TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Phase: NA
Conditions: HIV
Sponsor: Friends Research Institute, Inc.

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Version 4.1 
 
July 16, 2021 
 
ATN 160 –  TechStep: Technology-based Stepped Care to Stem Transgender Adolescent 
Risk Transmission 
 
 
Funded 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) 
 
The National Institute on Minority Health and Health Disparities (NIMHD) 
 
 
 
Protocol Chair: 
 
 
 
 
Cathy J. Reback, PhD 
Friends Research Institute  
University of California Los Angeles 
Los Angeles, CA 
 
Protocol Co-Chair: 
Keith J. Horvath, PhD 
San Diego State University 
San Diego, CA 
 
Trial Registration: 
ClinicalTrials.gov NCT04000724 

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ATN 160 –  TECHSTEP: TECHNOLOGY-BASED STEPPED CARE TO STEM 
TRANSGENDER ADOLESCENT RISK TRANSMISSION 
 
 
 
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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TABLE OF CONTENTS 
 
ATN 160 –  TechStep: Technology-based Stepped Care to Stem Transgender Adolescent 
Risk Transmission ................................................................................................................. 2 
PROTOCOL TEAM ROSTER ............................................................................................... 5 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................................................. 6 
STUDY ABSTRACT .............................................................................................................. 7 
Study Design or Schema ....................................................................................................... 9 
1.0  
INTRODUCTION ...................................................................................................... 10 
1.1 
Background ........................................................................................................... 10 
1.2  
Rationale ............................................................................................................... 11 
2.0 
STUDY OBJECTIVES .............................................................................................. 12 
3.0 
STUDY DESIGN ....................................................................................................... 13 
3.1  
Study Phases ........................................................................................................ 13 
3.2  
Study Population ................................................................................................... 14 
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment 
Procedures ...................................................................................................................... 14 
4.0  
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS .............................. 15 
4.1  
Inclusion and Exclusion Criteria ............................................................................ 15 
4.2 
Exclusion Criteria .................................................................................................. 16 
4.3 
Recruitment ........................................................................................................... 17 
4.4 
Screening .............................................................................................................. 18 
4.5 
Informed Consent.................................................................................................. 19 
5.0  
STUDY PROCEDURES ........................................................................................... 21 
5.1 
Enrollment Procedures .......................................................................................... 21 
5.2 
Randomization Procedures ................................................................................... 22 
5.3 
Intervention/Investigation Procedures ................................................................... 22 
6.0  
EVALUATIONS AND MEASURES for Phase 1 focus groups ................................... 25 
6.1 
Screening .............................................................................................................. 25 
6.2 
Focus Group ......................................................................................................... 25 
6.3 RCT ........................................................................................................................... 25 
6.4. 
Premature Discontinuation/Off-Study Evaluations/Measures ................................ 26 
7.0 
DATA COLLECTION AND SITE MONITORING ....................................................... 26 
7.1 
Development of Protocol and Case Report Forms ................................................ 26 
7.2 
Data Records ........................................................................................................ 26 
7.3  
Data Collection ...................................................................................................... 27 

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7.4 
Data Submission ................................................................................................... 30 
7.5 
Data Quality Assurance......................................................................................... 32 
7.6 
Role of Data Management .................................................................................... 32 
7.7 
Study Site Monitoring and Record Availability ....................................................... 32 
8.0 
PARTICIPANT MANAGEMENT................................................................................ 32 
8.1 
Tracking Participants / Follow-up .......................................................................... 32 
8.2 
Compensation ....................................................................................................... 33 
8.3 
Intervening on “Social Harms" ............................................................................... 33 
8.4 
Criteria for Premature Study Discontinuation ......................................................... 35 
9.0 
MONITORING UNTOWARD EFFECTS ASSOICATED WITH OR RESULTING FROM 
STUDY ................................................................................................................................ 36 
9.1 
Site research staff must first follow their own IRB’s procedure for reporting and 
managing untoward effects. ............................................................................................. 36 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS ........................................................ 37 
10.1 
Introduction ........................................................................................................... 37 
10.2 
Power Estimates  .................................................................................................. 37 
10.3 
Statistical Analysis Plan ........................................................................................ 38 
10.4 
Missing Data ......................................................................................................... 38 
11.0 
HUMAN SUBJECTS ................................................................................................. 39 
11.1 
Participants’ Confidentiality ................................................................................... 39 
11.2 
Certificate of Confidentiality ................................................................................... 39 
11.3 
Risks and Benefits ................................................................................................ 40 
11.4 
Institutional Review Board (IRB) Review and Informed Consent ........................... 42 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances .... 42 
11.6 
Waiver of the Requirement for Signed Consent Form ........................................... 43 
11.7 
Prisoner Participation ............................................................................................ 43 
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) .................................................................................................................... 44 
11.9 
Study Discontinuation ........................................................................................... 44 
12.0 
PUBLICATION OF RESEARCH FINDINGS ............................................................. 44 
13.0 
REFERENCES ......................................................................................................... 45 
 
 
 
 
 

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PROTOCOL TEAM ROSTER 
 
 
 
Lisa Hightow-Weidman 
Travis Sanchez 
Demetria Cain 
Joshua Rusow  
David Benkeser 
Michael Hudgens  
Sonia Lee   
Sylvie Naar  
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
AC 
 
 
Analytic Core 
ACASI  
 
Audio Computer Assisted Self-interview 
AIDS  
 
Acquired Immunodeficiency Syndrome 
ART 
 
 
Antiretoviral Therapy  
ATN 
 
 
Adolescent Medicine Trials Network for HIV/AIDS Interventions 
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 
ICH 
 
 
International Conference on Harmonization 
IRB 
 
 
Institutional Review Board 
MC 
 
 
Management Core 
MSM  
 
Men who have Sex with Men 
NICHD  
 
National Institute of Child Health and Development 
NIDA  
 
National Institute on Drug Abuse  
NIH 
 
 
National Institutes of Health 
PI 
 
 
Principal Investigator 
OHRP  
 
Office for Human Research Protections 
QNS 
 
 
Query and Notification System 
RCG                           Radiant Creative Group 
RCT 
 
 
Randomized Controlled Trial 
RDC 
 
 
Remote Data Capture 
SRV 
 
 
Subject Recruitment Venue 
SSL 
 
 
Secure Sockets Layer 
TC 
 
 
Technology Core 
Trans  
 
transgender feminine, transgender masculine, gender non-conforming 
TWM  
 
Thrive With Me 
UMN  
 
University of Minnesota 
VL 
 
 
Viral Load 
YAB 
 
 
Youth Advisory Board 
YLWH  
 
Youth Living With HIV 
YO 
 
 
Years Old 
YT 
 
 
Youth Thrive 
YYA 
 
 
Youth and Young Adults 

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STUDY ABSTRACT 
 
DESIGN:  
TechStep is a three-arm, technology-based randomized 
controlled trial (RCT), with a stepped care approach, 
among high-risk HIV-negative trans youth and young 
adults (YYA) for reducing sexual risk behaviors and 
increasing PrEP uptake.   
 
DURATION: 
Trans YYA are enrolled for 9 months in the RCT. 
 
SAMPLE SIZE: 
Total study sample is 355 of which the following will be 
enrolled for each phase: 1) up to 80 participants for focus 
groups to inform intervention adaption; 2) 275 participants 
for a randomized controlled trial of TechStep, with 
participants randomized to either text messaging stepped 
care (n=108), WebApp stepped care (n=83) or control 
(n=83) condition. 
 
 
POPULATION:  
Participants will include YYA who are self-identified trans 
feminine, trans masculine or gender non-conforming or 
whose birth sex and current gender do not match; ages 
15 to 24 years; HIV-negative; and sexually active. For 
Phase 1, participants must self-report never having 
received a positive HIV test result; participants age 15-20 
must report any kind of sex in the previous 12 months, 
while participants age 21-24 must report vaginal or anal 
sex (either insertive or receptive; excluding sex toys) in 
the previous 12 months. For Phase 2, participants must 
have a confirmed HIV negative serostatus and report anal 
or vaginal sex (either insertive or receptive; excluding sex 
toys) in the previous 12 months. For Phase 2, participants 
will be recruited from SRVs in Houston, Los Angeles, 
New York City, Philadelphia, and Boston.   
 
STRATIFICATION:  
Focus group discussions will be stratified by age (50% 15-
20 years old; 50% 21-24 years old). 
 
DATA 
COLLECTION: 
Focus group discussions will be conducted in-person, 
digitally recorded, and professionally transcribed. There 
will be five data collection (screening, baseline, 3-month, 
6-month, and 9-month) time points for the RCT. Visits will 

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be conducted in-person at the SRV, online, or some 
combination of in person or online. The ACASI will be 
completed using online survey tools. An HIV test, STI 
panel, urine screen for recent illicit drug use, and blood 
microsampling, for those who report PrEP uptake, to 
verify PrEP adherence will be collected in-person at the 
participant’s SRV or via mailed self-collection kits. HIV 
testing during enrollment is mandatory, and encouraged 
during follow-ups. All biological specimen collection with 
the excepton of HIV testing at enrollment is optional but 
encouraged. Process data of participant activity at each 
step of the intervention, as well as the control 
intervention, will be collected.  
 
OBJECTIVES: 
Primary Aim 1: Conduct formative research to develop 
the stepped care (text messaging, WebApp, and 
eCoaching) interventions and refine iterations through 
input from focus groups with trans YYA at the four study 
sites (n=80) and a youth advisory board (YAB). 
 
Primary Aim 2:  In a 3-arm RCT (N=275), assess the 
differential immediate and sustained effects of a low 
intensity information (“Info”) arm compared to a text 
messaging stepped care intervention (text messaging 
plus step to eCoaching for YYA with continued high risk) 
arm compared to a WebApp stepped care intervention 
(WebApp plus step to eCoaching for YYA with continued 
high risk) arm for reducing sexual risk behaviors and 
increasing PrEP uptake among high-risk, HIV-negative 
trans (15-24 years old). 
 
Secondary Aim 3: Determine the added benefit of text 
messaging plus eCoaching versus text messaging alone 
and of WebApp plus eCoaching versus WebApp alone for 
reducing sexual risk behaviors and increasing PrEP 
uptake. 
 
Secondary Aim 4: Assess the differential immediate and 
sustained effects of low intensity information compared to 
text messaging only compared to WebApp only for 
reducing sexual risk behaviors and 
increasing PrEP uptake. 
 
