Increasing Engagement and Improving HIV Care Outcomes Via Stigma Reduction in an Online Social Networking Intervention Among Racially Diverse Young Men Who Have Sex With Men and Transgender Women
Phase: NA
Conditions: HIV Infections, Sexually Transmitted Diseases, Stigma, Social
Sponsor: University of Pennsylvania

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HealthMpowerment Stigma 
Increasing engagement and improving HIV care outcomes via stigma reduction in an online 
social networking intervention among racially diverse young men who have sex with men and 
transgender women. 
 
Funding Sponsor:  
 
The National Institute on Minority Health and Health Disparities (NIMHD) 
 
 
SIGNATURE PAGE 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable U.S. Food and Drug 
Administration regulations; standards of the International Conference on Harmonization 
Guideline for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee 
determinations; all applicable in-country, state, and local laws and regulations; and other 
applicable requirements (e.g., US National Institutes of Health, Division of AIDS) and 
institutional policies. 
Investigator of Record:  
José Bauermeister, PhD, MPH 
Department of Family and Community Health 
University of Pennsylvania School of Nursing 
418 Curie Blvd 
Philadelphia, PA 19104-4217 
Phone: 215-898-9993 
Email: bjose@upenn.edu 
 
Signed: 
 
Date: 5/6/2024 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
PROTOCOL TEAM ROSTER ...................................................................................................... 5 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................................................. 7 
STUDY ABSTRACT ....................................................................................................................... 9 
STUDY SCHEMA ......................................................................................................................... 10 
1.0 
INTRODUCTION ......................................................................................................... 11 
1.1 
Background ................................................................................................................................ 11 
1.2 
Rationale ..................................................................................................................................... 12 
2.0 
STUDY OBJECTIVES ................................................................................................ 13 
2.1 
Primary Objective: .................................................................................................................... 13 
2.2 
Secondary Objective: ................................................................................................................ 13 
2.3 
Study Hypotheses/Research Questions .................................................................................... 13 
3.0 
STUDY DESIGN ......................................................................................................... 13 
3.1 
Study Population ....................................................................................................................... 14 
3.2 
Sample Size ................................................................................................................................ 14 
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment 
Procedures .................................................................................................................................. 14 
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS ....................... 16 
4.1 
Inclusion Criteria (All study arms) .......................................................................................... 16 
4.2 
Exclusion Criteria ...................................................................................................................... 17 
4.3 
Recruitment ............................................................................................................................... 17 
4.4 
Informed Consent ...................................................................................................................... 17 
4.5 
Screening .................................................................................................................................... 18 
5.0 
STUDY PROCEDURES ............................................................................................. 19 
5.1 
Enrollment Procedures ............................................................................................................. 19 
5.2 
Locator/Contact Information ................................................................................................... 20 
5.3 
Randomization Procedures ...................................................................................................... 20 
5.4 
Intervention/Investigation Procedures .................................................................................... 20 
6.0 
EVALUATIONS AND MEASURES .......................................................................... 24 
6.1 
Behavioral Evaluations (all CASI survey instruments are attached to the protocol) ......... 24 
6.2 
Clinical and Laboratory Evaluations (if applicable) .............................................................. 25 

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7.0 
DATA COLLECTION AND SITE MONITORING ................................................... 25 
7.1 
Development of Protocol and Case Report Forms ................................................................. 25 
7.2 
Data Records .............................................................................................................................. 25 
7.3 
Data Collection .......................................................................................................................... 25 
7.4 
Data Submission ........................................................................................................................ 27 
7.5 
Data Quality Assurance ............................................................................................................ 28 
7.6 
Role of Data Management ........................................................................................................ 28 
8.0 
PARTICIPANT MANAGEMENT ............................................................................... 28 
8.1 
Tracking Participants / Follow-up ........................................................................................... 28 
8.2 
Compensation ............................................................................................................................ 28 
8.3 
Intervening on “Social Harms" ................................................................................................ 29 
8.4 
Criteria for Premature Study Discontinuation ....................................................................... 32 
9.0 
MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING 
FROM STUDY ............................................................................................................. 32 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS .................................................... 33 
10.1 Introduction ............................................................................................................................... 33 
10.1.1 
Paradata Metrics ................................................................................................................. 33 
10.1.2 
Mixed-Methods Paradata Forum Coding .......................................................................... 33 
10.2 Power Estimates ........................................................................................................................ 33 
10.3 Statistical Analysis Plan ............................................................................................................ 34 
10.4 Missing Data .............................................................................................................................. 36 
11.0 
HUMAN SUBJECTS ................................................................................................... 36 
11.1 Participants’ Confidentiality .................................................................................................... 36 
11.2 Participants’ Confidentiality .................................................................................................... 37 
11.3  Institutional Review Board (IRB) Review and Informed Consent ........................................ 39 
11.4 Waiver of the Requirement for Parental Permission for Special Circumstances ............... 40 
11.5 Prisoner Participation ............................................................................................................... 40 
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) ................................................................................................... 41 
11.7 Study Discontinuation ............................................................................................................... 41 
12.0 
PUBLICATION OF RESEARCH FINDINGS ........................................................... 41 
13.0 
BIOHAZARD CONTAINMENT .................................................................................. 41 

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14.0 
REFERENCES ............................................................................................................ 42 
 
 
 

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PROTOCOL TEAM ROSTER 
 
Kathryn Muessig, PhD 
Protocol Co-Chair 
Florida State University College of Nursing 
Vivian M. Duxbury Hall 
98 Varsity Way 
Tallahassee, FL 32306-4310 
Phone: (850) 644-3296 
Email: kmuessig@fsu.edu  
 
Lisa Hightow-Weidman, MD, MPH 
Co-Investigator 
Vivian M. Duxbury Hall 
98 Varsity Way 
Tallahassee, FL 32306-4310 
Email: lhightowweidman@fsu.edu 
Seul Ki Choi, PhD 
Co-Investigator 
University of Pennsylvania School of Nursing 
418 Curie Blvd, Rm 235L 
Philadelphia, PA 19104 
Email: skchoi@nursing.upenn.edu 
 
Sabina Hirshfield, PhD 
Co-Investigator 
STAR Program, Department of Medicine  
SUNY Downstate Medical Center 
450 Clarkson Avenue, BSB 4-32 
Brooklyn, NY 11203 
Email: sabina.hirshfield@downstate.edu 
 
Marta Mulawa, PhD  
Co-Investigator 
Duke Global Health Institute 
Duke University 
310 Trent Drive 
Durham, NC 27710 
Email: marta.mulawa@duke.edu  
 
Subhash Aryal, PhD 
Co-Investigator 
Johns Hopkins University School of Nursing 
525 N. Wolfe Street 
Baltimore, Maryland 21205 
Email: saryal5@jh.edu  
 

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Willey Lin, MBIOT, PMP 
Research Coordinator 
University of Pennsylvania School of Nursing 
418 Curie Blvd, Rm 235L 
Philadelphia, PA 19104 
Phone: (215) 746-3554 
Email: willey@nursing.upenn.edu  
 
Aimee Rochelle, MPH 
Study Coordinator  
Florida State University College of Nursing 
Vivian M. Duxbury Hall 
98 Varsity Way 
Tallahassee, FL 32306-4310 
Email: arochelle@fsu.edu 
Jenni Tran, PhD 
Postdoctoral Fellow 
University of Pennsylvania School of Nursing 
418 Curie Blvd, Rm 235L 
Philadelphia, PA 19104 
Email:  jtgtran@nursing.upenn.edu  
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
AIDS 
Acquired Immunodeficiency Syndrome 
ART 
Antiretroviral treatment 
BL 
Baseline 
CAI 
Condomless Anal Intercourse 
CASI 
Commuter Assisted Self-Interview 
CDC 
Centers for Disease Control and Prevention 
CFAR 
Center for AIDS Research 
CRF 
Case report form 
DBS 
DSMB 
Dried blood spot 
Data Safety Monitoring Board 
DCF 
Data Collection Form 
GLMM 
Generalized linear mixed models 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
HMP 
HealthMpowerment 
IGHID 
Institute for Global Health & Infectious Diseases 
IRB 
Institutional Review Board 
LGBTQ 
Lesbian, Gay, Bisexual, Transgender, and Queer 
MSM 
Men who have sex with men 
NIH 
OCS 
National Institutes of Health 
One Cow Standing 
PI 
Principal Investigator 

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PID 
Participant ID 
OHRP 
Office of Human Research Protection 
RCT 
Randomized controlled trial 
SEM 
Structural equation modeling 
SID 
Study ID number 
SMS 
Short text message service 
SSL 
Secure Socket Layer 
UNC 
University of North Carolina 
U. Penn 
University of Pennsylvania  
VS 
Viral Suppression 
YAB 
Youth Advisory Board 
YBLMT 
Young Black or Latino men who have sex with men and transgender 
women 
YBMT 
Young Black men who have sex with men and transgender women 
YMSM 
Young men who have sex with men 
 
 
 

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STUDY ABSTRACT 
 
Multiple stigmas related to sexuality, race, and HIV infection negatively impact HIV testing, 
engagement in HIV care, and consistent viral suppression (VS) among young Black or Latino men 
who have sex with men and transgender women (YBLMT). At present, few interventions have 
addressed the effects of intersectional stigma among HIV-infected and uninfected populations. In 
response to the National Institutes of Health RFA-MH-18-606, this study tests whether a 
smartphone application (app) intervention tailored for intersectional stigma amelioration can elicit 
online social support, promote intervention engagement, and mitigate the impact of multiple 
stigmas on HIV-related outcomes. We will recruit and enroll 1,050 young (ages 15-29), racially 
and ethnically diverse men who have sex with men and transgender women affected by HIV 
across the United States. Using a HIV-status stratified randomized trial design, participants will 
be assigned into one of three conditions (information-only control, a researcher-driven social 
network intervention, or a peer-referred social network intervention). Behavioral assessments will 
occur at baseline, 3, 6, 9 and 12 months; biomarkers (viral load) are scheduled for baseline, 6 
and 12 months (for HIV-positive participants). HIV negative/status unknown participants may 
order through the app up to 3 HIV OraQuick self-tests.  
 
