback will be specifically sought on the 
subjective impact of the app on increased HIV testing and PrEP uptake among YMSM. 
Participant feedback will also be solicited on the acceptability of the assessments with respect 
to duration and relevance. 
Qualitative data will be obtained from all participants through brief exit interviews using VSee 
software. A developed interview guide will gather information from participants:  1) acceptability 
and utility, 2) assess how the app and intervention components could be strengthened, 3) 
identify areas needing improvement for future iterations, and 4) the acceptability of the 
assessments with respect to duration and relevance.  
Exit interviews will last approximately 30 minutes. Study team members at Fenway Health who 
conduct the interviews will document the feedback on the Exit Interview Summary CRF during 
the online interview, and review them with study investigators during weekly team meetings. 
Participants who seroconvert during Aim 2 (two month technical pilot) will be offered a referral 
for HIV care, including confirmatory HIV testing and linked to HIV care if confirmatory testing is 
positive; continue to have access to the app, and be invited to complete the 2-month follow up 
CASI assessment and the exit interview. A referral for linkage to care will be offered by the SRV 
clinic. A set of questions will be asked regarding the participant’s experience, particularly as it 
pertains to app use and linkage to care. 
 
Aim 3: Pilot Randomized Controlled Trial (RCT) 
 
Approximately 60 YMSM recruited from 2 to 4 iTech SRV sites (~15 to 30 at each SRV) will be 
enrolled and randomized (2:1) to one of two conditions: a) Intervention arm: download the 
MyChoices app and provided links to local HIV/STI testing and PrEP resources (n=40); or b) 
Control arm: an initial provision of links to local HIV/STI testing and PrEP resources (n=20). 
Individuals will then be followed for 6 months. The primary outcomes will be feasibility and 
acceptability of the app among participants in the intervention arm at 3 month follow up.  
Secondary outcomes will be preliminary efficacy of the app to increase HIV and STI testing (via 
self-report) and PrEP uptake (via self-report) by comparing rates of each at follow up timepoints. 
Additionally, every 3 months, participants will complete a brief online quantitative assessment to 

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measure sexual behavior, HIV testing patterns, linkage to PrEP and other prevention services, 
HIV/STI test results, and general health care access. Among those in the experimental 
condition, we will track usage patterns to assess frequency of use of specific app functionalities. 
At 3 months post enrollment, all participants who seroconvert (regardless of study arm) and up 
to 20 participants in the intervention arm will also be asked to provide extensive feedback during 
interviews conducted online by study staff at Fenway Health using VSee technology (described 
fully below) on functionality, technical performance, errors and bugs encountered, overall 
experiences using the app, and feedback for further refinement.  
Participants will be selected for interviews using purposive sampling based on level of 
engagement with the app, whether participants completed HIV/STI testing and/or initiated PrEP 
during the study, and to achieve diversity based on sociodemographics (e.g. age, race/ethnicity). 
Additionally, we will offer interviews to all participants who have a confirmed HIV diagnosis. In 
addition to asking about their experiences using the app, these participants will also be asked 
about additional information or support that would have been helpful at the time of receiving a 
positive HIV test result, and their experiences in getting linked to HIV care. By purposively 
sampling certain participants for the exit interviews, the goal is to select “information-rich cases 
from which one can learn a great deal about issues of central importance to the purpose of the 
research.”76  
 
For the pilot RCT, there will be three major assessment points: Baseline, 3-month, and 6-month 
post-baseline. Baseline assessments will be conducted in-person at the SRV. Participants can 
choose to do follow up assessments remotely or in person. At each major assessment, 
participants will complete an assessment battery via a secure web-based data entry system, 
which is guided by the SCT model and based on our formative work and prior experience; 
however, the final list of measures will be determined during the open pilot.  
Qualitative data will be obtained from participants through brief  interviews using VSee software. 
A developed interview guide will gather information from participants:  1) acceptability and utility, 
2) assess how the app and intervention components could be strengthened, 3) identify areas 
needing improvement for future iterations, and 4) the acceptability of the assessments with 
respect to duration and relevance.  
Exit interviews will last approximately 30-60 minutes. Study team members at Fenway Health 
who conduct the interviews will document the feedback on the Exit Interview Summary CRF 
during the online interview, and review them with study investigators during weekly team 
meetings. 
The primary outcomes will be: 
Acceptability. To measure acceptability of the “MyChoices” app, the System Usability Scale 
(SUS)—a validated 10-measure scale that assesses subjective usability of a system, or, in this 
case, an app—will be assessed through the quantitative survey at the follow up time points. It is 
scored from 0 to 100, and a score of 50 or greater indicates that the app is acceptable. 
 
Feasibility. To determine feasibility, we will use app analytics to determine whether at least 
60% of individuals randomized to the intervention condition opened the “My Choices” app at 
least one time after their initial introduction to the app by research staff by the 3-month follow up 
assessment. We will also assess the proportion of participants who complete their HIV testing 
plan (regardless of testing intervals)—a primary function of the app. 

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Secondary outcomes will be:  
Preliminary Efficacy. 
• 
HIV and STI testing frequency 
o Self-repored HIV testing 
o Self-reported STI testing 
o Paritcipants will be asked about frequency and results of all HIV/STI tests 
o Participants will be asked to sign medical release forms for the release of their 
testing results from the respective testing site so that study staff can collect 
official results through medical record abstraction 
• 
PrEP interest and uptake 
o PrEP care linkage: participants will self-report whether, in the past 3 months, they 
made and attended a clinic appointment for PrEP initiation, whether they were 
prescribed PrEP, and whether they utilized PrEP. 
 
 
3.1  
Study Population 
For all aims of the study, participants will be HIV uninfected YMSM between ages 15 and 24 and 
self-report evidence of high risk for acquiring HIV infection. 
 
YMSM of color will be oversampled in order to reach a target enrollment of approximately 50% 
and ensure sufficient representation in the population with the most need. Oversampling will be 
accomplished by focusing efforts on venues more likely to be frequented by YMSM of color. The 
recruitment strategies can be adaptive over the enrollment period to help ensure the specified 
targets. 
 
3.2 
Sample Size 
Aim 1: Theater Testing Focus Groups 
We will conduct theater testing with up to 40 YMSM in up to four groups at 2 iTech SRV sites. 
 
Aim 2: Open Technical Pilot 
The “MyChoices” app and intervention procedures will be evaluated and revised during a 2-month 
open technical pilot with up to 15 YMSM at 2 iTech SRV sites. 
 
Aim 3: Pilot Randomized Control Trial 
Approximately 60 YMSM in 2-4 iTech sites (~15 to 30 at each site) will be enrolled and randomized 
(2:1) to one of two conditions: a) download the app and provided links to local HIV/STI testing 
resources (n=40); or b) an initial provision of links to local HIV/STI testing resources (n=20).  
Randomization is site-specific and stratified by age (15-18, 19-24). 
 
 

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4.0  
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS 
4.1 
Inclusion Criteria 
For Aim 1 only 
● Age 15 to 24 years 
● Assigned male sex at birth 
● Identify as male 
● Self-report being HIV uninfected or HIV status-unknown at screening 
● Self-report at least one episode of anal intercourse with a male partner during the last 6 
months 
● Able to understand, read, and speak English 
● Own or lease an Apple (iOS) or Android mobile phone  
 
 
For Aims 2 and 3 
For Aims 2 and 3 
• 
Age 15 to 24 years. 
• 
Assigned male sex at birth and male identified. 
• 
Self-report being HIV uninfected or HIV status-unknown at screening. 
• 
Self-report having not had an HIV test in the past 3 months (for Aims 2 and 3 only). 
• 
Self-report not currently taking PrEP (for Aims 2 and 3 only). 
• 
Participants ages 15-18: self-report at least one episode of anal intercourse with a male 
or transfemale partner during the last 6 months. 
• 
Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection 
including at least one of the following: 
o at least one episode of condomless anal intercourse with an HIV-infected or 
unknown HIV status male or transfemale partner during the last 6 months; or 
o anal intercourse with 2 or more male or transfemale sex partners during the last 
6 months; or 
o exchange of money, gifts, shelter, or drugs for anal sex with a male or 
transfemale partner during the last 6 months; or 
o sex with a male or transfemale partner and has had an STI during the last 6 
months. 
• 
Able to understand, read, and speak English. 
• 
Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 
3 only), and has an active data plan 
 
4.2 
Exclusion Criteria 
• 
Currently enrolled in another HIV intervention study.* 
• 
Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.* 
• 
Enrollment in earlier aim of MyChoices study** 
• 
Any medical, psychiatric, or social condition or other responsibilities that, in the 
judgment of the investigator, would make participation in the study unsafe, complicate 

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interpretation of study outcome data, or otherwise interfere with achieving the study 
objectives.  
• 
Not willing and/or not able to download the MyChoices application 
 
*These criteria are only for the technical pilot and pilot RCT. 
 
**Individuals who participated in a focus group for Aim 1 ARE eligible to participate in the open 
pilot for Aim 2, provided they meet all other eligibility criteria. Individuals who participated in a 
focus group for Aim 1 and/or the technical pilot in Aim 2 ARE NOT eligible to enroll in the Aim 
3 pilot RCT. 
 
