Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)
Phase: NA
Conditions: HIV Prevention
Sponsor: University of North Carolina, Chapel Hill

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Work2Prevent: Employment as HIV prevention for young men who have sex with men 
(YMSM) and young transgender women (YTW) 
 
 
A Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 
 
 
Sponsored by: 
The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD) 
 
 
with co-funding from: 
 
The National Institute on Drug Abuse (NIDA) 
 
The National Institute of Mental Health (NIMH) 
 
National Institute on Minority Health and Health Disparities (NIMHD) 
 
 
 
 
 
 
 
 
Protocol Chair: 
Brandon Hill, Ph.D 
 
Protocol Vice-Chair: 
Robert Garofalo, MD, MPH 
 
NICHD Health Scientist Administrator: 
Sonia S. Lee, Ph.D. 
 
NCT03313310 

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TABLE OF CONTENTS 
STUDY MANAGEMENT ............................................................................................................. 6 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ............................................... 7 
STUDY ABSTRACT ...................................................................................................................... 9 
STUDY SCHEMA ........................................................................................................................ 11 
1.0 
INTRODUCTION........................................................................................................ 12 
1.1  Background ............................................................................................................................... 12 
1.2  Rationale .................................................................................................................................... 13 
2.0 
STUDY OBJECTIVES ................................................................................................ 13 
2.1  Primary Objective .................................................................................................................... 13 
2.2  Secondary Objective ................................................................................................................. 13 
2.3  Tertiary Objective .................................................................................................................... 13 
2.4  Study Hypotheses/Research Questions ................................................................................... 14 
3.0 
STUDY DESIGN .......................................................................................................... 14 
3.1  Study Population ....................................................................................................................... 15 
3.2 
Sample Size ................................................................................................................................ 15 
3.3 
Outcome Measures ................................................................................................................... 15 
3.4 
Biological Specimens ................................................................................................................ 15 
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS .................... 16 
4.1 
Inclusion Criteria ...................................................................................................................... 16 
4.2 
Exclusion Criteria ..................................................................................................................... 17 
4.3 
Recruitment and Screening ..................................................................................................... 18 
4.4 
Informed Consent ..................................................................................................................... 18 
4.5 
Contact Information ................................................................................................................. 19 
4.6 
Co-enrollment Guidelines ........................................................................................................ 19 
5.0 
STUDY PROCEDURES ............................................................................................. 19 
5.1 
Intervention Enrollment Procedures ...................................................................................... 21 
5.2 
Intervention/Investigation Procedures ................................................................................... 21 
6.0 
EVALUATIONS AND MEASURES ......................................................................... 22 
6.1 
Pilot-Test Screening .................................................................................................................. 23 
6.2 
Baseline/Enrollment ................................................................................................................. 23 
6.3 
Workshop Intervention ............................................................................................................ 23 
6.4 
Post-Intervention ...................................................................................................................... 24 

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6.5 
Intervention Follow-Up ............................................................................................................ 24 
7.0 
DATA COLLECTION AND SITE MONITORING ................................................ 24 
7.1 
Development of Protocol and Case Report Forms ................................................................ 24 
7.2 
Data Records ............................................................................................................................. 24 
7.3  Data Collection and Submission .............................................................................................. 24 
7.4 
Data Quality Assurance ........................................................................................................... 25 
7.5 
Role of Data Management ........................................................................................................ 25 
7.6 
Study Site Monitoring and Record Availability .................................................................... 25 
8.0 
PARTICIPANT MANAGEMENT............................................................................. 26 
8.1 
Tracking Participants / Follow-up .......................................................................................... 26 
8.2 
Study Visit Management .......................................................................................................... 26 
8.3 
Compensation ............................................................................................................................ 27 
8.4 
Intervening on “Social Harms" ............................................................................................... 27 
8.5 
Criteria for Premature Discontinuation ................................................................................. 29 
9.0 
MONITORING & REPORTING SAFETY EVENTS  ............................................ 29 
9.1 
Study Team Review .................................................................................................................. 29 
9.2       Reportable Safety Events  ...................................................................................................... 30 
9.3 
Safety Event Reporting Periods .............................................................................................. 30 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS ................................................. 31 
10.1 Study Design .............................................................................................................................. 31 
10.2 Sample Size and Power Estimates ........................................................................................... 31 
10.3  Statistical Analysis Plan ........................................................................................................... 31 
10.4 Missing, Unused and Spurious Data ....................................................................................... 32 
11.0 
HUMAN SUBJECTS ................................................................................................... 33 
11.1 Participant Confidentiality ...................................................................................................... 33 
11.2 Certificate of Confidentiality ................................................................................................... 33 
11.3 Risks and Benefits ..................................................................................................................... 34 
11.4 Institutional Review Board (IRB) Review and Informed Consent ...................................... 34 
11.5 Waiver of the Requirement for Parental Permission for Special Circumstances............... 35 
11.6 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) ................................................................................................... 35 
11.7 Study Discontinuation .............................................................................................................. 35 
12.0 
PUBLICATION OF RESEARCH FINDINGS ......................................................... 36 

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13.0 
BIOHAZARD CONTAINMENT ............................................................................... 36 
14.0 
REFERENCES ............................................................................................................. 36 
APPENDIX I ................................................................................................................................. 39 
Schedule of Evaluations ..................................................................................................................... 39 
APPENDIX II ............................................................................................................................... 40 
Phase I Documents ............................................................................................................................. 40 
Focus Group Guide ............................................................................................................................ 41 
Key Informant Employers Guide ...................................................................................................... 43 
Informant YMSM and YTW Guide ................................................................................................. 45 
Screening Instrument ......................................................................................................................... 48 
APPENDIX III .............................................................................................................................. 49 
Planned Enrollment Report – Pilot Test .......................................................................................... 49 
APPENDIX IV .............................................................................................................................. 50 
iFOUR Description ............................................................................................................................. 50 
APPENDIX V ............................................................................................................................... 52 
Certificate of Confidentiality ............................................................................................................. 52 
 
 
 

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ATN PROTOCOL TEAM ROSTER 
 
Protocol Chair 
Brandon Hill  Ph.D. 
6030 S Ellis Ave 
Chicago, IL 60637 
Phone: 773.834.8509 
E-mail: bhill2@bsd.uchicago.edu 
 
Protocol Vice-Chair 
Robert Garofalo, MD, MPH 
4711 N. Broadway 
Chicago IL 60640 
Phone: 312-227-6110 
E-mail: rgarofalo@luriechildrens.org 
 
ATN CC Co-Investigator 
Lisa C. Strader 
UNC Dept. of Biostatistics 
Collaborative Studies Coordinating Center 
137 E. Franklin Street, Ste. 203 
Chapel Hill, NC 27514 
Phone: (919) 966-8333 
E-mail: lstrader@unc.edu 
 
NICHD Health Scientist Administrator 
Sonia S. Lee, Ph.D 
Eunice Kennedy Shriver National Institute of 
Child Health and Human Development 
(NICHD) 
6710B Rockledge Drive 
Bethesda, MD 20817 
Phone: (301) 594-4783 
E-mail: leesonia@mail.nih.gov 
 
Protocol Manager 
Rachel Goolsby 
UNC Dept. of Biostatistics 
Collaborative Studies Coordinating Center 
137 E. Franklin Street, Ste. 203 
Chapel Hill, NC 27514 
Phone: 919 843-0685 
Fax: 919 962-3265 
E-mail: rwgoolsby@email.unc.edu 
 
University of Chicago Site Chair 
Darnell Motley Ph.D 
6030 S Ellis Ave 
Chicago, IL 60637 
Phone: 773-834-4862 
E-mail: dmotley@bsd.uchicago.edu 
 
 
Project Manager 
Project Statistician 
Kris Rosentel, MPH 
Micah McCumber  
6030 S Ellis Ave 
UNC Dept. of Biostatistics 
Chicago, IL 60637 
Collaborative Studies Coordinating Center 
Phone: 901-878-9875 
137 E. Franklin Street, Ste. 203 
 
E-mail: micahmc@email.unc.edu 
 
 

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STUDY MANAGEMENT 
Before the recruitment and enrollment of participants, the participating study site must have the protocol 
and consent form approved by their local Institutional Review Boards (IRBs). In addition, study site must 
receive protocol registration approval from the ATN Coordinating Center (CC) by submitting a complete 
registration packet with the site’s IRB approved documents and a site registration form. All original 
approved documents must be maintained at the clinical site. 
 
All queries for this protocol should be sent to the ATN (151) project team using the ATN Protocol Query 
and Notification System (QNS) accessible via the ATN website (https://sites.cscc.unc.edu/atn/). The 
appropriate team member will respond to queries generally within 48 business hours via the ATN QNS. 
The Protocol Manager, with the help of other ATN CC personnel, Protocol Chair and/or NICHD, if 
necessary, will answer queries related to general protocol implementation, eligibility and CRF 
completion. The Protocol Chair or his/her designee will respond to study and participant management, 
exemptions and/or untoward event queries. This study follows the ATN Policy for Guidance for Safety 
and Impact Reporting. Queries and replies will automatically be archived at the ATN CC. The CC will 
post those queries deemed relevant to all sites on the ATN 151 FAQ page, where they will be available 
for future reference.  
 
This study will use the Audio Computer-Assisted Self-Interview (ACASI) to collect study data.  All 
questions related to the ACASI should be directed to the ATN Help Desk at the ATN CC by calling the 
toll-free ATN ACASI helpline at 1 (866) 257-7242 or by email (ATNhelp@unc.edu). 
 
For protocol registration issues, contact the ATN Coordinating Center ATNhelp@unc.edu.   
 
 
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
ACASI  
 
Audio Computer Assisted Self Interview 
AEs                                Adverse Events  
AFC 
AIDS Foundation Chicago 
AIDS  
 
Acquired Immunodeficiency Syndrome 
ATN 
 
 
Adolescent Medicine Trials Network for HIV/AIDS Interventions 
CAB 
Community Advisory Board 
CDART 
 
Carolina Data Acquisition and Reporting Tool 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CGSHP 
Lurie Children’s Hospital Center for Gender, Sexuality and HIV Prevention 
Ci3 
Center for Interdisciplinary Inquiry & Innovation in Sexual and Reproductive Health 
CRF 
 
 
Case Report Form 
CT 
 
 
Chlamydia  
DHHS  
 
U.S. Department of Health and Human Services 
CC 
 
 
ATN Coordinating Center 
eCRF  
 
Electronic Case Report Form 
GC 
 
 
Gonorrhea 
GEE 
Generalized Estimating Equations 
HBM 
Health Belief Model 
HIPAA  
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
HRSA 
Heath Resources and Services Administration 
IATA 
International Air Transport Association 
ICH 
 
 
International Conference on Harmonization 
iFOUR 
Increase Individual Income and Independence Program 
IRB 
 
 
Institutional Review Board 
LGBT 
Lesbian Gay Bisexual Transgender 
MATEC 
Midwest AIDS Training and Education 
MSM 
Man who has sex with men 
NICHD  
 
National Institute of Child Health and Development 
NIDA  
 
National Institute on Drug Abuse  
NIH 
 
 
National Institutes of Health 

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OHRP  
 
Office of Human Research Protection 
OSHA 
Occupational Safety and Health Administration 
PI 
 
 
Principal Investigator 
PrEP 
 Pre-Exposure Prophylaxis 
QA 
Quality Assurance 
QNS 
 
 
Query and Notification System 
RA 
Research Assistant 
SE Model 
Supported Employment Model 
SAEs                              Serious Adverse Events 
SID 
 
 
Study Identification Number 
SMC 
Study Monitoring Committee 
SPSS 
Statistical Package for the Social Sciences 
STI 
Sexually Transmitted Infections 
T1 
Baseline study visit 
T2 
Post-Intervention study visit 
T3 
Month 8 follow-up visit 
UC 
University of Chicago 
UEs                                Untoward Events    
UNC 
University of North Carolina 
YMSM 
Young Men Who Have Sex with Men 
YTW 
Young Transgender Women 
 

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STUDY ABSTRACT 
DESIGN:  
Work2Prevent will advance the science by adapting, tailoring, and 
pilot-testing a novel social and structural-level HIV intervention 
for YMSM and YTW of color ages16-24 aimed at increasing 
economic stability (i.e., employment) through youth empowerment 
and asset development, and decreasing HIV risk behaviors (i.e., 
sex work) associated with social and economic marginalization. 
DURATION: 
Pilot-testing will last approximately 22 months   
POPULATION:  
All focus group, pilot-test, and the majority of key informant 
interview study participants will be Black/African American and/or 
Hispanic/Latinos males and transgender women (those assigned 
male at birth), ages 16-24 who identify as either: (1) a man who has 
sex with men (MSM) and/or gay or bisexual man; or (2) a 
transgender woman and/or transsexual male-to-female/transwoman. 
Additionally, key informant interview study participants will be any 
race/ethnicity and sex/gender, but will be identified as an employer 
and/or hiring manager of an LGBT-inclusive company.  
STUDY INTERVENTION: 
Intervention will consist of a series of 4 workshops that promote job 
seeking self-efficacy and job readiness. These workshops will be 
adapted from the existing iFOUR curriculum, a job readiness 
program for transwomen developed by the Chicago House. The 
iFOUR curriculum will be adapted based on feedback from the 
CAB, focus groups, and key informant interviews.   
DATA COLLECTION: 
Data will be collected through transcribed, digital audio-recorded 
interviews, ACASI, and eCRFs. 
PRIMARY OBJECTIVES: 
Determine the essential components of a theoretically-driven and 
developmentally-appropriate employment intervention aimed at 
increasing job seeking self-efficacy and readiness among YMSM 
and YTW of color ages 16-24. 
SECONDARY OBJECTIVES: 
Review and adapt relevant intervention components from the 
existing evidence-based employment program for HIV-positive 
adults (iFOUR) to YMSM and YTW of color.  
TERTIARY OBJECTIVES: 
Refine and pilot-test the employment intervention.  
Refine and Pilot-test the intervention in community-based settings. 
RISK/BENEFIT CATEGORY: 
Minimal 
MONITORING: 
Routine team monitoring of any adverse impact of the study will 
rely on the ATN Protocol Query & Notification System, a real-time, 
web-based interactive reporting system. Sites will also record and 
enter in the study database, all untoward events associated with 