The primary outcome is stratified by HIV status and defined as successful engagement in care 
(consistent VS for HIV-positive participants and routine testing for HIV-negative participants). The 
specific aims are: 1) Test whether a smartphone application (app) intervention that promotes user-
generated content and engagement to address intersectional stigma is associated with 
improvements in the HIV prevention and care continuum (HIV testing, antiretroviral adherence, 
VS) as compared to an information-only control arm; 2) Explore whether user engagement, as 
measured by quantitative and qualitative paradata, mediates the intervention’s stigma- and HIV 
care-related outcomes; and, 3) Examine how changes in intersectional stigma and improvements 
across the HIV care continuum vary between the researcher-driven vs. peer-referred social 
network intervention conditions. Our research study is innovative given its focus on intersectional 
stigma as a key target of intervention, and its ability to assess how different kinds of online social 
network structures influence participants’ engagement over time, reduce experiences of 
intersectional stigma, and improve successful engagement in care. This research addresses a 
critical need to reduce the effects of multiple stigmas in a priority population using an intervention 
delivered through a highly appealing, widely utilized technology. If effective, this form of stigma 
amelioration via online support can be broadly disseminated to reduce HIV transmission and 
improve care among YBLMT.

 
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STUDY SCHEMA 
 
 

 
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1.0 
INTRODUCTION 
1.1 
Background 
Young Black and Latino men who have sex with men (MSM) and transgender women who have 
sex with men (YBLMT) have the highest rates of new HIV infections compared with non-Hispanic 
White peers of the same age.1 Dynamics within YBLMT’s social and sexual networks (e.g., 
stigma, discrimination, social isolation) likely contribute to higher HIV incidence even when 
engaging in fewer individual-level risk behaviors,54-56 and limit their continued engagement in the 
HIV care continuum.12,15,16,19,57-59  
 
Intersectional stigma impedes efforts across the HIV care continuum by inhibiting protective 
behaviors (e.g., condom/PrEP use, sustained viral suppression) and decreasing care utilization 
(e.g., linkage and retention in HIV care).5,6,9,11-18,57,58,60 These effects are particularly severe for 
YBLMT who face multiple sexual minority-, race/ethnicity-, and HIV-related stigmas,6,10,11,19,61 as 
these stressors can have additive or multiplicative negative health effects.11,62-68 These 
overlapping stigmas also foster environments that enable and drive high-risk behaviors20-22 and 
limit options to build healthy relationships and supportive networks.20,21,23  
 
Social networks offer powerful means for improving the HIV prevention and care continuum for 
YBLMT,31,69-71 yet few interventions have focused on intersectional stigma as a key intervention 
target for HIV prevention and care.30,38,41-46 To date, most stigma-focused interventions are 
delivered in-person, focus on an older or general age range, or exclusively focus on either HIV-
positive or HIV-negative populations. The logistical requirements of these interventions may not 
fit the realities of YBLMT, particularly if they anticipate and/or have experienced stigma. Given 
that nearly all YBLMT in the United States (U.S.) have regular access to a smartphone, computer, 
or internet-enabled device,72,73 the Internet’s 4A’s: affordability, accessibility, availability, and 
anonymity may circumvent YBLMT’s stigma concerns, facilitate open dialogue, and encourage 
HIV testing and care through supportive interactions with peers across the country.48,74-76  
 
Few published eHealth interventions have been developed specifically for YBLMT.44,48,77-80 While 
a growing number of studies describe intersectional stigma among YBLMT,81-84 few interventions 
have addressed intersectional stigma on HIV care outcomes and none have done so for HIV-
positive and HIV-negative YBLMT together. HealthMpowerment (HMP), a mobile web-based 
intervention, was designed to remove logistical, financial, and social stigma barriers48 by engaging 
HIV-positive, negative, and status-unknown YBLMT in a supportive, online community.47 HMP 
provides a platform to capitalize on the strength of social networks.47,78,85,86 In a randomized 
controlled trial (RCT) with 474 YBMT (ages 18 – 30; 8.4% also identified as Latinx/Hispanic; 2.7% 
transgender), the social support features of HMP Original were the most frequently used 
intervention components. Engagement with these features was associated with improved HIV 
care outcomes (see Preliminary Findings below). HIV-negative and HIV-positive MSM 
participants in the original HMP intervention also demonstrated a decrease in condomless anal 
intercourse (3 months).47 Among HIV-positive participants, increases in viral suppression (VS) at 
3, 6 and 12 months was seen among both intervention and control participants.87 In HMP Stigma, 
we will capitalize on the social support elicited through HMP Original to curtail intersectional 
stigma and strengthen YBLMT’s continued engagement in HIV care (i.e., routine HIV testing for 
HIV uninfected, and sustained VS for HIV-infected YBLMT). 
 

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1.2 
Rationale 
 
Across every stage of the HIV care continuum, YBLMT underperform compared to their White 
peers.2-4 Among interventions for Black or Latino sexual and gender minorities,26-46 few focus on 
intersectional stigma as a key intervention target.30,38,41-46 Stigma-reduction interventions are 
primarily delivered in-person, focus on older ages, or include either HIV-positive or HIV-negative 
MSM. HealthMpowerment (HMP Original; R01MH093275) was designed to engage HIV-positive, 
negative, and status-unknown YBLMT and to reduce sexual risk via a mobile optimized online 
platform.47 This approach helped remove logistical, financial, and stigma barriers to intervention 
participation; however, engagement as measured by detailed data collected as users interact with 
mHealth interventions (i.e. paradata) varied greatly between participants.48 Through a R21 study 
(MH105292), we explored whether participants in the HMP intervention arm reported reductions 
in HIV-related stigma outcomes. Using behavioral data and intervention paradata, our mixed-
methods results suggest that participants’ user-generated content (e.g., discussions in HMP’s 
diverse forums) regarding intersectional stigma was associated with improved psychological well-
being and HIV care outcomes.49-51 
 
A gap in knowledge exists regarding how participants’ engagement with mHealth interventions is 
linked to HIV prevention and care outcomes.88,89 Paradata can provide purposeful process metrics 
(e.g., timestamps in system logs to quantify time spent using the intervention, types of features 
used) to assess intervention engagement.88,89 We will use paradata to gauge how intersectional 
stigma and HIV care continuum outcomes differ based on participants’ frequency (exposure), time 
spent (engagement), and types of intervention components participants used (usage) in the app. 
We will also use paradata to characterize YBLMT’s discussions with each other within HMP 
Stigma social networks, and study how these exchanges influence intervention engagement and 
HIV care continuum outcomes over time.  
 
We propose to enhance HMP (HMP Stigma) by leveraging the social support elicited through 
user-generated content to focus centrally on intersectional stigma reduction and promote 
YBLMT’s successful engagement in care. Furthermore, given that paradata can help identify what 
intervention components should be kept, removed, or redesigned between versions of a 
smartphone application (app) intervention,52,53 we will leverage lessons learned from HMP 
Original alongside feedback from our Youth Advisory Board (YAB) to improve intervention 
engagement (e.g., expanding HMP’s gamification elements, improving chat and upload features). 
Given that HMP is fundamentally relational in nature, we will also test whether HMP Stigma is as 
efficacious and engaging when participants are recruited by researchers (i.e., researcher-created 
HMP network) as compared to being referred by participants themselves (i.e., peer-referred HMP 
network). This approach offers a unique opportunity to understand who participates in these 
networks, what network structures emerge, and how peer exchanges differ between the two HMP 
networks.99-105 We hypothesize that participants assigned to the peer-referral condition will have 
greater success in eliciting peer social support, promoting intervention engagement, and 
achieving the desired stigma- and HIV-related outcomes than participants in the researcher-
created HMP network. 
 
We will recruit a sample of 1,050 racially and ethnically diverse men who have sex with men 
(MSM) and transgender women (ages 15-29) affected by HIV across the United States. Using a 
HIV-status stratified randomized trial design, participants will be assigned into one of three 
conditions (information-only control, a researcher-driven social network intervention, or a peer-

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Page 13 of 61 
referred social network intervention). Behavioral assessments will occur at baseline, 3, 6, 9 and 
12 months; biomarkers (viral load) are scheduled for baseline, 6 and 12 months. The primary 
outcome is also stratified by HIV status and defined as successful engagement in care (consistent 
viral suppression for HIV-positive participants and routine testing for HIV-negative participants). 
We will also collect mixed-methods paradata (e.g. number of log-ins and posts, total time spent, 
features used, length and stigma content of posts) to characterize the nature of virtual exchanges 
between participants and examine if their discussions of intersectional stigma over time result in 
improvements in HIV outcomes.  
 