4.3 
Recruitment  
Active recruitment will be carried out by study staff at iTech SRVs (Fenway Health in Boston, MA, 
the Children’s Hospital at Montefiore in the Bronx, New York, UNC-CH in Chapel Hill, NC, and/or 
PRISM Health at Emory University in Atlanta, GA) by recruiting individuals at organizations and 
venues where YMSM attend, including STI clinics, community-based organizations for LGBT 
youth, events, etc. At recruitment venues, trained recruiters will approach youth and offer them 
information about the study (either verbally or by offering them a business card or advertisement 
flyer), including brief descriptions of the study design and contact information (study email and 
phone number).  Youth may also choose to complete an online eligibility screener during in-
person recruitment.  For Aim 3 (pilot RCT), we will follow respondent-driven sampling (RDS) 
methods and use a long-chain referral method to supplement recruitment, especially with the 
adolescents (15-17) who may be harder to reach than young adults (18-24).   
 
Additionally, passive approaches for recruitment will include posting study information via flyers, 
posters, and palm cards describing the study at these venues. Moreover, online recruitment will 
be conducted, with the support of the iTech Technology Core, using popular online social media 
outlets (e.g., Facebook, Grindr, etc.). These efforts have been successful in other projects with 
this population, and as such, we do not anticipate having problems reaching our target sample.  
 
Potential subjects will be approached by trained clinic staff at participating sites. They will be 
informed of the nature of the study, the information to be collected, and the evaluations and 
assessments that are involved. Those who express interest in the study will be required to provide 
informed consent or assent and have eligibility criteria confirmed by study staff before enrolling 
into the study. 
 
All recruitment materials will be submitted to the UNC-CH IRB as the single IRB (IRB of Record) 
with a description of intended use for approval prior to use.  
 
 
4.4 
Informed Consent  
Informed consent/assent. The informed consent process will occur on the day the enrollment 
visit is held. Interested persons will be guided through the informed consent process by study 
staff, who will explain all study procedures, answer questions concerning the study and consent 

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process, and offer a copy of the informed consent/assent form. The research staff member will 
give the participant as much time as needed and will address any questions or concerns they 
may have. The participant will be allowed to take the consent/assent form home and review it 
before enrolling in the study if the participant needs more time to review the form. The research 
staff member will ask the participant questions to gauge comprehension. The consent/assent form 
describes all study procedures, including confidentiality and privacy, information about potential 
risks, discomforts, benefits of participation, and information regarding who they can contact with 
further questions. It also states that participation is voluntary, that participants may decide not to 
take part or to withdraw from the study at any time without penalty or loss of any benefit to which 
they might otherwise be entitled, and that study participation is in no way related to being able to 
access or continue getting care or services at any participating study site. Participants can refuse 
to answer any question, and can withdraw from the study at any time. The PIs, Co-PIs, or 
designee at each site will review all informed consents and assents.   
 
Assessing for decisional capacity. For all participants, the research assistant (RA) reviews the 
informed consent/assent to make an assessment of the youth’s decisional capacity and ability to 
provide consent/assent prior to signing, using a 2-step process. First, the RA determines if the 
person understands the study goals by asking “Can you tell me what this study is about?” In step 
2, potential participants will be asked questions designed to assess their capacity to understand, 
appreciate, reason with, and express a choice about participation in our specific protocol. 
Participants will be asked to: name things they will be expected to do during the study; explain 
what they would do if they no longer wished to participate in the study; explain what they would 
do if they experienced distress during the study; and identify potential risks for participating in the 
study. For youth who cannot answer these questions, the RA will go back and review the relevant 
elements of consent with the participant again and repeat the process. Youth who appear not to 
understand after repeated review will not be enrolled in the study. 
Waiver of parental consent. We will request that the UNC-CH IRB as the single IRB (IRB of 
Record) grant a waiver of parental consent to participate in this research study for youth 
participants who are 15 to 17 years of age. The research team has been granted waivers of 
parental permission for prior studies with sexual minority youth. Under 45 CFR 46.408 (c), an IRB 
has the authority to waive parental permission if it determines that “a research protocol is designed 
for conditions or a subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects” and “an appropriate mechanism for protecting 
the children who will participate as research subjects is substituted” and “that the waiver is not 
inconsistent with Federal, State, or local law.” A waiver of signed consent and parental/legal 
guardian permission will be sought given that minor individuals can often seek sexually 
transmitted infection (STI) and HIV testing without parental/legal guardian permission, depending 
on each site’s state laws, and given that many of the youth in our study are likely to be gender 
and/or sexually fluid or have an attraction to persons of the same gender, but may not be out to 
their parents; requiring parental permission may place participants at risk for outing themselves 
as part of the LGBT community or being at risk for HIV infection. A waiver of parental permission 
for studies with LGBT youth that do not involve greater than minimal risk is a common practice 
among researchers working in the area of gay and lesbian health/mental health. This is done to 
avoid the selection biases operating in only recruiting youth whose parents are both aware of and 
comfortable with their sexual orientation. Commonly, these youth have explored their sexual 
orientation without their parents’ knowledge as the youth struggle with issues of disclosure and 
its consequences within the social, religious, and economic context of their families. A 

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requirement for parental permission in this type of study could not only affect a person’s 
willingness to participate, but could also potentially impact the ability of researchers to engage in 
this type of research with sexual minority youth. 
 
 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, 
then requiring parental permission for youth in these circumstances is not a reasonable 
requirement.  Additional privacy protections are provided in that all assessments, notes, reports, 
and other records will be identified by only a coded number to maintain participant confidentiality. 
These records and any forms that do contain identifying information (e.g., consent/assent forms, 
contact information) will be kept in a locked, limited access area (such as a locked file cabinet) at 
the participating site. 
 
4.5 
Screening 
All potential participants (whether recruited online or in-person) will complete an online screening 
survey to obtain consent/assent to be screened and verify all inclusion criteria. Screening may 
occur on the same day as enrollment or beforehand. The online screening survey will begin with 
a script that will be read by participants to explain the purpose of screening and clarify that if they 
are eligible, they will be invited to participate in the study. The script will also provide general 
information about the research study, the nature of the screening questions and related potential 
risks, the approximate length of the  screening (~5 minutes), the confidentiality of the screening 
information, the use of any screening information obtained, the ability to skip any questions or 
withdraw at any time, and contact information of key study personnel. After reading this screening 
script, participants will be asked if they are interested in participating and agree to voluntarily 
complete the screening procedure. Participants will electronically indicate their agreement and 
then take the survey. The study will use SSL encryption for transfers of information online and 
data will be stored in the secure, HIPAA-compliant servers of SurveyGizmo. The Emory AC team 
maintains a business partner HIPAA agreement with SurveyGizmo. 
 
For those who meet eligibility criteria, the survey will ask for the first name, e-mail, and phone 
number of the participant. Potential participants who do not meet eligibility criteria but are 
residents of a recruiting city and are at least 15 years of age will be asked if they would like to be 
contacted about other research studies and, if so, to provide contact information. Participants 
under 15 years of age are not asked to provide contact information. 
 
The Analytic Core will securely share the contact information of eligible participants with SRV 
sites via a secure iTech Box account. SRV staff will enter the eligible participant into SMART 
(described in more detail later in the protocol) for scheduling and contact participants to schedule 
an in-person visit at the SRV. SRVs will also have the option to have the participant complete 
the online screener the day of the in-person visit; study staff can view eligibility on the browser 
window once the screener is complete or review the automatic eligibility email sent after survey 
completion. 
 
 
 

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5.0 
 STUDY PROCEDURES 
 
5.1 Enrollment 
Individuals who are eligible will be contacted and scheduled for an in-person visit to the SRV at 
the participant’s earliest convenience. SRVs will also have the option to have the participant 
complete the online screener the day of the visit. During the visit, the eligibility of the participant 
will be confirmed, details of the study will be explained and informed consent/assent obtained.  
 
Individuals who do not consent or assent to participate will be asked if they are willing to provide 
their reason for declining participation; responses will be recorded on a CRF. Individuals assessed 
as ineligible for enrollment will have the reason(s) for ineligibility recorded.  
 
The study team may request tabulated information on individuals who participated in the 
enrollment process, but did not provide informed consent/assent and the reasons these 
individuals refused to participate. These data will provide general information on the population 
that is recruited at the SRVs into the study. 
 
After informed consent/assent is obtained, the participant will complete a CASI baseline 
assessment. For Aim 3, randomization will only occur AFTER a baseline assessment is 
completed.  
 
In Aim 3, participants assigned to the intervention group will be considered enrolled in the study 
after they have completed the baseline assessment, been randomized, and completed app 
onboarding (for the intervention arm). Participants assigned to the control arm will be considered 
enrolled in the study after they have completed the baseline assessment, been randomized, and 
been given standard of care materials.  
 
CRFs will be completed by study staff to capture the participant’s eligibility and enrollment. 
 
5.2 
Locator/Contact Information  
Once the participant is consented/assented, designated site study staff will complete a 
Locator/Contact Information Worksheet with the participant and/or enter the participant’s contact 
information directly into SMART Web during the enrollment visit. Participants will be asked to 
provide a working phone number and/or valid email address through which they can be reached. 
Participants will also be asked to provide social media contact information, if the participant is 
willing. In addition, participants will be asked to provide valid contact information for two family 
members and/or friends who can be called in the event the participant cannot be reached by 
phone or email. Participants will be asked if messages can be left at the numbers provided. Study 
staff will not leave messages unless expressly permitted to do so by the participant which also 
will be documented on this form. If permission is given to leave messages, site study staff will 
assure participants that messages left with a family member or friend will only ask the participant 
to contact study staff and will not include any protected health information or information related 
to study participation.  