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study participation, which will be reviewed on the protocol team’s 
implementation monitoring calls. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY SCHEMA 
 
STUDY VISITS 
 
Community Pilot-Test Enrollment
n=up to 40
Intervention Pilot-Test Enrollment
n=up to 70
Intervention Pre-Test Enrollment
n=up to 5
Community advisory board (CAB) 
n=up to 12
Focus groups and Key Informants
Focus Groups: n=up 
to 80
Key Informants:           
n=up to 64
Baseline 
(T1)
Workshop classes
Phase 2: 0-12 weeks of T1
Phase 3: 0-4 weeks of BL
Post-Intervention 
(T2)
Phase 2 & 3: 0-2 weeks 
after last class
Follow-Up (T3)
Phase 2: 8 months (±4 wks) 
after last class 
Phase 3: 3 months (±2 wks) 
after last class

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1.0 
INTRODUCTION 
1.1  
Background 
Young men who have sex with men (YMSM) and young transgender women (YTW) face enormous 
disparities. In particular, HIV risk and infection among YMSM and YTW remains a significant public 
health problem. Furthermore, YMSM and YTW experience social and economic marginalization, which 
leads to high rates of unemployment, sex work, drug use, homelessness, and HIV risk. Sex in exchange for 
money, drugs, and/or food among YMSM and YTW of color is a significant public health problem. 
Adolescent sex work places YMSM and YTW at increased risk for STIs, HIV, poor mental health 
outcomes, and substance abuse. Interventions that trace and disrupt the pathways between social and 
structural determinants of HIV infection are needed. Structural-level interventions foster agency to allow 
individuals to act in their own and their communities’ best interests, and have been positively associated 
with the uptake of behavioral and biomedical technologies, as well as the promotion of health-enabling 
environments. To date, few structural interventions targeting adolescent sexual and gender minorities 
exist, and we know of no studies that have explicitly examined the role of employment on HIV risk and 
prevention for YMSM and YTW. Employment as prevention has the potential to be a scalable intervention 
that can be deployed among at-risk YMSM and YTW. 
In the US, YMSM and YTW, experience high rates of HIV infection (CDC, 2012, 2013; Herbst et al., 
2008). In 2010, YMSM, including YTW, age 13-24 represented 19% of all new HIV infections, and 72% 
of infections among adolescents (CDC, 2012). However, such disparities cannot be attributed to 
individual-level risk alone, but are situated within larger social and structural contexts that proximate 
YMSM and YTW of color to increased HIV exposure (Baral et al., 2013; Bauer, Travers, Scanlon, & 
Coleman, 2012; Brennan et al., 2012; Garofalo, Osmer, Sullivan, Doll, & Harper, 2006; IOM, 2011; 
Operario & Nemoto, 2010). Despite advancements in LGBT rights, LGBT people face persistent stigma, 
discrimination, and victimization in school, the workplace, housing, and health care (Melendez et al., 
2006; Santos et al., 2014).  Such inequities are met with limited legal protections as few state laws 
specifically protect LBGT people. As a result, a fair majority of YMSM and YTW of color live in poverty, 
experiencing high rates of homelessness, unemployment, and limited access to health and HIV 
services(Bradford, Reisner, Honnold, & Xavier, 2013; Gayles, Kuhns, Kwon, Mustanski, & Garofalo, 
2016; Meyer, 2003; Millett et al., 2012; Santos et al., 2014; Sevelius, Patouhas, Keatley, & Johnson, 
2014). 
Faced with few economic options and protections, YMSM and YTW may migrate to non-traditional 
economies or “street careers” as a means of survival. In a study conducted by Adolescent Medicine Trials 
Network for HIV/AIDS Interventions (ATN) members in Los Angeles (Belzer) and Chicago (Garofalo) 
[Co-I for this proposal], 76% of 151 YTW ages 15-24 reported engaging in sex work, with 35% in the past 
3-months(Auerbach, Parkhurst, & Caceres, 2011; Xavier, Bobbin, Singer, & Budd, 2005). Among HIV-
positive YTW, 23% were involved in sex work—underscoring the link between adolescent sex work and 
HIV (Xavier et al., 2005). In a large study of YMSM of color (n=3,316, median age 19), roughly 12% 
reported engaging in sex work (past 6-months) (Melendez & Pinto, 2007). Sex work and HIV risk are 
further complicated by drug and alcohol abuse (Gayles et al., 2016).  Scalable, low-cost, but potentially 
high impact, structural-level interventions that trace and disrupt the pathways between social and 
economic marginalization and adolescent HIV infection are sorely needed (Clements-Nolle, Marx, & 
Katz, 2006; Kammerer, Mason, Connors, & Durkee, 2001; Lomabrdi, Wilchins, Priesing, & Malouf, 
2002). Structural interventions, such as comprehensive sex education, universal condom access, clean 
syringe exchange, and increased healthcare coverage have significantly reduced the incidence of HIV 
(Bockting, Miner, Swinburne Romine, Hamilton, & Coleman, 2013; Bradford et al., 2013; Clements-
Nolle et al., 2006; Durso, Kastanis, Wilson, & Meyer, 2013; Grant et al., 2011; Kammerer et al., 2001; 
Lomabrdi et al., 2002; Reisner, Bailey, & Sevelius, 2014). The objective of the proposed study is to  

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target economic stability (i.e., employment) as a structural-level intervention for preventing adolescent 
HIV. The proposed study will adapt and pilot-test an effective theoretically-driven, employment program 
for HIV-positive adults (iFOUR) (A Broken Bargain for LGBT Workers of Color, 2013; Dyer et al., 
2013; Fletcher, Kisler, & Reback, 2014; Kipke, Weiss, & Wong, 2007; Sifra Quintana, Roshenthan, & 
Krehely, 2010; Wilson et al., 2009) to the needs of at-risk YMSM and YTW of color, ages 16-24. This 
proposal is responsive to the NIH HIV/AIDS high priority topic by developing, testing, and implementing 
a new strategy to improve HIV prevention.  
1.2  
Rationale 
The goal of this project is to adapt, tailor, and pilot-test a novel social and structural-level HIV 
intervention for YMSM and YTW of color aimed at increasing economic stability (i.e., employment) 
through youth empowerment and asset development, and decreasing HIV risk behaviors (i.e., sex work) 
associated with social and economic marginalization. 
The specific aims of this project are to: 
1. Determine the essential components of a theoretically-driven and developmentally-appropriate 
employment intervention aimed at increasing job self-efficacy and readiness among YMSM and 
YTW of color ages 16-24.  
2. Review and adapt relevant intervention components from the existing evidence-based employment 
program for HIV-positive adults (iFOUR) to YMSM and YTW of color.  
3. Refine and pilot-test the employment intervention. 
4. Refine and pilot-test the employment intervention in community-based settings  
2.0 
STUDY OBJECTIVES 
2.1  
Primary Objective 
The primary objective is to determine the essential components of a theoretically-driven and 
developmentally-appropriate employment intervention aimed at increasing job seeking self-efficacy and 
readiness among YMSM and YTW of color ages 16-24. Up to 10 focus groups with YMSM and YTW of 
color who are currently employed or unemployed but seeking employment will inform the adaptation of 
the intervention. Key informant interviews with YMSM of color, YTW of color, and LGBT-inclusive 
employers will address intervention content. 
2.2  
Secondary Objective 
The secondary objective is to review and adapt relevant intervention components from the existing 
evidence-based employment program for HIV-positive adults (iFOUR) to YMSM and YTW of color. The 
study will assemble a community advisory board (CAB) of YMSM and YTW of color, youth-serving 
vocational specialists, employment training and placement experts, and sexual health educators to advise 
the investigative team on the translation of qualitative findings into curriculum adaptations. 
2.3  
Tertiary Objective 
The tertiary objective is to refine and pilot-test the employment intervention. All qualitative findings will 
be incorporated into a protocol with the iterative feedback of the CAB. Next, we will pre-test the Baseline 
visit, workshop sessions, and Post-Intervention visit with a sample of up to 5 participants. We will pilot-test 
the entire intervention among up to 70 at-risk YMSM of color and YTW of color and then in community-
based settings with up to 40 at-risk YMSM of color and YTW of color in a single-arm pre/post trial, 

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assessing feasibility and acceptability. Study outcomes include: (1) job seeking self-efficacy and readiness; 
(2) employment; (3) HIV risk behaviors; and (4) STI and HIV infections.  
2.4  
Study Hypotheses/Research Questions  
We hypothesize that this intervention will be both feasible and acceptable to the target populations and 
that the intervention will increase job self-efficacy and readiness, as well as decrease HIV risk behavior. 
This study will lead to a final intervention manual to be tested in an R01-type, large multi-site trial across 
the ATN study sites. 
3.0 
STUDY DESIGN 
All research activities except for the community-based pilot will occur at the University of Chicago 
(UC), Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health (Ci3). Ci3 is 
a foundation and federally funded research center focused on advancing adolescent sexual and 
reproductive health and rights through innovative research methodologies, intervention strategies, and 
novel solutions to broad social problems. Ci3 has a dedicated research team skilled in cross-disciplinary 
collaboration focused on adolescent health along with a broad network of community partners working 
with LGBT adolescents, and environments that will support the successful development, 
implementation, and evaluation of the project. 
Community-based pilot-testing will be conducted by study staff in the community at the following 
organizations:  
 
The Village (Chicago Center of HIV Elimination, University of Chicago) 
 
TaskForce Prevention and Community Services 
 
Ann & Robert H. Lurie Children’s Hospital of Chicago  
Each community setting has a private area for the confidential conduct of the study, including study visits 
and workshop sessions.    
Conceptual Model: Our conceptual model (Figure 1) draws on the existing iFOUR theoretical 
framework that operationalizes the Health Belief Model (HBM) and the Supported Employment Model 
(SE) to hypothesize the potential relationship between adolescent employment and HIV risk. We 
propose that employment, and subsequent economic connection and stability, serves as a structural-level 
intervention for adolescent HIV. Based on prior research, we hypothesize that the adapted and tailored 
iFOUR intervention will facilitate increased job seeking self-efficacy and job readiness [Path A] and 
ultimately increase employment placement and maintenance [Path B]. Further, we hypothesize that 
establishing economic stability will decrease engagement in HIV risk behaviors and increase HIV 
prevention and care [Path C], and decrease involvement with known social determinants of HIV (e.g., 
sex work, drug abuse) [Path D], that are directly linked to HIV transmission and acquisition [Paths E & 
F] among YMSM and YTW of color. 

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3.1  
Study Population 
All focus group, pilot-test, and the majority of key informant interview study participants will be 
Black/African American and/or Hispanic/Latinos males and transgender women (those assigned male at 
birth), ages 16-24 who identify as either: (1) a man who has sex with men (MSM) and/or gay or bisexual 
man or (2) transgender woman and/or transsexual male-to-female/transwoman. Additionally, key 
informants and study participants will be any race/ethnicity and sex/gender, but will be identified as an 
employer and/or hiring manager of an LGBT-inclusive company. Targeted Planned Enrollment tables 
contain the detailed breakdown for each recruitment and enrollment activity (Appendix III). 
3.2 
Sample Size 
Focus Groups:  We will recruit up to 80 YMSM and YTW of color, ages 16-24, to participate in one of up 
to 10 focus groups. 
Key Informant Interviews: We will recruit up to 64 key informant YMSM (n=up to 12), YTW (n=up to 
12), and LGBT-inclusive employers (n=up to 40) to participate in key informant interviews. 
Community Advisory Board: Up to 12-member CAB of YMSM, YTW, youth-serving employment and 
vocational specialist, LGBT employment training and placement experts, and sexual health educators. 
Intervention Pre-Test: We will pre-test the adapted employment intervention with a small sample of up to 
5 YMSM of color and YTW of color. 
Intervention Pilot-Test: We will pilot-test the adapted employment intervention with a diverse sample of 
up to 70 YMSM of color and YTW of color. 
Community Pilot-Test: We will test the intervention with a sample of up to 40 YMSM of color and 
YTW of color in community-based settings. 
3.3 
Outcome Measures 
Study outcomes include: (1) job seeking self-efficacy and readiness; (2) employment; (3) HIV risk 
behaviors; and (4) STI and HIV infections. 
3.4 
Biological Specimens 
Project staff members who have completed mandatory training will conduct HIV/STI testing. Study 
participants will be screened for drug use and STIs such as chlamydia, gonorrhea, syphilis, and HIV 