Our study is innovative given its focus on intersectional stigma as a key target of intervention. 
This research addresses a critical and significant need to reduce the effects of multiple stigmas 
in a priority population using an intervention delivered through a highly appealing, widely-utilized 
technology. If effective, our intervention can be broadly implemented to address intersectional 
stigma and to optimize successful engagement in HIV prevention and care among YBLMT. 
 
2.0 
STUDY OBJECTIVES 
2.1 
Primary Objective:  
The primary outcome is successful engagement in care, defined as consistent viral suppression 
for HIV-positive participants and routine testing for HIV-negative participants. 
2.2 
Secondary Objective: 
A secondary objective is whether user engagement, as measured by both quantitative and 
qualitative paradata, mediates the intervention effects observed in stigma and HIV care outcomes. 
 
An additional secondary outcome is how changes in intersectional stigma and improvements 
across the HIV care continuum vary between the researcher-driven vs. peer-referred social 
network intervention conditions.   
  
2.3 
Study Hypotheses/Research Questions   
Our proposal is built on the scientific premise that network interventions can encourage behavior 
change.31,90-95 Given that YBLMT widely use social networking sites and applications (apps) to 
socialize with similar others,28,48,76 HMP Stigma seeks to promote social support by creating a 
virtual community for YBLMT; thus, we hypothesize that: 
 
A. Compared to YBLMT assigned to an information-only condition, YBLMT assigned to HMP 
Stigma will report greater reductions in stigma, and be more successful at buffering the 
negative sequelae of intersectional stigma and circumventing barriers to successful 
engagement in the HIV care continuum.71,96 
3.0 
STUDY DESIGN 
The study will consist of two phases: 
 
1) Refinement and finalization of HMP Stigma 
2) A three-arm RCT of HMP Stigma  
 

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3.1 
Study Population 
 
We will enroll 1,050 YBLMT from across the United States into this 3-arm randomized trial. 
Participants’ self-reported HIV status at baseline will be used for allocation in our HIV-status 
stratified randomization procedure. 
 
3.2 
Sample Size 
 
Participants self-reporting as HIV positive at baseline will be randomized across the three arms 
(N=150 per arm). Participants who self-report being HIV negative or serostatus unknown at 
baseline will be randomized (N=150 per arm) into either the Information-Only Control (Attention-
Control) or the Researcher-Created HMP Network (Intervention Arm 1). Given that we are 
allowing the 150 HIV-positive participants assigned to the Peer-Referral version of HMP 
(Intervention Arm 2) to invite two peers into their social network, we do not know the baseline HIV 
prevalence among recruited peers. To avoid a priori assumptions of who will be invited, we 
estimate that half will be HIV-negative or sero-unknown.  
 
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment 
Procedures 
3.3.1 Refine and Finalize HMP Stigma.  
During Year 1, we will work with our technology partner, One Cow Standing (OCS), to build the 
HMP Stigma app. Once refinements are finalized, members of the research team, technology 
partner, and YAB will conduct internal usability testing of the app to ensure full functionality of 
HMP Stigma and the backend data-capture. All features of HMP Stigma will be tested during this 
time including ordering HIV test kits and HemaSpot protocols. OCS will fix any technical problems 
and finalize the platform for the RCT. The three domains to be modified in Year 1 are: 
 
Technical Refinements: Technical refinements to HMP will focus on (1) the deployment of the 
peer-referral mechanism for participants assigned to the peer-referral HMP arm, and (2) system 
for ordering and tracking HemaSpot/HIV in-home test kits across three arms. We will also 
enhance our paradata tracking system, as we observed that many participants in the original HMP 
engaged with content (e.g., reading posts, viewing multimedia, scrolling through, liking content) 
even if they had not posted (these users are often termed “lurkers”). In HMP Stigma, we will 
extend our paradata metrics to collect detailed data on exposure and engagement with app 
content, whether as a contributor or lurker. This approach will allow us to fully track the underlying 
network structure of app engagement and its influence on the intervention’s outcomes.  
 
Modifications to Intervention Content: Modifications to intervention content will be informed by 
our prior results of HMP and the Stigma framework. We will bolster HMP’s social support 
components to create a virtual space that elicits sharing and discussion from participants about 
their stigma-related experiences. The YAB will be significantly engaged in refining the final 
intervention content. YAB members will review a selection of the pre-populated Forum topics and 
the Knowledge Center’s written content in terms of readability and relevance. In addition, we will 
elicit YAB member contributions of new content in terms of articles, forum posts, and discussion 
topics to reflect recent advances in HIV (e.g., PrEP, U=U), to be inclusive of our populations’ 

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diverse identities around race/ethnicity, HIV status, and gender, and to make HMP feel “lived-in” 
before enrolling study participants. 
 
Modifications to Promote User Engagement. In HMP Original, those who remained more 
engaged in the intervention had greater improvements in study outcomes.47 HMP Stigma will use 
multiple strategies to ensure participants are engaged with the intervention. First, we will employ 
and expand the most highly rated and frequently utilized features of the original HMP intervention 
(the Forum, Ask an Expert (provider Q&A), Knowledge Center and Quizzes). Second, we will 
convert the original HMP points-based reward system (which was not highly rated by participants) 
to a system whereby participants earn badges for completing activities and milestones within the 
app. We have used a similar badge system within a medication adherence app for YMSM which 
was rated with high acceptability by participants.187 We will further incentivize this system by 
releasing new badges throughout the course of the study. 
 
3.3.2 Intervention and control arms 
Participants in all arms will have access to a Care Navigator through the intervention or control 
app. The Care Navigator will utilize existing online databases of resources (e.g. AIDSVu.org 
Locators, CDC’s GetTested.cdc.gov locators, POZ.com’s Service directory) to connect 
participants to trusted HIV testing and care services in their communities as needed. The Care 
Navigator will also monitor the Forums to identify additional HIV knowledge needs and manage 
the Ask an Expert provider Q&A to triage medical questions to one of two board-certified HIV care 
providers. During all study years the Care Navigator will work closely with the YAB to elicit service-
related needs and concerns among YBLMT that can be integrated into HMP Stigma.  
 
Control Arm: The HMP Stigma Information-Only Control Arm will feature a streamlined version 
of the app that provides curated information and other content for YBLMT. This content will follow 
the design of HMP Original where control arm participants had access to HIV-related Knowledge 
Center articles of the main intervention without access to the engagement features such as the 
interactive forums or doctor Q&A. HIV-negative and sero-unknown participants will also be able 
to request HIV home test kits. Our choice of control arm balances equipoise with research study 
design; in HMP Original, control arm participants also experienced a statistically significant 
intervention benefit.47 We have taken this effect into account in our sample size calculations.  
 
HMP Stigma: We have used the Stigma Framework128 alongside our findings from HMP Original 
to guide the design of our proposed intervention features and content (Table 1) and study 
measures (Table 2).  Eligible, enrolled participants who are randomized to intervention Arms 1 
(researcher-created network) and 2 (peer-referred networks) will have access to all the features 
of HMP Stigma. These features include forums where users can start or participate in threads, a 
knowledge center filled with short articles on a range of topics that can be added and commented 
on, a provider platform where health questions can be submitted to be answered by a health care 
provider, a user profile where users can personalize and update their information, and finally, an 
ordering platform where users can order and track testing kits.  
 
Table 1: HMP Stigma Core Intervention Components and Scientific Rationale 
Intervention Feature & Description 
Scientific rationale 
Paradata metricsa 

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HMP Forums: Discussion boards where users 
can start new discussion threads or respond to 
or “like” content posted by other participants.  
Pre-populated thread topics will correspond 
to stigma framework constructs. 
# of: posts created, posts 
read/liked; total time 
spent; content of posts  
Knowledge Center: Brief articles on health and 
wellness tailored for YBLMT, including featured 
sections on HIV/STI prevention and care.  
Content will correspond with original HMP 
intervention, and aligns with the Integrated 
Behavior Model.  
# of: articles read, 
quizzes completed; total 
time spent 
Provider Platform: HIV/STI/sex questions 
answered by a prevention and HIV care doctor 
within 72 hours. 
Provide evidence-based answers to users’ 
health questions, including linkage to care. 
# of: posts created, posts 
read; total time spent; 
content of questions 
User Profile: Profile page showing participant’s 
username, favorites, and badge progress. 
Personalization and gamification features 
may incentivize continued user 
engagement.  
# of: times visited, 
badges earned 
Test ordering: Ability to order HIV self-test kit. 
Provide an opportunity to get tested if users 
experience barriers to get tested locally.  
# tests ordered 
a Each unique user action on HMP will be captured with date and timestamps.  
 
Peer-referred HMP Network Arm: Participants randomized to Intervention Arm 2 (peer-referred 
network) will be enrolled into a parallel (but separate) version of HMP Stigma. The only difference 
between Arm 1 and Arm 2 is that participants in Arm 2 will have a referral feature in their profile 
that allows them to earn $20 in e-gift cards if they successfully refer and enroll 2 peers of their 
choosing ($10 per peer) in the first 45 days of their study participation. The referral feature will 
create a customized link for each participant that can be emailed or text messaged to invite peers 
into the study.189 Simple instructions will be provided at enrollment and in the app describing how 
to refer them. Participants may send referral links until two of their peers have screened eligible 
and enrolled in the study. Participants may send referrals from Day 1 – 45 of their time in the trial. 
If two of a participant’s referred peers successfully enroll within that time window, at that point, 
the original participant will receive a notice from the study team that they have successfully 
reached their referral quota and the referral feature will deactivate. their referral incentives and 
HMP usernames of their referrals within their profile. While they will be able to see whether their 
peer has enrolled and what username the peer created, they will not receive any information 
about any of their peers’ survey responses, including those who screened ineligible. Referred 
peers will see the HMP username of their referrer; they will not be eligible to refer their own peers.  
 