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The Contact Information Worksheet will not contain any study data and will be maintained under 
double locks at the study site, separate from all study records, with access limited to designated 
site research personnel. 
 
5.3 
Randomization Procedures  
Aim 1 (focus group theater testing) and 2 (open pilot) will not include random assignment. 
 
Aim 3 Pilot Randomized Controlled Trial: 
Only participants who express willingness to download the “MyChoices” app for HIV prevention, 
meet eligibility criteria, provide informed consent/assent, and complete a baseline assessment 
will be eligible for randomization. Randomization will occur at a 2:1 ratio with 40 YMSM 
randomized to the experimental condition (~10 to 20 at each site) and 20 randomized to the 
control condition (~5 to 10 at each site).  Randomization will be stratified by site and age (15-18, 
19-24). 
 
This allocation will allow us to efficiently gather additional data on app utilization. Randomization 
will be based on a pre-generated list created by the Analytic Core, with random blocks of size 
three or six. After consent/assent and completion of the survey assessment, the study coordinator 
will assess whether the participant is randomized to receive the Intervention or Control condition. 
“MyChoices” Intervention Condition: Individuals who receive “MyChoices” will be given brief 
instructions on the purpose of the app, how to access it, and an overview of how to use it. 
Participants will be encouraged to explore all components of the app and use it routinely. 
Standard of Care Condition: Following screening, participants in both conditions will receive 
standard of care prevention material consisting of online provision of information regarding 
recommendations for HIV testing and referrals to local HIV testing sites and prevention services. 
 
5.4 
Intervention/Investigation Procedures 
Following an iterative process of app development, “MyChoices” will be further refined through 
theater testing with focus groups (Aim 1) and an open technical pilot (Aim 2) at  iTech SRV 
sites. To plan for an R01 efficacy trial proposed within the current iTech project, we will conduct 
a pilot RCT (Aim 3) to assess acceptability, feasibility, and preliminary efficacy of MyChoices. 
 
5.4.1 
Aim 1: Theater Testing Focus Groups 
To refine the “MyChoices” app and enhance components designed to increase PrEP uptake 
among YMSM, study staff at each SRV will conduct theater testing of the app. In these groups, 
we will demonstrate the mobile app to participants and elicit feedback on the following topics: 
overall feedback on the interface, appeal, and usability; ways to maximize acceptability; 
components that they like and/or dislike; and areas for improvement (e.g., strategies for condom 
promotion). Moreover, in order to enhance components aimed to increase PrEP uptake and 
guided by the SCT model, we will elicit input from participants in the following areas:  1) potential 
content to address PrEP-related self-regulation may include recommendations to speak with a 
provider about PrEP if their risk assessment indicates potential eligibility, and how their risk may 

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be impacted if they take PrEP; 2) content and functionalities to improve PrEP use self-efficacy 
including videos showing couples discussing PrEP, GPS-enabled provision of links to local PrEP 
providers which allows them to manage their own PrEP care, and guidance on questions to ask 
providers about PrEP (e.g., dosing, side effects, necessary follow-up); 3) potential content to 
address environmental influences on PrEP uptake, including information on insurance and other 
payment options for PrEP. Additionally, to prepare for the pilot RCT, we will ask participants about 
their attitudes regarding documenting their testing practices and results through signed medical 
releases and sending photos of test results to document completed testing. Theater testing 
groups will last 60-90 minutes, and discussions will be audio recorded and transcribed verbatim 
by the AC.  
 
5.4.2 
Aims 2 and 3: MyChoices Intervention 
For all participants enrolled in the Aim 2 open technical pilot and for participants randomized to 
the intervention arm of the Aim 3 pilot RCT, study staff will assist participants in downloading the 
app, provide instruction on its use, and will be available to explain the relevant app features or 
set up customizable features (e.g., reminders for HIV testing). Participants will also be 
encouraged to explore and use other components of the app.  
“MyChoices” was guided by the SCT model and includes three major functions that are designed 
to promote self-efficacy, self-regulation, goal-setting, and environmental influences in order to 
impact behavior change (see Table below). Tracking and Self-Monitoring HIV Risk:  In order to 
target self-regulation, brief surveys within the app are used to assess behavioral patterns of 
YMSM, particularly around sexual relationships, which are then used to help customize the app 
for each user. For example, users who report having a main partner will be informed about couples 
counseling, or users who report difficulties using condoms will be provided information about PrEP 
and provided links to HIV prevention services at local sites. Users are also able to enter HIV and 
STI test results to keep track of past test dates and results. HIV and STI Prevention Information:  
In order to improve self-efficacy for HIV testing and HIV prevention overall, quizzes and 
infographics that appeal to YMSM have been incorporated into the app, focusing on promotion of 
HIV prevention and regular HIV testing. Infographics are interactive to allow users to obtain more 
detailed information on topics that are most relevant to them, thus personalizing the app 
experience. Links to videos of YMSM discussing the following are included:  approaches that 
YMSM can use to prevent HIV transmission (including condoms, treatment as prevention, and 
PrEP); reasons for routine HIV testing; and the importance of engaging in care if one tests 
positive, or initiating PrEP if one tests negative and anticipates engaging in condomless anal sex. 
The app also allows users to order OraQuick HIV home testing kits and STI home collection kits 
referred to as CareKits (for gonorrhea and Chlamydia and syphilis), and to explore different types 
of condoms and lubricants to learn more about them, as well as to create customized packages 
of these items to be shipped to them or to a local site where they are comfortable picking up a 
package. Test kits and condom packages will be provided as a service through the iTech 
Technology Core and will be packaged specifically for this project. STI home collection CareKits 
will include a pre-paid mailer to be returned to Kraft Laboratory at Emory University for testing. 
These kits have been used in an ongoing RCT of “Keep It Up”, for which U19 co-PI, Dr. Patrick 
Sullivan is the Atlanta site PI, and they have been acceptable to the young (18-29 year old) men 
in that study. The study will follow the STI and HIV CareKit, Condom and Lubricant Ordering 
Standard Operating Procedures developed by the CareKit team at Emory. Additionally, the app 
includes information on testing sites and local PrEP clinics (e.g., telephone, address, hours of 

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testing, etc.), and external links to specific site web pages that are near the user (determined 
using GPS technology). HIV Testing Plan:  Acknowledging the central role of goal setting and 
environmental influences on health behavior, the app allows users to create an HIV testing plan 
by allowing them to compare and choose different screening options (e.g., home self-testing, 
antigen, rapid). Questions about HIV transmission behaviors and testing history are then asked 
to create a tailored testing plan. After an HIV testing plan is developed, users have the option to 
customize reminders for the timeframe selected (e.g., user is pinged every 3 months as a 
reminder to get tested). Users are able to select from a list of phrases or create their own to ensure 
privacy. Moreover, geofencing technology allows users to be notified when in the vicinity of testing 
locations, based on the GPS location, during the testing timeframe.  
 
 
Social Cognitive Theory constructs, associated “MyChoices” components and 
intervention measures 
SCT 
Constructs 
App Components 
Measures 
Self-regulation 
Self-monitoring through:  risk assessments; 
HIV testing plan; HIV/STI results tracking; 
STI symptoms checklist  
Frequency of use of relevant 
app components; perceived 
HIV/STI risk 
Self-efficacy 
Infographics and videos showing youth 
talking about HIV testing; GPS-enabled links 
to local HIV testing clinics; ordering of home-
based testing kits, condoms, etc. 
HIV testing self-efficacy; PrEP 
use self-efficacy; condom use 
self-efficacy 
Goal-setting 
HIV testing plan with goal setting for testing 
frequency 
Frequency of use of HIV 
testing plan 
Environmental 
influences 
Customized reminders for HIV testing based 
on testing plan, including use of geofencing 
technology 
Frequency 
of 
use 
of 
reminders; 
frequency 
of 
testing due to geofencing 
technology 
 
Standard of Care Comparison Condition. Following screening, participants in both conditions 
will receive standard of care prevention materials. These will consist of online provision of 
information regarding recommendations for HIV testing and referrals to local HIV testing sites and 
prevention services, along with an informational brochure about PrEP. 
 
5.4.3 Research Staff Training  
All proposed study staff have participated in the required trainings in participation and conduct of 
studies that involve human subjects, and any future study staff will do so upon hiring. Training for 
all staff includes (but is not limited to) an overview of the study, study procedures and human 
subjects issues (informed consent process, confidentiality), methods for establishing comfort with 
the sensitive issues, including discussion of sexual behaviors, that will likely arise in the course 
of the focus groups or assessments, review of the study instruments, their required elements and 
the inherent flexibility built into them Human Subjects Protection for Social and Behavioral 
Research, Good Clinical Practice, informed consent, quality management, confidentiality, and 
reporting of adverse events. 
 

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For Aim 1 focus groups, the PI team at Fenway Health will train study staff at the SRV locations 
to facilitate the focus group discussions. 
 
5.4.4 Medical Record Abstraction 
The goal of the medical record abstraction is to explore whether it is feasible to collect more 
objective measures of HIV and STI testing and PrEP uptake, and to compare the medical records 
to self-reported data on these measures. Medical record abstraction will occur following the 
completion of the final follow-up assessment and will cover the entire study period. This 
abstraction will only occur if the participant has signed a medical records release form for the 
institution where records are being requested from. Signing a medical record release is not a 
requirement of enrollment—participants may refuse without being withdrawn from the study. Only 
records verifying HIV and STI testing information, and records related to PrEP initiation will be 
requested. The period of abstraction will begin at the baseline visit and end up to 12 weeks 
following the 6 month follow-up assessment in order to accurately capture any PrEP initiation 
activity following mobile app use. Standard study CRFs with study ID will be completed using the 
medical records, and all medical records will be immediately de-identified (black out any 
identifiers) and labeled with study ID. 
 