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infection at the baseline and follow-up visits. Clinical specimens may include 15-20 mL first-catch 
urine, anal swab (GC,CT), oral/laryngeal swab,  and finger stick. Participants with reactive STI or HIV 
tests will be referred to affiliated clinics at each site for evaluation and treatment. All participant referral 
clinics will be comprehensive and follow the Ryan White HIV/AIDS Programming instruction as 
developed by the HRSA HIV/AIDS Bureau. Senior Investigators are practicing physicians at study 
referral sites with experience in YMSM and YTW health, and will provide any subsequent mental health, 
medical case management, and psychosocial support service referrals as needed for participants. 
Following the protocols of our previous studies involving HIV testing, HIV-positive participants at 
follow-up will not receive HIV testing if they produce documentation of a previous diagnosis (e.g., 
medications, lab report). In addition, phase 3 participants with a known HIV positive status at the time 
of consent will not receive HIV testing at baseline or follow-up.  
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS 
4.1 
Inclusion Criteria 
4.1.1 
Focus Group Inclusion Criteria  
Must meet the following six criteria: 
1. Male or assigned male at birth (YTW)  
2. Identify as a man who has sex with men (YMSM) and/or gay bisexual man or transgender 
woman/transwoman  
3. Identify as African American/Black, Hispanic/Latino, and/or a racial/ethnic minority or person of 
color  
4. 16-24 years old  
5. English-speaking (primary)  
6. One of the following: 
a. Currently employed  
b. Unemployed but seeking employment 
4.1.2 
Key Informant Interviews Inclusion Criteria for YMSM and YTW 
Must meet the following six criteria: 
1. Male or assigned male at birth (YTW) [YMSM/YTW only] 
2. Identify as a man who has sex with men (YMSM) and/or gay bisexual man or transgender 
woman/transwoman  
3. Identify as African American/Black, Hispanic/Latino, and/or as a racial/ethnic minority or 
person of color 
4. 16-24 years old  
5. English-speaking (primary) 
6. One of the following: 
a. Currently employed  
b. Unemployed but seeking employment 
 4.1.3 Key Informant Interviews Inclusion Criteria for LGBT-Inclusive Employers 
Must meet the following four criteria: 
1. Employers and/or managers at LGBT-inclusive companies which: 

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a. Scored 80% or higher on the Human Rights Campaign, Corporate Equality Index 
2015-2016 or 
b. Is a company currently listed as an Out & Equal, LGBT CareerLink employer or 
c. Is a non-profit organization with an LGBT-focused mission or 
d. Is an LGBT-owned small business (<200 employees) or 
e. Is a company or organization participating in an LGBTQ job fair 
2. Located in the Chicago area 
3. English-speaking  
4. 18 years or older 
4.1.4 
Phase 2 Intervention Pre Test & Pilot-Test Inclusion Criteria 
Must meet the following eight criteria: 
1. Male or assigned male at birth (YTW)  
2. Identifies as a man who has sex with men (YMSM) and/or gay bisexual man or transgender 
woman/transwoman  
3. Identifies as African American/Black, Hispanic/Latino, and/or as a racial/ethnic minority or 
person of color 
4. 16-24 years old 
5. English-speaking (primary)  
6. HIV negative or of unknown status 
7. Currently unemployed but seeking employment or employed only part-time 35 hrs or less on 
avg/wk)  
8. Able to attend a 4-session employment program 
4.1.5 
Phase 3 Community Pilot Inclusion Criteria 
Must meet the following eight criteria: 
1. Male or assigned male at birth (YTW)  
2. Identifies as a man who has sex with men (YMSM) and/or gay bisexual man or transgender 
woman/transwoman  
3. Identifies as African American/Black, Hispanic/Latino, and/or as a racial/ethnic minority or 
person of color 
4. 16-24 years old 
5. English-speaking (primary)  
6. Currently unemployed but seeking employment or employed only part-time 35 hrs or less on 
avg/wk)  
7. Able to attend a 4-session employment program 
8. Did not participate in Phase 2 pilot 
 
4.2 
Exclusion Criteria 
4.2.1 
Focus Groups  
Must not meet any of the following: 
1. Individuals identify as non-Hispanic White 
2. Individuals not assigned male at birth 

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4.2.2 
Community Advisory Board Exclusion criteria:  
Must not meet any of the following: 
1. Under age 18 
2. White, Asian, Native American, and any other ethnic group not Black or Latino  
There are no exclusions regarding sex/gender for the Community Advisory Board. 
4.2.3 
Intervention Pilot-Test Exclusion Criteria 
Must not meet any of the following: 
1. Individuals identify as non-Hispanic White 
2. Individuals not assigned male at birth 
3. Phase 2 only: Individuals with a known HIV positive-status at baseline 
4.3 
Recruitment and Screening 
Recruitment. Study participants will be recruited by research assistants (RAs) and study recruiters who 
are also members of the target population. For the CAB, focus groups, and key informant interviews, 
participants will be recruited by the RAs through pre-existing network connections, including the Chicago 
Center for HIV Elimination and snowball sampling. Planned recruitment strategies for LGBT-Inclusive 
Employers also include attending LGBTQ job fairs and emailing LGBTQ non-profits, LGBTQ-owned 
small businesses, and employers in the Human Rights Campaign Corporate Equality Index or Out & 
Equal, LGBT CareerLink lists. 
For the pilot interventions, participants will be recruited actively by RAs and study recruiters in primary 
and community clinics serving YMSM and YTW of color, and local gathering places and events for 
YMSM and YTW such as night clubs, House & Ball events, and other public places that serve the LGBT 
community (e.g., LGBT centers). Additionally, participants will be asked to refer friends or acquaintances 
that may be eligible. Passive recruitment will include posting study flyers and posters, and describing the 
study on Facebook and other social media websites.   
4.4 
Informed Consent  
Consent Process. Eligible study participants will be taken through the informed consent process in a 
private room. RAs will review the consent process to make a formal assessment of the participant’s 
decisional capacity to consent prior to signing using a 2-step process. First, the RA will determine if the 
person understands the study goals by asking “Can you tell me what this study is about?” In step 2, 
potential participants will be asked questions designed to assess their capacity to understand, appreciate, 
reason with, and express a choice about participation in our specific protocol. Participants are asked to: (1) 
name things they will be expected to do during the study; (2) explain what they would do if they no longer 
wished to participate in the study; (3) explain what they would do if they experienced distress during the 
study; and (4) identify potential risks for participating in the study. Respondents will be enrolled only if 
they are able to provide clear and correct answers to each of these items. If study staff feels there is a 
question about the need for a more formal assessment of the decisional capacity of a potential participant, 
they will contact the Project Lead or other senior staff. Additionally, study staff will inform the person 
that the research study is voluntary and their decision whether or not to participate will not impact their 
relationship with the research site or any subsequent participation in research studies or care provided by the 
study site. If they agree to participate, they will be immediately enrolled in the study (Appendix VI). 

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Parental Consent. We will not require parental consent for study enrollment and participation. Parental 
consent may decrease participation rates because some youth will fear that they may be “outed” as a result 
of participation. Disclosure of sexual orientation or gender identity may place participating youth at risk 
for parental harassment, abuse or expulsion from the home. The nature and scope of the proposed research 
do not pose more than “minimal risk” to participants (45 CFR Part 46.102): “the probability and 
magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than 
those ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.” Study measures are standard in this population, as are waivers of parental 
permission for survey and interview studies. Additionally, risk behavior assessments will be based on the 
National Youth Risk Behavior Survey 2015, which has been administered to youth in 9th to 12th grade. 
HIV/STI testing is also common (and encouraged) among this group, and does not require parental 
permission or notification in the state of Illinois. 
To compensate for waiver of parental consent participants receive a formal individual assessment of 
capacity to consent (above) to ensure their understanding of study goals, procedures, and risks from 
disclosure of sensitive information (see Consent Process). Consistent with national policy 
recommendations from the Society for Adolescent Medicine, requiring parental permission for the 
proposed study would have a number of possible negative effects, including: (1) reducing the validity of 
the findings by effectively eliminating potential participants unwilling to share permission forms with 
their parents/guardians; (2) increasing risk to some youth whose parents have a negative response to the 
material in the permission forms that would (correctly) suggest their child has a minority or alternative 
gender identity; and (3) adding little in the way of actual subject protection, given the minimal risk of 
study participation.  
4.5 
Contact Information  
Once consented, study staff will complete a Contact Information Form with the participant. Participants 
will be asked to provide a working phone number or valid email address through which they can be 
reached, and if messages can be left at or texted to the numbers provided. Study staff will not leave or 
send messages unless expressly permitted to do so by the. If permission is given to leave phone messages, 
site staff will assure participants that any 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. 
The Contact Information Form will not contain any study data and will be maintained under double locks 
at the study site, separate from all study records, with access limited to designated site research personnel. 
4.6 
Co-enrollment Guidelines 
Studies that open after this protocol is implemented can be considered for co-enrollment either by 
requesting a blanket, one-time approval from the protocol team or by requesting case-by-case permission 
for co-enrollment in writing from the protocol chair.  
5.0 
STUDY PROCEDURES 
Aim 1: Determine the essential components of a theoretically-driven and developmentally-
appropriate employment intervention aimed at increasing job seeking self-efficacy and readiness 
among YMSM and YTW of color ages 16-24. Two formative assessment strategies will be used to 
determine the essential components of the employment intervention: (1) focus groups and (2) key 
informant interviews (Aim 1). First, focus groups be conducted with currently employed and 
unemployed (but seeking employment) YMSM and YTW. The goal of the focus groups will be to 

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explore and identify the following: perceived barriers to employment, beliefs in the benefit of 
employment, and career counseling needs of YMSM and YTW. Additionally, key components, 
including potential models of the adapted iFOUR employment curriculum will be shared and discussed 
with participants in order to gauge relevance and potential modifications for the target population. 
Next, we will conduct key informant interviews with YMSM, YTW, and LGBT-inclusive employers. 
The goal of this phase of formative research will be to hone and identify key areas related to barriers 
and facilitators to hiring and retaining YMSM and YTW: YMSM and YTW career readiness, 
identifying an inclusive employer, and post- placement support necessary to retain YMSM and YTW 
(Appendix II example interview guide). 
Focus Groups:  Recruitment and Enrollment. We will recruit up to 80 YMSM and YTW of color, ages 16-
24, to participate in one of up to 10 focus groups . 
Key Informant Interviews: Recruitment and Enrollment. We will recruit up to 64 key informant YMSM 
(up to 12), YTW (up to 12), and LGBT-inclusive employers (up to 40) to participate in key informant 
interviews. Over 35 major corporate employers in Chicago have a Corporate Equality Index of 100% (e.g., 
Groupon, Inc., McDonalds Corp., etc) (HRC, 2015). 
 
Aim 2: Review and adapt relevant intervention components from the existing evidence-based 
employment program for HIV-positive adults (iFOUR) to YMSM and YTW of color. 
Convene a Community Advisory Board (CAB). Up to a 12-member CAB of YMSM, YTW, youth-
serving employment and vocational specialists, LGBT employment training and placement experts, and 
sexual health educators will be led by Dr. Hill and the investigative team. Members of the CAB will 
meet no less than 20 times over the course of the project to review and interpret qualitative findings into 
distinct curriculum adaptations. The CAB will be instrumental in providing information on curriculum 
content, appropriateness, cultural sensitivity and specificity, study methodology, and best methods for 
enhancing participation, as well providing ongoing feedback and interpretation of data. The CAB will 
ensure that the adaptations reflect YMSM’s and YTW’s experience and employment needs (Aim 2).  
Aim 3: Refine, pre-test, and pilot-test the employment intervention. In order to achieve Aim 3, we 
will incorporate all qualitative findings and refine the final intervention curriculum modules using 
additional feedback from the CAB. In addition, the CAB will assist with Phase 2 by pre-testing and 
providing feedback on Phase 2 data collection instruments.  
The adapted employment intervention will first be pre-tested (Baseline, workshops, Post-intervention) with 
an initial sample of up to 5 participants in order to test the implementation of assessments and workshop 
activities. Refinement to workshop activities will be considered if activities do not fit within the session 
time-period or participants do not understand or comprehend the activity.   
Next, the intervention pilot-test of the final adapted employment intervention will be completed with a 
diverse sample of up to 70 YMSM and YTW, ages 16-24, in a single-arm longitudinal pre/post study of 
the employment intervention to evaluate feasibility, acceptability, program satisfaction, and preliminary 
efficacy using assessments at Baseline (T1), Post-Intervention (T2), and 8 Months Follow-Up (T3).  
Aim 4: Refine and pilot-test the intervention in community-based settings. In order to achieve Aim 4, we 
will refine the procedures and intervention so that it may be conducted within community-based settings 
in order to further test the implementation of assessments and workshop activities in Phase 3.  
The adapted employment intervention will be completed with a diverse sample of 40 YMSM and YTW, 
ages 16-24, in a single-arm longitudinal pre/post study of the employment intervention to evaluate 
feasibility, acceptability, program satisfaction, and preliminary efficacy using assessments at Baseline 
(T1), Post-Intervention (T2), and 3 Months Follow-Up  (T3). 