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS 
4.1 
Inclusion Criteria (All study arms)  
• 
Aged 15-29 years (inclusive) at time of screening  
• 
Identify as Black/African American and/or Latino/Hispanic  
• 
Current U.S. resident (verified by zip code) 
• 
Speak and read English  
• 
Report anal intercourse in the past 6 months 
• 
Assigned male sex at birth (no restrictions on current gender identity) 
• 
Has a smartphone 
• 
If HIV-positive, does not report a hemophilia diagnosis or current use of anti-coagulation 
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Additional Inclusion Criteria (Referred Peers from Peer-Referral Arm) 
• 
Invited by current participant in Intervention Arm 2 (approximately 300 participants) 
• 
Any race/ethnicity 
 
4.2 
Exclusion Criteria 
• 
Under the age of 15 years 
• 
Over 29 years of age 
• 
Does not speak or read English 
• 
Assigned female at birth 
• 
Reports 0 episodes of anal intercourse in the past 6 months  
• 
Currently incarcerated 
• 
Planning to move out of the United States in next 12 months 
• 
Does not reside in the United States 
• 
Does not have a smartphone 
• 
If HIV-positive and reports a hemophilia diagnosis or current use of anti-coagulation 
medication 
 
4.3 
Recruitment  
We will reach the population using social media ads on sites including Facebook, Tumblr, 
Instagram, BGC Live, Jack’d, Grindr, Scruff, and other comparable social media platforms (see 
example copy and images in “Recruitment materials.docx”). Final platforms and materials will be 
developed alongside our YAB. Social media platforms allow us to specify our audience based on 
socio-demographic characteristics (e.g., age, race/ethnicity) to increase their specificity to our 
population. Ads will link interested individuals to a Qualtrics screener where they may verify their 
eligibility, email the team, or locate a toll-free number if they want to talk to a team member about 
the study. Via co-I Hirshfield, we have access to an online registry with over 1,000 U.S. men, 
many of whom are HIV-positive, who have expressed interest in participating in other HIV-related 
studies. We will collaborate with online groups (e.g., Young Black Gay Men's Leadership Initiative; 
Trans Women of Color Collective) and other advocacy groups to post study and recruitment 
information. We foresee recruiting 25-30 participants per month during Years 2-4; this staggered 
design will allow us to accommodate the enrollment and testing of YBLMT in the trial and also 
allow time for the social networks to develop. 
 
4.4 
Informed Consent  
Informed consent/assent. Individuals interested in screening for study participation will be 
consented/assented for screening after reading information about the study and screening 
procedures. Those who consent to take the screener survey will answer questions to determine 
their eligibility. Those who do not consent to take the screener will be routed to a public site (e.g., 
Google). Individuals who complete the screener but are initially ineligible will be asked if they 
would like provide their first name and email address to be contacted about other research studies 
in the future, then will be routed to a public site (e.g., Google). For those who are initially eligible 
based on their screener responses, we will confirm they are eligible by our HIV status quotas. If 
ineligible by HIV status, we will send an email to inform them. If eligible by HIV status, we will 

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email each person a unique link to the study’s informed consent form. The consent/assent form 
describes all study procedures, including confidentiality and privacy, information about potential 
risks, discomforts, benefits of participation, and information regarding who they can contact with 
further questions. It also states that participation is voluntary, that participants may decide to not 
take part or to withdraw from the study at any time without penalty or loss of any benefit to which 
they might otherwise be entitled, and that study participation is in no way related to being able to 
access care or services. 
 
Waiver of parental consent. We will request that the U. Penn IRB as the central IRB (IRB of 
Record) grant a waiver of parental consent to participate in this research study for youth 
participants who are 15 to 17 years of age. The research team has been granted waivers of 
parental permission for prior studies with sexual minority youth. Under 45 CFR 46.408 (c), an IRB 
has the authority to waive parental permission if it determines that “a research protocol is designed 
for conditions or a subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects” and “an appropriate mechanism for protecting 
the children who will participate as research subjects is substituted” and “that the waiver is not 
inconsistent with Federal, State, or local law.” A waiver of parental permission for studies with 
lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth that do not involve greater than 
minimal risk is a common practice among researchers working in the area of gay and lesbian 
health/mental health. This is done to avoid the selection biases operating in only recruiting youth 
whose parents are both aware of and comfortable with their sexual orientation. Commonly these 
youth have explored their sexual orientation without their parents’ knowledge as the youth 
struggle with issues of disclosure and its consequences within the social, religious, and economic 
context of their families. A requirement for parental permission in this type of study could not only 
affect a person’s willingness to participate, but could also potentially impact the ability of 
researchers to engage in this type of research with sexual minority youth. Additionally, minors can 
often seek sexually transmitted infection (STI) and HIV prevention services without parental/legal 
guardian permission, depending on each site’s state laws. 
 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, 
then requiring parental permission for youth in these circumstances is not a reasonable 
requirement.  Additional privacy protections are provided in that all assessments, notes, reports, 
and other records will be identified by only a coded number to maintain participant confidentiality. 
These records and any forms that do contain identifying information will be kept in a locked, limited 
access area (such as a locked file cabinet) at the participating site.  
 
4.5 
Screening 
As part of app development, we will create a web-based research dashboard for use with the 
HMP app.  We will use a secure (256-bit), HIPAA-compliant dashboard for app content, participant 
information, and participant app data. Individuals who consent to take the screener survey will be 
asked to provide their first name, email address, and phone number, then to answer questions to 
determine their eligibility. Those who do not consent to take the screener will be routed to a public 
site (e.g., Google). All individuals who complete the screener will be asked if they would like to be 
contacted about other research studies in the future, then will be routed to a public site (e.g., 
Google). For those who are initially eligible based on their screener responses, we will then 
confirm they are eligible by our HIV status quotas. If ineligible by HIV status, we will send an email 
to inform them. If eligible by HIV status, we will email them a unique link to the study’s informed 
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Compared to the gold standard (in-person interviewing), a limitation of online research – like mail 
and phone surveys – is the challenge of verifying a respondent’s authenticity. Using best 
practices190,191 (see ”HMP SOP-Applicant Verification.docx”) we will attentively reduce the 
likelihood of duplicative entries, bots, and/or catfishing (fake online personas). Verified 
participants will be allocated to the study arms using our HIV-stratified randomization procedure.  
Web-based recruitment screener: The online survey is hosted by Qualtrics, which will include 
the eligibility script, consent/assent to be screened, and the screener questions. For those who 
meet eligibility criteria, we will ask for the first name, email, and phone number of the participant. 
We use Secure Socket Layer (SSL) encryption for online transfers of information, and data will 
be stored on Qualtrics’ secure, HIPAA-compliant servers.  
5.0 
STUDY PROCEDURES 
5.1 
Enrollment Procedures 
 
We will enroll a total of 750 participants. Of these participants, 300 will be HIV-negative and 450 
will be HIV-positive. After participants are consented, participants will complete a baseline CASI 
survey and then will be randomized into the Tailored Information-Only Control (Attention Control), 
Researcher-Created HMP Network (Intervention Arm 1), or HMP with Peer-Referral Network 
(Intervention Arm 2). Intervention Arm 2 will only have 150 HIV-positive participants randomized 
to it, as the remaining participants will be peers who are referred by their peers and enroll if 
eligible. Upon enrollment, all participants will be provided a link to access the HMP app through 
the Apple App Store or the Google Play Store for Android. Once downloaded, participants will 
create their app account by entering their email address, creating a username, password, and 
PIN, entering their mailing address, opting in or out of notifications, and selecting an avatar. 
 
Those randomized in the Tailored Information-Only Control (Attention Control) will be given a 
streamlined version of the app. They will have access to the Care Locator and Knowledge Center 
articles and be able to message the Care Navigator. HIV-negative and sero-unknown participants 
will be able to request HIV home test kits. HIV-positive participants will be sent HemaSpot devices 
at Baseline, 6 months, and 12 months. They will not have access to the interactive forums, 
activities, or the Ask and Expert feature. 
 
Those randomized in the Researcher-Created HMP Network (Intervention Arm 1) will have 
access to the full HMP app, including access to the Arm 1 Forum in which participants will be able 
to create threads and comment on any threads in the forum, whether moderator- or user-
generated.  
 
Those randomized to the Peer-Referral Network (Intervention Arm 2) will have access to the full 
HMP app, including access to the Arm 2 Forum in which participants will be able to create threads 
and comment on any threads in the forum, whether moderator- or user-generated. The only 
difference between this version and the Intervention Arm 1, is that two thirds of the users (300) 
that comprise this group are added by peer referral by the 150 participants who were randomized 
into this arm.  
 

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Intervention Arms 1 (Researcher-generated) and 2 (Peer Referred) will operate as two distinct 
virtual communities. Participants will not be able to communicate across arms and will only be 
able to view the posts of participants in their Arm.  
 