Secondary Aim 5: Determine the impact of structural- 
(e.g., 
transphobia, 
housing 
insecurity, 
educational 
attainment, access to healthcare) and individual-level (e.g., 
identity formation, gender transition, gender expression, 

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stigma, 
discrimination) 
trans-specific 
factors 
as 
moderators of intervention outcomes. 
STUDY DESIGN OR SCHEMA 
Figure 1. TechStep Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Text arm increasing from 83 to 108 as of February 2021. 
 
 
 

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1.0  
INTRODUCTION 
1.1 
Background 
National evidence suggests that as many as 8% of US youth self-identify as either “transgender,” 
“gender nonconforming,” or “other gender”.7 Evidence further demonstrates that trans youth face 
a “health syndemic,” i.e., a set of reinforcing structural, cultural, and behavioral factors that place 
trans youth at dramatically increased risk for negative physical, social, and mental health 
outcomes.
8-11 For example, trans youth demonstrate significantly elevated rates of sexual risk-
taking relative to their cisgender/gender-conforming peers,
9,12,13,14 including rates of condomless 
anal intercourse ranging from 27-59% and rates of engagement in sex work ranging from 24-
75%.
1,14 Increased rates of sexual risk behavior(s) among trans youth are associated with the 
population’s increased experiences of physical/sexual abuse and victimization, mental health 
disorder, incarceration, and homelessness,
9,14,15 as well as substance use, sex work, and 
substance use during sex.
2,9,14 Due to this health syndemic, trans youth are at substantially 
increased risk for HIV infection, as well as other STIs, relative to their cisgender youth 
counterparts.
1,2 Despite these needs, there is persistent evidence of inadequate training regarding 
the care of trans youth among traditional healthcare providers;
16 the difficulties trans youth report 
accessing 
traditional 
healthcare
13,17 
and 
the 
frequent 
reports 
by 
trans 
youth 
of 
prejudice/discrimination when receiving traditional healthcare
17,18 demonstrate the critical need 
for avenues of sexual health information and intervention which extend beyond traditional brick-
and-mortar service and which cater to the special needs of trans youth. 
Mobile technology-based intervention approaches have the unique advantages of being unleashed 
from traditional face-to-face requirements within brick-and-mortar settings, and therefore are 
highly scalable. Because of this, mobile interventions may be delivered anywhere and at any time, 
so long as users have their mobile device with them. This “always on” feature allows mobile 
interventions to be delivered during times when users need relevant intervention the most. Finally, 
interventions delivered via mobile phone can also be delivered at no/low cost, provide a high 
degree of confidentiality, and cultivate motivational communication among users, all elements of 
special relevance to trans youth populations.
28 
All adolescents, including trans youth,
19 demonstrate frequent use of text messaging and mobile 
Internet-enabled technology to seek out protective sexual health information.
20 Trans youth 
explicitly cite mobile phones as critical tools in their ability to engage with sexual health 
information, as text messaging conversations, mobile apps, and other mHealth delivery modalities 
provide portals where trans youth report feeling comfortable to seek out health-related knowledge 
specific to trans individuals (e.g., hormone therapy, pubertal suppression
21) adopt and express new 
and different identities, connect to other trans youth to seek out information and resources.
19,22,23 
Evidence demonstrates that youth find text messages about sexual health easy to understand, 
trustworthy, friendly, convenient, and that the text message format promotes the ability to 
assimilate and share sexual health information at their own pace; youth also indicate that sexual 
health messages delivered via text increase confidence and reduce sexual stigma.
24 In-depth 
interviews with trans youth revealed overwhelming endorsement of digital spaces, particularly 
those accessible for free or at low cost via mobile phones,
23 as critical sources of transgender-
specific health information
25,26 and resilience in the face of prejudice and 
perceived 
discrimination.
22,23 Among mobile deliverable intervention modalities, text messaging and 
smartphone apps in specific have been identified as particularly well-suited to the needs of trans 
populations, whose gender expression may serve as an obstacle to standard brick-and-mortar 
treatment.
27 

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Although systematic review indicates that mobile health interventions are particularly efficacious at 
increasing HIV protective behaviors among vulnerable and key HIV risk populations such as trans 
youth,
28 a recent systematic review revealed that only 18% of mobile phone-based HIV 
prevention/care interventions provide any information tailored to LGBT populations, and none 
were tailored specifically to trans individuals.
29 One digital intervention designed for LGBT youth, 
but not specifically tailored for trans youth, successfully increased safer sex outcomes among 
participants,
30 and another intervention designed for young African American/Black MSM and trans 
women, but was not specifically for trans women, demonstrated significant improvements in 
participant social support, social isolation, and depressive symptoms.
31,32 The TechStep study will 
fill a critical gap in the scientific advancement of technology-based interventions for trans youth by 
a) creating the first technology-based trans youth-specific HIV prevention interventions optimized 
for mobile phone delivery; and, b) employing the two intervention delivery modalities identified as 
most promising for use among trans YYA (i.e., text messaging and mobile app). 
As part of the UNC/Emory Center for Innovative Technology (iTech), we propose to test the 
efficacy of TechStep for trans YYA. In this 4-year study, 275 high-risk trans YYA between the 
ages of 15-24 will be randomized to receive text messaging, a WebApp, or an information-only 
control intervention for 6 months, with assessments occurring at baseline and 3-, 6- and 9-months. 
YYA who do not evidence improvements in sexual risk and/or PrEP uptake at the 3-month 
assessment will be randomized to either receive weekly eCoaching sessions in addition to their 
assigned text messaging or WebApp intervention, or remain in the original intervention in a 2:1 
ratio. The primary endpoint is reduced sexual risk behaviors and/or PrEP uptake, adherence and 
persistence at month 6.  
1.2  
Rationale 
There is a clear need to develop effective prevention interventions that meet the needs of trans 
YYA. Trans YYA – especially racial and ethnic minorities – are at very high risk for acquiring HIV 
and other STIs, the impact of which is compounded by the lack of culturally competent healthcare 
providers. For this reason, the suite of technology-based interventions developed in TechStep 
and assessed for effectiveness in a 3-arm RCT represents an important advance in intervention 
science toward developing tailored and scalable interventions for this population. 
1.2.1 Youth Advisory Boards (YAB) of trans YYA 
 
Two Youth Advisory Boards will be convened. There will be a physical YAB in Los Angeles, and 
a virtual cross-site YAB via telecommunication comprised of members from the Houston, New 
York, and Philadelphia SRVs. The YABs will meet biannually throughout the course of the study 
and will provide feedback on all aspects of the TechStep study including the technology-based 
interventions, stepped care design, recruitment strategies, culturally competent study materials, 
and implementation. YAB participants provide expert advice and are not considered human 
subjects under the IRB. 
1.2.2 Focus groups with trans YYA 
 
Eight focus groups (two each in Houston, Los Angeles, New York and Philadelphia) will be 
conducted to gain feedback from trans YYA about the existing text messaging and WebApp 
interventions that will serve as the starting points for adapting these intervention approaches. 
Focus groups will be conducted at four SRVs (Houston, Los Angeles, New York City, and 
Philadelphia), two of which (Houston & Los Angeles) will focus on gaining feedback on the 
WebApp and two of which (New York & Philadelphia) will focus on gaining feedback on the text 

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messaging intervention. Feedback on these intervention strategies will help to ensure that they 
are culturally tailored to trans YYA.   
1.2.3 RCT of TechStep 
 
A 3-arm RCT of TechStep will be conducted with the following conditions: 1) a text messaging 
stepped care intervention, 2) a WebApp stepped care intervention, and 3) a low-intensity 
information control group. Those in either of the active technology-based intervention conditions 
who do not report a reduction in sexual risk and have not started PrEP, or those who report a 
reduction in sexual risk but have discontinued PrEP since their last assessment will be 
randomized to either step up to receive the technology-based intervention (text or WebApp) plus 
weekly eCoaching sessions or to remain on the original intervention.. The control group will 
consist of information about trans health, HIV/STI information and local resources for trans 
persons. A RCT was chosen since it is the gold standard for assessing the effectiveness of an 
intervention under tightly controlled conditions. The intervention and control groups will have 
access to information and intervention content for 6 months, with ACASI performed at baseline, 
and every 3 months thereafter for 9 months (i.e., 3-month, 6-month, & 9-month follow-up 
assessments). At all follow-up assessments, trans YYA will be assessed for their sexual risk 
behaviors and PrEP uptake, adherence and persistence. Assessments will include self-reported 
behavioral data, and biomarkers for HIV, STIs, current drug use, and PrEP adherence and 
persistence.  
2.0 
STUDY OBJECTIVES 
Primary Aim 1: Conduct formative research to develop the stepped care (text 
messaging, WebApp, and eCoaching) interventions and refine iterations through input 
from focus groups with trans youth and young adults (YYA) at the four study sites (n=80) 
and a youth advisory board (YAB). 
 
Primary Aim 2:  
 
In a 3-arm RCT (N=275), assess the differential immediate and sustained effects of a low intensity 
information (“Info”) arm compared to a text messaging stepped care intervention (text messaging 
plus step to eCoaching for YYA with continued high risk) arm compared to a WebApp 
stepped care intervention (WebApp plus step to eCoaching for YYA with continued high risk) arm 
for reducing sexual risk behaviors and increasing PrEP uptake among high-risk, HIV-negative 
trans (15-24 years old). 
 
Hypothesis 1a: There will be significantly greater reductions in sexual risk behaviors among 
those in the Text+Step and App+Step arms compared to the low intensity Info arm. 
 
Hypothesis 1b: There will be significantly greater uptake of PrEP among those in the 
Text+Step and App+Step arms compared to the low intensity Info arm. 
 
Secondary Aim 3:  
 
Determine the added benefit of text messaging plus eCoaching versus text messaging alone and 
of WebApp plus eCoaching versus WebApp alone for reducing sexual risk behaviors and 

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increasing PrEP uptake. 
 
Secondary Aim 4: Assess the differential immediate and sustained effects of low intensity 
information compared to text messaging only compared to WebApp only for reducing sexual risk 
behaviors and increasing PrEP uptake. 
 
Secondary Aim 5: Determine the impact of structural- (e.g., transphobia, housing insecurity, 
educational attainment, access to healthcare) and individual-level (e.g., identity formation, 
gender transition, gender expression, stigma, discrimination) trans-specific factors as 
moderators of intervention outcomes. 
 
Hypothesis 2: Structural- and individual-level trans-specific factors will moderate intervention 
outcomes, such that participants who report higher amounts and degrees of these factors 
will require more intensive intervention steps (i.e., eCoaching). 
 