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 5.1 
Intervention Enrollment Procedures 
An ATN Study Identification number (SID) will be assigned by the site staff in consecutive order from 
the Carolina Data Acquisition and Reporting Tool (CDART).  
5.2 
Intervention/Investigation Procedures 
Up to 70 participants will be enrolled for the intervention pilot part of phase 2 and up to 40 participants 
for phase 3. Participants will complete a 4 session workshop. Workshops will be in groups of 6-12. These 
workshops will be based on the pre-existing iFOUR program (description below) with modifications 
based on CAB, focus group, pre-test, and interviewer feedback. 
iFOUR 
The Increase Individual Income and Independence program (iFOUR) is an employment program that was 
developed over ten years ago to target the employment needs of HIV- positive people. The program was 
based on the Supported Employment framework that was developed to help connect people with a range 
of disabilities (physical and cognitive) to employment because of the benefits of employment, both 
monetary and non-monetary. Thus, researchers at the University of Illinois-Chicago collaborated with 
Chicago House, a housing and support organization for HIV- positive individuals, to develop a Supported 
Employment program for HIV- positive individuals. Like Supported Employment, iFOUR provides a 
variety of supports to aid in participants' job success, such as job training referrals, client-tailored job 
placement, post-employment assistance, and benefits planning. The program includes regular interviews 
to evaluate program outcomes, such as medication adherence, use of drugs and alcohol, and assessments 
of physical and mental health. Since 2005, the iFOUR program has been refined to better tailor to the 
needs of HIV- positive individuals, including the addition of one-on-one work with a career specialist. 
These specialists assess job readiness and are trained in the impact of HIV/AIDS on employment, so as to 
best assist participants with their career aspirations. They also assist with linking participants to additional 
educational resources and provide support with interview preparation and development of resumes and 
cover letters. iFOUR also includes a four-week training workshop that is tailored to the needs of HIV-
positive participants, dealing with questions such as workplace discrimination, benefits maintenance, and 
the relationship of health beliefs and work. The workshop also covers confidence and communication 
skills, while highlighting the non-monetary benefits of employment. The iFOUR program has had 
positive outcomes for participants, documented in several studies (Appendix IV). The goal of the current 
study is to tailor then pilot test the iFOUR program for individuals who are HIV-negative but at high-risk 
for acquiring HIV.   
5.2.3 
Research Staff Training  
Prior to engaging in any study specific activities, staff must complete study trainings as outlined below: 
 
GCP training  
 
Human Subjects Protection training  
 
W2P Workshop Facilitator Training: Members of the research team who facilitate workshop 
sessions will be trained by staff who have run the iFOUR program. This training includes an 
overview of how iFOUR was implemented, challenges in implementation, and best practices for 
ensuring the utility of career readiness training. 
 
Title IX Training: All staff will complete annual Title IX training in the prevention of sexual 
assault and sexual misconduct via “Intersections: Preventing Harassment and Sexual Violence”  
 
Suspected Child Abuse Reporting Training: All staff will review guidelines related to their status 
as mandated reporters of suspected child abuse and neglect if applicable by state law. 
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Child Abuse: Training for Mandated Reporters,” which defines when mandated reporters must 
contact Child Support Services if abuse or neglect is suspected.  
 
HIV Testing Training: Staff engaged in the collection of biological samples will complete a 4 
hour specialized training on HIV client-centered counseling techniques, HIV prevention 
strategies, and other sensitive issues through the Midwest AIDS Training and Education Center. 
 
Ready Set PrEP! Training: All staff will complete training regarding HIV prevention and PrEP 
access through the AIDS Foundation of Chicago’s (AFC) “Ready Set PrEP!” This training 
focuses on how antiretroviral medication can be used for prevention of HIV transmission and 
how social determinants of health impact PrEP access.  
5.2.4 
Intervention Monitoring/Quality Control 
Research staff running the workshops will complete fidelity assessments during administration of each 
workshop class to help ensure and evaluate homogeneity across workshop groups. In addition, workshop 
staff will conduct a debriefing session after the administration of each workshop class in order to note any 
issues or observations.   
6.0 
EVALUATIONS AND MEASURES  
The study procedures will unfold in three phases, outlined below. 
Phase 1 
Focus groups and key informant interviews will be conducted. Focus group participants will be asked to 
discuss perceived barriers to employment, beliefs in the benefits of employment, and career counseling 
needs of YMSM and YTW of color. Participants will also be asked to review key components of models 
of the adapted iFOUR employment curriculum to gauge relevance and potential modifications. Key 
informant interviews will be conducted and the topics covered in will be similar to the focus groups, 
while allowing for more in-depth investigation of individual experiences. 
Phase 2 
Based on the data collected during phase 1, we will develop the adapted employment intervention and 
complete an initial pre-test consisting of the Baseline visit, workshops, and Post-Intervention visits. We 
will then pilot the intervention with participants in a single-arm longitudinal pre-/post-study. At Baseline, 
participants will complete a 30-60 minute audio-computer assisted self-interview (ACASI) survey covering 
sociodemographics, employment variables, HIV risk behavior variables, and potential modifying variables. 
Participants will also be asked for biological specimen collection for HIV/STIs screening and drug testing 
(such as urine, oral/laryngeal swab, finger stick, and anal swab). Upon completion of the employment 
intervention at Post-Intervention, participants will be asked to complete a second 30-45 minute ACASI 
survey regarding employment variables, HIV risk behavior variables, as well as the feasibility, acceptability 
and satisfaction of the program. After 8 months post-intervention, participants will be asked to return to the 
study site to complete the Follow-Up visit and repeat ACASI survey assessing sociodemographics, 
employment variables, HIV risk behavior variables, and potential modifying variables, as well as to provide 
repeat biological specimens for HIV/STIs screening and drug testing. 
Phase 3 
We will further adapt study procedures and the employment intervention so that it may be administered in 
community-based settings. All study procedures for Phase 3 are same as Phase 2 except that the Follow-
Up visit is at 3 months follow-up, and the ACASI surveys are shorter in length at 20-45 minutes each visit.      

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6.1 
Pilot-Test Screening  
Interested participants will be pre-screened for eligibility by the ATN 151 Screening Form, either via 
phone with study staff or online via a Qualtrics survey. Participants who are eligible at pre-screen will 
then be scheduled for their Baseline study visit.   
After informed consent, participants will be assigned a SID and then asked items from the ATN 151 
Eligibility Form to confirm that the participant meets study criteria.  
Table 1: Description of variables to be collected at each of the three study time points. 
Study visits 
Variables collected 
Baseline Visit (T1) 
Sociodemographics, employment variables, HIV 
risk behavior variables, and potential modifying 
variables 
HIV/STI screening and drug testing 
Workshop Intervention  
Workshop fidelity and debriefing  
Post-Intervention Visit (T2) 
Employment 
variables, 
variables 
assessing 
feasibility, acceptability, and satisfaction of 
intervention, and HIV risk behavior variables 
Follow-up Visit (T3) 
Phase 2: 8 Months  
Phase 3: 3 Months  
Sociodemographics, employment variables, HIV 
risk behavior variables, and potential modifying 
variables 
HIV/STI screening and drug testing 
6.2 
Baseline/Enrollment 
After informed consent and eligibility has been confirmed, participants will undergo biological specimen 
collection for HIV/STIs screening and drug testing. Please note that for Phase 3, if a participant has a 
known positive HIV status they will not undergo HIV testing. Participants will be given an iPad tablet and 
headphones and asked to complete an ACASI survey. The survey includes items on: sociodemographics, 
employment variables, HIV risk behavior variables, and potential modifying variables including perceived 
transgender discrimination scale, job seeking self-efficacy, managing interview, resilience, employment 
and job search, integrated motivations, internal self-concept, goal internalization, perceived social 
support, drug use, alcohol use, sexual history, commercial sex work, homelessness, condom intentions, 
money inventory, and PrEP awareness.    
6.3 
Workshop Intervention  
After the Baseline visit (T1), participants have up to 12 weeks to complete workshop classes for Phase 2 and 
up to 4 weeks for Phase 3, otherwise they will go on to complete the T2 and T3 visits. Participants who do not 
complete any workshop classes may still complete the T3 visit. 

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6.4 
Post-Intervention  
At the completion of the workshop intervention, participants have 0-2 weeks to complete the post-
intervention visit (T2). Participants will complete an ACASI survey assessing the feasibility, 
acceptability, and satisfaction of the program, as well as employment variables such as perceived 
discrimination, job self-efficacy, managing interviews, resilience, employment and job searching, motivations, 
goal setting, financial planning, and variables such as perceived social support, drug and alcohol use, sexual 
history, sex work, housing situation, condom use, and HIV risk behaviors.  
6.5 
Intervention Follow-Up  
For Phase 2 the follow-up visit (T3) is scheduled for 8 months post-intervention (±4 weeks), and for 
Phase 3 the follow-up visit is scheduled for 3 months post-intervention (±2 weeks). At this visit, 
participants will repeat biological specimen collection for HIV/STIs screening and drug use. If a 
participant already has a known positive HIV status they will not undergo HIV testing. Participants will 
repeat the ACASI survey with items on sociodemographics, employment variables, HIV risk behavior 
variables, and potential modifying variables such as perceived transgender discrimination scale, job 
seeking self-efficacy, managing interview, resilience, employment and job search, integrated motivations, 
internal self-concept, goal internalization, perceived social support, drug use, alcohol use, sexual history, 
commercial sex work, homelessness, condom intentions, money inventory, and PrEP awareness. 
7.0 
DATA COLLECTION AND SITE MONITORING 
7.1 
Development of Protocol and Case Report Forms 
The ATN CC, in collaboration with the Protocol Team, is responsible for the development of this 
protocol as well as the Case Report Forms (CRFs) and Audio Computer-Assisted Self Interview 
(ACASI). All CRFs for this study will be available for download from the ATN study website.  
7.2 
Data Records  
Participant-related study information will only be identified through a SID which will be on all participant 
CRFs and ACASI response files. Participant names or other personally-identifying information will not 
be used on any study documents except that contact information approved by the study participant will 
appear on study contact forms and reports, which will be securely maintained by both the site and the CC. 
All study-related information will be kept in double-locked, limited access areas at the study site. A log 
that links the names of participants to their SID number will also be kept under double locks and separate 
from all other research records, accessible only to the study staff, ATN site monitors, and representatives 
from the NICHD. Original source documents for individual participants will be maintained at the study 
site and will be accessible only to the study staff. Data from original source documents will be transcribed 
on CRFs as applicable.   
Individuals who complete the pre-screening process but who do not consent to participate will only have 
information collected on the ATN 151 Screening Form, which will be entered into the study database 
using a method to maintain anonymity. 
7.3  
Data Collection and Submission 
Research staff will be responsible for ensuring that CRF data is entered into CDART within one calendar 
week of data collection in a timely manner. Data edits through range checks and field inconsistencies will 

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be built into the CDART database to enable real time correction of key entries and CRF completion 
errors. 
All data collected using ACASI will be developed within the CDART web-based system. The 
participant’s SID will be used in order to link the interview responses to the participant’s CRF data. The 
ACASI data will be collected on Apple iPad devices using Qualtrics and the CDART data management 
tool. Data are stored on secure servers maintained by the ATN CC. No data is written to the iPad hard 
drive. Since data are persisted to the secure servers during data collection, if a network failure occurs 
during an interview little to no data will be lost. The secured servers comply with FIMSA regulations and 
are tightly controlled, and inaccessible to any person or application without appropriate credentials. 
Focus group and key informant interviews will be digitally audio-recorded with participant consent. 
Immediately upon completion, the digital audio files will be uploaded to a secure server. The audio 
recordings will be uploaded to a secure website belonging to a transcription company (CastingWords), 
who will listen to the recordings, transcribe them into a Microsoft Word file, and upload the transcript 
files to their secure website for download by study staff. Transcripts will be checked against audio 
recordings for accuracy. Once that process is complete, the audio files will be destroyed. Dr. Hill will 
ensure that the audio files are destroyed by the transcription company, and permanently deleted from the 
University of Chicago OBGYN server.  
Data from focus groups and key informant interviews will be transferred to the ATN CC. This data and 
all data collected using CDART will be submitted to the NICHD’s Data and Specimen Hub (DASH) after 
completion of the study in accordance with the NICHD DASH Data Archive Policy 
(https://dash.nichd.nih.gov/Resource/Policies) and the NIH Grants Policy Statement 
(https://grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm).  
7.4 
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. ATN sites will specify their QA plan at protocol registration in the 
Protocol Implementation Plan.  
7.5 
Role of Data Management 
The CC will provide instructions concerning ACASI administration, the recording of study data on CRFs, 
data entry, and data transmission to the CC via CDART at the completion of the study. It is the 
responsibility of the CC to assure the quality of computerized data. This role extends from protocol 
development to generation of the final study databases. 
7.6 
Study Site Monitoring and Record Availability 
Site monitors from the CC will visit participating study sites to review participant records, ICFs, CRFs 
and supporting source documentation, compliance with the protocol, and the 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., CRFs, ICFs) and pertinent source records readily 
available for inspection by the local IRB, the site monitors, the NICHD, the Office of Human Research 
Protection (OHRP), or the sponsor’s designee for confirmation of the study data. 

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8.0 
PARTICIPANT MANAGEMENT 
8.1 
Tracking Participants / Follow-up 
Site study staff will track participant study recruitment and retention for all study visits, as well as 
intervention sessions completed by participants.   
8.2 
Study Visit Management 
After the Baseline visit, participants have up to 12 weeks to complete workshop classes for Phase 2 and up to 4 
weeks for Phase 3, otherwise they may go on to complete the post-intervention and follow-up visits as outlined 
below. Participants who do not complete any workshop classes may still complete the follow-up visit. 
Participants may withdraw from the study at any time, and may be considered lost to follow up if they are 
unable to be reached after a minimum of three documented contact attempts. 
 