5.2 
Locator/Contact Information  
Once a participant has been consented, enrolled, and downloaded the study app, they will be 
asked to provide a phone number in addition to their email address where they can be reached. 
Participants will also be asked to provide their mailing address so we can send their HIV test kit 
or HemaSpot device to them. Study staff will not send mail unless the participant has confirmed 
their mailing address and is aware they will be receiving a package. The app will assure 
participants that HIV test kit and HemaSpot packaging does not reveal their participation in a 
research study. Additionally, the app will tell participants that all email and text message 
correspondence will not include any protected health information or information related to study 
participation.  
 
5.3 
Randomization Procedures  
 
Research-team recruited participants will be allocated to the 3 arms using a computer-generated 
blocked randomization, with stratification by HIV status. For that purpose, randomly permuted 
blocks of sizes 3 and 6 will be used in order to maintain the integrity of the randomization process. 
Participants recruited into Intervention Arm 2 through peer-referral will not be randomized as the 
social network component requires these participants to remain clustered with their nominator.  
 
5.4 
Intervention/Investigation Procedures 
5.4.1. Randomized Trial Design  
We will test whether a smartphone application (app) intervention (HMP Stigma) that promotes 
user-generated content and engagement to address intersectional stigma is associated with 
successful engagement in care as compared to an information-only control arm consisting of 
online informational articles and resources curated for YBLMT (Specific Aim 1). We will then 
examine how user engagement mediates the changes observed in stigma and HIV care outcomes 
across the 12-month follow-up period (Specific Aim 2). To describe how the social network 
composition of HMP Stigma affects user engagement and our HIV prevention and care outcomes 
across a 12-month follow-up period (Specific Aim 3), we will allow the composition of the 
intervention networks to vary. Participants randomized to Intervention Arm 1 will engage in a 
researcher-created network where half of the participants are HIV-positive. Participants 
randomized to Intervention Arm 2 will engage in a peer-referred network in which they may invite 
2 peers (irrespective of race/ethnicity and/or HIV status) into the study. All participants who are 
randomized into Arm 2 will be HIV positive and we assume that peers they refer will be a mix of 
HIV-negative, HIV-positive, and HIV-unknown status. 
 
5.4.2 HemaSpot Package, Delivery and Tracking:120  
At baseline and months 6 and 12, HIV-positive participants will be mailed a HemaSpot package 
which contains: 1) one HemaSpot kit with all necessary materials to perform a finger prick, a 
biohazard bag, and study labels; 2) an instructional booklet for how to properly collect a specimen 
for the HemaSpot device; 3) a return envelope addressed to the processing lab with pre-paid 
postage; and 4) a lab sheet which includes the participant’s study ID. The U. Penn team will 

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coordinate the shipment of HemaSpot kits. Upon receipt of the package, participants will read an 
instructional booklet (which we have already developed at an 8th grade reading level) that 
describes how to collect the specimen, complete the lab sheet, and mail the package. The 
instructional booklet will also direct participants to an instructional video online, developed by the 
study team. Additionally, participants will be able to view the instructional booklet and video in the 
app. After collecting their blood specimen, YBLMT will mail their HemaSpot device and lab sheet 
directly to the processing lab using the provided return envelope with the pre-paid USPS label. 
The processing lab will then update a kit receipt log spreadsheet documenting the participant’s 
study ID and date of receipt. Laboratory staff will store HemaSpot devices and test them in 
batches (and note the testing date), according to their internal protocol. Study staff will track all 
outgoing and incoming packages using USPS tracking numbers. Participants are informed they 
will not receive the HIV VL results of their HemaSpot devices, as it is not a valid FDA-approved 
clinical device; it is solely for research purposes. Our team has successfully used these methods 
before with YBLMT.120  
 
If the processing lab receives a HemaSpot device with a sample that cannot be processed (e.g. 
broken device, inadequate specimen, inappropriate specimen), the U. Penn team will review the 
study app’s paradata to determine whether that participant viewed the instructional video. If the 
participant viewed the instructional video, the U. Penn team will contact them and ask if they want 
to try completing another test. If the participant agrees, the U. Penn team will ship them another 
HemaSpot kit. Once the lab receives the second completed kit, the participant will receive a 
second $20 incentive, regardless of the specimen’s viability. If a participant submitted a 
HemaSpot device with a sample that cannot be processed but they did not view the instructional 
video, they will not be offered another kit. 
 
5.4.3 HIV Testing 
Participants who self-report as HIV negative or unknown will be able to request up to 3 in-home 
OraQuick HIV tests. These HIV tests help maintain equipoise with the HemaSpot procedures for 
HIV-positive counterparts in the trial. We have made these HIV test kits optional. Some 
participants may benefit from an in-home test if they experience HIV stigma in their communities, 
yet others may prefer to get tested in-person (e.g. at a local community-based agency, primary 
care doctor, or testing bus). We will ask participants to upload a photo to the app of the HIV test 
stick that shows their test result. This is also an optional activity. In post hoc analyses, we will 
compare those who requested in-home test kits with those who report testing at community 
agency in the follow-up assessments. If participants report a HIV positive result (whether through 
in-home test kit testing results, a flagged HIV status change in their follow-up surveys, or by 
notifying the study team directly in the app), our Care Navigator will reach out within 3 business 
days to support and facilitate linkage to resources and care, including identifying a convenient 
location for confirmatory testing (if needed) at a local agency. The study team will not report HIV 
positive OraQuick results to local health departments, as this is a screening test, not a diagnosis. 
The Care Navigator will encourage and support participants in seeking confirmatory testing and 
linkage to care for the remainder of their time in the study. 
 
5.4.4 Surveys 
As noted in Table 2, we include a summary of the primary and secondary outcomes, key 
intervention mechanisms of change, and potential covariates. Assessments will not take more 
than 50 minutes to complete. We have taken several steps to ensure that the assessments are 
developmentally appropriate. Consistent with best practices, we will use validated measures 
developed as part of the NIH Adolescent Medicine Trials Network (ATN) for HIV/AIDS 

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Interventions studies. We will use gate-keeping questions to decide whether participants should 
receive other probes within a domain. For example, a participant who has not reported lifetime 
substance use will not be asked additional substance use questions. 
 
5.4.5 Qualitative interviews 
A purposive sub-sample of up to 45 participants (approximately 5 from control and 20 from each 
intervention arm) will be invited to complete qualitative interviews during the intervention. 
Interviewees will be chosen to represent a variety of participant perspectives based on 
intervention engagement (intervention high/low users, lurkers), as well as sociodemographic 
profiles. Interviews will be completed remotely using a HIPAA compliant videoconferencing 
platform such as VSee or Zoom. The UNC Project Coordinator will conduct interviews following 
a semi-structured guide focused on overall intervention satisfaction, HMP’s perceived impact on 
stigma and HIV outcomes, and participants’ evaluation of the social networking features 
(intervention arms only). Control arm participants are included in this evaluation as we expect the 
information-only intervention will also show a modest impact. Interviews will be conducted at 
various points during the intervention to better understand intervention use over time and to 
reduce “survivors bias” of only interviewing participants who are retained for 12 months. 
Interviews will last 30 to 45 minutes, will be audio recorded with the participant’s consent, and will 
be transcribed by study staff or a HIPAA compliant transcription service (e.g. Verbalink, 
Transcriptionstar). Multiple interviews may be conducted with the same participant to assess 
changes in intervention engagement and social support over time.   
 
5.4.5 Research Staff Training  
 
The Principal Investigators and all project personnel satisfy the NIH requirement for training in the 
protection of human research participants. The requirement is successful completion of a course 
designed to provide investigators and their staff with a comprehensive understanding of ethical 
and regulatory aspects of conducting research on human subjects, including online security and 
data safety. Successful completion entails a self-study review of selected resources and the 
achievement of a passing grade on an individualized on-line test. Training and successful 
completion of the on-line examination has been documented and is on file for all personnel listed 
on this application. Furthermore, all study personnel will have either completed the Human 
Subject Training established by their institution or the CITI program. In addition, in compliance 
with the new NIH policy, graduate students and staff will participate in at least 8 hours of 
mandatory case study and discussions regarding scientific integrity and human subjects. Any 
additional personnel who may join the project will complete this training before they handle any 
subject data. Further, issues regarding confidentiality will be reinforced prior to each intervention 
and data collection with project personnel. 
 
5.4.6 Intervention Monitoring/Quality Control 
In accordance with the National Institutes of Health (NIH) requirements, we will adopt a Data and 
Safety Monitoring Plan. The Principal Investigators (Bauermeister & Muessig) will provide 
oversight of all study procedures and quality assurance checks.  The Data Safety and Monitoring 
Plan includes the following protocols: All records pertaining to the study and all of the original and 
electronic files containing collected data will be securely stored by the Principal Investigators at 
each site in a locked metal file cabinet housed in an off-site office location. To ensure participants’ 
safety as well as the data’s validity and integrity, only staff with extensive experience in the area 

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of HIV prevention will be hired.  As noted throughout the proposal, staff will be trained related to 
data collection procedures (recruitment, data collection, HIV rapid testing, dried blood spot 
testing).  Staff will also be extensively trained relating to confidentiality and required research 
ethics training and certification.  All staff will have signed a confidentiality agreement. 
 
We have several mechanisms to ensure the security and integrity of the data. The intervention 
content, questionnaires, and personal information will be secured with role-based security that 
will provide different types of users with different access privileges. Further, we will have separate 
data collection modules, located in different firewalled servers, to collect personal identifying 
information, questionnaire data, and to run the study app. At a high level, the three user types 
and their associated privileges are:  
 
a. Participants –will be the actual participants and, once consented, they will be able to go through 
the intervention screener, assessments, and use the study app. 
 
b. Research Project staff – will view/access personal data related to participants. They will also 
be able to process participant incentives and email/call participants to remind them of follow-up 
assessments. Research staff at the MPIs’ institutions (University of Pennsylvania; University of 
North Carolina) will be able to maintain users (view/add/modify users), and generate export files 
for analysis. 
 
c. Research Investigators – will be the master users with access to the study app and OCS 
dashboard and will be required to use a valid user ID and password to log into/access these 
systems.  
 