 
3.0 
STUDY DESIGN 
3.1  
Study Phases 
We will develop and evaluate TechStep in two phases. In Phase 1, we will establish Youth 
Advisory Boards (YABs) to inform intervention features and content, as well as conduct focus 
groups to seek input into intervention components. In Phase 2, TechStep will be evaluated in a 
randomized controlled efficacy trial (see TechStep Schema). For Phase 1, all participants (n=80) 
must meet the eligibility criteria listed in Section 4. A recruitment target of 275 HIV-negative trans 
YYA will be enrolled in Phase 2 to assess whether Text+Step or WebApp+Step is more effective 
in reducing sexual risk behaviors and increasing PrEP uptake, adherence and persistence for 
HIV-negative trans YYA than a low-intensity control condition. Trans YYA will be recruited from 5 
SRVs (Boston, Houston, Los Angeles, Philadelphia, New York), screened, and randomized to 
receive either the Text+Step intervention, the App+Step intervention, or basic information on 
HIV/STIs, trans health, and referrals only in the control condition. The step component may 
provide weekly eCoaching sessions in addition to the original intervention (i.e. text or app) for 
YYA who do not evidence improvement in sexual risk and/or PrEP uptake. Sexual risk behaviors 
and PrEP uptake, adherence, and persistence will be assessed at the enrollment visit, and 3-, 6-
, and 9-month follow-up assessment time points.  
Phase 1: Formative Research and Community Input  
Two Youth Advisory Boards will be convened. There will be a physical YAB in Los Angeles, and 
a virtual cross-site YAB via telecommunication comprised of members from the Houston, New 
York, and Philadelphia SRVs. The YABs will meet at least biannually throughout the course of 
the study and will provide feedback on all aspects of the TechStep study including the technology-
based interventions, stepped care design, recruitment strategies, culturally competent study 
materials, and implementation.  
We will conduct two focus groups with up to 10 trans YYA per group, at 4 SRVs (8 focus groups 
total). At each SRV, one focus group will consist of participants between the ages of 15-20 and 
the other focus group will be with participants between the ages of 21-24. Focus groups in 
Houston and Los Angeles will be used to gain feedback on the WebApp (also referred to in this 
protocol as an “app”) component of the intervention, while focus groups in New York and 
Philadelphia will be used to gain feedback on the text messaging component of the intervention. 

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Focus groups will be transcribed verbatim and a content analysis will be assisted by the Analytic 
Core (AC).  
Phase 2: Randomized Controlled Trial to Test Efficacy of TechStep 
Trans YYA will be recruited from 5 SRVs (Boston, Houston, Los Angeles, New York, and 
Philadelphia) to participate in a 3-arm RCT to determine immediate and sustained effects of the 
Text+Step intervention versus the App+Step intervention compared to an information-only control 
condition (“Info” arm). All participants will receive one of the interventions for 6 months, with 
assessments occurring at baseline and every 3 months thereafter until month 9. Trans YYA 
randomized to either of the technology-based intervention arms (Text or WebApp) will be 
evaluated at the 3-month follow-up assessment time points to determine if they remain at the 
current level of intervention, or if they are eligible for randomization to also receive eCoaching 
sessions in addition to their originally assinged intervention. All participants assigned to the 
Text+Step intervention arm will begin with the text messaging intervention. Participants assigned 
to the App+Step intervention arm will begin with the WebApp intervention. At the first follow-up 
assessment time point, information about their sexual behavior in the past 3 months and whether 
they began or stopped using PrEP will be used to determine if they require a more intensive 
intervention approach. Participants who do not demonstrate intervention responsiveness at the 
3-month follow-up assessment will be re-randomized, in a 2:1 ratio, to either  remain in the original 
technology-based intervention (i.e., Text or App) or add eCoaching to the original technology-
based intervention (i.e., Text+eCoaching or App+eCoaching). This re-randomization will allow for 
a comparison of intervention effects between the technology-based interventions (i.e., text or app) 
plus eCoaching to the technology-based intervention alone. The control condition will receive the 
same information-only intervention for the entire 6-month intervention period. 
3.2  
Study Population 
We propose to enroll 355 trans YYA for the purposes of this study. Up to 80 participants will be 
recruited for focus group discussions (with the goal of 5-7, a minimum of 3 and a maximum of 10 
per group), and 275 participants (n=108 Text+Step, n=83 App+Step and n=83 control) will be 
recruited to participate in the TechStep RCT.  
Inclusion criteria for the focus groups and RCT are described in Section 4.0 (note: the Youth 
Advisory Board members are not considered human subjects for research and, therefore, 
inclusion criteria are not listed for YABs). 
 
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment 
Procedures 
3.3.1 Focus Groups 
 
Focus groups will be stratified by age such that 2 focus groups (1 consisting of youth 15-20 year 
olds and 1 consisting of young adults 21-24 years old) will be conducted at 4 SRVs. Study staff 
at each SRV will oversee that approximately 5-7 participants (with a minimum of 3 and a maximum 
of 10) are recruited for each of the 2 focus groups conducted at that site.  
3.3.2 RCT 
 
In the RCT, participants will be randomized 1:1:1 to the Text+Step intervention or App+Step 

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intervention or control condition. Randomization procedures are further explained in Section 5.2. 
 
4.0  
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS 
4.1  
Inclusion Criteria  
4.1.1 Inclusion Criteria for Phase 1 Focus Groups with Youth (15-20 years old)  
• 
Self-identified as trans feminine, trans masculine or gender non-conforming OR birth sex 
and current gender differ; 
• 
Between the ages of 15 to 20 years old;  
• 
Reports any sex with another person in the previous 12 months;  
• 
Self-report HIV negative serostatus.  
• 
Live in the area and availability to meet with research staff at either the Baylor College of 
Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children’s Hospital of 
Philadelphia, Children’s Hospital Los Angeles, or the Center for HIV Educational Studies 
and Training (CHEST) in New York City;  
• 
Have a mobile device with SMS and Internet access capabilities; and 
• 
English-speaking (since the intervention will be built in English).  
4.1.2  Inclusion Criteria for Focus Groups with Young Adults (21-24 years old)  
 
• 
Self-identified as trans feminine, trans masculine or gender non-conforming OR birth sex 
and current gender differ; 
• 
Between the ages of 21 to 24 years old;  
• 
Reports vaginal or anal sex (either insertive or receptive) with another person in the 
previous 12 months;  
• 
Self-report HIV negative serostatus.  
• 
Live in the area and availability to meet with research staff at either the Baylor College of 
Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children’s Hospital of 
Philadelphia, Children’s Hospital Los Angeles, or the Center for HIV Educational Studies 
and Training (CHEST) in New York City;  
• 
Have a mobile device with SMS and Internet access capabilities; and 
• 
English-speaking (since the intervention will be built in English).  
4.1.3  Inclusion Criteria for Randomized Controlled Trial Inclusion Criteria 
• 
Self-identified as trans feminine, trans masculine or gender non-conforming OR birth sex 
and current gender differ; 

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• 
Between the ages of 15 to 24 years old;  
• 
Report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another 
person in the previous 12 months;  
• 
Negative HIV test; 
• 
Availability to meet with research staff in person or online at the Baylor College of Medicine 
(BCM) Adolescent Medicine Trials Unit in Houston, Children’s Hospital of Philadelphia, 
Children’s Hospital Los Angeles, PRIDE Health Research Consortium New York City, or 
the Fenway Institute in Boston;  
• 
Have a mobile device with SMS (text messaging) and Internet access capabilities; and 
• 
Read and speak English (since the intervention will be built in English). 
4.2 
Exclusion Criteria 
4.2.1  Exclusion Criteria for Focus Groups with Youth (15-20 years old)  
• 
Does not self-identify as trans feminine, trans masculine or gender non-conforming OR 
birth sex and current gender match;  
• 
Younger than 15 years of age or over 20 years of age;  
• 
Does not report sex with another person in the previous 12 months;  
• 
Does not self-report a HIV negative serostatus.  
• 
Doesn’t live in the area or is unable to meet with research staff at either the Baylor College 
of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children’s Hospital of 
Philadelphia, Children’s Hospital Los Angeles, the Center for HIV Educational Studies and 
Training (CHEST) in New York City ;  
• 
Does not have a mobile device with SMS and Internet access capabilities;  
• 
Not English-speaking and/or does not read English (since the intervention will be built in 
English); 
• 
Unwilling or unable to comply with protocol requirements; 
• 
Unable to understand the Informed Consent/Assent Form. 
4.2.2  Exclusion Criteria for Focus Groups with Young Adults (21-24 years old)  
 
• 
Does not self-identify as trans feminine, trans masculine or gender non-conforming OR 
birth sex and current gender match;  
• 
Younger than 21 years of age or over 24 years of age;  
• 
Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with 
another person in the previous 12 months.  

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• 
Does not live in the area or is unable to meet with research staff at either the Baylor 
College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children’s 
Hospital of Philadelphia, Children’s Hospital Los Angeles, the Center for HIV Educational 
Studies and Training (CHEST) in New York City;  
• 
Does not have a mobile device with SMS and Internet access capabilities;  
• 
Not English-speaking and/or does not read English (since the intervention will be built in 
English); 
• 
Unwilling or unable to comply with protocol requirements; 
• 
Unable to understand the Informed Consent/Assent Form. 
4.2.3  Exclusion Criteria for Randomized Controlled Trial  
• 
Does not self-identify as trans feminine, trans masculine or gender non-conforming OR 
birth sex and current gender match;  
• 
Younger than 15 years of age or over 24 years of age;  
• 
Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with 
another person in the previous 12 months.  
• 
Reactive or indeterminate HIV test;  
• 
Unable to meet in person or online with research staff at the Baylor College of Medicine 
(BCM) Adolescent Medicine Trials Unit in Houston, Children’s Hospital of Philadelphia, 
Children’s Hospital Los Angeles, PRIDE Health Research Consortium in New York City, 
or the Fenway Institute in Boston for the Baseline and 3 month assessment;  
• 
Does not have a mobile device with SMS (text messaging) and Internet access 
capabilities;  
• 
Not English-speaking and/or does not read English (since the intervention will be built in 
English); 
• 
Unwilling or unable to comply with protocol requirements; 
• 
Unable to understand the Informed Consent/Assent Form. 
 