For participants that complete all 4 workshop sessions, the post-intervention visit will need to be 
completed w/in 2 weeks of the last workshop session, otherwise they may go on to complete the 
follow-up visit at 8 months (±4 weeks) after the last workshop session for Phase 2 and at 3 months (±2 
weeks) for Phase 3.  
 
For participants that complete at least one but less than all four of the workshop sessions in the time 
allowed (within 12 weeks of baseline for Phase 2, and 4 weeks for Phase 3), the post-intervention visit  
will need to be completed within 14 weeks of Baseline for Phase 2 and within 6 weeks for Phase 3. 
Otherwise, participants may go on to complete the follow-up visit at 8 months of the last class 
completed (±4 weeks) for Phase 2, and 3 months of the last class completed (±2 weeks) for phase 3.  
 
For participants that do not complete any workshop sessions, the follow-up visit will need to be 
completed at 8 months (±4 weeks) after Baseline for Phase 2, and 3 months (±2 weeks) for Phase 3.  
8.2.1 
Completing the Audio Computer Assisted Self-Interview 
 The participant is reminded of his or her right to discontinue at any time with no penalty and 
the right to choose to leave any questions unanswered;  
 The participant is given headphones and a iPad in an accommodating, private and quiet area;   
 The research staff assists with ACASI tutorials; and 
 If the participant requires a break, research staff will make sure the computer program is exited 
and re-entered properly so that the participant’s privacy is maintained  
8.2.1 
Debriefing and Referral Procedures for Audio Computer Assisted Self-Interview Participants 
 The participant will be debriefed about possible reactions to answering questions of a sensitive 
nature, such as short-term feelings of sadness or anxiety. Participants will be instructed to 
contact study personnel or to consult the list of referrals provided if feelings persist or worsen 
after several days; 
 Referrals for mental health services will be provided to all participants, if warranted; and 
 At the completion of the ACASI, the research staff member present during the session will ask 
the following question: “Is there anything else about the interview that you would like to 
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If the respondent says “no,” they should be thanked for participation. The respondent will be given 
contact information for mental health personnel available at UC and informed that they can also 
contact study personnel in the event that issues or concerns arise later.   
If the response indicates the participant is in urgent need of mental health assistance, site staff should 
follow their individual site procedures for acute mental health referrals. Site staff should contact a 
supervisor immediately and stay with the study participant until the supervisor, mental health 
professional or emergency services, if needed, arrives. Otherwise, the interviewer should say, "If you 
decide that you would like to speak with a counselor, here is the contact information for a counselor 
and a list of agencies in the community that provide this service” and provide the list of referrals. 
8.3 
Compensation 
Focus Groups:  Participants will receive $40 each for focus group participation. 
Key Informant Interviews: LGBTQ-friendly employers will be offered a $10 gift card for key informant 
interview participation. All other participants will receive $40 for key informant interview participation. 
CAB:  $30 per meeting. 
Intervention Pre-Test: Participants will receive $30 for completing visit surveys at T1 and T2, $40 for 
providing optional biologic specimens at T1, and $20 per workshop session attended, for a possible total 
of $180. 
Intervention Pilot: Participants will receive $30 for completing visit surveys at each time point, $40 for 
providing optional biologic specimens at T1 and T3, $40 per workshop session attended, for a possible total 
of $330.  
Intervention Community Pilot: Participants will receive $30 for completing visit surveys at each time 
point, $40 for providing optional biologic specimens at T1 and T3, and $30 per workshop session attended, 
for a possible total of $290.  
8.4 
Intervening on “Social Harms"  
8.4.1 
Potential risks 
Potential risks consist of participants being uncomfortable or emotionally upset as a result of the questions 
asked in the assessments, and potential breaches of confidentiality. However, participants are allowed to 
discontinue the study at any time and to not respond to questions they are uncomfortable with, without 
any penalty. All information disclosed to the research team will remain confidential, even if a participant 
chooses to withdraw from the study. Additionally, study participants can ask study staff to provide any 
needed referrals to counselors or other support if they become emotionally upset. Study participants will 
also have access to a clinician or social worker who can help them address any feelings and/or questions 
which arise over the course of their participation. The investigative team has conducted studies with 
hundreds of assessment visits and has managed all visits successfully. Procedures for youth who do 
experience discomfort are detailed below. 
All study records that identify the participant will be kept confidential, however there is a risk of loss of 
confidentiality such as by mandated reporting of child abuse/neglect for participants 16-17 years old. All 
healthcare professionals are required by law to report suspected cases of abuse and/or neglect. Although 
several of the proposed assessment measures include elicit information about experiences of 
discrimination and sexual behaviors, they do not specifically address child abuse or neglect. Thus, a report 
of abuse or neglect will only occur if the participant knowingly volunteers this information. In addition, 

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all participants are told in the consent process that statements of potential harm-to-self or others may 
require further assessment and/or reporting. The research team has specific procedures in place for 
referrals and strict confidentiality reporting. 
Additionally, a potential risk to confidentiality may occur if a participant tests positive for HIV or an STI 
during the course of the study. All participants will be told of reporting requirements during the consent 
process. If a participant tests positive for HIV or an STI, s/he will be referred to the Chicago Center for 
HIV Elimination (CCHE) for confirmatory HIV testing and appropriate care. CCHE is required to report 
all new cases of HIV by name and contact information to the Illinois Department of Public Health. Other 
information, including risk factors and sex contacts, are also requested for partner services. As an 
additional safeguard, the proposed study has two practicing physicians who have extensive experience 
treating STIs and HIV/AIDS among YMSM and YTW of color. 
There is a general potential risk of a breach in confidentiality of participant information. However, all 
investigators and study staff have been involved in several local and national studies of YMSM and YTW 
and have considerable experience implementing measures to protect participant confidentiality. Some of 
these steps include signed confidentiality agreements, in-service training on confidentiality, and the 
assignment of study ID numbers for all participants. Additionally, all front-line research staff who will be 
working with the participants throughout the project will undergo routine ethics training and complete 
specialized confidentiality training around HIV and other sensitive issues through the Chicago 
Department of Public Health. All staff will have completed training regarding HIV prevention and PrEP 
access through the AIDS Foundation of Chicago’s (AFC) “Ready Set PrEP!” should participants request 
additional information on these services. All staff will complete the Midwest AIDS Training and 
Education (MATEC) training and CDC Passport to Partner Services HIV and STI Prevention training 
prior to implementation. All data will be collected on secure network hosted by the university technology 
services. 
8.4.2 
Potential coercion 
Any study that pays a stipend may produce coercion. Eliminating the possibility of coercion by not 
awarding stipends would make it impossible to conduct many studies, and would shortchange subjects 
who provide time and energy, and may incur costs such as bus, train or cab fares. The resolution to this 
problem is to ensure that stipends are not inappropriately large, to probe potential subjects to make sure 
they have not been coerced, and to give persons who may have been coerced the opportunity not to 
enroll in the study in a manner that will protect them from retribution by the person coercing them. We 
believe we meet these conditions. The employment program session stipends proposed are similar to 
other studies used by members of the investigative team, and have not raised issues of coerciveness. 
8.4.3 
Protection against risk 
8.4.3.1 Discomfort or distress during the research   
Because there is a potential for discomfort or distress due to the research topic, we will make every effort 
to create a secure environment (ensuring privacy) prior to conducting baseline and follow-up assessments 
and intervention sessions. Participants will be told that they do not have to answer any question they do 
not wish to. Participants experiencing mild distress during the assessments will be offered a small break or 
will be rescheduled to complete the assessment at a later date. In the unlikely event that a participant 
experiences considerable distress, we will make a referral (if needed) for clinical assessment and/or 
counseling provided at each of the primary sites. Participants will be given the names and office phone 
numbers of the assessor, the Site Lead, and the Project Coordinator, and will be provided with referrals 
for mental health and support services. The Site Lead will be on-call for any serious problems that arise 
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8.4.3.2 Disclosure of abuse, homicide or suicide risk  
A number of procedures will be taken to minimize risk to participants. The consent procedures will 
explicitly state that participation in the research is voluntary, and that questionnaires will include items 
about sexual history, substance use, and sexual risk behaviors. Participants will be informed of the 
confidentiality of their responses as well as the limits of that confidentiality. If a participant discloses 
suicidal ideation, any type of violence, or homicidal intent, the research team will assess the level of risk 
and determine the best course of action (e.g., sending the participant to the emergency room, notifying the 
police). Youth under age 18 will be informed that disclosure of violence or victimization relating to a 
family member will require an evaluation by onsite behavioral health staff to determine the best course of 
action, and that under conditions of immediate danger or harm may require reporting or notification to 
appropriate authorities (i.e. the police or the Department of Children and Family Services). A 
determination of the decision-making capacity of the participants will be done prior to obtaining consent 
and research staff will pay particular attention to participants’ understanding of the risks associated with 
disclosure of information and the implications of that disclosure in accordance with state law. 
During all study visits, there will be an on-site behavioral health clinician or social worker to provide 
clinical backup to the RA, particularly concerning issues of child abuse, neglect, and suicidality. The on-
site behavioral health staff will have specific clinical expertise in managing the unique challenges facing 
young sexual and gender minorities. Consistent with abuse and/or neglect reporting requirements, should 
a report to the authorities be required, the information provided will be from the Project Lead at each site. 
No mention of the youth’s participation in this particular research project will be disclosed. We will 
inform participants that criminal behavior (i.e. drug use) is not reported to authorities and that the 
information is entirely confidential. These procedures will be reviewed in writing and in person by the RA 
as part of the informed consent process to help youth assess whether they wish to participate in the 
research, and to minimize the inadvertent disclosure of information. Regardless of age, if a participant 
discloses suicidal ideation or intent, the behavioral health clinician or social worker will be available to 
assess the level of risk and to help determine the best course of action (e.g. send to the emergency room). 
8.5 
Criteria for Premature Discontinuation 
Participants may choose to withdraw themselves from the study at any time. The study is voluntary and 
the alternative to participating in any phase of the study is not participating.  
9.0 
MONITORING & REPORTING SAFETY EVENTS  
Site staff must follow their oversight IRB's procedure for reporting and managing safety events, as well as 
the ATN CC procedures outlined below and in Chapter 10 of the ATN Manual of Policies and Procedures 
(MOPP). Safety events are reported using the ATN QNS accessible through the ATN website 
(https://www2.cscc.unc.edu/atn/). All safety events will be reviewed by the study team and reported to 
NIH. 
9.1 
Study Team Review 
Given that this study is a short pilot study of a behavioral intervention with a single arm (a pre-/post 
study), this study will use study team review for clinical research monitoring (CRM), where the study 
team consists of the Protocol Team at UC, a NIH representative, and the Coordinating Center (CC) at 
UNC Chapel Hill. Safety events will be reviewed by the study team on a case-by-case basis at team 
meetings which will occur at least monthly. The members of the study team and data to be reviewed at the 
meetings are described below.     

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Study team members: 
 
Protocol Chair(s)  
 
ATN Coordinating Center Investigator  
 
Protocol Manager  
 
Project Manager  
 
NIH Representative 
During the study team meetings, data quality and participant safety (e.g., number and type of safety 
events, recruitment and retention) will be reviewed and the team will determine what actions are 
necessary, if any. The study team will also previously reported safety events for which new information is 
available. 
The CC will monitor accrual and retention based on reports which they will generate monthly. Reports 
will include accrual, baseline characteristics, data quality, and completeness. If there are any problems 
with accrual or retention rates at specific sites, the CC will work with the site to identify operational 
issues or problems and take appropriate action.  
9.2       Reportable Safety Events  
There are three types of reportable safety events that require expedited reporting in QNS (within 2 
reporting days of site awareness):  
1. Adverse events (AEs) deemed to be possibly related or definitely related to the study that are 
severity grade 3 or higher 
2. All serious adverse events (SAEs) 
3. Untoward events (UEs) deemed to be possibly related or definitely related to the study that are 
severity grade 3 or higher 
Please note that all community UEs (not graded) and UEs grades 1-2, as well as AEs grades 1-2, do not 
require expedited reporting. These types of events must be reported within 5 reporting days of site 
awareness, and are up to the discretion of the site investigator and protocol team as to whether or not they 
are reportable.  
Once entered into QNS and after study team review, safety event reports should be printed and filed with 
participant records (or with regulatory documents if not related to a specific participant). In addition, 
study staff must also follow their oversight IRB procedures for reporting and managing safety events.  
For more information regarding the definitions of each type of safety event and details on reporting, 
please refer to the ATN CC MOPP Chapter 10.  
9.3 
Safety Event Reporting Periods 
Safety events must be reported throughout the duration of a study. If the event involves a specific study 
participant, events must be reported for the duration of that participant’s enrollment in the study. After the 
protocol-defined reporting period ends, only events that study staff become aware of on a passive basis 
(from publicly available information) should be reported. 
The duration of the reporting period for community UEs events begins at project start-up and continues 
through any professional or lay publication of study findings. If the online reporting system is not 
available after study closure, electronic reports should be made directly to Program Staff at NICHD. 