5.4.5 Intervention Monitoring/Quality Control 
Given that the intervention is in the form of a mobile app, there will not be interventionists providing 
content. A study checklist will be used to ensure that the research staff member assists 
participants in downloading the app, provides instruction on its use, and explains the relevant app 
features and sets up customizable features (e.g., reminders for HIV testing). 
 
App analytics, including logins to the app and use of different app components, will be monitored 
for the technical pilot and pilot RCT aims of this project. Any issues that are detected will be 
discussed with the protocol team and site research staff, and a remediation plan will be developed 
and implemented at the sites. 
 
6.0 
EVALUATIONS AND MEASURES  
The screening assessment must be performed within 30 days before study enrollment. 
 
All evaluations and measures will be reviewed and approved by the UNC-CH IRB prior to use 
with human subjects. Below is a summary of the measures for each aim of the study. 
 
6.1 
Aim 1: Focus groups 
6.1.1 
Pre-entry or screening evaluations/measures (at -30 – 0 days prior to enrollment) 
● Age (15 to 24 years) 
● Sex (assigned male sex at birth) 
● Current gender identity (male) 

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● HIV status (self-report being HIV uninfected or HIV status-unknown) 
● HIV testing history  
● PrEP use history  
● Reports at least one episode of anal intercourse with a male partner during the last 6 
months 
● Own or lease an Apple (iOS) or Android mobile phone 
 
6.1.2 
Quantitative assessment (at enrollment visit) 
• 
Demographics 
o Age, sex, gender identity, race/ethnicity, education 
• 
Health 
o STD testing history and diagnoses, HIV testing history, PrEP use history 
• 
Sexual Risk Behavior 
o Number of partners, condom use 
• 
Technology use 
o Use of internet and mobile apps, accessing health information, meeting sexual 
partners, interests in health apps 
 
6.1.3 
Focus group guide (at enrollment visit) 
● 
Overall feedback on the interface, appeal, and usability;  
● 
Ways to maximize acceptability;  
● 
Components that they like and/or dislike, and areas for improvement 
● 
Feedback on specific content and functionalities guided by SCT model, including self-
regulation, self-efficacy, and environmental influences 
● 
Feedback on HIV/STI self-testing collection kits and instructions 
● 
Attitudes regarding documenting their testing practices and results through signed medical 
releases and sending photos of test results to document completed testing 
 
6.2 
Aims 2 and 3: Open technical pilot and pilot RCT 
6.2.1 
Pre-entry or screening evaluations/measures (at -30 – 0 days prior to enrollment) 
● Age (15 to 24 years) 
● Sex (assigned male sex at birth) 
● Current gender identity (male) 
● HIV status (self-report being HIV uninfected or HIV status-unknown) 
● HIV testing history (self-report having not had an HIV test in the past 3 months) 
● PrEP use history (self-report not currently taking PrEP) 
● Participants ages 15-18: self-report at least one episode of anal intercourse with a male 
or transfemale partner during the last 6 months 
● Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection 
including at least one of the following: 

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▪ 
at least one episode of condomless anal intercourse with an HIV-
infected or unknown HIV status male or transfemale partner during the last 6 
months 
▪ 
anal intercourse with 2 or more male or transfemale sex partners 
during the last 6 months 
▪ 
exchange of money, gifts, shelter, or drugs for anal sex with a 
male or transfemale partner during the last 6 months;  
▪ 
sex with a male or transfemale partner and has had an STI during 
the last 6 months 
● Able to understand, read, and speak English 
● Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 3 
only) and has an active data plan 
 
6.2.2 
Pre-intervention (baseline) evaluations/measures (at enrollment visit) 
• 
HIV Testing: participants will be asked to self-report on frequency of HIV testing 
• 
PrEP care linkage: participants will self-report whether, in the past 3 months, they made 
and attended a clinic appointment for PrEP initiation, whether they were prescribed PrEP, 
and whether they utilized PrEP 
• 
Additional behavioral measures 
o Sexual risk behaviors:  we will use the AIDS-Risk Behavior Assessment (ARBA), 
a computerized self-interview designed to assess self-reported sexual behaviors.  
o Substance use:  To assess risky substance use, we will use the ASSIST screening 
tool – an 8-item validated questionnaire developed by the World Health 
Organization and addiction researchers. We will also ask the degree to which they 
use each substance during sex.   
 
Access to and utilization of health care: we will assess whether participants 
see a medical provider regularly, whether they received testing for STIs, 
other than HIV, and if they were treated. 
o SCT model constructs  
 
Self-regulation:  perceived HIV and STI risk, and STI symptom knowledge 
 
Self-efficacy:  HIV testing, PrEP use, and condom use self-efficacy 
 
Environmental influences:  perceived utility of reminders for HIV testing  
 
Potential moderators of the intervention 
• 
Demographics:  Age, student status, education level, income, living 
situation, employment, insurance status, depressive symptoms, 
anxiety, trauma, and abuse 
 
6.2.3 On study evaluations/measures 
● 
Biological endpoints via home test kits 
● HIV infection: this proposal will utilize the OraQuick® ADVANCE™ [sensitivity: 99.6% 
(98.5–99.9); specificity: 100% (99.7–100)], an HIV rapid test that is FDA-approved for 
HIV-1 and HIV-2 testing for at-home testing (intervention arm).  
● Participants in the intervention arm will be asked to self-report STI and HIV testing 
results into the MyChoices app.  
● Additionally, we will also request all participants (control and intervention arms) to sign 

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medical release forms for the release of their official testing results from the respective 
testing site so that study staff can collect official results. 
 
6.2.4 
Follow-up assessments (2-month post-baseline for open pilot and 3- and 6-month 
post-baseline for pilot RCT; study window: ± 4 weeks)  
All of the same measures assessed at baseline as well as the following additional measures: 
 
• 
Acceptability 
o System Usability Scale (SUS):  a validated 10-measure scale that assesses 
subjective usability of a system, or, in this case, an app. It is scored from 0 to 100, 
and a score of 50 or greater indicates that the app is acceptable. 
• 
Feasibility 
o We will use app analytics to determine whether at least 60% of individuals 
randomized to the intervention condition opened the “My Choices” app at least one 
time after their initial introduction to the app by research staff. 
o Proportion of participants who complete their HIV testing plan 
• 
HIV Testing:  participants will be asked to self-report on frequency of HIV testing since last 
assessment. The primary HIV testing measure will be the proportion of participants who 
self-report at least one test during the follow up period. We will also explore the 
concordance of self-report with data collected by medical release and using data 
electronically self-reported in the app, including home testing kits provided by request 
through the app. 
• 
App-Specific Measures 
o Frequency and duration of app use 
o Pages and functionalities most and least utilized 
o Responses to each question within the assessment, quiz, screening, and test 
results reporting 
o Information about each test plan event: location, date(s), type selected, frequency 
o Which testing locations were viewed, and whether they were accessed using the 
map or the list view. 
o Reminder settings and preferences 
o Number of HIV testing kits, STI home testing CareKits, condoms, and lube 
requested 
 
6.2.5 
Exit interview guide (0-30 days following: final assessment for Aim 2, three months 
post enrollment for Aim 3) 
● 
acceptability and utility of the app 
● 
feedback on how the app and intervention components could be strengthened 
● 
identify areas of the app needing improvement for future iterations 
● 
feedback on study procedures 
● 
acceptability of the assessments with respect to duration and relevance 
● 
seroconversion and app use, linkage to care 
 

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7.0  
DATA COLLECTION AND SITE MONITORING 
7.1 
Development of Protocol and Case Report Forms 
The Management Core, in collaboration with the Protocol Team, is responsible for the 
development of this protocol as well as the Case Report Forms (CRFs)) needed to collect the 
information required to implement this protocol.  
 
7.2 
Data Records  
Participant-related study information will be identified through a study ID number (SID) and 
participant code comprised of the first letter of the participant’s first name and two-digit day of 
birth on all participant CRFs, audio files, transcripts, and Computer-Assisted Self Interview (CASI) 
files. All study-related information will be kept in double-locked, limited access areas at each study 
site. Participant names and their SID and initials will be stored separate from other study 
information in SMART, accessible only to designated study staff, iTech site monitors, and 
representatives from the NICHD. SIDs will not be entered into the mobile app and instead a unique 
app ID will be assigned to each participant and used when logging into the app. These unique 
App IDs are assigned via the Study App ID log and connected to the app via back-end web access 
by study staff. Original source documents for individual participants will be maintained at the 
respective SRV site and will be accessible only to the study staff. Data from original source 
documents will be transcribed on CRFs as applicable.    
 
7.3  
Data Collection  
7.3.1 
CRFs 
Study monitoring data, including information about eligibility, demographic data, and monitoring 
untoward effects, will be collected on CRFs. All CRFs for this study will be available for download 
from a secure iTech Box account.  
 
7.3.2 Study assessments 
Self-administered assessments at baseline and at follow-up visits (for the open pilot and pilot 
RCT) will be completed by participants on study computers (for baseline) and personal devices 
(for follow-up assessments, though participants will also be given the option to return to the SRV 
to complete the follow-assessment on study computers) via online Computer assisted self-
interview (CASI) surveys hosted on SurveyGizmo.com. We use SSL encryption for transfers of 
information online and data will be stored in the secure, HIPAA-compliant servers of 
SurveyGizmo. The Emory AC team maintains a business partner HIPPA agreement with 
SurveyGizmo. 
 