Data Monitoring: Ongoing monitoring will be conducted by the MPIs and Project Directors 
throughout the study. In addition, the University of Pennsylvania IRB (as prime IRB) will conduct 
regular reviews of study protocols, changes in study protocols, and adherence to protocols in the 
field. The PIs are required to report any unexpected study-related adverse events to the IRB and 
NIH. We will convene a Data Safety and Monitoring Board which will consist of experts in HIV 
medical care and prevention, clinical trials, and a biostatistician.  
 
Data Safety and Monitoring Board (DSMB): We will convene a Data Safety Monitoring Board 
(DSMB). The DSMB will meet biannually to review the study progress, review modifications, and 
monitor compliance with IRB rules, human subjects’ procedures and the Office of Human 
Research Protection (OHRP) regulations. The DSMB will advise the PIs, and Co-investigators on 
participant safety and efficacy of the randomized controlled intervention. The overall purposes of 
having the DSMB will be to: 
• 
Protect the safety of trial participants   
• 
Identify unexpectedly high dropout rates that threaten the study’s ability to produce 
credible results  
• 
Identify protocol violations that suggest clarification of changes to protocol are needed  
• 
Identify unacceptably slow rates of accrual  
• 
Identify high rates of ineligibility  
• 
Ensure the validity of study results  
 

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Responsibilities of the DSMB: The primary responsibility of the DSMB is to safeguard the 
interest of study participants. Therefore, the DSMB must approve the safety measures in the 
protocol to preserve the study credibility and facilitate the availability of timely and reliable findings 
to the broader clinical community. In addition, the DSMB will:  
• 
Provide written documentation confirming review of the protocol and agreement with the 
study design and the data safety monitoring plan.  
• 
Be available to the Investigator for consultation concerning any adverse study events.  
• 
Review the progress of the study carefully and diligently with special attention to reports 
of adverse events, drop-outs, or perhaps some other reports generated by group leaders  
• 
Provide a written report to the IRB which summarizes oversight activities and 
recommendations, and any concerns regarding subject safety.  
• 
Consider the impact of newly published findings bearing on the safety profile of the 
study.  
 
DSMB Process: The first meeting will discuss the study protocols and establish guidelines for 
monitoring the study including plans for interim analysis and stoppping rules based on NIH 
guidelines for this study. Part of the meeting will be open with the PI and Study Team present and 
part will be closed with only DSMB members. Throughout the duration of the project, biannual 
meetings or calls will take place. In addition, the MPIs will send quarterly emails to the DSMB 
members to update them on project progress. 
 
We will use a unique registration ID for each participant and have the rest of their details 
maintained securely outside of the computer database. Code numbers and contact information 
will be accessible only to the Research Investigators and Research Project staff. All data will be 
secured during transmission by using a 256-Bit SSL encryption or higher. The SSL certificate will 
be from VeriSign or other certificate providers of repute. Critical data fields will be encrypted and 
stored in the database. The database server itself will be located within the security of the secure 
and dedicated university firewalls. Breaks in confidentiality will occur in the event that a participant 
is a danger to themselves or to others, or is in danger from others. We will report this in 
accordance with rules for mandatory reporting. There is a statement in the consent form and 
assent form notifying participants of this possibility.  
 
 
6.0 
EVALUATIONS AND MEASURES  
6.1 
Behavioral Evaluations (all CASI survey instruments are attached to the protocol) 
6.1.1 Pre-entry or screening evaluations/measures 
• 
CASI Survey  
 
6.1.2 Pre-intervention (baseline) evaluations/measures 
• 
CASI Survey  
 
6.1.3 Three-month evaluations/measures 
• 
CASI Survey  
 

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6.1.4 Six-month evaluations/measures 
• 
CASI Survey 
• 
Qualitative interview (approximately 22 interviews completed by this mid-point)  
 
6.1.5 Nine-month evaluations/measures 
• 
CASI Survey  
 
6.1.5 Twelve-month and Closeout evaluations/measures 
• 
CASI Survey 
• 
Qualitative interview (approximately 45 total interviews completed by study end)  
  
 
6.2 
Clinical and Laboratory Evaluations (if applicable) 
 
6.2.1 HemaSpot Testing 
• 
HIV-positive participants submit HemaSpot devices by mail for viral load testing at 
baseline, 6- and 12-month follow-up points.  
 
 
6.2.2 In-Home Oral HIV Testing 
• 
Participants will submit photos of their in-home oral HIV testing results throughout the 
12-month active study.  
 
7.0 
DATA COLLECTION AND SITE MONITORING 
 
7.1 
Development of Protocol and Case Report Forms 
The research team at UNC-CH is responsible for the development of this protocol, and in assisting 
the research team at U. Penn with the Case Report Forms (CRFs) or Data Collection Forms 
(DCFs) needed to collect the information required to implement this protocol.  
7.2 
Data Records  
Participant-related study information will be identified through a study ID number on all participant 
CRFs or DCFs, audiotapes and Computer Assisted Self Interviewing (CASI) files.  Participant 
names or other personally identifying information will not be used on any study documents.  All 
study-related information will be kept on secure servers in password-protected files..   
 
7.3 
Data Collection  
 
7.3.1 CRFs /DCFs 

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Study monitoring data, including information about eligibility, demographic data, and monitoring 
untoward effects, will be collected on CRFs created in the OCS dashboard. All CRFs for this study 
must be entered into the OCS dashboard in order to be saved on a secure UNC server. 
 
The OCS dashboard will be used to collect key study enrollment data (e.g., enrollment and 
randomization assignment), study milestones such as completion or discontinuation, study 
laboratory results, and adverse events (AE). During active study conduct, the research team will 
maintain the CRFs within the OCS dashboard. 
 
7.3.2 CASI Data – Study surveys 
All CASI data will be collected through the secure HIPAA-compliant Qualtrics platform.   
Participants will utilize their own devices (phone, tablet, computer/laptop) to complete online CASI 
surveys. A description of the survey, including a time estimate, will be provided at the beginning 
of each survey. Participants will have 45 days to complete the survey, which will be sent to the 
participant via email, text, as a push notification from the app, and/or as an in-app notification. 
Surveys are attached:  “Qualtrics_Baseline.docx,” “Qualtrics_3-Month_FUP.docx,” “Qualtrics_6-
Month_FUP.docx,” “Qualtrics_9-Month_FUP.docx,” and “Qualtrics_12-Month_FUP.docx”.  We 
use SSL encryption for transfers of information online and data will be stored on secure HIPAA-
compliant servers.  
 
7.3.4 CASI Data Security 
 
CASI Data Security 
Only authorized research team members with a login name and password will be able to access 
and open survey responses through Qualtrics.  To ensure data privacy, as soon as data is entered 
(in real-time), it will be encrypted and immediately stored in a secure database. 
 
7.3.5 Video Platform Description   
A HIPAA-compliant video platform will be used for this study. Either Zoom or a comparable 
platform may be used to conduct qualitative interviews (offered to select participants at 6 and 12 
months) remotely, or may be used as an option for participants to speak with study staff during 
enrollment. Participants will have the option to conduct face-to-face video chat, video chat in 
which they can see the interviewer, but the interviewer cannot see them, or audio chat only. Zoom 
is compatible on PCs, tablets, and smartphones; as well as maintains the option to conduct an 
audio conference without the video component.  
 
End-to-end encryption: Zoom encrypts all presentation content at the application layer using the 
Advanced Encryption Standard (AES) 256-bit algorithm. Zoom end-to-end chat encryption allows 
for a secured communication where only the intended recipient can read the secured message. 
Zoom uses public and private keys to encrypt the chat session with Advance Encryption Standard 
(AES256), and session keys are generated with device unique hardware ID to avoid data being 
read from other devices. This ensures that the session cannot be eavesdropped or tampered with. 
 

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Cloud Control Infrastructure: A distributed network of low-latency multimedia routers (software) 
resides on Zoom’s communications infrastructure. With these low-latency multimedia routers, all 
session data originating from the host’s device and arriving at the participants’ devices is 
dynamically switched — never stored persistently through the Zoom communications 
infrastructure. Zoom’s communications infrastructure for real-time video, audio, and data 
communications resides on Zoom dedicated servers, which are housed in SSAE 16 SOC2 
compliant datacenters on opposite sides of the US. Zoom sessions are completely temporary and 
operate analogously to the popular mobile conversation over the public mobile network. In 
addition to unique security beneﬁts, Zoom’s communications infrastructure also enables an 
extremely scalable and highly available meeting infrastructure unrestricted by the limitations of 
physical data centers. 
 
The Zoom client communicates with the multimedia router to establish a reliable and secure 
connection. At the time of instantiation, the Zoom client will determine the best method for 
communication, attempting to connect automatically using udp and tcp port 8801, 8802 and 8804 
or HTTPS (port 443/TLS).The Zoom sessions will contain identifying information, as in VSee 
above, but this information will be stripped form the recorded Zoom sessions before they are sent 
to the analysis team for content analysis.  
 