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All potential safety events should be reported as soon as possible after site staff become aware of the 
event. Events that require expedited reporting (are grade 3 or higher or SAEs of any grade) must be 
reported within 2 reporting days (see guidance below) of site awareness. Grades 1 & 2 events and all 
community UEs must be reported within 5 reporting days of site awareness. 
Reporting Days:  
• A reporting day starts at 12:00 AM (midnight) and ends at 11:59 PM local time. 
• A day is counted as a reporting day regardless of the time of day that awareness occurred. The 
day a site indicates that site personnel became aware of an EAE that meets reporting criteria shall 
count as day 1 if that day occurs on a reporting day (i.e., Monday through Friday). If that day 
occurs on a non-reporting day (i.e., Saturday or Sunday), then the next reporting day shall count 
as day 1. 
• Monday through Friday count as reporting days. 
• Saturday and Sunday are not considered reporting days. 
• Any holiday that occurs on a Monday through Friday counts as a reporting day. 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS 
10.1 
Study Design 
This protocol uses three distinct phases, each with its own study design. Phase I will consist of qualitative 
research using focus groups of both: (1) the study population (i.e., YMSM and YTW); and (2) employers 
of the study population. The goal of Phase I is to tailor the intervention, designed to increase employment 
in an adult population, to the study population. 
Phase II and III of the protocol will use a pre-/post design to determine preliminary efficacy of the revised 
intervention tailored to youth and designed to increase employment. Additional secondary outcomes, and 
potential mediators and effect modifiers of the intervention, will be considered. 
10.2 
Sample Size and Power Estimates 
Given the exploratory nature of this study and limited access to this population, a power calculation was 
not performed. A repeated measures design was chosen to reduce the variability in the estimate of the 
treatment effect, at the expense of having a comparison group. This trade-off was appropriate given the 
exploratory nature of a pilot study and the limited access to the study population. 
10.3  Statistical Analysis Plan 
10.3.1 Data Analysis 
The analytic plan is designed to: (1) tailor the adult intervention to youth; (2) assess intervention 
feasibility, acceptability, and satisfaction; and (3) determine preliminary efficacy of the intervention by 
comparing pre-/post assessments of employment and sexual risk behaviors. 
Phase I 
Data collection, storage, and analysis will take place at the study site (University of Chicago) and will be 
the responsibility of the Protocol Chair. 
Interviews and focus groups will be transcribed and coded by trained qualitative researchers. These 
transcripts will be coded for patterns and themes that emerge from the data, and these data will be used to 
inform the revision of the employment intervention that will then be pilot-tested. All focus groups and 

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key informant interviews will be digitally audio-recorded, transcribed (verbatim), and analyzed using 
emergent inductive logic data aggregation and analysis in Atlas.ti 7.0. Major emergent themes will be 
used to create a codebook and two-independent coders will analyze all data separately and compare 
coding schema for internal reliability (Kappa) (Aim 1). Descriptive statistics will be used to analyze the 
proportions and central tendencies for all feasibility, acceptability, and satisfaction measures: helpfulness, 
comprehensibility, quality, content appropriateness, engagement, utility, satisfaction, belief in efficacy, 
and recommendation to a friend. 
Datasets for Phase I will be cleaned, verified and archived, and then entered into SPSS for analyses. All 
database files will be password-protected and backed up to a secure university server daily. 
Phase II and III 
10.3.1.1 Descriptive statistics 
Descriptive statistics will be used to analyze the proportions and central tendencies for participant 
sociodemographic characteristics collected in the surveys completed by participants in the pilot-tests. We 
will first generate frequencies, means, and other measures of central tendency as appropriate to describe 
our sample and outcomes at each of the three time points (T1, T2, T3). Sensitivity analyses will be 
performed to address extreme outlying variables, including the removal of records with extreme outlying 
values from analyses.  
Changes in primary and secondary outcomes between Baseline (T1) and Follow-Up (T3) will be assessed 
using paired t-tests for continuous variables and McNemar’s test for categorical variables. Other statistical 
tests that appropriately account for the correlation in the dataset will be considered as needed. All 
hypothesis testing will be done at an alpha-level of 0.1, given the pilot/exploratory nature of the study. 
10.3.1.2 Modeling 
The primary goal of the modeling will be to help evaluate what characteristics could be mediators or 
effect modifiers of the effect of the intervention. Continuous outcomes will be analyzed using linear 
regression or generalized linear models, discrete outcomes will be analyzed using Poisson regression, and 
logistic regression will be used for binary and categorical outcomes. Only variables that have a 
statistically significant univariate relationship with the given outcome, at an alpha-level of 0.2, will be 
considered as potential mediators or effect modifiers for the effect of the intervention. 
Datasets for Phase 2 and 3 will be collected using CDART and cleaned, verified and archived by the ATN 
CC.  
10.4 
Missing, Unused and Spurious Data 
Every effort will be made to ensure that the amount of missing data is kept to a minimum, as missing data 
can complicate the statistical analyses and/or result in biased parameter estimates.  
Several procedures will be used to conduct data analysis when data for either outcomes or covariates are 
missing. The first step will be to assess the extent and pattern of missing data. If data are missing for only 
a few cases, then data analysis will be conducted only on study participants with complete data. However, 
when such a strategy would result in loss of data from a substantial proportion of participants, or if this 
approach would lead to biased or inaccurate results, then multiple imputation will be used.  
When the primary endpoint is missing, one data analysis will be conducted using only cases with the 
endpoint. 
Participants who do not complete all of the workshops will still be included in the analysis if they attend 
the follow up visit (T3), in a similar manner as intent-to-treat, where individuals are assumed to have 
received the intervention that was intended. We will also conduct a sensitivity analysis excluding these 

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participants, in an attempt to understand their potential impact on the preliminary estimates of 
intervention efficacy. 
11.0 
HUMAN SUBJECTS 
This study will be conducted in compliance with the protocol, ICH Good Clinical Practice guidelines, and 
45 CFR Part 46. 
11.1 
Participant Confidentiality 
All laboratory specimens, ACASI visit surveys, evaluation forms, and other research-related records will 
be identified by SID only to maintain participant confidentiality. Only contact information approved by 
the study participant will appear on any study contact forms and reports, and these will be securely 
maintained by both the site and the CC. All records with personally-identifying information will be 
maintained under double locks at the study site, with access limited to designated site research personnel. 
Any study records that need to be transported between community sites and the study site will be securely 
maintained in locked boxes and transported only by authorized personnel listed in a Note to File.  
Any laboratories used to test biological specimens will not have any study-specific identification recorded 
on their labels or associated requisition forms. Study data will not be released without written permission 
of the participant (and parent or legal guardian, when applicable), except as mandated by the law. 
Once all data has been collected, identifying participant information (including name) will be stripped 
from the database. Consents will only be accessible to designated research staff, and stored in a locked 
filing cabinet in secure offices.  
Computer files consisting of the participant tracking database, study data files, and transcriptions will be 
stored on a UNC server. The participant tracking database contains contact information and is used to 
schedule and track study visits, and is completely password protected. The tracking database does not 
contain any clinical (i.e., personal health information) or research-based information; it only has 
information the participant has agreed to provide for the purposes of tracking and communication. 
Data files are exported from the web-based ACASI program (administered on a web-based iPad platform) 
to a UNC server and imported into the CDART database for storage and analysis. Transcripts are entered 
into Atlas.ti for storage and analysis also on the UNC server. Data files do not include information that 
could be used to identify the participant from the data file alone. CDART is protected with industry 
recognized security standards which will encrypt data and will be further protected by login credentials 
for limited access, to protect participant confidentiality. 
11.1.1 Record Retention 
All data will be destroyed 7 years after the study is completed or per NIH and/or institutional guidelines, 
whichever is more conservative. Identifiers will be stripped from any study databases or logs at the 
completion of the study.  
11.2 
Certificate of Confidentiality 
To further protect the privacy of the study participants, the ATN has obtained a Certificate of 
Confidentiality from the U.S. Department of Health and Human Services (DHHS). With this Certificate 
in place, the ATN researchers cannot be forced to turn over identifying information about a study 
participant in any Federal, State, or local criminal, administrative, legislative, or other proceedings. This 
Certificate does not prevent a study participant from volunteering to turn over their research information 

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nor does it prevent researchers from providing research-related information to others when requested by 
the study participant (Appendix V). 
11.3 
Risks and Benefits 
11.3.1 Risks 
Participants in this study are exposed to few risks. The primary risks are loss of confidentiality and 
potential discomfort or embarrassment in discussing some of the sensitive and personal topics probed in 
the interviews, focus groups, and surveys. Data and safety monitoring will be performed by the trained 
data collectors and research team to assure that data are entered completely and participant confidentiality 
is maintained. If necessary, research staff will complete an Untoward Event report and immediately 
inform the Principal Investigator, so that s/he can ensure accurate reporting to the IRB. Finally, the 
Principal Investigator will include a summary of all Untoward Events as part of continuing IRB review.  
Risks to participants in this research study may include:   
Risk Category: Research not involving greater than minimal risk (45 CRF §46.404 and 21 CFR §50.51)  
Participation in this study poses no more harm or discomfort to research participants than they may 
experience in normal daily life or during routine physical or psychological examinations or tests.  
Participation in this study does not involve any physical risk. However, there is some risk of emotional 
discomfort or distress due to the personal nature of some questions. Participants will be informed that 
they are free to decline to answer any questions, or withdraw from participation at any time without 
penalty. Participants will be instructed to contact study personnel or to consult the list of referrals 
provided if feelings persist or worsen after several days. If the response indicates the participant is in 
urgent need of mental health assistance, site staff should follow their individual site procedures for acute 
mental health referrals. Site staff should contact a supervisor immediately and stay with the study 
participant until the supervisor, mental health professional, or emergency services, if needed, arrives. 
11.3.2 Benefits   
Information from this study may benefit other youth, now or in the future, by understanding methods to 
motivate HIV-positive young people to start and adhere to their prescribed HIV treatments. 
11.4 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, the informed consent documents, and any subsequent modifications will be reviewed and 
approved by the IRB or ethics committee responsible for the oversight of the study. The informed consent 
will describe the purpose of the study, the procedures to be followed, and the risks and benefits of 
participation.   
Signed informed consent will be obtained from the participant (or parent, legal guardian, or person with 
power of attorney for participants who cannot consent for themselves). The participant’s assent must also 
be obtained if he or she is able to understand the nature, significance, and risks of the study. The signed 
original consent/assent form will be kept on file at the site and a copy of the consent/assent form will be 
given to the participant and to the parent or legal guardian, if applicable.   
11.4.1 Risk Category: Minimal Risk  
Permission will be sought from at least one parent or guardian in accordance with local IRB/EC approved 
procedures unless the IRB/EC has waived the requirements for obtaining parental or guardian permission 
in accordance with 45 CFR §46.408 (c).  

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Assent of the children involved in this study will be sought in accordance with the regulations at 45 CFR 
§46.408(a) or 21 CFR §50.55 and local IRB/EC-approved policies and procedures. 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances  
Participating site IRBs will be requested to grant a waiver of parental/legal guardian consent to participate 
in this research study for youth participants under the age of legal majority based on state or local laws.  
Under 45 CFR Part 46.4116 (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.”  
The protocol team would submit that: 
 
This study is not considered greater than minimal risk. Participants will complete surveys and supply 
specimens for routine HIV monitoring. None of the content of this study is beyond what would be 
covered during routine medical or psychological visits or procedures related to the problem behaviors 
being studied. The probability of harm from participating in this study is no greater than that 
occurring in routine care. 
 
The ATN site involved in the study and most other community agencies offering HIV-related services 
are confidential and do not require parental/legal guardian notification or permission to treat under 
state regulations. 
 
Contacting a parent/legal guardian could constitute a breach of confidentiality for these HIV-positive 
participants and could potentially put some HIV-positive youth at risk for abuse or ousting from the 
home if parents/guardians are not aware of their HIV status. 
 
It is expected that there will be participants who have not disclosed their HIV status to 
parents/guardians nor will the parents/guardian be aware of the participant’s risk behaviors. 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 
HIV-related research with youth. 
 
Adequate protection has been substituted by the mechanisms in place to protect the privacy and 
confidentiality of participants and by the treatment referrals offered if needed. 
Under Illinois law (410 ILCS 305/9) minors can consent to STI and HIV testing without the consent or 
knowledge of said minor’s parent.   
11.6 
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) 
Site is responsible for adherence to their individual institution’s HIPAA policies and procedures. 
11.7 
Study Discontinuation 
This study may be discontinued at any time by the NICHD.  

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12.0 
PUBLICATION OF RESEARCH FINDINGS 
NICHD and ATN policies will govern publication of the results of this study. Publication of the results of 
this trial will be governed by the ATN Publications Policy, which will be established by the Publications 
Committee. Any presentation, abstract or manuscript will be made available for review by the 
Publications Committee prior to submission.  
13.0 
BIOHAZARD CONTAINMENT  
As the transmission of HIV and other blood borne pathogens can occur through contact with 
contaminated needles, blood, and blood products, appropriate blood and secretion precautions will be 
employed by all personnel in the drawing of blood and shipping and handling of all specimens for this 
study, as currently recommended by the Centers for Disease Control and Prevention. These procedures 
can be found at www.cdc.gov.   
 
ATN specimens will be transported in accordance with Federal and local laws, and in compliance with 
OSHA blood-borne pathogens standards as applicable. This policy includes the samples being transported 
by ground to the local laboratory. Compliance will be achieved by education of personnel involved with 
packaging and transporting specimens. 
 