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7.3.3 CASI Data Security 
Only authorized users with a login name and password will be able to access and open the 
assessment through the internet site. To ensure data privacy, as data are entered in real time, it 
will be encrypted during transmission to the SurveyGizmo server, and that data will be regularly 
downloaded by AC staff and stored in a secure database within the AC data center at Emory 
University.  
 
7.3.4 VSee Platform Description  
For the online qualitative interviews being conducted in the Aim 2 open technical pilot and Aim 3 
RCT, the study staff interviewers will rely on VSee platform. When using VSee, participants will 
have the option to use VSee in several formats:  face-to-face video chat, video chat in which 
they can see the interviewer but the interviewer cannot see them, audio chat only, or a text-
based conversation. VSee is compatible on PCs, tablets and smartphones. Unlike other video-
chat platforms (e.g. Skype), VSee is HIPAA-compliant. VSee includes the following functions to 
protect users:  
End-to-end encryption without a man-in-the-middle listener. In WebEx, Vidyo, Tandberg, and 
Polycom architectures, media is sent to a server (also called a video relay or MCU). Although 
encryption is applied from the user’s computer to these servers, the servers still have full access 
to the user’s media. In contrast, VSee uses end-to-end encryption where no server, including 
VSee servers, has the decryption key. VSee uses public/private RSA keys to exchange a 256-
bit AES session key with the property that only the endpoints have the AES session key. VSee 
uses FIPS 140-2 certified 256-bit AES encryption.  
One port. VSee uses a single port for call signaling and media. The VSee protocol is structured 
so that only the outgoing port needs to be open because return traffic is always structured as 
responses to outgoing traffic. This allows administrators to set a policy where if users inside 
their network are using VSee, then their firewall lets VSee traffic securely cross the firewall; 
however, if users inside their firewall stop using VSee, then the firewall will block external port 
scans.  
Automatic HTTP/SSL tunneling. VSee prefers to use UDP since it allows higher performance 
video. However, if the firewall does not allow UDP, VSee will automatically switch to HTTP/SSL 
tunneling.  
Cloud Control. VSee's cloud solution allows enterprises to maintain central control of their 
security policies to a large number of end points even though the service is hosted by VSee. It 
does this by having VSee clients always connect first to VSee servers in the cloud, where the 
policies are controlled. The cloud servers determine whether any of these security policies 
should be applied and enforces them at the VSee client. This allows us to set our own security 
settings and to record the sessions.  
No-install client. Video conferencing software clients tend to be large and to leave a big footprint 
on the user’s system. Almost all of them require administrator permissions to install. Once the 
client software gains administrator permissions, they can severely compromise computer 

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security. VSee is a lightweight client that does not require administrator permissions or 
installation.  
VSee offers the HIPAA-required Business Associate Agreement (BAA) where VSee agrees to 
be responsible for keeping all patient information secure and to immediately report any breach 
of personal health information. In this study, the iTech Technology Core will enter into a BAA 
with VSee, and this will be extended to cover the proposed activities. The VSee sessions will 
include identifying information (e.g., images of the participant, voice recordings). All identifying 
information will be stripped from the recorded VSee sessions before they are sent to the 
analysis team for content analysis.  
7.4 
Data Submission 
7.4.1 
CRFs 
Although the iTech projects will involve substantial online follow-up, this protocol will also use 
CRFs to collect data on key study visit data (e.g., enrollment and randomization assignment), 
study milestones such as completion or discontinuation, results from medical records, study 
laboratory results, and adverse events (AE). AC staff will work with study investigators and the 
MC to develop and design the CRFs. During study conduct, the SRVs will maintain the CRFs in 
secured locations, and transmit CRF data to the AC using DataFax, a leading multi-site 
database environment for HIV RCT. DataFax can receive and transcribe CRF data via fax and 
scan, or allow for direct data entry. It provides for monitoring form completion and data quality, 
and a system for data querying and resolution with SRVs, while maintaining an audit trail. The 
AC uses DataFax for MSM studies and RCT and maintains a DataFax Linux server at Emory. 
7.4.2 
Audio Data  
All focus groups and individual qualitative interviews will be audio recorded and audio recordings 
will be transcribed verbatim by a professional transcription service through the AC. Audio files will 
be erased after being transcribed and transcripts will be de-identified.  
 
All audio files will be kept confidential and stored in a locked/limited access folder on secured 
servers, which is only accessible to designated study staff. All members of the research team will 
be trained in confidentiality and have signed confidentiality agreements. A professional 
transcription service, experienced in the handling of confidential data, will be used to fully 
transcribe verbatim all audio files. Prior to receipt of the first audio file, the transcription service 
will be instructed to exclude from the typed transcript identifying information (e.g., a name) that 
may have been verbalized during the course of the focus groups. 
 
7.4.3 
CASI Data Transmission 
Only authorized users with a login name and password will be able to access and open the survey 
through the internet site. To ensure data privacy, as data are entered in real time, it will be 
encrypted during transmission to the SurveyGizmo server, and that data will be regularly 

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downloaded by AC staff and stored in a secure database within the AC data center at Emory 
University. 
 
7.4.4 Retention 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 mobile 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 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. 
 

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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. 
 
 
7.4.5 Mobile application data 
MyChoices follows best practices for collecting, storing, and transmitting data. The application will 
be available to users in Android (and iOS for Aim 3 only) as a native app. Users initially access 
the app by entering their email address and a registration key (supplied following completion of 
the eligibility survey), and setting up a user-generated password. On subsequent visits to the app, 
users must supply their username and password, or may choose to create a PIN through their 
device settings. If the app is removed from a user’s device, all associated data is removed from 
the device. In this case, user data is not deleted from the developer database. To capture data 
analytics as described above (see Data Collection), user app activity is sent to a web-based 

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administration portal (Admin Portal). The Admin Portal is a Microsoft SQL Server and .NET 
application hosted in a FedRAMP compliant hosting environment. The Admin Portal is secured 
via SSL encryption and each user requires a unique username and password for access. Only 
study staff at the coordinating site and staff at the analytic core will have access to this data. 
Within the Admin Portal, de-identified data on app usage is stored. SIDs will not be entered into 
the mobile app and instead a unique app ID will be assigned to each participant and used when 
logging into the app. These unique App IDs will be provided by the developer. Only designated 
study staff will be able to link the unique app ID to the SID. If the app data were accessed 
independently without the SID link, no participant information would be identifiable. No personal 
information is stored in the Admin Portal at this time, other than the user’s email address. 
 
7.5 
Data Quality Assurance 
Investigators receiving federal funding must adhere to the Code of Federal Regulations (CFR) to 
protect research participants and produce reliable study information. Sites participating in 
research sponsored by the NICHD need to have an internal quality assurance (QA) plan that will 
identify problems and correct errors in research study records.  
 
7.6 
Role of Data Management 
The MC will provide instructions concerning the recording of study data on the CRFs, and entry 
of the data into RDC (and CASI/CAPI administration and transmission if applicable). 
  
7.7 
Study Site Monitoring and Record Availability 
Site monitors from the MC will visit participating study sites to review a selected portion of the 
individual participant records, including assent/consent forms, CRFs and supporting source 
documentation to ensure the protection of study subjects, compliance with the protocol, and 
accuracy and completeness of records. Regulatory files, as required, will also be inspected to 
ensure that regulatory requirements are being followed. 
 
The site investigator will make study documents (e.g., assent/consent forms, case report forms) 
and pertinent hospital or clinic records readily available for inspection by the local IRB, the UNC-
CH IRB as the single IRB (IRB of Record), the site monitors, the NICHD, the Office of Human 
Research Protection (OHRP), or the sponsor’s designee for confirmation of the study data. 
 
8.0 
PARTICIPANT MANAGEMENT 
8.1 
Tracking Participants / Follow-up 
Study staff will verify participant contact information at baseline and update this information if 
needed at time of follow-up.   
 
Study staff will contact participants prior to their target date to complete follow-up study 
procedures. Study staff will use both a preferred and, if necessary for youth who are difficult to 

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reach, backup method of contact as indicated at baseline (e.g. mail, alternate phone numbers, e-
mail, text message, social media contact information), to contact participants to complete follow 
up study procedures.   Additional reminders will be provided on/after the target date as needed to 
ensure completion of study visit procedures. Subjects will be asked whether or not messages 
can be left for each of the phone numbers that they provide. They will be informed that 
messages will not contain any information regarding the nature of the project.  
   
    
8.2 
Compensation 
The decisions around compensation will be determined separately by each SRV, listed in the 
SRV’s informed consent/assent form, and approved by the single IRB (the UNC-CH IRB). 
 
The web-based CASI survey and online exit/in-depth interview will be conducted online, 
however participants will be able to come into the SRV to complete these procedures if 
preferred on SRV computers or tablets.   Site study staff will be notified when a subject has 
completed a CASI survey and online exit/in-depth interview on his own and the compensation 
will be provided to the participant. Compensation can be provided in person, or sent to 
participants electronically or via mail, if allowed at the SRV. 
 