7.3.6 Backup Recording 
All qualitative interviews may also be recorded using a back-up digital audio recorder. Audio files 
will be erased after being transcribed and transcripts will be de-identified. All audio files will be 
kept confidential and stored in a locked/limited access folder on secured servers, which is only 
accessible to designated study staff. All members of the research team will be trained in 
confidentiality and have signed confidentiality agreements. A professional transcription service, 
experienced in the handling of confidential data, will be used to fully transcribe verbatim all audio 
files. Prior to receipt of the first audio file, the transcription service will be instructed to exclude 
from the typed transcript identifying information (e.g., a name) that may have been verbalized 
during the course of the interviews.  
 
7.4 
Data Submission 
7.4.1 CRFs 
CRFs will be used to collect data on adverse events (AE), protocol deviations, early participant 
terminations, and social harms. The research staff will complete and store the CRFs in the 
secure (256-bit) HIPAA-compliant dashboard built by OCS. 
7.4.3 CASI Data Transmission 
Only authorized research team members with a login name and password will be able to access 
and open the survey through the internet site.  To ensure data privacy, as soon as data is entered 
(in real-time), it will be encrypted during transmission to the study staff using Secure Socket Layer 
technology.  The data will then be immediately stored in a secure database on a server within the 
research data center. 
 
7.4.4 Retention data  
 

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7.5 
Data Quality Assurance 
Investigators receiving federal funding must adhere to the Code of Federal Regulations (CFR) to 
protect research participants and produce reliable study information.  Sites participating in 
research sponsored by the NIMHD need to have an internal quality assurance plan that will 
identify problems and correct errors in research study records.  
 
7.6 
Role of Data Management 
We will use a secure (256-bit) HIPAA-compliant dashboard built by OCS to manage all 
participants. Datasets will identify participants using an ID number.  
 
8.0 
PARTICIPANT MANAGEMENT 
8.1 
Tracking Participants / Follow-up 
A detailed retention plan (see “HMP SOP-Recruitment and Retention.docx”) will draw on our prior 
successful protocols with hard to reach populations to achieve ≥80% retention rate for the 3-
month assessment.47 In our experience, successful retention has several key elements. First, it is 
critical to obtain accurate follow-up contact information. We will use best practices to retain 
participants while being sensitive to undue disclosure of YBLMT participating in the study. One 
barrier to retention among youth is changing cell phone numbers. Study staff will include a 
reminder for participants in the 3-, 6-, and 9-month survey emails to update their email and SMS 
contact information if it has changed in the past 3 months. Every effort will be made to reduce 
attrition as retention is critical to our study efforts. In the event that participants do not respond 
complete a follow-up survey within 7 days of the first email and in-app request, they will receive 
a second email with the link and an in-app notification. A third attempt will be made before the 
study coordinator or Care Navigator calls participants. Correlates of missing data and attrition will 
be carefully examined. Participants who miss one or more follow-up assessments may still 
continue in the study. We will compare those who completed different follow-up interviews with 
those who did not on key predictors from the baseline assessment to check for possible sample 
bias. The use of the Expectation-Maximization algorithm in the longitudinal analyses will also aid 
to overcome missing data concerns when appropriate.192,193  
    
8.2 
Compensation 
We will collect behavioral assessments at baseline (BL), 3, 6, 9, and 12 months.  Participants will 
earn up to $340 for completing the 5 behavioral surveys. Amounts per assessment vary based 
on estimated survey duration (BL-$50, 3mo-$35; 6mo-$50, 9mo-$35, 12mo-$60). Any participant 
who completes four of the five behavioral assessments will receive a $50 bonus incentive at the 
end of the study. We will collect HemaSpot blood samples for HIV Viral Load from HIV-positive 
participants at BL, 6, and 12 months. For equipoise, we will also offer free in-home HIV testing 
kits for all HIV-negative and HIV-unknown YBLMT. Participants will receive $20 for using the pre-
paid shipping packaging to return HemaSpot device to the lab for processing (if HIV-positive) or 
for uploading a photograph of the HIV test stick that shows their in-home HIV test result (if HIV-
negative or sero-unknown). HIV-positive participants are eligible for the incentive if they return 
their HemaSpot device to the lab within 45 days of receiving it. If an HIV-positive participant 
submits a HemaSpot device with a sample that cannot be processed and we confirm in the app’s 
paradata that they have viewed the instructional video, they will be offered a chance to redo the 

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test kit. If they complete a replacement test and mail it to the lab, they will receive another $20 
incentive, regardless of the specimen’s viability. 
 
Participants who report seroconverting during the study or who upload a positive HIV test stick 
photo, after receiving confirmatory testing will be eligible to begin receiving HemaSpot device 
testing and incentives following the study’s planned schedule. We will use paradata metrics to 
characterize users’ engagement across the three arms. 
 
8.3 
Intervening on “Social Harms"  
 
Potential Risks 
We identified the following items as possible risks to subjects and described how we plan on 
addressing those risks: 
 
1. Emotional discomfort: Some participants may be uncomfortable answering questions 
about their past and/or current HIV risk behaviors (e.g., sexual behavior, substance use). 
Participants may also feel uncomfortable answering questions about their sexual 
attractions, or their sexual and gender identity. However, it is important to note that 
emotional discomfort is an event encountered routinely in daily life and potential discomfort 
would likely not exceed what is typically encountered in these youths’ experiences. All 
information used in enrollment and recruitment describing the research activities will 
include a detailed description of the content and expected participation of the respondent, 
such that the respondent is aware of the nature of the questions to be included in the 
surveys. The study app will provide these details in full, during the consent process, and 
once the participant has created their password protected profile they will be able to 
access full information on the expectations of participation and the types of questions they 
will be asked. Informed consent documents will inform research participants of the need 
to keep answers to questions confidential. 
 
2. Psychological distress is a potential risk to participants during the completion of the 
surveys, reading the intervention content and during the qualitative interviewing. We will 
provide participants with information to allow them to contact the study team at any time if 
they experience psychological distress related to participation in the study. If psychological 
distress is apparent, we will refer crisis cases to the National Runaway Safeline which is 
available 24 hours a day, 7 days a week. We will use established protocols from our prior 
studies conducted with youth and men who have sex with men (MSM) for research staff 
to guide them in responding to crisis or harm situations, including attempting to contact 
the participant to assess risk level and provide appropriate follow-up (e.g., crisis hotline, 
safety check, suicide hotline). We will notify participants when we must engage in 
mandatory reporting during the consent process and when the participant decides to share 
a reportable event with study staff. 
 
3. Unintended disclosure is also a potential risk. Data will be protected by extensive 
confidentiality procedures as described below. Data will be collected confidentially; this 
will be fully described in the informed consent. We have extensive data procedures 
already in place to ensure security of the data and information provided by participants:  

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• 
Data will be encrypted at all times, from the point of entry into CASI to the point of 
backup and to analysis. Data will be encrypted using standardized software (e.g., 
256-bit, PGP).  
• 
Data will be de-identified and linked by the Study ID to minimize risk of inadvertent 
disclosure.  
• 
Data will not be released to non-study staff at any time.  
• 
All electronic data sharing between sites will be done only on the secure server.  
 
Study staff will be trained on confidentiality standards and proper interviewing techniques. 
This will include the following points: 
• 
Always maintain anonymity of the participant data and confidentiality of person. 
• 
Participant names will not be included in any data collection instruments, biomarker 
containers, or intervention forum posts. The only numbers used to label and identify 
data from the participant are the Participant ID or their username (app handle) for the 
intervention. 
• 
Questionnaires and audiotapes are to be linked using the Survey ID number and the 
interview date. No personal identifiers should be written or affixed to the test results 
or lab slips. 
• 
Protect the electronic security of all databases. 
• 
Computers that can access electronic data should be physically secured and should 
be protected by coded passwords. Networks must be demonstrated to be secure by 
the IT department prior to use. 
• 
Only authorized persons are to have access to electronic databases.  
• 
Project staff must shred documents containing sensitive information before disposing 
of them. 
 
4. Privacy and confidentiality concerns: Participants will be reminded at the beginning of 
each survey to consider their surroundings and the privacy of their device and internet 
connection.  All communication between study staff and participation will not include 
sensitive information about HIV, MSM, or anything that may reveal their participation in a 
study or answers to any of the questions answered in the surveys.  
 
Participants will be asked to provide two forms of contact information. Because 
participants are providing these pieces of identifiable information, there is a possibility that 
their participation in a research study could be disclosed in the following ways: (1) if 
someone other than the participant sees the intervention content; (2) if someone besides 
the participant reads the email sent with the link to the follow-up survey in which 
participants will enter their results; or (3) if someone besides the participant sees the study 
text messages, or online surveys on participants’ computer, tablet or phone. The risk of 
disclosure of participation in a research study through receiving study related emails, 
receiving text messages, interacting with the online surveys or with the study application 
on the participants’ cell phone will be minimized in the following ways: (1) participants 
must enter a PIN to gain access to the app if it has been 5 minutes since the app was 
open on their device, or 15 minutes if the app was open but inactive as a fail-safe to avoid 
unintended disclosure; (2) emails with a links surveys will not make any reference to the 
nature of the survey; (3) participants will be encouraged to delete any text messages 
received as part of the study to protect them from an unauthorized individual viewing the 
messages, and to interact with the study application when in private (e.g., turn on screen 

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lock, complete surveys when alone). Participants will be notified of these risks in the 
consent process. 
 