4.3 
Recruitment  
The following recruitment strategies will be utilized to ensure enrollment targets are met and a 
diversity of participants are enrolled. 1) Online Recruitment: Online banner ads targeting trans YYA 
will be placed through geo-mapping on websites and social media in SRV cities. We will also 
distribute digital flyers to community leaders who will inform their email distribution lists with 
information on how to participate in the study. Additional online recruitment may also be 
conducted, including but not limited to recruiting via online social media outlets (e.g., Facebook, 

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Instagram, Snapchat, etc.). 2) SRV and other Community-based Outreach: flyers and posters will 
be created and distributed in SRVs and other community-based organizations and clinic settings 
that cater to trans YYA. The flyers and posters will contain details about how to contact a SRV 
Research Assistant for further information or how to screen online for the RCT. 3) Peer Referral: 
Participants who screen eligible for the RCT will be asked to refer friends who are also trans YYA. 
For the 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). 4) Clinic-based recruitment may include reviewing 
medical charts of existing patients for potential eligibility, or referrals from other providers in the 
clinic. 5) Former participants who have previously given consent to be contacted for future 
research may also be directly contacted for recruitment and screening. 6) Print Media: Ads will be 
placed in print media that trans YYA read. 7) Street- and Venue-based Outreach: Research 
Assistants will utilize a semi-structured time-space sampling methodology to conduct street- and 
venue-based outreach identified through the Trans Youth Community Advisory Board and ongoing 
community mapping at locations where young trans YYA congregate. Research Assistants will be 
trained on appropriate outreach strategies, how to build and maintain ongoing trust and rapport, 
and how to conduct confidential screening. 
4.4 
Screening 
All potential participants (whether recruited online, in-person or over the phone) 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 screening survey.  
SRV staff may also screen participants using the online screener in person, over the phone, or 
over a teleconferencing platform such as Zoom or a comparable platform. The SRV staff will 
obtain verbal consent from the participant to screen, read the screening questions from the the 
online survey to the participant, and record the participant’s responses in the online screener.  
The online survey is hosted on Alchemer and we will use SSL encryption for transfers of 
information online and data will be stored in the secure, HIPAA-compliant servers of Alchemer. 
The Emory AC team maintains a business partner HIPAA agreement with Alchemer.  For those 
who meet eligibility criteria, the survey will ask if they are willing to provide their first name, e-mail, 
and a phone number. Potential participants who do not meet eligibility criteria will be asked if they 
would like to be contacted about other research studies and, if so, to provide contact information. 
The Analytic Core will securely share the contact information of eligible participants with SRV 
sites via a secure Box or Microsoft OneDrive account. SRV staff will enter the eligible participant 
into SMART for scheduling and contact participants to schedule an in-person visit at the SRV or 
an online enrollment visit. Study staff also have the option of scheduling and completing some 
study visit activities in person and some of the study visit activities online to provide flexibility 
during the COVID-19 pandemic and afterwards and to be responsive to participant needs.  

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YYA who screen eligible and provide contact information will be contacted by SRV staff and 
provided with information about the date and time of the focus group (in Phase 1) or to schedule 
an in person or online baseline enrollment visit (in Phase 2). An email will be sent to potential 
focus group participants immediately after they are scheduled for the focus group that includes 
the focus group date, time, location and staff contact information. Potential focus group 
participants will be sent a reminder three days prior to the focus group, as well as on the day of 
the focus group.  
YYA who screen ineligible (see section 4.2 for exclusion criteria) will be informed at the conclusion 
of the screener that they are not eligible for the study. 
 
4.4.1 Contact Info 
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. Participants will also 
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. For 
participants randomized to the eCoaching intervention, the eCoaches based at PRIDE will ask 
participants in the eCoaching intervention to provide them with contact information similar to what 
the participant provided to the SRV when they were enrolled.  
 
4.5 
Informed Consent  
Informed consent/assent. The informed consent process will occur on the day the enrollment 
visit is held. Consent may be done online, in person, or over the phone. A teleconference platform 
such as Zoom (see Section 7.3.6 for description of the Zoom platform) or other comparable 
platform will be used for online study visits and consenting. 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 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.  The informed consent/assent form may be on paper or online 

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via a HIPAA-compliant, secure online platform, such as Alchemer or Qualtrics (see Section 7.3.7 
for details on Qualtrics). 
 
Assessing for decisional capacity. For all participants, the research assistant (RA) reviews the 
informed consent/assent to make an assessment of the participant’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 a question such as, “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 YYA 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. YYA 
who appear not to understand after repeated review will not be enrolled in the study. If the 
enrollment process occurs online, research staff will talk with potential participants via phone or 
online teleconference platform such as Zoom (see Section 7.3.6 for description of the Zoom 
platform) or other comparable platform to assess for decisional capacity and to address any 
questions or concerns the person may have. 
Waiver of parental consent. We will request that the UNC-CH IRB as the central 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 trans 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 disclosing 
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 or gender identity. Commonly, these youth have explored their 
sexuality or gender expression 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 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 gender and 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, 

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contact information) will be kept in a locked, limited access area (such as a locked file cabinet) at 
the participating site. 
 
5.0  
STUDY PROCEDURES 
5.1 
Enrollment Procedures 
5.1.1 Focus group enrollment 
 
Screening procedures are explained above in section 4.4. All persons who screen eligible for the 
study will be guided through the informed consent process (section 4.5) on the day the focus 
group is held. Research staff administering the consent process will pay particular attention to 
whether the potential participant appears confused or otherwise unable to complete the informed 
consent process, and will stop enrollment of that participant in the focus group.  
Following informed consent, trans YYA will be walked to the focus group room where they will 
complete a brief paper-and-pencil Focus Group Participant Survey (e.g., additional demographics 
and technology use survey) before the focus group begins. After informed consent/assent is 
obtained and the Focus Group Participant Survey is completed, participants will be deemed 
enrolled in the study.  
 
Participants will be compensated for their time once the focus group has ended. Participants who 
leave the focus group early will be compensated the same amount regardless of how long they 
are present.  
 
5.1.2 RCT Enrollment 
Screening procedures are explained above in section 4.4. All persons who screen eligible for the 
study will be guided through the informed consent process (section 4.5) on the day of their 
enrollment appointment. Research staff administering the consent process will pay particular 
attention to whether the potential participant appears confused or otherwise unable to complete 
the informed consent process, and will stop enrollment of that participant in the RCT. 
Following informed consent, trans YYA will go through baseline assessment procedures of having 
HIV testing, blood microsampling analysis for those who self-report PrEP use, screening for STIs 
and drug use through a urine screen (note: HIV testing is the only required biological specimen 
collection, all others are voluntary), and the survey measures through an ACASI. Biological 
specimen collection may be done in person during the study visit or via self collection kits mailed 
to participants. For mailed self collection, the biological specimens may be collected after the 
baseline enrollment visit and must be returned within 90 days. After randomization, participants 
will receive more information about the arm they are randomized into (e.g. how to use the 
WebApp, the frequency of text messages, or how to access the resources and information). For 
in person enrollment visits, participants will be deemed enrolled in the study after baseline 
procedures and the enrollment visit are completed. For online enrollment visits, participants will 
be deemed enrolled in the study after they are randomized and onboarded.  

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5.2 
Randomization Procedures  
For the purpose of Phase 1 focus groups, participants will not be randomized.  
Randomization for the RCT is explained in section 3.3.2. 
During the RCT, after completion of the baseline ACASI, participants will be randomized 1:1:1 to 
the Text+Step intervention or App+Step intervention or control condition, based on a 
randomization sequence developed by the AC lead statistician and loaded into DFexplore (see 
section 7.4.1 for more details on DFexplore). The randomization sequence will be stratified by city 
and use random permuted blocks of size 3. 
 
5.3 
Intervention/Investigation Procedures 
5.3.1 Focus Groups 
Focus groups will be conducted in person and at 4 SRVs (Houston, Los Angeles, New York, and 
Philadelphia). Two focus groups will be conducted at each of the 4 SRVs. Focus groups are 
anticipated to last approximately 120 minutes, and light refreshments and food will be served at 
each group. Research staff will conduct the focus groups. The focus groups conducted in New 
York and Philadelphia will be used to gain feedback from trans YYA on the text messaging 
intervention of TechStep, while the focus groups in Houston and Los Angeles will be used to gain 
feedback on the WebApp. All focus groups will be audio recorded (equipment provided by the 
research staff). The Protocol Chair will coordinate with SRV staff to arrange participant 
compensation at the end of each focus group. A minimum of 3 persons must be present at the 
beginning of the focus group to conduct the focus group. If 1 or 2 persons are present at the 
beginning of the focus group, we will ask that it be rescheduled and they will be compensated for 
transportation costs. 
5.3.2.  Focus Group Recruitment 
Focus group participants will be recruited from SRVs, other community settings, online, and 
through peer referrals. Specifically, focus group participants may be recruited through poster 
advertisement placed at each SVR or at community sites that collaborate with the SRV. The 
posters will contain details about how to contact a Research Assistant for further information 
regarding the focus groups. Ads will be posted on social media and with brief information about 
the purpose of the focus groups as well as information about compensation. Interested individuals 
can screen online or can email the SRV Research Assistant to find out more and get screened 
for eligiblity over the telephone or in-person. When a participant screens eligible to participate in 
a focus group, they will be asked to refer any friends who are also trans YYA. If the SRV has a 
YAB, some participants may be recruited directly from the YAB 
5.3.3  RCT 
Enrollment for the RCT will be conducted in person or or online at 5 SRVs (Boston, Houston, Los 
Angeles, New York, and Philadelphia). Online study visits may be carried out via an online 
videoconferencing software, such as Zoom (see Section 7.3.6 for description of the Zoom 
platform) or a comparable platform. 
 