14.0 
REFERENCES 
Auerbach, J. D., Parkhurst, J. O., & Caceres, C. F. (2011). Addressing social drivers of HIV/AIDS for the 
long-term response: conceptual and methodological considerations. Glob Public Health, 6 Suppl 
3, S293-309. doi:10.1080/17441692.2011.594451 
Baral, S. D., Poteat, T., Stromdahl, S., Wirtz, A. L., Guadamuz, T. E., & Beyrer, C. (2013). Worldwide 
burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis, 
13(3), 214-222. doi:10.1016/S1473-3099(12)70315-8 
Bauer, G. R., Travers, R., Scanlon, K., & Coleman, T. A. (2012). High heterogeneity of HIV-related 
sexual risk among transgender people in Ontario, Canada: a province-wide respondent-driven 
sampling survey. BMC Public Health, 12, 292. doi:10.1186/1471-2458-12-292 
Bockting, W. O., Miner, M. H., Swinburne Romine, R. E., Hamilton, A., & Coleman, E. (2013). Stigma, 
mental health, and resilience in an online sample of the US transgender population. Am J Public 
Health, 103(5), 943-951. doi:10.2105/AJPH.2013.301241 
Bradford, J., Reisner, S. L., Honnold, J. A., & Xavier, J. (2013). Experiences of transgender-related 
discrimination and implications for health: results from the Virginia Transgender Health Initiative 
Study. Am J Public Health, 103(10), 1820-1829. doi:10.2105/AJPH.2012.300796 
Brennan, J., Kuhns, L. M., Johnson, A. K., Belzer, M., Wilson, E. C., Garofalo, R., & Adolescent 
Medicine Trials Network for, H. I. V. A. I. (2012). Syndemic theory and HIV-related risk among 
young transgender women: the role of multiple, co-occurring health problems and social 
marginalization. Am J Public Health, 102(9), 1751-1757. doi:10.2105/AJPH.2011.300433 
A Broken Bargain for LGBT Workers of Color. (2013). Retrieved from http://www.lgbtmap.org/policy-
and-issue-analysis/workers-of-color 

ATN 151 
 
 
Version 5.2 
 
 
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CDC. (2012). Estimated HIV incidence in the United States, 2007-2010. Retrieved from 
http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental 
CDC. (2013). HIV Surveillance- Adolescents and Young Adults. Retrieved from 
http://www.cdc.gov/hiv/pdf/statistics_surveillance_Adolescents.pdf 
Clements-Nolle, K., Marx, R., & Katz, M. (2006). Attempted suicide among transgender persons: The 
influence of gender-based discrimination and victimization. J Homosex, 51(3), 53-69. 
doi:10.1300/J082v51n03_04 
Durso, L. E., Kastanis, A., Wilson, B. D. M., & Meyer, I. H. (2013). Provider Perspectives on the Needs 
of Gay and Bisexual Male and Transgender Youth of Color. Retrieved from Los Angeles, CA: 
http://williamsinstitute.law.ucla.edu/wp-content/uploads/ACCESS-final-rev-aug-2013.pdf 
Dyer, T. P., Regan, R., Wilton, L., Harawa, N. T., Ou, S. S., Wang, L., & Shoptaw, S. (2013). Differences 
in substance use, psychosocial characteristics and HIV-related sexual risk behavior between 
Black men who have sex with men only (BMSMO) and Black men who have sex with men and 
women (BMSMW) in six US cities. J Urban Health, 90(6), 1181-1193. doi:10.1007/s11524-013-
9811-1 
Fletcher, J. B., Kisler, K. A., & Reback, C. J. (2014). Housing status and HIV risk behaviors among 
transgender women in Los Angeles. Arch Sex Behav, 43(8), 1651-1661. doi:10.1007/s10508-014-
0368-1 
Garofalo, R., Osmer, E., Sullivan, C., Doll, M., & Harper, G. (2006). Environmental, psychosocial, and 
individual correlates of HIV risk in ethnic minority male-to-female transgender youth. Journal of 
HIV/AIDS Prevention Children & Youth, 7(2), 89-104.  
Gayles, T., Kuhns, L., Kwon, S., Mustanski, B., & Garofalo, R. (2016). Socio-economic disconnection as 
a risk factor for increased HIV infection in young men who have sex with men (YMSM). Journal 
of LGBT Health.  
Grant, J. M., Mottet, L. A., Tanis, J., Harrison, J., Herman, J. L., & Keisling, M. (2011). Injustice at 
Every Turn: A Report on the National Transgender Discrimination Survey. Retrieved from 
Washington, D.C.:  
Herbst, J. H., Jacobs, E. D., Finlayson, T. J., McKleroy, V. S., Neumann, M. S., Crepaz, N., & Team, H. 
A. P. R. S. (2008). Estimating HIV prevalence and risk behaviors of transgender persons in the 
United States: a systematic review. AIDS Behav, 12(1), 1-17. doi:10.1007/s10461-007-9299-3 
HRC. (2015). Corporate Equality Index 2015: Rating American workplaces on lesbian, gay, bisexual, 
and transgender equality. Retrieved from http://hrc-assets.s3-website-us-east-
1.amazonaws.com//files/documents/CEI-2015-rev.pdf  
IOM. (2011). The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for 
Better Understanding. Retrieved from Washington, D.C.:  
Kammerer, N., Mason, T., Connors, M., & Durkee, R. (2001). Transgender health and social service 
needs in the context of HIV risk. In W. O. Bockting & S. Kirk (Eds.), Transgender and HIV 
Risks, Prevention, and Care (pp. 39-57). New York, NY: Haworth Press. 
Kipke, M. D., Weiss, G., & Wong, C. F. (2007). Residential status as a risk factor for drug use and HIV 
risk among young men who have sex with men. AIDS Behav, 11(6 Suppl), 56-69. 
doi:10.1007/s10461-006-9204-5 
Lomabrdi, E. L., Wilchins, R. A., Priesing, D., & Malouf, D. (2002). Gender violence: Transgender 
experiences with violence and discrimination. Journal of Homosexuality, 42(1), 89-101.  

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Melendez, R. M., Exner, T. A., Ehrhardt, A. A., Dodge, B., Remien, R. H., Rotheram-Borus, M. J., . . . 
Hong, D. (2006). Health and health care among male-to-female transgender persons who are HIV 
positive. Am J Public Health, 96(6), 1034-1037. doi:10.2105/AJPH.2004.042010 
Melendez, R. M., & Pinto, R. (2007). 'It's really a hard life': love, gender and HIV risk among male-to-
female transgender persons. Cult Health Sex, 9(3), 233-245. doi:10.1080/13691050601065909 
Meyer, I. H. (2003). Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: 
conceptual issues and research evidence. Psychol Bull, 129(5), 674-697. doi:10.1037/0033-
2909.129.5.674 
Millett, G. A., Jeffries, W. L. t., Peterson, J. L., Malebranche, D. J., Lane, T., Flores, S. A., . . . Heilig, C. 
M. (2012). Common roots: a contextual review of HIV epidemics in black men who have sex 
with men across the African diaspora. Lancet, 380(9839), 411-423. doi:10.1016/S0140-
6736(12)60722-3 
Operario, D., & Nemoto, T. (2010). HIV in transgender communities: syndemic dynamics and a need for 
multicomponent interventions. J Acquir Immune Defic Syndr, 55 Suppl 2, S91-93. 
doi:10.1097/QAI.0b013e3181fbc9ec 
Reisner, S. L., Bailey, Z., & Sevelius, J. (2014). Racial/ethnic disparities in history of incarceration, 
experiences of victimization, and associated health indicators among transgender women in the 
U.S. Women Health, 54(8), 750-767. doi:10.1080/03630242.2014.932891 
Santos, G. M., Wilson, E. C., Rapues, J., Macias, O., Packer, T., & Raymond, H. F. (2014). HIV 
treatment cascade among transgender women in a San Francisco respondent driven sampling 
study. Sex Transm Infect, 90(5), 430-433. doi:10.1136/sextrans-2013-051342 
Sevelius, J. M., Patouhas, E., Keatley, J. G., & Johnson, M. O. (2014). Barriers and facilitators to 
engagement and retention in care among transgender women living with human 
immunodeficiency virus. Ann Behav Med, 47(1), 5-16. doi:10.1007/s12160-013-9565-8 
Sifra Quintana, S., Roshenthan, J., & Krehely, J. (2010). On the Streets: The Federal response to Gay nad 
Transgender Homeless Youth. Retrieved from http://www.americanprogress.org/wp-
content/uploads/issues/2010/06/pdf/lgbtyouthhomelessness.pdf  
Wilson, E. C., Garofalo, R., Harris, R. D., Herrick, A., Martinez, M., Martinez, J., . . . the Adolescent 
Medicine Trials Network for, H. I. V. A. I. (2009). Transgender female youth and sex work: HIV 
risk and a comparison of life factors related to engagement in sex work. AIDS Behav, 13(5), 902-
913. doi:10.1007/s10461-008-9508-8 
Xavier, J. M., Bobbin, M., Singer, B., & Budd, E. (2005). A needs assessment of transgendered people of 
color living in Washington, DC. International Journal of Transgenderism, 8(2-3), 31-47.  
 
 

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APPENDIX I 
Schedule of Evaluations 
Study Component 
Pre-Pilot 
Pre-
Screening T1: Baseline 
T2: Immediate Post-
Intervention 
T3: 8 Month Follow-Up 
 
Formative Research 
 
 
 
 
 
 
Focus Group Interviews 
X 
 
 
 
 
 
Key Informant Interviews 
X 
 
 
 
 
 
Community Advisory Board 
X 
X 
X 
X 
X 
 
Pre-Test 
X 
X 
X 
X 
 
Intervention Pilot Test 
 
 
 
 
 
 
Time Window 
 
 
 
0-2 weeks post-
intervention 
± 4 weeks 8 months post-
intervention 
 
Pre-Screening Survey 
 
X 
 
 
 
 
Informed Consent 
 
 
X 
 
 
 
Eligibility Survey 
 
 
X 
 
 
 
ACASI: Sociodemographics, 
employment variables, HIV risk 
behavior, and potential effect 
modifiers 
 
X 
X 
 
X 
 
Biospecimen: HIV/STI screening 
and drug testing 
 
 
X 
 
X 
 
ACASI: Feasibility, acceptability, 
and satisfaction of intervention, 
employment variables, HIV risk 
behavior 
 
 
 
X 
 
 
Untoward Events Assessment 
X 
X 
X 
X 
X 
 

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APPENDIX II 
Phase I Documents 

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Focus Group Guide 
Work2Prevent Focus Group Guide 
Hi everyone. Thanks for volunteering to talk with us. My name is X and this is X. X will be assisting me 
and taking notes during our group.  
There are no right or wrong answers. We just want to hear about your thoughts and experience. You may 
feel the same or differently than others in the group. This is okay. If you want to follow up on what 
someone has said, you want to agree, disagree, or give an example, feel free to do that. You can direct 
your comments to others in the group to respond. We just ask that only one person speaks at a time.  
I am here to ask questions, listen, and make sure everyone has a chance to share. We would like to hear 
from all of you so if you’re talking a lot, I may ask you to give others a chance. If you aren’t saying much, 
I might call on you to share your ideas. We will be recording the session to make sure we don’t miss 
anything you say, but what you say will not be linked to your name in the course of our research.  
Also, we want to remind you to please not share what you hear in this group today. By nature, a focus 
group is neither private nor confidential. However, it is important that what we say here stays within the 
group. If you want to use the bathroom, please feel free, we just ask that you get up quietly. Please keep 
your cell phones turned off until we finish the session. We really appreciate your full participation. 
Let’s begin. To find out a bit more about each other, we will go around the circle. When it is your turn, 
please tell us your first name, your favorite city (other than Chicago), and where you’d like to go on 
vacation if you could go anywhere in the world. 
1. I’d like to start by talking about employment in general. What kinds of jobs have you had in your 
lifetime? What is your favorite job that you have had? What did you like about that job? What is 
your least favorite job? What did you not like about that job? 
2. Let’s talk about the job search. How do you find out about jobs you might want to apply for? 
[Probe: internet – what sites in particular?, friends, family, etc.] When looking online, what do 
you search for? When you look at a job posting, what makes you decide to apply? What makes 
you decide not to? 
3. Now let’s talk about applying for a job. What kinds of things have you had to do to apply for a 
job? [Probe: in person vs. online application] Have you had to provide a resume? How did you 
get your resume ready? What do you include on your resume? What do you leave off?  
4. Okay, let’s say you get an interview for a job. How do you prepare for the interview? What do 
you wear? What time do you show up? How does your self-presentation during an interview 
differ from your self-presentation on a regular day?  
5. What kinds of experiences have you had during job interviews? What questions have you been 
asked? What was the hardest question to answer? Have you been asked things that seemed 
inappropriate (unprofessional)? Can you give examples? Have you ever not gotten a job because 
of your sexual orientation or gender identity? How do you know that was the reason?  

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6. So let’s say you get hired for a job (congratulations!). What kinds of challenges might a young 
(gay man OR trans woman) of color face when starting a new job? When if ever do you disclose 
your (sexual orientation OR gender identity)? [Transwomen: How do you deal with providing 
paperwork that might not match your gender presentation?] 
7. Thinking about discrimination at work now: Have you ever had to interact with a 
(homophobic/transphobic) co-worker or boss? What happened? How did you respond? Were 
there any people at that job who supported you? Were there any policies against discrimination?   
8. What is the longest you have ever worked at the same place? What was it about that job that 
made you want to stay? Did your employer have policies that kept other co-workers or 
supervisors from discriminating against you because of your sexual orientation or gender 
identity? What were those policies? How were they communicated to employees? How were they 
enforced?  
9. Thinking about positive work environments now: Have you ever had a job where you felt safe 
being “out” about your sexual orientation/gender identity? What made that environment feel safe 
and supportive? What could employers promote that kind of supportive environment?  
Thank you so much for your time and input! We really appreciate your participation, and we value your 
feedback.  
 