 
8.3 
Intervening on “Social Harms"  
Some of the questions in the quantitative assessments are related to potentially sensitive topics 
including intimate relationships, drug use, and sexual behaviors. Social, psychological, and 
interpersonal harms may include being discriminated, feeling stigmatized, emotional distress, as 
well as feelings of discomfort and embarrassment. Additionally, this study involves provision of 
home HIV/STI testing which may cause participants to worry or become anxious. If the HIV/STI 
test results are reactive (e.g., a “preliminary positive” on the HIV rapid antibody test), participants 
may become depressed or feel anxious. 
All study sites have specific policies governing the treatment of human subjects. These policies 
specify that medical and psychological assistance will be available in the immediate environment 
in the event a participant should experience any adverse reactions resulting from study 
procedures.  
While participants will be informed that they may refuse to answer any question at any time, 
responses or reactions to certain questions may indicate distress on the part of the participants. 
Participants experiencing mild distress during a study visit will be offered a small break or to 
reschedule the interview at later date. In the unlikely event that a participant experiences 
considerable distress, they will be offered a voluntary clinical assessment and/or counseling on 
site. As a result of participant self-report, study staff discovery, or routine study assessment, the 
study staff may become aware of a social harm. Study staff will be trained to make appropriate 
referrals for clinical care in consultation with the PIs or designee to help participants cope with 
any feelings and/or questions they have which may arise. All information disclosed to the 
researcher will remain confidential if the participant chooses not to complete the study.   
 

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If at any time during the study, a participant divulges that he or she is at risk for harm, including 
but not limited to being abused or experiencing violence, if harm is suspected or likely, or if the 
participant states he or she is suicidal/homicidal, measures will be taken to ensure his or her 
safety. Reporting will be done as appropriate to the situation and the legal statutes, including 
reporting to child protection agencies or other appropriate agencies, and referrals will be provided 
to appropriate support, counseling, or treatment resources. 
 
8.4 
Criteria for Premature Study Discontinuation 
The principal investigator has the authority to withdraw any participant at any time if it their opinion 
it would be in the best interest of the participant. The participant will be informed of this withdrawal 
and explained the rationale. Withdrawal will be documented in the study tracking system. 
 
Subjects will be prematurely discontinued from the study if any of the following occurs:  
a. The subject withdraws consent/assent;  
b. The participant is unwilling or unable to comply with study procedures; 
c. The investigator believes that ongoing participation may cause harm to the 
participant or study staff; 
d. The investigator believes that ongoing participation may impact the integrity of the 
study data; 
e. The study is cancelled by the NIH (or iTech, or other administrative entity); 
f. The study is cancelled for other administrative reasons; or 
g. Death of the subject. 
 
Participants may end their participation in the study at any time. Participants who are 
prematurely discontinued from the study may be allowed to re-enroll into the study on a case-by- 
case basis. No further data collection will occur from the date the decision is made to 
permanently discontinue the subject from the study. Participants who experience distress during 
the study while in the SRV clinic will be offered counseling on site. Participants who experience 
distress during the study and do not come to the SRV clinic for a visit will be provided a list of 
community referrals via phone or e-mail. Any unexpected adverse events that meet the New 
Safety Information (NSI) reporting criteria will be immediately reported to the UNC-CH IRB and 
the respective sites’ IRBs if applicable. The Study Stop Form will be completed at this time. 
 
Participants who seroconvert during the study will not be discontinued from the study and will 
continue to have access to the app and its functions.   
 
9.0  
MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING FROM STUDY 
Site study staff must first follow their own IRB’s procedure for reporting and managing untoward 
effects.  
 
There are two types of untoward effects to be identified:  (1) those related to the participant, and 
(2) those related to the study staff. 
 
1. The study will catalogue any untoward effect related to the participant. Reporting is 
required for occurrences including social harms, psychological distress, and serious life- 

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threatening events such as suicide attempts. These may be immediately apparent to the 
study staff, such as the participant’s emotional upset requiring referral for counseling; or 
they may be delayed and reported later to study staff, such as physical harm to an 
individual for having participated in the study.  
 
Study staff will notify the iTech team of any untoward effects using the iTech QNS 
accessible through the iTech website (www.itechnetwork.org) within 24 hours of becoming 
aware of these untoward effects. Study staff will be briefed during the training on the scope 
of possible untoward effects and instructed to report events.  
 
In addition to social or emotional harm, this study will collect, manage, and report on 
adverse events related to home HIV and STI testing kits ordered through the MyChoices 
app. It is anticipated that adverse events will be reported to study staff by phone or 
during study visits. Study staff will record adverse events on an adverse event CRF. 
Unanticipated Adverse Events (UAE) associated with these kits will be reported to the 
study site’s IRB as applicable. In this case, a UAE is any AE that the investigator 
determines to be attributable to the HIV or STI home testing event that is serious or not 
previously identified in nature, severity, or degree of incidence in the product’s labeling. 
The determination of a UAE will be made by the Principal Investigator at the SRVs.  
i. A positive HIV or STI result, as determined by the FDA-approved testing, will 
not be documented as an AE, as HIV results are part of the endpoint evaluation 
of the study. 
ii. The study will follow the UNC-CH IRB policy and each SRV’s IRB policy for the 
reporting of Serious Adverse Events (SAE). The Principal Investigator at the 
SRVs will determine seriousness, relationship to study participation, and 
severity. An adverse event is serious if it: 
1. Is fatal or life-threatening 
2. Requires or prolongs hospitalization. 
3. Results in persistent or significant disability/incapacity 
4. Is a congenital anomaly/birth defect, or is medically significant, may 
jeopardize the subject, and may require medical or surgical 
intervention to prevent one of the outcomes listed above. 
 
2. Study staff may encounter untoward events during sessions that personally affect them. 
Training and guidance will seek to minimize this risk. Nonetheless, an assessment of the 
cost of conducting this study must include cataloguing these events as well. The protocol 
chairs should be notified of these events so that they may be immediately addressed, 
evaluated, and guidance modified or expanded to minimize similar risk to other study staff. 
 
10.0  
STATISTICAL/ANALYTIC CONSIDERATIONS 
10.1 
Introduction 
Qualitative and quantitative data analysis will be supported by the iTech Analytic Core. 
 

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10.2 
Power Estimates  
10.2.1 
Aim 1: Theater Testing Focus Group Discussions 
For qualitative data collection, sample size is driven by thematic saturation.  While this can 
occur with as few as 6-12 people (Guest 2006), it is typical to include approximately 20-40 in 
qualitative health research. 
 
10.2.2 
Aim 2: Open technical pilot 
We judge that 12-15 participants would be enough to trial all intervention procedures and obtain 
feedback on study procedures and documents. 
 
10.2.3 
Aim 3: RCT pilot 
As a pilot study, the primary emphasis is on establishing acceptability and feasibility of 
“MyChoices.” Power to find group differences in the efficacy outcomes is limited; to find 
statistical significance, the effect sizes would need to be large. With a two-tailed p-value of 0.05, 
60 randomized at a 2:1 ratio and with 20% attrition there will be 80% power to detect a 50% 
difference across the two conditions. The large minimum detectable effect size, typical of pilot 
studies, will require careful interpretation in light of overall patterns. 
 
10.3  Statistical Analysis Plan 
10.3.1 Aim 1: Theater Testing Focus Group Discussions.  
A rapid analysis of the data from the theater testing will be conducted by the PI team at Fenway 
Health using detailed notes taken during the focus group discussion. Additionally, the iTech 
Analytic Core will assist with more in-depth coding of the data from the theater testing. A 
codebook of a priori and emergent themes, including operational definitions of all codes and 
sample quotations to illustrate how to apply each code, will be created. Two study team 
members will then use the codebook to independently code the compiled user profiles while a 
third team member will review these sections of coded data and resolve discrepancies. A 
random sample of 20-40 instances will be drawn for the coders to begin with and calculate an 
inter-rater reliability score based on their code assignments. If this score is <95%, we will refine 
the codebook definitions and re-train the coders. Coders will then complete the coding of the 
remaining instances and we will calculate an inter-rater reliability score. Discrepancies will then 
be reviewed and resolved by the research team.74 We will use Dedoose software to assist with 
theme identification, coding textual data, and describing relationships among codes (via code 
co-occurrence and memoing functions). Coding and analytic activities will be discussed during 
weekly team meetings. These data will allow us to make final refinements to the app as well as 

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the intervention protocol and assessment battery prior to initiation of the open technical 
evaluation (Aim 2) and RCT pilot (Aim 3). 
10.3.2 Aim 2: Open Technical Pilot 
Each participant will be given access to the app for 2 months. Following this period, they will be 
asked to complete a survey on intervention satisfaction and an online exit interview. We will 
solicit feedback about the acceptability and utility, and assess how the app and intervention 
components could be strengthened, identifying areas needing improvement for future iterations. 
Participant feedback will be specifically sought on the subjective impact of the app on study 
outcomes. Participant feedback will also be solicited on the acceptability of the assessments 
with respect to duration and relevance.  
Intervention satisfaction will be assessed using the mean score on the System Usability Scale 
(SUS), a validated 10-measure scale that assesses subjective usability of a system, or, in this 
case, an app. It is scored from 0 to 100, and a score of 50 or greater indicates that the app is 
acceptable. 
A rapid analysis of the data from the exit interviews will be conducted by the PI team at Fenway 
Health using the detailed notes taken on the Exit Interview Summary CRF. Additionally, the 
iTech Analytic Core will assist with more in-depth coding of the data from the exit interviews. A 
codebook of a priori and emergent themes, including operational definitions of all codes and 
sample quotations to illustrate how to apply each code, will be created. Two study team 
members will then use the codebook to independently code the compiled user profiles while a 
third team member will review these sections of coded data and resolve discrepancies. A 
random sample of 20 instances will be drawn for the coders to begin with and calculate an inter-
rater reliability score based on their code assignments. If this score is <95%, we will refine the 
codebook definitions and re-train the coders. Coders will then complete the coding of the 
remaining instances and we will calculate an inter-rater reliability score. Discrepancies will then 
be reviewed and resolved by the research team.74 We will use Dedoose software to assist with 
theme identification, coding textual data, and describing relationships among codes (via code 
co-occurrence and memoing functions). Coding and analytic activities will be discussed during 
weekly team meetings. 
After analyzing both the qualitative and quantitative data from the open technical pilot (as 
described above), we will triangulate the findings in order to refine the app, intervention protocol, 
and assessment tools prior to the RCT pilot (Aim 3). The study team will meet to discuss 
themes that emerged in the qualitative interview exit interviews, usage patterns, and 
acceptability ratings, and obtain staff input in order to come to a consensus on specific 
adaptations that need to be implemented for Aim 3.75  
 