Enrollment procedures are anticipated to last approximately 120 minutes and consists of informed 
consent/assent, the baseline ACASI survey, and HIV, STI and drug screen testing, and blood 
microsampling for those who self-report PrEP use (of the biological specimen collection, only HIV 

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testing is mandatory). For online enrollment visits, some or all of the biological specimen collection 
may be done via mailed self-collection kits after the enrollment visit. Participants, if they choose 
to do so, will be able to meet with research staff via live, secure video chat, to answer questions 
about the at-home self-collection kit components and procedures. Particularly, study staff will be 
able to answer questions and go over results of rapid HIV test results if participants prefer to self-
administer a rapid test in addition to or in lieu of a lab processed HIV test. Rapid HIV test results 
will be confirmed with research staff via secure video chat, or by uploading a photo of the test 
results to a secure online survey hosted by Alchemer. During enrollment, participants will be 
randomized into either the Text+Step arm, the App+Step arm, or the information-only (i.e. “Info”) 
arm. Participants randomized into the Text+Step arm will be given information about the 
frequency of text messages they should expect. Participants randomized into the App+Step arm 
will be guided by research staff to log onto the WebApp for the first time and obtain basic 
information on how to navigate the app. Participants randomized into the “Info” arm will learn how 
they will gain access to the information available in that arm and the basic description of that 
information. At the end of the enrollment visit, all participants will be invited to schedule their 3-
month follow-up appointment. 
Participants can schedule and attend a 3-month follow-up visit in person or online as early as 14 
days prior to the calendar date that falls three months after their enrollment date, and as late as 
75 days after the calendar date that falls three months after their enrollment date. At the 3-month 
follow-up visit, participants will undergo additional HIV, STI and drug screen testing, blood 
microsampling for those who report PrEP uptake or continued PrEP use, as well as take another 
ACASI survey. Biological specimen collection may be done in person during the study visit or via 
self-collection kits mailed to participants. For mailed self-collection, the biological specimens may 
be collected and returned at any point during the visit window. Participants, if they choose to do 
so, will be able to meet with research staff via live, secure video chat, to answer questions about 
the at-home self-collection kit components and procedures. Particularly, study staff will be able to 
answer questions and go over results of rapid HIV test results if participants prefer to self-
administer a rapid test in addition to or in lieu of a lab processed HIV test. Rapid HIV test results 
will be confirmed with research staff via secure video chat, or by uploading a photo of the test 
results to a secure online survey hosted by Alchemer. Participants in the technology-based 
intervention groups (i.e. the Text+Step or the App+Step arm) that do not reduce sexual risk 
behaviors  or self-report a recent STI diagnosis and do not initiate PrEP or adhere to PrEP at 
effective levels will be randomized 2:1 into either additional eCoaching with their technology-
based intervention or remain with their originally assigned intervention. Stepping will be 
determined using a series of questions: 1) participants that self report PrEP adherence (4+ doses 
taken per week for each of the past 2 weeks) will not step, otherwise: 2) participants who self-
report a new STI (syphillis, chlamydia, or gonnorhea) diagnosed outside of the study in the past 
3 months will be eligible for step by randomization, otherwise; 3) participans who self-report 
sexual risk in the form of: a) condomless anal or vaginal sex, b) sex with exchange partners, c) 
sex while feeling the effects of stimulants (methamphetamine, powder cocaine, or crack cocaine) 
or d) sex after binge drinking (5+ drinks at one time) in the past three months will be eligble for 
step by randomization. Those that are randomized to step up to additional eCoaching will meet 
the eCoach online at the 3-month visit or during the 3-month visit window for an introductory visit 
and to schedule their next eCoaching session. 
Participants can schedule and attend a 6-month follow-up visit in person or online as early as 14 
days prior to the calendar date that falls six months after their enrollment date, and as late as 75 
days after the calendar date that falls six months after their enrollment date. At the 6-month follow-
up visit, particpants will undergo additional HIV, STIs and drug screen testing, blood 
microsampling for those who report PrEP uptake or continued use, as well as take another ACASI 
survey. Of the biological specimen tests, only HIV testing is required, however the others (i.e., 

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STI testing, uring screening, and blood microsampling for those reporting PrEP use) are 
encouraged.  Biological specimen collection may be done in person during the study visit or via 
self-collection kits mailed to participants. For mailed self-collection, the biological specimens may 
be collected and returned at any point during the visit window. Participants, if they choose to do 
so, will be able to meet with research staff via live, secure video chat, to answer questions about 
the at-home self-collection kit components and procedures. Particularly, study staff will be able to 
answer questions and go over results of rapid HIV test results if participants prefer to self-
administer a rapid test in addition to or in lieu of a lab processed HIV test. Rapid HIV test results 
will be confirmed with research staff via secure video chat, or by uploading a photo of the test 
results to a secure online survey hosted by Alchemer. The active intervention period ends after 6 
months, and therefore participants will no longer have access to their intervention to which they 
were assigned after month 6.  
Participants can schedule and attend a 9-month follow-up visit as early as 14 days prior to the 
calendar date that falls nine months after their enrollment date, and as late as 90 days after the 
calendar date that falls nine months after their enrollment date. Participants will return to the SRV 
at the 9-month follow up for HIV, STI, and drug screen testing, blood microsampling for those 
report PrEP uptake or use, as well as a final ACASI to measure sustained effects of the 
intervention. Of the biological specimen tests, only HIV testing is required, however the others 
(i.e. STI testing, uring screening, and blood microsampling for those reporting PrEP use) are 
encouraged. Biological specimen collection may be done in person during the study visit or via 
self-collection kits mailed to participants. For mailed self-collection, the biological specimens may 
be collected and returned at any point during the visit window. Participants, if they choose to do 
so, will be able to meet with research staff via live, secure video chat, to answer questions about 
the at-home self-collection kit components and procedures. Particularly, study staff will be able to 
answer questions and go over results of rapid HIV test results if participants prefer to self-
administer a rapid test in addition to or in lieu of a lab processed HIV test. Rapid HIV test results 
will be confirmed with research staff via secure video chat, or by uploading a photo of the test 
results to a secure online survey hosted by Alchemer. 
5.3.4  Research and Training Staff 
Research staff at individual SRVs who interact with study participants at assessments do not need 
to be clinicians. A research assistant (RA) level position is sufficient to obtain informed consent, 
oversee administration of the brief survey, and assist with the focus groups as needed. If a 
participant asks a question that the RA does not feel equipped to answer, the RA will contact 
research staff at Friends Research Institute or San Diego State University and then follow-up with 
the participant. SRV study staff and research staff at Friends Research Institute and San Diego 
State University will monitor for participant self- or other harm ideation or behaviors during the 
focus group that may require involvement from the clinical team at the SRV. 
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 research staff includes (but is not limited to) an overview of the study, study procedures and 
human subjects issues (informed consent process, confidentiality), a demonstration of all 
technology components, 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, Good Clinical Practice, informed consent, quality 
management, confidentiality, and reporting of adverse events.  
 

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5.3.5 Intervention Monitoring/Quality Control 
A focus group summary form  will be completed by SRV staff and the Protocol Chairs. The form 
will include focus group id, date, city, age group, and the number of participants scheduled and 
in attendance, as well as a space to write any comments about the focus group for later reference.  
6.0  
EVALUATIONS AND MEASURES FOR PHASE 1 FOCUS GROUPS  
6.1 
Screening 
All local sites will use the methods described in section 4.4 to screen participants for eligibility 
characteristics that meet inclusion criteria for the youth and young adult focus groups (see section 
4.1). Participants must be screened for inclusion prior to the scheduled focus group day and time.  
6.1.1 Administrative and Behavioral Procedures 
• 
Screening assessment 
• 
Collection of contact information  
6.1.2 Clinical Procedures  
• 
None 
6.1.3 Laboratory Procedures 
• 
None 
6.2 
Focus Group  
Potential participants will receive reminders to attend the focus group through email and/or text 
the day they screen eligible for the study, 3 days in advance of the focus group, and 1 day in 
advance of the focus group. The following are a list of procedures that will be conducted before 
the focus group begins.  
 
6.2.1 Administrative and Behavioral Procedures 
• 
Informed Consent 
• 
Focus Group Participant Survey  
6.2.2 Clinical Procedures  
• 
None 
6.2.3 Laboratory Procedures 
• 
None 
6.3 RCT 
Eligible participants will be contacted to schedule an enrollment appointment through email and/or 
text within one or two business days following their screening. Reminders to attend the enrollment 
appointment will be sent via email and/or text 3 days in advance of their appointment, and 1 day 
before their appointment. The following data will be collected for each study visit time point 
(enrollment/baseline, 3-, 6-, and 9-month follow-up). Biological specimen collection may be done 
in person during the study visit or via self-collection kits mailed to participants. For mailed self-
collection, the biological specimens may be collected and returned at any point point during the 
visit window. Some specimens may not be collected if the participant objects or if study staff 
determine that it would not be feasible and/or safe for the participant to receive a mailed self-
collect kit.  
 

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6.3.1 Administrative and Behavioral Procedures 
• 
Informed consent/assent (enrollment only) 
• 
ACASI 
6.3.2 Clinical procedures 
• 
HIV testing (required) 
• 
STI testing (not required) 
o Gonorrhea 
o Syphlilis 
o Chlamydia 
• 
Blood microsampling for PrEP uptake/use (not required) 
• 
Urine drug screen for current drug use (not required) 
6.3.3 Laboratory Procedures 
• 
HIV testing for HIV status (required) 
• 
STI testing to detect the presence of: (not required) 
o Gonorrhea 
o Syphlilis 
o Chlamydia 
• 
Urine drug screen for current drug use (not required) 
 
6.4. 
Premature Discontinuation/Off-Study Evaluations/Measures 
Participants who discontinue study participation during the focus group will be asked to provide a 
reason for discontinuing the study and paid the full compensation amount. Participants who 
discontinue study participation during the RCT will be asked to provide a reason for discontinuing 
the study and provided compensation consistent with their participation up to that point. 
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 initial of the participant’s first name and their two digit day 
of the month born on all participant CRFs, audio files, transcripts, and survey data files. Participant 
names or other personally identifying information will not be used on any study documents and 
should be redacted from focus group transcripts. All study-related information will be kept in 
double-locked, limited access areas at each study site. Participant names and their SID and 
participant code will be stored in the SMART system which is separate from other study 
information, and is accessible only to designated study staff, iTech site monitors, and 
representatives from the NICHD. Original source documents for individual participants will be 
maintained at the respective SRV and will be accessible only to the study staff. Data from original 
source documents will be transcribed on CRFs as applicable.    

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7.3  
Data Collection  
7.3.1 Focus group data collection 
Focus group discussions will be transcribed verbatim from the digital audio-recording and de-
identified by assigning unique numerical codes. 
Two independent researchers will analyze the focus group data using the qualitative software 
program Dedoose (or equivalent software) to code, sort, search, and extract text to develop and 
explore emergent themes. To calculate an inter-rater reliability score, each researcher will 
independently develop themes to compile into a preliminary codebook that will be refined during 
multiple iterations of transcript review. After which notes, themes, and subthemes will be 
compared and reviewed, and inconsistencies will be reconciled. 
 
7.3.2 CRFs  
Study monitoring data for all study phases, 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 Box or Microsoft OneDrive, a secure content management platform, 
and/or available electronic in DFexplore.  
 