 
 

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Key Informant Employers Guide 
 
Key Informant Interviews: LGBT-inclusive employers 
Thank you for agreeing to participate in this interview.  We are hoping to gather important information in 
order to better understand the experiences of hiring managers in supporting diversity in hiring, 
specifically among LGBT individuals.  We appreciate your time and are very interested in your point of 
view and opinion. 
We would greatly appreciate it if you could please turn off your cell phone during the session. 
Before we start, I would like to remind you that there are no right or wrong answers to the questions as 
we talk.  We are holding this interview because we want to learn about your experiences and to hear from 
you.  Any information shared in this session will be confidential. Any information you share will be de-
identified to protect the anonymity of you and your employer. You do not have to answer any questions 
you do not wish to answer. If you need to take a break at any point, please let me know. 
1. Please tell me about your position at X company  
a. How long have you worked at X company? 
b. How long have you been in your current position? 
c. What is your role in the hiring process? 
d. How many people have you been involved in hiring? 
 
2. What you typically look for in an employee?  (May need to specify type/level of employee)  
a. Probes: specific skills, disposition/personality, experience, work ethic, diversity  
b. Can you give me an example of a recent hire? What was the position you were hiring for? 
What were you looking for in that employee? How did you determine that the person you 
hired was the right person for the job?  
  
3. Now thinking a bit more specifically about LGBT people - can you tell me about any protocols or 
policies you have to recruit, hire, and retain individuals who identify as LGBT, that is lesbian, 
gay, bisexual or transgender? (probe: Lesbian, Gay, Bisexual, Transgender) 
 
a. Probe: Are your policies the same for all of those groups, or are there different policies 
for sexual orientation and gender identity? Can you explain the reasoning behind that? 
How does that work in practice? 
b. Probe: Let’s talk specifically about recruiting employees here: what policies do you have 
to recruit LGBT employees? How successful have these policies been? What do you 
think could be done to improve these policies? 
c. Probe: What about policies to retain LGBT employees? How successful have these 
policies been? What do you think could be done to improve these policies? 
 
4. What are some challenges that someone who is LGB might face working in this field?  
a. What about challenges someone who is LGB might face working at this 
organization/company specifically?  
b. How do the higher-ups at your company address these challenges? 
c. How do the other staff at your company address these challenges? 
d. Can you give an example of this from your own company?  
 
5. What are some challenges that someone who is transgender might face working in this field?  

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a. What about challenges someone who is transgender might face working at this 
organization/company specifically?  
b. How do the higher-ups at your company address these challenges? 
c. How do the other staff at your company address these challenges? 
d. Can you give an example of this from your own company?  
 
6. What are some benefits to the company from having LGBT employees? 
a. Can you give an example of how an LGBT individual has added value to your company? 
 
7. How do your clientele factor into your company’s policies and practices regarding certain sexual 
and gender minorities?  (probe: Lesbian, Gay, Bisexual, Transgender) 
 
8. How might other employees and key stakeholders (board members, shareholders, funders, etc) 
factor into your company’s policies and practices regarding certain sexual and gender minorities? 
 
9. What barriers to hiring and retaining young transwomen of color in particular have you 
experienced? (Probe: job readiness, interview performance, stereotypes of other employees, self-
presentation, personality/disposition, etc.) 
 
10. What barriers to hiring and retaining young gay or bisexual men color in particular have you 
experienced? (Probe: job readiness, interview performance, stereotypes of other employees, self-
presentation, personality/disposition, etc.) 
 
 
 

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Informant YMSM and YTW Guide 
 
Work2Prevent IDI Guide for MSM/TW 
Hi there, my name is _____. Thanks for volunteering to talk with me today. Before we get started on the 
interview, I’d just like to remind you of a few things. First, there are no right or wrong answers. I just 
want to hear about your thoughts and experience. Second, I’ll be recording the interview today so that I 
can focus on the interview instead of taking notes. The recording will only be used for our research, and 
your answers will be confidential, meaning that your name will never be used in connection with reports 
from this study. Third, you may skip any question you do not want to answer, and you may end the 
interview at any time. If you need a break at any point, just let me know. Finally, I ask that you keep your 
cell phone on silent or turned off until we finish the interview. I really appreciate your full participation. 
Do you have any questions for me at this point? Feel free to ask at any point if something comes up. 
Okay, let’s get started!   
1. I’d like to start by talking about your employment history. Please walk me through all of the jobs 
you’ve had, starting with your very first paid employment.  
a. What was your first job? How old were you when you got it? How long did you work there? 
What kinds of things did you do?  
b. What was your next job? [Repeat questions for each job until present time.] 
c. What was your favorite job that you have had? What did you like about that job? What was 
your least favorite job? What did you not like about that job? 
2. Now let’s talk about the job search. How do you find out about jobs you might want to apply for? 
How did you find out about the last job you had? [Probe: internet – what sites?, friends, family, 
etc.]  
a. When looking online, what do you search for? When you look at a job posting, what makes 
you decide to apply? [Probe: skills, experience, job type, location, compensation, etc.] What 
makes you decide not to? 
b. When you hear about a job from family or friends, what sorts of things do you ask? [Probe: 
skills, experience, job type, location, compensation, etc.] What makes you more likely to 
apply for a job that someone tells you about? What makes you less likely to apply?  
c. When you see a help wanted ad or sign, how do you decide whether to apply for the job 
advertised? [Probe: skills, experience, job type, location, compensation, etc.] 
d. Have you figured out any ways to tell if an employer is LGBT friendly? If yes, how did you 
figure this out? Have you been able to apply this when looking for jobs? If not, are there 
things that employers could do that would help you know that they are LGBT friendly?  
3. Now let’s talk about applying for a job. What kinds of things have you had to do to apply for a 
job? [Probe: in person vs. online application] [Probe: Think about the last job you applied for…] 

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a. Have you had to provide a resume? How did you get your resume ready? What do you 
include on your resume? What do you leave off? When did you first create a resume? How 
often have you revised or rewrote it?  
4. Okay, let’s say you get an interview for a job. How do you prepare for the interview?  
a. What do you wear? How does your self-presentation during an interview differ from your 
self-presentation on a regular day? 
b. What time do you show up? How do you act?  
5. Think specifically about the last job you applied for: did you interview for that? What happened 
during the interview? What questions did the interviewer ask?  
a. How did that interview compare to other job interviews you’ve had? What kinds of 
experiences have you had during job interviews?  
b. What questions have you been asked? What was the hardest question to answer? Have you 
been asked things that seemed inappropriate (unprofessional)? Can you give examples?  
c. Have you ever not gotten a job because of your sexual orientation or gender identity? What 
made you think that was the reason?  
6. So now let’s talk about what happens when you start a new job. What kinds of challenges have 
you faced as a young (gay man OR trans woman) of color when starting a new job?  
a. When (if ever) have you disclosed your (sexual orientation OR gender identity) to your co-
workers? What about to your boss?  
b. [Transwomen: How do you deal with providing paperwork that might not match your gender 
presentation?] 
7. Thinking about discrimination at work now: Have you ever had to interact with a 
(homophobic/transphobic) co-worker or boss? Can you tell me about that experience? 
a. What happened? How did you respond?  
b. Were there any people at that job who supported you? What did they do? 
c. Were there any policies against discrimination at your job? What were those policies? How 
were they enforced, if at all?  
8. What is the longest you have ever worked at the same place?  
a. What was your job? What was it about that job that made you want to stay?  
b. Did your employer have policies that kept other co-workers or supervisors from 
discriminating against you because of your sexual orientation or gender identity? What were 
those policies?  

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c. How were they communicated to employees?  
d. How were they enforced?  
9. Thinking about positive work environments now: Have you ever had a job where you felt safe 
being “out” about your sexual orientation/gender identity?  
a. What made that environment feel safe and supportive?  
b. How could more employers promote that kind of supportive environment?  
Thank you so much for your time and input! I really appreciate your participation, and I value your 
feedback.  
 
 
 
 
 

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Screening Instrument 
 

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APPENDIX III 
Planned Enrollment Report – Pilot Test 
This report format should NOT be used for collecting data from study participants. 
Study Title:  Work-to-Prevent: Employment as HIV prevention for young men who have sex 
with men (YMSM) and young transgender women (YTW) [Pilot Test (n=70)] 
Domestic/Foreign:    Domestic   
Comments:  We define male to include anyone who was assigned male at birth, which would 
include young transgender women (YTW) 
 
Ethnic Categories 
Racial Categories 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
 
Female 
Male 
Female 
Male 
 
American Indian/ Alaska 
Native 
0 
0 
0 
0 
   0 
Asian 
0 
0 
0 
0 
   0 
Native Hawaiian or Other 
Pacific Islander 
0 
0 
0 
0 
   0 
Black or African American 
0 
48 
0 
4 
  52 
White 
0 
0 
0 
12 
  12 
More Than One Race 
0 
4 
0 
2 
   6 
Total 
   0 
  52 
   0 
  18 
  70 
PHS 398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015) 
 
OMB No. 0925-0001/0002 
 
Page 1 
Planned Enrollment Report 
 
 

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APPENDIX IV 
iFOUR Description 
Description of the iFOUR Program  
The Increase Individual Income and Independence program (iFOUR) is an employment program that was 
developed over ten years ago to target the employment needs of HIV-positive people. The program was 
based on the Supported Employment framework that was developed to help connect people with a range 
of disabilities (physical and cognitive) to employment because of the benefits of employment, both 
monetary and non-monetary. Thus, researchers at the University of Illinois-Chicago collaborated with 
Chicago House, a housing and support organization for HIV-positive individuals, to develop a Supported 
Employment program for HIV-positive individuals. Like Supported Employment, iFOUR provides a 
variety of supports to aid in participants' job success, such as job training referrals, client-tailored job 
placement, post-employment assistance, and benefits planning. The program includes regular interviews 
to evaluate program outcomes, such as medication adherence, use of drugs and alcohol, and assessments 
of physical and mental health. Since 2005, the iFOUR program has been refined to better tailor to the 
needs of HIV-positive individuals, including the addition of one-on-one work with a career specialist. 
These specialists assess job readiness and are trained in the impact of HIV/AIDS on employment, so as to 
best assist participants with their career aspirations. They also assist with linking participants to additional 
educational resources and provide support with interview preparation and development of resumes and 
cover letters. iFOUR also includes a four-week training workshop that is tailored to the needs of HIV-
positive participants, dealing with questions such as workplace discrimination, benefits maintenance, and 
the relationship of health beliefs and work. The workshop also covers confidence and communication 
skills, while highlighting the non-monetary benefits of employment. The iFOUR program has had 
positive outcomes for participants, documented in several studies (see references below). The goal of the 
current study is to tailor and then pilot test the iFOUR program for individuals who are HIV-negative but 
at high-risk for acquiring HIV.   
Related References 
Cook, Judith A.; Razzano, Lisa A.; Swarbrick, Margaret A.; Jonikas, Jessica A.; Yost, Chantelle; Burke, 
Larisa; Steigman, Pamela J.; Santos, Alberto. Health Risks and Changes in Self-Efficacy Following 
Community Health Screening of Adults with Serious Mental Illnesses.  PLoS ONE. Apr2015, Vol. 10 
Issue 4, p1-15. 15p. DOI: 10.1371/journal.pone.0123552. 
Cook, Judith A.; Razzano, Lisa A.; Burke-Miller, Jane K.; Blyler, Crystal R.; Leff, H. Stephen; Mueser, 
Kim T.; Gold, Paul B.; Goldberg, Richard W.; Shafer, Michael S.; Onken, Steven J.; McFarlane, William 
R.; Donegan, Kate; Carey, Martha Ann; Kaufmann, Caroline; Grey, Dennis D. Effects of co-occurring 
disorders on employment outcomes in a multisite randomized study of supported employment for people 
with severe mental illness.  Journal of Rehabilitation Research & Development. 2007, Vol. 44 Issue 6, 
p837-850. 
Hamilton, Marie M.; Razzano, Lisa A.; Martin, Nicole B. The Relationship Between Type and Quality of 
Social Support and HIV Medication Adherence.. Journal of HIV/AIDS & Social Services , 2007, Vol. 6 
Issue 1/2, p39-63. 
Razzano et al. (2013). The Role of Employment in HIV Wellness & Recovery. USCA. 
Razzano, Lisa A.; Hamilton, Marie M.; Yost, Chantelle; Pashka, Nicole J.; Perloff, Judith K. Employment 
Outcomes for Individuals With HIV/AIDS and Co-Occurring Mental Health Factors. American Journal 

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of Psychiatric Rehabilitation. Jan-Mar2015, Vol. 18 Issue 1, p19-41. 23p. 4 Charts. DOI: 
10.1080/15487768.2015.1001700 
Razzano, Lisa A.; Hamilton, Marie M.; Perloff, Judith K. Work status, benefits, and financial resources 
among people with HIV/AIDS. Work. 2006, Vol. 27 Issue 3, p235-245. 
Razzano, Lisa A.; Hamilton, Marie M. Health-related barriers to employment among people with 
HIV/AIDS.  Journal of Vocational Rehabilitation. 2005, Vol. 22 Issue 3, p179-188.

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