10.3.3 Aim 3: RCT Pilot 
The primary analyses will summarize acceptability (mean score on the SUS) and feasibility 
(participants utilizing the app at least once during follow-up) of the app at 3-month follow up, 
overall for the intervention arm, with asymptotic normal 95% confidence intervals. Point estimates 
for mean acceptability ≥50 and for proportion accessing the app >0.60 will be considered the 
minimum criteria for acceptability and feasibility, consistent with industry standards.64, 65  

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The primary efficacy analysis will compare HIV testing (defined by the proportion that self-report 
at least one HIV test result during follow-up) between the study arms. Secondary analyses will 
examine group differences in self-reported PrEP-related appointments and documented (e.g., via 
MRA) HIV test results. Moreover, group differences in measures related to the SCT model 
constructs (e.g., HIV testing self-efficacy) will be assessed. All analyses will use two-tailed tests 
of significance, with significance at alpha = 0.05. We will follow an intent-to-treat model, analyzing 
participants in the study arm to which they were assigned. We will examine the equivalence of 
random assignment to groups with regards to key baseline characteristics, including socio-
demographics, prior HIV testing patterns, and sexual risk-related variables. In the event that 
randomization does not work to balance these characteristics, we will assess whether baseline 
differences may account for differences in outcomes. 
A rapid analysis of the data from the 3-month qualitative interviews will be conducted by the PI 
team at Fenway Health using the detailed notes taken on the Interview Summary CRF. 
Additionally, the iTech Analytic Core will assist with more in-depth coding of the data from the 
interviews. A codebook of a priori and emergent themes, including operational definitions of all 
codes and sample quotations to illustrate how to apply each code, will be created. Two study 
team members will then use the codebook to independently code the compiled user profiles 
while a third team member will review these sections of coded data and resolve discrepancies. 
A random sample of 20 instances will be drawn for the coders to begin with and calculate an 
inter-rater reliability score based on their code assignments. If this score is <95%, we will refine 
the codebook definitions and re-train the coders. Coders will then complete the coding of the 
remaining instances and we will calculate an inter-rater reliability score. Discrepancies will then 
be reviewed and resolved by the research team.74 We will use Dedoose software to assist with 
theme identification, coding textual data, and describing relationships among codes (via code 
co-occurrence and memoing functions). Coding and analytic activities will be discussed during 
weekly team meetings. 
 
Note: Any deviations from the analysis plans outlined above or in the sections that follow will be 
documented and justified in the Statistical Analysis Plan developed for this protocol. 
 
10.4 
Missing Data 
Several procedures will be used to conduct data analysis when data for either outcomes or 
covariates are missing. The first step will be to assess the extent and pattern of missing data. If 
data are missing for only a few cases, then data analysis will be conducted only on study 
participants with complete data. However, when such a strategy would result in loss of data from 
a substantial proportion of participants, or if this approach would lead to biased or inaccurate 
results, then some form of imputation will be performed. The form of imputation used will depend 
on the nature of the data that are missing. For example, data that are collected repeatedly might 
be imputed using the “last value carried forward” method; and in some instances, interpolation 
between neighboring points might also be used. When the primary endpoint is missing, one data 
analysis will be conducted using only cases with the endpoint. Subsequent analysis will be done 
where missing endpoints are imputed. Hot-deck imputation or regression imputation may also be 
used in this context. 
 

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11.0  
HUMAN SUBJECTS 
This study will be conducted in compliance with the protocol, ICH Good Clinical Practice 
guidelines, and 45 CFR Part 46. 
 
11.1 
Participants’ Confidentiality 
 
All records with personally identifying information will be kept in a locked, limited access area 
(such as a locked file cabinet) or in a secure limited access database (such as SMART). All 
computer entry and networking programs will be done with coded numbers only. Clinical 
information will not be released without written permission of the participant, except as necessary 
for monitoring by the MC or NICHD. 
 
Every effort will be made to ensure that study participants are protected from risks.  
Breach of Confidentiality:  A potential risk to participants is violation of confidentiality. We will 
take the utmost caution to protect the confidentiality of all responses. We will minimize this risk 
by maintaining confidentiality and discretion throughout all iTech research procedures and data 
management and analysis.  
All audio files will be kept confidential and stored in a limited access folder on Box, accessible 
only to study staff. All members of the research team will be trained in confidentiality and have 
signed confidentiality agreements. A professional transcription service, experienced in the 
handling of confidential data, will be used to fully transcribe verbatim all audio files. Prior to 
receipt of the first audio file, the transcription service will be instructed to exclude from the typed 
transcript identifying information (e.g., a name) that may have been verbalized during the course 
of the theater testing focus groups. 
All in-person study visits will be conducted in a private room. Hard and soft-copy participant data 
with be identified by an ID number only, and a link between names and ID numbers will be kept 
separately under lock and key. Locator information and informed consent/assent will be filed in 
designated name files. Provided they contain no identifying information, clinical data may be 
stored together with other data forms. Otherwise, the data and forms will be filed separately. Soft 
copy data will be stored on study-specific secure and password-protected network drive folders 
and will only be accessible to study staff. Hard copy data are stored in locked cabinets within 
restricted and secure areas at study sites. The study site will maintain all study documentation for 
at least five years after the completion of the study. Study staff at all sites are trained in 
confidentiality and have signed confidentiality agreements. Study staff have been trained in ethical 
human subjects research techniques in order to minimize participant risk as much as possible. 
From our experiences, these methods have proven to be effective to protect against risks.  
 
 
Responses to the assessments will be recorded anonymously and transmitted over the internet 
using industry-standard SSL encryption technology (the same technology used for online 
banking). The names and contact information of participants will not be collected at this time. 
Survey responses will remain anonymous and will not be linked to individual participant’s names 
or contact information at any point during the study. 

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Participants interested in ordering home STI testing kits (i.e. CareKits) or condoms/lubricants will 
be directed to a separate data collection instrument on SurveyGizmo. After selecting the items 
they would like to order, participants will be asked to provide names, mailing addresses, and 
preferred contact information (email or cell phone number for SMS). This personal information will 
be used only for the purposes of fulfilling the order, confirming participation in the study and 
returning lab testing results, and will be kept in a password-protected file on a secure drive. STI 
testing lab results will be posted to HIPAA-compliant web-based platform SMART in Aim 3 for 
participants to access (see Section 7.4.4 for more information on SMART).  
 
 
11.2 
Certificate of Confidentiality 
This research specifically targets a vulnerable population, children (YMSM ages 15-17). We will 
take every available step to minimize the risk of identifying/linking data being subpoenaed, 
stolen, or inadvertently released. First, the iTech will request a Certificate of Confidentiality from 
the NIH. Second, all research staff members are required to complete ethical clearance 
certification regarding protection of human’s subjects through their relevant IRBs. Third, all 
studies will have documented procedures to safeguard against the risk of the linking information 
being stolen by keeping such information in a locked spaces to which only essential study 
personnel who have completed CITI certification for human subjects research ethics training 
(http://citiprogram.org) will have access.  
A Certificate of Confidentiality for the iTech will be sought prior to enrolling participants. As 
noted on the NIH website (http://grants.nih.gov/grants/policy/COC/faqs.htm#187), a Certificate 
of Confidentiality will help the research team “...avoid compelled ‘involuntary disclosure’ (e.g., 
subpoenas) of names and other identifying information about any individual who participates as 
a research subject (i.e., about whom the investigator maintains identifying information) during 
any time the Certificate is in effect.” We have applied for and received Certificates of 
Confidentiality for other NIH-funded research projects, and given the sensitive nature of the data 
collected for this project, do not foresee difficulty securing one for this study.  
11.3 
Risks and Benefits 
11.3.1 
Risks 
Risks to participants in this research study may include:   
 
The measurements that are involved in this study require fingerstick to collect blood samples. 
This procedure may cause local discomfort, bleeding, or bruising; rarely small clot or infection can 
occur at the blood draw site. This measurement should not be considered greater than minimal 
risk in and of itself given its routine use in general health care delivery.  
 