7.3.3 Survey Data 
Online surveys will be hosted on Alchemer. We use SSL encryption for transfers of information 
online and data will be stored in the secure, HIPAA-compliant servers of Alchemer. The Emory 
AC team maintains a business partner HIPAA agreement with Alchemer.  
All data collected via the online screener, photo uploads of HIV test results into Alchmer, and in 
the ACASI during the RCT will remain confidential; no personal identifying information will be 
collected. The participant’s unique SID# will be used in order to link the survey information entered 
to the participant’s CRF data.   
Photos of participant HIV rapid test results uploaded into Alchemer. The results will be made 
available by Emory to SRV staff via a site-specific live “portal” download CSV spreadsheet that is 
accessible through a password protected link that Emory provides to each SRVs.  The password 
protected CSV file download will have the participant’s study ID and a url link to the photo. 
 
7.3.4  Online Survey Data Security 
Only authorized study staff will have access the online screener data through the Internet site. To 
ensure data privacy, as data are entered in real time, it will be encrypted during transmission to 
the Alchemer 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. 
 
7.3.5  VSee Platform Description 
VSee is a private video-chat software that the study may use for private and confidential meetings 
between participants and eCoaches. 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 coach but 
the coach 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:  

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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 as 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 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.  
 
7.3.6  Zoom Platform Description 
Zoom software may be used to conduct online study visits, consenting, and eCoaching sessions 
remotely. Participants will have the option to conduct face-to-face video chat, video chat in which 
they can see the study staff, but the study staff cannot see them, or audio chat only. Zoom is 
compatible on PCs, tablets, and smartphones; as well as maintains the option to conduct an audio 
conference without the video component. Emory University has entered into a BAA with Zoom, 
where Zoom agrees to be responsible for keeping all patient information secure and report any 
breaches of protected health information (PHI). 
End-to-end encryption. Zoom encrypts all presentation content at the application layer using the 
Advanced Encryption Standard (AES) 256-bit algorithm. Zoom end-to-end (E2E) chat encryption 
allows for a secured communication where only the intended recipient can read the secured 
message. Zoom uses public and private keys to encrypt the chat session with Advance Encryption 
Standard (AES256), and session keys are generated with device unique hardware ID to avoid 

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data being read from other devices. This ensures that the session cannot be eavesdropped or 
tampered with. 
Cloud Control Infrastructure. A distributed network of low-latency multimedia routers (software) 
resides on Zoom’s communications infrastructure. With these low-latency multimedia routers, all 
session data originating from the host’s device and arriving at the participants’ devices is 
dynamically switched — never stored persistently through the Zoom communications 
infrastructure. Zoom’s communications infrastructure for real-time video, audio, and data 
communications resides on Zoom dedicated servers, which are housed in SSAE 16 SOC2 
compliant datacenters on opposite sides of the US. Zoom sessions are completely temporary and 
operate analogously to the popular mobile conversation over the public mobile network. In 
addition to unique security beneﬁts, Zoom’s communications infrastructure also enables an 
extremely scalable and highly available meeting infrastructure unrestricted by the limitations of 
physical data centers. 
The Zoom client communicates with the multimedia router to establish a reliable and secure 
connection. At the time of instantiation, the Zoom client will determine the best method for 
communication, attempting to connect automatically using udp and tcp port 8801, 8802 and 8804 
or HTTPS (port 443/TLS). 
The Zoom sessions will contain identifying information, as in VSee above, but this information will 
be stripped form the recorded Zoom sessions before they are sent to the analysis team for content 
analysis.  
 
7.3.7  Qualtrics Platform Description 
Qualtrics may be used for study surveys and online informed consent/assent forms. 
Qualtrics uses Transport Layer Security (TLS) encryption (also known as Hypertext Transfer 
Protocol Secure (HTTPS)) for all transmitted data.  Survey data are protected with passwords 
and HTTPS referrer checking.  The data is hosted by third party data centers that are Statement 
on Standards for Attestation Engagements (SSAE)-16 Service Organization Control (SOC) II 
certified.  All data at rest are encrypted, and data on deprecated hard drives are destroyed by 
U.S. Department of Defense methods and delivered to a third-party data destruction service. 
Qualtrics deploys the general requirements set forth by many Federal Acts including the Federal 
Information Security Management Act (FISMA) of 2002.  They meet or exceed the minimum 
requirements as outlined in Federal Information Processing Standards (FIPS) Publication 200. 
Health Insurance Portability and Accountability Act (HIPAA) Statement: With some restrictions, 
Qualtrics may be designated as a Business Associate when the Qualtrics BA Agreement is signed 
with a Covered Entity—those organizations that are required to comply with HIPAA privacy 
rules.  All client data are considered confidential, and treated as such. 
Related to HIPAA, Health Information Technology for Economic and Clinical Health Act (HITECH) 
are updated assessment rules to ensure that data are properly protected and best security 
practices are followed.  By using secure and certified data centers, Qualtrics ensures the highest 
protection and testing as per HITECH requirements. 
 

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7.4 
Data Submission 
7.4.1 CRFs 
Although the iTech projects will involve substantial online follow-up, CRFs will be used to collect 
key study visit data (e.g., enrollment and randomization assignment), study milestones such as 
completion or discontinuation, 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 either 
electronically using DFexplore or by submitting scanned paper forms using DFSend. DFexplore 
and its DFdiscover platform is a leading multi-site database environment for HIV RCT that can 
receive and transcribe CRF data via scanned PDFs, or allow for direct electronic 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 DFexplore for MSM studies 
and RCTs and data is maintained by the parent company DF/net on a cloud-based server with 
Microsoft Azure.  
 
7.4.2 Audio Data  
Audio-recoded data for the focus groups will initially be stored as a digital file on a secure 
encrypted server. All focus group discussion may also be recorded using a back-up digital audio 
recorder. 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. Focus group discussions will be transcribed verbatim from 
the digital audio-recording and de-identified by assigning unique numerical codes. After 
transcripts are verified by the research team and one year after the study is over, audio files will 
be destroyed.  
All survey data will only be identified with a unique study number and stored on a secure encrypted 
server by the AC team. Only SRV research staff, the AC team, and the research team at Friends 
Research Institute, San Diego State University and the University of Minnesota will have access 
to the data. 
eCoaching sessions will be audio recorderd for fidelity checks and supervision. 
 
7.4.3 Online Survey Data Transmission 
Only authorized users will be able to access the online screeners and other surveys through the 
Internet site. See section 7.3.2 on online survey data security.  
 
7.4.4 Participant Contact Database  
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 
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access to PHI. SMART is a licensed service of the Center for AIDS Research (CFAR) at Emory 
University, Prevention Science Core. Utilization of the mobile app is optional and the admin web 
portal will fully function without it. 
 
The following information outlines the security of the three SMART components: (1) the admin 
web portal, (2) the participant app, and (3) a web service that acts as a liaison between the mobile 
app and the study database. 
 
Admin Web Portal. The admin web portal is a web-based application developed using Microsoft 
.NET technologies. It uses SQL server as backend database. The application requires two servers 
to host: (1) Web server [Windows server with IIS] and (2) SQL server [Standard or Enterprise 
version]. Both these servers are to be placed behind a firewall. Web server will have a public IP 
to access the server using VPN. SSL certificate is to be installed on the web server. The admin 
website will be rendered over SSL (https). 
 
The application uses form authentication (no integrated authentication such as AD). All passwords 
are stored encrypted within the database. System will also be using database level encryption, 
which will prevent any copying of information from one database to another. Web application also 
uses an automatic logout feature after a certain period of inactivity. By default, the inactivity 
duration is set to three minutes. 
 
Study staff can only first gain access to the admin web portal if granted by a study or site 
administrator. Their assigned user role will determine their permissions to perform different 
actions and even view PHI. Email notifications are sent from the system (without the need to login) 
when: (1) a staff member requests to reset their password, (2) role assignments to a study are 
made, (3) an event/visit staff are scheduled to work is nearing, (4) a new task is 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. 
 
SMART 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 

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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. 
 
7.5 
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 AC and MC will provide instructions concerning the recording of study data on the CRFs, 
submission of CRFs, and administration and transmission of ACASI data.  
7.7 
Study Site Monitoring and Record Availability 
Site monitors from the MC and AC 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) 
readily available for inspection by the local IRB, the central IRB, the site monitors, the NICHD, the 
Office for Human Research Protections (OHRP), or the sponsor’s designee for confirmation of 
the study data. 
 
8.0 
PARTICIPANT MANAGEMENT 
 
8.1 
Tracking Participants / Follow-up 
 

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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 YYA who are difficult to 
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.  Participants 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 method and amount of compensation will be determined separately by each site, listed in the 
site’s informed consent/assent form, and approved by the central IRB (the UNC-CH IRB). RCT 
participants will be compensated at each of their appointments at the SRV, including the 
enrollment/baseline visit and each of the 3-, 6-, and 9-month assessment points. 
8.3 
Intervening on “Social Harms" 
We identified the following 3 items as possible risks to subjects for the overall study period and 
described how we plan on addressing those risks: 
1. Protecting against others finding out about their gender identity during focus groups. 
Participants will be alerted to this given that the focus groups are in person. The 
description of the purpose of the study will clearly state that the study is designed to 
promote face-to-face discussion with other trans YYA, and we will recommend that 
persons who are highly uncomfortable with such exchanges may be better served by not 
enrolling in the study. Once enrolled, we also minimize this risk of identification to 
participants by asking participants to come up with a pseudonym that do not contain 
personally identifying information. Additionally, we will establish “group rules” that include 
requesting that no information about the identity of participants or what is said in the focus 
group is shared outside of the focus group. Although we cannot guarantee their anonymity, 
we will take appropriate safeguards to minimize this risk.  
2. Protecting against discomfort in answering personal questions during the focus group 
discussions. This risk is similar to #1 above, and we will use comparable safeguards to 
protect against it. Thus, we intend to fully inform participants of the purpose and nature of 
the study prior to their participation. Participants are informed that they are free not to 
answer questions, and they may stop participation at any time. Since a “decline to answer” 
option is provided to the survey completed just before the focus group, there is a constant 
reminder of their participant rights throughout the study. Thus, we believe the risk to 
participants is minimal and we have adequately anticipated and set into place protocols to 
address potential risks that may arise. 
3. Protecting against concerns about the security of their data during focus groups and RCT. 
Well-established security processes will be followed, that include the following: 
• 
Participants’ identifying information is housed in a separate cloud-based password-
protected study management platform, SMART, which is separate from survey data 
and other collected outcome data. Only authorized study staff will be granted access 

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to the platform through requests initially made to the Analytic Core at Emory University, 
or subsequently through the designated study coordinator. SMART regulates staff 
permissions to view participant information based on assigned user roles, which also 
stratifies participant data by site/location, such that staff from other sites will not be 
able to view participant data except from their site/location. Study staff will not be able 
to download participant data from the cloud-based platform. Only designated analysts 
at the Analytic Core at Emory University will have access to data downloads from 
SMART for reporting purposes.   
• 
At the end of the study, the identifying information (participants’ names and contact 
information) is destroyed. The original data records will be archived for a minimum of 
3 years following the conclusion of the study or longer if institutional requirements 
dictate, and three copies of the de-identified dataset will be maintained (a working one 
and two archived at different sites). 
• 
All project staff will be required to complete the NIH online training in research ethics. 
Further training and supervision will focus research staff on confidentiality concerns 
both during and after the study. The project coordinator in conjunction with the Protocol 
Chairs are responsible for ensuring that all research staff involved in this study 
document their NIH training.  
There are two risks associated with receiving the WebApp: 
1. Protecting against going to the site by mistake. We have a secure site (https:) with an 
introductory page clearly specifying the nature of the study. Sensitive survey or 
intervention content is protected behind screening questions and a username/password, 
and therefore in the opening study webpage, we could not think of anything that would be 
deemed offensive by any persons or those who might be vulnerable. In this way, we have 
minimized the risk to a level that is negligible.  
 