To minimize the risk of participants feeling uncomfortable about answering personal questions, 
we will use Computer-Assisted Self Interview (CASI) methods for the study's surveys. In CASI, 
participants read survey questions on a laptop computer or mobile phone and use a 

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combination of mouse click and keyboard/touchscreen entry to input the answers themselves. 
Study staff may be available to assist participants with questions or technical difficulties on the 
CASI. Participants will also be able to refuse to answer any question that makes them 
uncomfortable.  
To minimize risks to confidentiality, we will secure study data with all appropriate physical, 
electronic, and operational protections. Data will be stored in a physically secure environment. 
All data files will have encryption and strong password protection. Any identifiable data will 
either be stored on Emory University's secure servers, on fully encrypted computers, or on 
paper forms securely stored at the study sites. CASI surveys and online eligibility screening will 
take place on an encrypted commercial survey website, SurveyGizmo 
(http://www.surveygizmo.com/survey-software- features/secure-link/). This site has been used 
by the investigators for thousands of online surveys with MSM with no data security breaches. 
Access to data will be on a role-based standard; only those study staff who require access to 
each type of data to complete their study-related roles will be allowed access. All study staff will 
be trained in security and confidentiality procedures, and will sign a confidentiality agreement 
before receiving access to any participant data.  
We will also develop 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, 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 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 UNC-CH IRB before being used for contact 
with participants.  
We use SSL encryption for transfers of information online, and SurveyGizmo has a business 
partner HIPPA agreement with Emory. SurveyGizmo’s servers are HIPAA compliant.  
The Analytic Core will use Dedoose software to perform all qualitative analyses. Dedoose is a 
web-based application for organizing and analyzing textual, audio, and video data (qualitative) 
along with outstanding functionality for their integration with survey, test score, ratings, and 
demographic data (quantitative). Dedoose employs the highest levels of data encryption 
available for a web application in all data storage, back up, and transmission. Dedoose allows 
for a project specific encryption feature. When using this feature, only Dr. Muessig or her 
designee will hold the additional encryption key needed to be entered in order to view the 
project. This gives Dr. Muessig exclusive control over who can view the project under any 
circumstances.  
In addition to a Certificate of Confidentiality, we will protect participants in the following ways:  
1. Breach of confidentiality. We will take every precaution to minimize risks to study participants. 
All AC research staff members are required to complete ethical clearance certification regarding 
protection of human subjects through UNC-CH or Emory University. We also have a strong data 
and safety monitoring plan in place to protect participants. Adverse events will be reported to 
the UNC-CH and Emory IRBs, individual research PI institutional IRBs and SRV site-specific 
IRBs per each institution’s IRB reporting requirements using Adverse Event Reporting Forms 

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created by the Analytic Core (AC). When possible, reports will be sent within 24 hours of 
notification by the PIs. Annual updates on enrollment and retention will also be sent to the IRBs. 
All data collection will take place in secure and supervised clinical settings. All study personnel 
names on this application have completed training and received certification in Human Subjects 
Research Protection (CITI Program) and HIPAA regulations. They will continue to renew this 
training in compliance with institutional policies.  
11.3.2 
Benefits   
Few direct benefits to participants are anticipated in the theater testing focus group discussions.  
However, the participants may feel good about themselves as a result of helping researchers 
address issues related to HIV prevention for YMSM. If the app is successful at increasing HIV 
testing and PrEP uptake, those receiving the intervention may benefit from increased receipt of 
HIV prevention services. 
 
11.4 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, the informed assent/consent documents and any subsequent modifications will be 
reviewed and approved by the UNC-CH IRB who is responsible for the oversight of the study.  
The informed assent/consent will describe the purpose of the study, the procedures to be 
followed, and the risks and benefits of participation.   
 
Written informed assent/consent will be obtained from the participant for Aims 2 and 3.  The 
signed original assent/consent form for Aims 2 and 3 will be kept on file at the SRV site, and a 
copy of the assent/consent form will be given to the participant.  Sample informed 
assent/consent forms are included with IRB submission. 
 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances 
For all aims of the study, the UNC-CH IRB will be requested to grant a waiver of parental 
permission to participate in this research study for youth participants under the age of 18.   
 
Under 45 CFR 46.408 (c), an IRB has the authority to waive parental permission if it determines 
that “a research protocol is designed for conditions or a subject population for which parental or 
guardian permission is not a reasonable requirement to protect the subjects” and “an appropriate 
mechanism for protecting the children who will participate as research subjects is substituted” and 
“that the waiver is not inconsistent with Federal, State, or local law.” 
 
A waiver of parental permission for studies with lesbian, gay, bisexual, transgender and 
questioning (LGBT) youth that do not involve greater than minimal risk is a common practice 
among researchers working in the area of gay and lesbian health/mental health. This is done to 
avoid the selection biases operating in only recruiting youth whose parents are both aware of and 
comfortable with their sexual orientation. Commonly these youth have explored their sexual 
orientation without their parents’ knowledge as the youth struggle with issues of disclosure and 
its consequences within the social, religious, and economic context of their families. A 

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requirement for parental permission in this type of study could not only affect a person’s 
willingness to participate, but could also potentially impact the ability of researchers to engage in 
this type of research with sexual minority youth. 
 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, 
then requiring parental permission for youth in these circumstances is not a reasonable 
requirement.  Additional privacy protections are provided in that all assessments, notes, reports, 
and other records will be identified by only a coded number to maintain participant confidentiality. 
These records and any forms that do contain identifying information (e.g., assent/consent forms, 
contact information) will be kept in a locked, limited access area (such as a locked file cabinet) at 
the participating study sites. 
 
11.6 
Waiver of the Requirement for Signed Consent Form  
11.6.1 For Study Participation 
For Aim 1 theater testing focus groups, we will be applying for a Waiver of Written 
Documentation of Informed Consent to obtain just a verbal consent from participants prior 
to participation in the focus group. This aim of the study is minimal risk and identifying 
information will only be collected for scheduling appointments (and not connected to any 
data) since no follow-up is required. A written assent/consent form will be reviewed with 
each potential study participant and provided to each assenting/consenting one. This form 
describes the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation.  
 
Pending IRB approval, the specific requirement for written informed consent (i.e., each 
participant’s signature) will be waived per U.S. Code of Federal Regulations Title 45 Part 
46 Subpart A Sections 46.116(d): 
 
 “(d) An IRB may approve a consent procedure which does not include, or which alters, 
some or all of the elements of informed consent set forth in this section, or waive the 
requirements to obtain informed consent provided the IRB finds and documents that”: 
 
1. 
The research involves no more than minimal risk to the subjects. 
 
It is unlikely that participants will be at any risk for harm as a result of study participation. 
No identifiers or contact information will be collected as a part of the focus groups; thus, 
obtaining a signature as a part of the informed consent process would increase risk for 
participants. Further, no other identifiers are necessary since participants will not be 
followed after the focus groups and there is no need for locator forms or any other 
collection of identifying information.  
 
2. 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects. 
 
The waiver of each participant’s signature will not affect the standard and reasonable 
protections afforded all research participants. Participation in the focus groups is 

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completely voluntary. Participants may decide not to take part or to withdraw from 
participation at any time without penalty or loss of any benefit to which they are otherwise 
entitled. The specific names of participants will not be recorded or made public at any time 
during the study, including publication of findings.  None of the information will become 
part of any medical record, and all study records will be strictly maintained according to 
current legal requirements.   
 
3. 
The research could not practicably be carried out without the waiver or alteration. 
 
Because we do not collect identifying information as a part of the focus groups, a written 
consent would require additional identifying information that could potentially link subjects 
to their participation in the study. 
 
4. 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation. 
 
For study-related questions or concerns, information to contact study staff and the IRB will 
be made available to the focus group participants. Additionally, all results from this study 
will be published in academic journals which are accessible to members of the public, 
including those who participated in the study.   
 
 
11.7  Prisoner Participation 
NICHD has concluded that this protocol does NOT meet Federal requirements governing prisoner 
participation in human subject research and should NOT be considered by the UNC-CH IRB for 
the recruitment of prisoners. Subjects enrolled who subsequently become incarcerated or are 
placed in detention may not continue study participation. Study visits cannot be conducted during 
the period of incarceration or detention.  
 
11.8 
45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health 
Information ("Privacy Rule" Pursuant to the Health Insurance Portability and Accountability Act - 
HIPAA) 
Each study site is responsible for adherence to their individual institution’s HIPAA policies and 
procedures. 
 
11.9 Repository Policies (if applicable) 
11.10 Study Discontinuation 
This study may be discontinued at any time by the UNC-CH IRB, NICHD, or other government 
agencies as part of their duties to ensure that research participants are protected.  
 

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12.0  
PUBLICATION OF RESEARCH FINDINGS 
Any presentation, abstract, or manuscript will be made available for review by the study 
sponsor(s) prior to submission.   
 
13.0  
BIOHAZARD CONTAINMENT 
As the transmission of HIV and other blood borne pathogens can occur through contact with 
contaminated needles, blood, and blood products, appropriate blood and secretion precautions 
will be employed by all personnel in the drawing of blood and shipping and handling of all 
specimens for this study, as currently recommended by the Centers for Disease Control and 
Prevention.  These procedures can be found at www.cdc.gov.   
 
Specimens will be transported in accordance with Federal and local laws, and in compliance 
with OSHA blood-borne pathogens standards. This policy includes the samples being 
transported by ground to the local laboratory. Compliance will be achieved by education of 
personnel involved with packaging and transporting specimens.  
 
All infectious specimens must be shipped as Diagnostic Specimens according to current IATA 
Shipping Guidelines for Infectious Substances Class/Div. 6.2.  Refer to individual carrier 
guidelines (e.g. FedEx, Airborne Express) for specific instructions. 
 

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14.0  
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