2. Protecting against hostile interactions and inaccurate information from one participant to 
another. Participants will be informed during the onboarding process of the “group rules” 
regarding interactions with one another (e.g., “Honesty is important; however, hostile or 
abusive language will not be tolerated and may be grounds for immediate removal from 
the study”). These “rules” will also be available with a link on all intervention web pages 
for review by participants at any time. The project coordinator will manually review an 
automated compilation of posts participants make on a daily basis to flag hostile 
interactions and inaccurate information. Hostile interactions between participants will be 
handled by, first, reminding the participants in the interaction of the “group rules” regarding 
appropriate interactions. If the hostility continues, the offending participants will be given 
a warning that the continued hostility will result in withdrawal from the study if it continues. 
On the third offense, the participant may be withdrawn from the study after discussion of 
the offense. Text containing hostile exchanges will be removed from the study website 
and unavailable to view. In cases in which inaccurate information is found, project staff be 
guided by experts on the team to post a comment that provides accurate information on 
the topic. In extreme cases, the Protocol Chairs or SRV Site PIs may decide to withdraw 
a participant before the third offense. We will ensure all clinic sites have a clear clinical 
protocol to address major issues that may come up at study visits or in online interactions. 
The major issues addressed in the procotol will be suicidal ideation, homicidality or violent 
ideation, emotional and cognitive disregulation, violent/aggressive or disruptive behavior, 
and intoxication. If research staff see concerning comments or messages online from 
participants regarding self-harm or harm of others, they will contact study site staff and 
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All 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.  
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. 
See section 11.3.1 for more information on potential social harm-related risks.  
8.4 
Criteria for Premature Study Discontinuation 
The Protocol Chairs and SRV Site PIs have 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. If a participant is withdrawn due to seroconversion, they will be offered referrals and 
linkages as necessary, and may be referred to an ATN study for HIV+ participants. 
 
Participants will be prematurely discontinued from the study if any of the following occurs:  
• 
The participant withdraws consent/assent 
• 
The participant is unwilling or unable to comply with study procedures 
• 
The participant fails to return or confirm HIV negative test results with research staff within 
90 days of their enrollment visit 
• 
The participant returns a HIV positive test result at the 3- or 6-month follow-up time point.  
• 
The participant seroconverts 
• 
The Protocol Chairs or Site PIs believe that ongoing participation may cause harm to the 
participant or study staff 
• 
The Protocol Chairs of Site PI believe that ongoing participant may impact the integrity of 
the study dataThe study is cancelled by the NIH (or iTech, or other administrative entity); 
• 
The study is cancelled for other administrative reasons;    
• 
Death of the participant 
 
Participants may end their participation in the study at any time. 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 unanticipated problem (UP) reporting criteria will be 
immediately reported to the UNC-CH IRB and the respective sites’ IRBs if applicable. The Study 
Stop CRF will be completed at this time. 

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9.0 
MONITORING UNTOWARD EFFECTS ASSOICATED WITH OR RESULTING FROM 
STUDY  
9.1 
Site research staff must first follow their own IRB’s procedure for reporting and managing 
untoward effects.  
There are three types of untoward effects to be identified:  (1) those related to the participant, (2) 
those related to the study staff, and (3) those related to the neighborhood/community (if 
applicable). 
First, the study will catalogue any untoward effect related to the participant. Reporting is required 
for occurrences including social harms, psychological distress, and serious life-threatening events 
such as suicide attempts. These may be immediately apparent to the study staff, such as the 
participant’s emotional upset state 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 these 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. 
Second, study staff may encounter untoward events during the focus groups or RCT 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. 
Third, a critically important area any community-based study intends to evaluate is the impact, 
including untoward effects, of the project on the community. This will be done informally for this 
protocol with untoward events being reported to the protocol team. 
All untoward effects/adverse events/unanticipated problems will also need to be reported to the 
UNC IRB if they meet all three of the following criteria: 
“Unanticipated problems involving risks to subjects or others” (UPIRSO) refers to any incident, 
experience, or outcome that:  
1) is unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied;  
2) is related or possibly related to a subject’s participation in the research; and  
3) suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.  
Events that meet the criteria for an UPIRSO and are also serious adverse events should be 
reported to the UNC IRB within one (1) week of the investigator becoming aware of the event.  
Any other events that meet the criteria for a UPIRSO should be reported to the IRB within two 
(2) weeks of the investigator becoming aware of the problem.  

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If the report cannot be completed in its entirety within the required time period, a preliminary report 
should be submitted. The report should be amended once the event is resolved and/or more 
information becomes available. 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS 
10.1 
Introduction 
10.1.1 Focus Groups Overview  
We will conduct eight focus groups with up to 10 trans YYA (one group with youth 15-20 years 
old and one group with young adults 21-24 years old) at 4 SRVs (Houston, Los Angeles, New 
York, and Philadelphia). Focus groups in Houston and Los Angeles will be used to obtain 
information specific to the Web App. Topics covered in those focus groups include: 1) challenges 
to obtaining culturally appropriate and comprehensive sexual health and other health services; 2) 
feedback from trans YYA about the “look and feel” and content of the original TWM and YouTHrive 
interventions; 3) suggestions for adapting the intervention for trans YYA similar to themselves. 
Focus groups in New York and Philadelphia will be used to obtain information specific to the text 
messaging intervention. Topics covered in those focus groups include: 1) feedback from the trans 
YYA about the adaptation of the Text Me, Girl! text-message library for HIV-positive young trans 
women to high-risk trans feminine, trans masculine, and gender non-conforming HIV-negative 
YYA; 2) specific editing of text messages for content that is culturally appropriate and relevant to 
HIV-negative trans YYA; 3) suggestions on content and appropriateness of text messages related 
to trans-specific sexual health; 4) suggestions on content and appropriateness of text messages 
related to biobehavioral HIV prevention strategies (e.g., PEP/PrEP). Focus groups (as opposed 
to in-depth quantitative interviews) were chosen to gain feedback in these areas because this 
setting will allow participants to explore together the ways in which the TechStep intervention 
meets their needs and how the intervention can be adapted to be community appropriate.   
 
10.2 
Power Estimates  
10.2.1  Focus Groups Power Considerations 
The purpose of focus groups is not to obtain generalizable data, but rather to obtain collective 
qualitative information to inform adaptation of the existing interventions for trans YYA. We are 
balancing feasibility with the need to obtain information from a spectrum of trans youth. As such, 
we will conduct 8 focus groups, targeting youth (ages 15-20) and young adults (ages 21-24) at 4 
different SRVs with the goal of reaching a maximum of 80 trans YYA. Given our prior experience 
and best practices for the conduct of focus groups, this will provide us with information from 
enough YYA to inform the adaptation process. 
 
10.2.2  RCT Power Considerations 
We performed extensive Monte Carlo simulations to assess the power for our primary analysis. 
We examined scenarios involving different dropout rates (5-15%), different relative efficacies of 
first-line (text or app) interventions relative to the eCoaching intervention, and different levels of 
strength of predictive covariates to be included in the analysis. Across a wide range of scenarios, 
we determined that we will have >80% power to detect a clinically meaningful effect, defined as 
an average decrease of at least 1.5 risky sexual encounters over the course of the study.  

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10.3  Statistical Analysis Plan 
10.3.1  Analyses of Focus Group Data.  
Focus group discussions will be transcribed verbatim from the digital audio-recording, de-
identified by assigning unique numerical codes, and entered into Dedoose software to assist with 
theme identification, coding textual data, and describing relationships among codes (via code co-
occurrence and memoing functions). Following established focus group analysis guidelines, we 
will create a codebook of a priori and emergent themes including operational definitions of all 
codes and sample quotations to illustrate how to apply each code. 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. We will draw a 
random sample of 20 instances 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 retrain 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. Coding and analytic activities will be discussed during weekly 
team meetings. 
 
10.3.2 Analyses of RCT  
Outcomes understudy include rates of condomless anal and vaginal sex, number of exchange 
partners, reports of sex while feeling the effects of stimulants (i.e. methamphetamine, powder 
cocaine, crack cocaine) or after binge drinking (5+ drinks at one time), self-report and confirmed 
STI diagnoses, and PrEP adherence measured through self-report and verified by blood 
microsampling. We will analyze both the primary and secondary questions in the RCT using 
longitudinal targeted minimimum loss-based estimation (LTMLE).38 This approach has several 
advantages over standard techniques for longitudinal data analysis. First, it appropriately 
accounts for the fact that only high-risk participants are eligible for randomization into the 
eCoaching intervention. Second, the method accounts for predictive and prognostic time-varying 
participant-level covariates, thereby increasing the power to detect intervention effects. Third, the 
method accounts for possibly informative missingness reducing bias in the estimates of causal 
effects. Implementation of LTMLE involves fitting several covariate adjusted models. First, a 
sequence of regressions are fit to model cumulative sexual risk behaviors at each time point 
adjusting for baseline and time-varying covariates. Second, a regression is fit to model the 
cumulative probability of participant dropout adjusting for baseline and time-varying covariates. 
These models will be fit using the super learner, a cross-validation-based estimator selection 
technique. This method aggregates results from a library of candidate regression estimators to 
build the most powerful predictor given the data at hand. In large samples, the method is 
guaranteed to perform as well as the unknown best-performing regression in the library. We will 
use Wald-style tests of each of the relevant null hypotheses using cross-validated influence-
function-based standard error estimates. 
 
10.4 
Missing Data 
Given the primary aim of the focus groups is to collect qualitative data, we do not anticipate 
missing data. That said, to protect against malfunction or user error in operating the audio 
recorders, we will have 2 audio recorders at each focus group. In addition, written notes the focus 
group discussion will be obtained.  

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For the RCT, as mentioned in Section 10.3.2, the LTMLE approach used in the primary analysis 
will account for missing data. 
 
11.0 
HUMAN SUBJECTS 
This study will be conducted in compliance with the protocol, ICH Good Clinical Practice (GCP) 
guidelines, and 45 CFR Part 46. 
11.1 
Participants’ Confidentiality 
All laboratory specimens, questionnaires, evaluation forms, reports, transcripts, and other records 
will be identified by a coded number only, to maintain participant confidentiality. All records with 
personally identifying information will be kept in a locked file cabinet in a limited secure access 
area at each SRV site, or in a secure limited access study database. 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. The main risk 
specific to the role of the AC is breach of confidentiality.  
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.  
Participants may be concerned about the security of their data, particularly since it is collected 
and stored electronically. The AC has significant experience developing security protocols for 
technology-based studies, and we will take a variety of steps to ensure participant security, 
including using a dedicated server behind a firewall, encryption of data, separation of identifiers 
from responses, and password-protected access to data. Therefore, we believe that this risk will 
be minimal. All of the apps and websites included in the iTech have features to ensure security 
and privacy.  
11.2 
Certificate of Confidentiality 
This research specifically targets a vulnerable population, trans YYA between the ages of 15-24. 
We will take every available step to minimize the risk of identifying/linking data being subpoenaed, 
stolen, or inadvertently released. First, the iTech has obtained a Certificate of Confidentiality from 
the NIH. Second, all research staff members are required to complete ethical clearance 
certification regarding protection of human 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 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.  
Per Section 2012 of the 21st Century Cures Act as implemented in the 2017 NIH Certificates of 
Confidentiality Policy, all ongoing or new research funded by NIH as of December 13, 2016 that 
is collecting or using identifiable, sensitive information is automatically issued a CoC.  
As noted on the NIH website (http://grants.nih.gov/grants/policy/COC/faqs.htm#187), a Certificate 

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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.”  
11.3 
Risks and Benefits 
11.3.1 Risks 
Risks to participants in this research study may include:   
Potential participants or participants enrolled in the study may have concerns about others finding 
out about their gender identity or other personal behavior (e.g., sexual behavior or substance 
use). We anticipate that the likelihood of this occurring is high for those randomized into the 
App+Step arm given that a major feature of the WebApp is for participants to network with one 
another and that eligibility for enrollment in the study requires participants to be a trans youth or 
young adult. We anticipate that the likelihood of this occurring is high during the focus groups as 
well, since they will be meeting in-person with other trans YYA for the focus groups. Subjects will 
be informed of the inclusion criteria and general questions that will be asked during focus groups 
during the recruitment period. Since subjects will be recruited directly within SRVs, they will have 
the opportunity to discuss with staff whether they feel comfortable being a part of such 
discussions. Clear consent procedures will also give opportunities for subjects to withdraw if they 
no longer feel comfortable participating in focus group discussions. For those in the RCT, subjects 
will be informed during the consent process of the basic features of the WebApp intervention and 
those who are not comfortable interacting with other trans YYA will be encouraged to not 
participate in the study.  
To minimize the risk of participants feeling uncomfortable about answering personal questions, 
we will provide an option for online methods for screening. For assessments, we will use ACASI 
methods for the study's surveys. In ACASI, participants read and hear aloud survey questions on 
a computer and use a 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 online screener of the ACASI. Participants will also be able to refuse 
to answer any question that makes them uncomfortable.  
Participants in the focus groups will be told of “group rules” at the beginning of the focus group, 
which includes asking them to not share the identities of attendees or content shared during the 
focus group.  
The measurements that are involved in this study require venipuncture to collect blood samples 
for syphilis testing. Syphilis is tested by serum RPR performed by a trained and certified 
phlebotomist. 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.  
Urine samples will be provided to test for gonorrhea, Chlamydia, and current drug use and will be 
collected under monitored conditions (i.e., using an FDA approved temperature strip to verify the 
specimen integrity).  Pharyngeal swabs are taken from the back of the throat to test for gonorrhea 
and Chlamydia and participants self-administer rectal swabs for gonorrhea and Chlamydia.   
Trained and certified research assistants will perform dried blood spot extraction. The procedure 
will only require a finger prick to extract a small amount of blood, and threfore the risk of infection 
or bruising is small. If needed, clinical staff will be on site to assist with any medical problems that 
may arise from this procedure. 

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Participants randomized into the App+Step arm may receive hostile communications or incorrect 
information from other participants during the course of the WebApp component. It is possible 
that some participants may respond aggressively or with hostility to other participants. Likewise, 
although well-intended, participants may provide inaccurate information about adherence or its 
risk factors to other participants by interactions through the website message boards/social 
networking wall. The WebApp intervention will include a clear section on Community Guidelines 
and will be monitored daily by research staff. Users have the option to “flag” objectionable content. 
We have protocols in place  for addressing hostile interaction in the site up to and including 
termination of participation in the study.  
Some participants in the Text+Step arm may not want others to see that they are getting 
messages related to sexual health or their gender identity. Participants will be given assistance 
with strategies for minimizing unauthorized access to their phone. Participants will be shown how 
to lock their phone, how to hide messages on the locked screen, establish and use a pin code to 
password protect their phone, and will be instructed to periodically delete the intervention text 
messages after they have been read. 
To minimize risks to confidentiality of focus group and RCT data, 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 or will be on fully 
encrypted laptops. Surveys and online eligibility screening will take place on an encrypted 
commercial survey website, Alchemer. This site has been used by the investigators for thousands 
of online surveys with vulnerable populations 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 a HIV-prevention research study, or a study that enrolls trans persons. 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 IRB before being used for 
contact with participants.  
We use SSL encryption for transfers of information online, and Alchemer has a business partner 
HIPAA agreement with Emory. Alchemer’s servers are HIPAA compliant.  
The AC 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 project specific 
encryption feature. When using this feature, only Dr. Kate 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 
(which correspond to the potential risks described earlier):  
1. Breach of confidentiality. We will take every precaution to minimize risks to study participants. 

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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,  and SRV site-specific IRBs per each institution’s IRB reporting 
requirements using Adverse Event Reporting Forms created by the AC. When possible, reports 
will be sent within 24 hours of notification by the Protcol Chairs. Annual updates on enrollment 
and retention will also be sent to the UNC IRB, and institutional IRBs if required.  
All data collection will take place in secure and supervised clinical settings. All study personnel 
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   
There are no direct benefits of participating in the focus groups. Participation in the RCT 
technology-based intervention arms (i.e., Text+Step and App+Step) may provide participants with 
information and exercises that help them locate and access trans-relevant local resources, build 
motivation to start or restart PrEP, build peer social support, and identify and address individual, 
social, structural, and cultural barriers to HIV risk reduction. Participants in the control arm (i.e., 
Info) may gain basic knowledge about HIV and trans-specific health issues and links to outside 
local resources. In either the experimental or control conditions, the primary benefit is access to 
health information that may assist participants to improve access to culturally appropriate HIV risk 
reduction resources, increase quality of life, reduce high-risk sexual behaviors and lower the risk 
of acquiring HIV. Secondary benefits include positive feelings related to having assisted in the 
development of a novel technology-based HIV risk reduction intervention for trans YYA.  
 
Compensation for participation is not considered a benefit, because we are simply reimbursing 
participants for their time, effort, and expenses. 
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 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.   
Consent/assent will be obtained to explain the nature, significance, and risks of the study. Sample 
informed consent/assent forms are included in the IRB submission. 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances 
The site IRBs and the UNC IRB as the central IRB will be requested to grant a waiver of parental 
permission to participate in this research study for youth participants under (not inclusive of) 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.” 

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A request for a waiver of the requirement for parental permission is requested for 2 reasons:  1) 
many trans youth would be reluctant to participate in this study – which focuses on HIV prevention 
and PrEP uptake, adherence and persistence – if they are required to get parental permission; 
and 2) many of the trans 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 disclosing themselves as part of the LGBT 
community or being at risk for HIV infection. For these reasons, we believe it is important to be 
granted a waiver for parental permission for this study population. 
11.6 
Waiver of the Requirement for Signed Consent Form  
11.6.1 For Study Participation 
In order to maintain the anonymity of the survey and fully protect the privacy of the volunteer study 
participants, the UNC IRB will be requested to waive the requirement for a record of a signed 
consent form. A written consent form will be reviewed with each potential study participant and 
provided to each consenting one. This form describes the purpose of the study, the procedures 
to be followed, and the risks and benefits of participation.  
Under 45 CFR §46.117 (c) (1) and (2), an IRB may waive the requirement for the investigator to 
obtain a singed informed consent for some or all of the subjects if it finds either:  (1) That the only 
record linking the subject and the research would be the consent document and the principal risk 
would be potential harm resulting from a breach of confidentiality. Each participant will be asked 
whether they want documentation linking them with the research, and the participant’s wishes will 
govern; or (2) that the research presents no more than minimal risk of harm to the participants 
and involve no procedures for which written consent is normally required outside the research 
context.” 
The protocol team believes that both #1 and #2 applies to this study and, both combined, justify 
a waiver of written consent.   
11.6.2 For Eligibility Screening 
An online consent process for the eligibility screening is proposed. The introduction to the 
screening interview includes all the required elements for consent (45 CFR 46.116). No identifying 
information on volunteers is recorded during the online screening until a participant is determined 
eligible (i.e., by marking “I do consent to be screened for eligibility”). Therefore, there will be no 
identifying link of who agreed to be screened or not screened for the study. In addition, the 
screening presents minimal risk to participants and involves no procedures that would require 
written consent outside of a research context. Under these conditions the IRB is authorized to 
modify the requirements to obtain a signed consent form for some or all subjects (45 CFR 46.117 
[c]). 
11.7 
Prisoner Participation 
NICHD has concluded that this protocol does NOT meet Federal requirements governing prisoner 
participation in human subjects research and should NOT be considered by local IRBs for the 
recruitment of prisoners.  

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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 site is responsible for adherence to their individual institution’s HIPAA policies and 
procedures. 
11.9 
Study Discontinuation 
This study may be discontinued at any time by the UNC IRB, NICHD, or other government 
agencies as part of their duties to ensure that research participants are protected.  
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.   
 
 

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13.0 
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