5. Emotional distress: Participants who learn that they are HIV-positive during the course 
of the study may be distressed to learn of their health condition. This poses the greatest 
emotional and physical risk to participants in the research study. The informed consent 
documents will outline the HIV testing process, stating that results will be delivered the 
same day for HIV testing, and will explain in full what a positive, negative, or indeterminate 
HIV test result means. Individuals who receive a positive HIV test result will be offered 
counseling, confirmatory testing, and referrals to care that are appropriate to their 
economic situation (e.g. those eligible for Ryan White Care will be linked to the appropriate 
services). All those receiving a positive result will be linked directly to the Care Navigator 
who can assist them in finding appropriate resources and/or linking to a case manager at 
a local agency. 
 
6. Risk of coercion: Although most participants in our trial will be recruited using online 
advertisements, participants in the HMP open network intervention arm (Peer-referral 
network, Intervention Arm 2) will be incentivized to refer two eligible peers into the study. 
Our consent processes and instructions for peer referral will ask participants to avoid 
unintentionally coercing peers. Peers who are invited into the study will have access to 
consent documents which will fully explain the study procedures, potential risks, and 
potential benefits. Referred peers will also be reminded that the study participation is 
voluntary and that refusing to participate in the study or withdrawing from the study is an 
option at any time. 
7. Risk of offensive/upsetting language or cyber bullying: We will strive to create a safe 
and comfortable app environment for all study participants. However, it is possible that 
participants in the two treatment arms may experience emotional discomfort or upset due 
to things other participants post through the intervention app’ forums. The forums are 
monitored by study staff, however we do not require posts to be pre-approved by study 
staff before they go live in the app. We will include “community guidelines” as part of the 
intervention app’s on-boarding process. This information is also included within the app 
as its own screen and reminders will be provided at all study follow-up assessments. 
These guidelines were developed and used successfully for participants in the original 
HMP intervention. Indeed, only one post out of 1497 posts met the criteria for a guideline 
violation. Thus, we believe the likelihood and seriousness of this risk is minimal. During 
the adaptation and final development of HMP Stigma we will ask Youth Advisory Board 
members to review and help update the guidelines to ensure they are comprehensive 
given the regular evolution of online environments and social media tools.  The guidelines 
will continue to include language around non-discrimination, non-offensive language, 
openness and confidentiality. As in the original HMP intervention, during the study RCT, 
study staff will monitor all participant posts during business hours with posts made outside 
of business hours reviewed in the morning of the next business day. If a participant posts 
something that could be considered in breach of the guidelines, study staff will remove the 
post, contact the participant to notify them, explain why the post was removed, provide 
them with a copy of the guidelines to review again and post a note from the study team to 
the forum reminding all participants to review and adhere to the guidelines. If a participant 
accumulates three violations of this nature, they will be immediately discontinued from the 
study. Any threat of harm to others would be grounds for considering immediate study 

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stop. The reason we choose to allow more than one violation is that one of the key 
mechanisms of change for the intervention is for participants to become more aware of 
the conscious and unconscious stigmatizing beliefs they hold – as well as to challenge 
these stigmatizing views in others. Thus, we think that these violations can provide a 
learning opportunity for all parties if handled intentionally. The grounds for discontinuation 
will be made clear during the informed consent process and will be stated explicitly online 
within the app use guidelines. Study protocol will include a Standard Operating 
Procedures manual for staff that will include directions for referral and follow-up in the 
event that a participant expresses emotional discomfort, distress, threats to self or others, 
or suicidality.  
 
8.4 
Criteria for Premature Study Discontinuation 
The principal investigator has the authority to withdraw any participant at any time if in their opinion 
it would be in the best interest of the participant. The participant will be informed of this withdrawal 
and explained the rationale. Withdrawal will be documented in the study tracking system. 
Subjects will be prematurely discontinued from the study if any of the following occurs:  
• 
The subject withdraws consent/assent;  
• 
The study is cancelled by the NIMHD; 
• 
The study is cancelled for other administrative reasons;    
• 
The subject becomes incarcerated or placed in detention during the study; or  
• 
Death of the subject. 
 
Participants may end their participation in the study at any time. No further data collection will 
occur from the date the decision is made to permanently discontinue the subject from the study. 
Participants who experience distress during the study will be provided a list of community referrals 
via phone or email. Any adverse events will be immediately reported to the U Penn IRB and the 
respective sites’ IRBs if applicable. The Study Stop and Adverse Event Forms will be completed 
at this time.  
9.0 
MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING FROM 
STUDY 
 
Site staff must first follow their own IRB’s procedure for reporting and managing untoward effects.  
 
There are three types of untoward effects to be identified:  (1) those related to the participant, (2) 
those related to the study staff, and (3) those related to the neighborhood/community. 
 
First, the study will catalogue any untoward effect related to the participant.  Reporting is required 
for occurrences including social harms, psychological distress and serious life-threatening events 
such as suicide attempts.  These may be immediately apparent to the study staff, such as the 
participant’s emotional upset requiring referral for counseling; or they may be delayed and 
reported later to study staff, such as physical harm to an individual for having participated in the 
study. Study staff will notify the team of these untoward effects by email. Study staff will be briefed 
during the training on the scope of possible untoward effects and instructed to report events. 
 
Second, study staff may encounter untoward events during sessions that personally affect them. 
Training and guidance will seek to minimize this risk. Nonetheless, an assessment of the cost of 

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conducting this study must include cataloguing these events as well. The protocol chairs should 
be notified of these events so that they may be immediately addressed, evaluated, and guidance 
modified or expanded to minimize similar risk to other staff. 
 
Third, a critically important area any community-based study intends to evaluate is the impact, 
including untoward effects, of the project on the community.  This will be done informally for this 
protocol with untoward events being reported to the protocol team. 
 
10.0 
STATISTICAL/ANALYTIC CONSIDERATIONS 
10.1 
Introduction 
10.1.1 Paradata Metrics  
We will measure temporal engagement by examining users’ visits to the app and time spent on 
app using HMP’s paradata timestamps at each login and logout. The paradata will also include 
information allowing us to link engagement for users who create, like, read, or otherwise interact 
with content in the app. We will also calculate scores for each participant based on their levels of 
“active” (posting, commenting) and “passive” (reading) engagement. Active engagement scores 
will be calculated by assigning one point for each time a participant posted or commented on app 
content. Passive engagement scores will be calculated using the paradata database to assign a 
participant one point for each time they read content. Aggregate engagement scores for each 
participant will be included as indicators and latent factors, as appropriate, in our analyses. This 
strategy will allow us to examine how different forms of engagement (e.g., temporal engagement, 
active engagement, passive engagement) influence our study outcomes. 
10.1.2 Mixed-Methods Paradata Forum Coding 
Expanding on the procedures developed and successfully employed in our R21,49 we will 
conduct a mixed-methods analysis of user-contributed content to the forums. All content and 
associated paradata of each user post will be captured by HMP’s backend database. We will use 
Dedoose cloud-based qualitative data analysis program to catalogue and code all instances of 
stigma-related content and characterize their potential contributions to HIV risk and care 
behaviors. First, two coders will independently identify all posts that contain stigma-relevant 
content. Next, they will conduct a content analysis to categorize the nature of the coded stigma 
content as enacted, community, anticipated, internalized, or challenged stigma. Coding 
discrepancies will be reviewed and resolved by a third analyst. Ongoing analysis progress will be 
discussed during biweekly YAB meetings and feedback sought on YAB members’ interpretations 
of participant forum conversations and emergent themes. The final coded dataset will be used for 
qualitative analyses and publications, as well as to create user-specific variables representing 
their engagement with each type of stigma-related domain. These data will be used to examine 
how engagement with stigma content is associated with changes across HIV outcomes (HIV 
testing, VS) directly and through proposed mediators (e.g., social support and isolation, substance 
use, depression). We successfully used this methodology in our R21 analysis and have 
established analytic protocols to carry out these procedures.49-51 
10.2 
Power Estimates  
The primary outcome for the proposed trial is stratified by HIV status and defined as successful 
engagement in care. For HIV-positive participants at baseline, we define successful engagement 
in HIV care as consistent VS across the 12-month trial (per IOM guidelines218). For HIV-negative 

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or sero-unknown at baseline, we define successful engagement in care as participation in routine 
HIV testing (2 HIV tests with at least 3 months apart from one another, per CDC guidelines219). 
We define power as correctly identifying the difference in the proportions of YBLMT with sero-
specific engagement in HIV care within 12 months of each intervention arm (2 arms: HMP Stigma 
with researcher-created network, HMP Stigma with peer-referred network) to the control arm 
(Information Control), thus powering for 3 independent hypothesis tests. Our sample size 
calculations are based on pair-wise HIV-stratified comparisons of the 3 groups in terms of 
proportion of successful engagement using a two-sided significance level of 0.05 altered by the 
number of comparisons using a Bonferroni adjustment (significance level is 0.017 for 3 
comparisons). To have 80% power to detect a minimum effect size (OR=1.9) of successful 
engagement in care between the 3-arm trial, we will require at least 450 HIV-negative and 450 
HIV-positive participants to detect a 17% difference in successful engagement in. In the event of 
a 20% loss to follow-up, we will have sufficient power to detect an OR=2.1 (18% difference) at 
alpha=.017. Participants may continue the study even if they miss an assessment intermittently. 
We will compare those who completed different follow-up interviews with those who did not on 
key baseline predictors to check for possible sampling bias. Our analysis will use ITT as 
appropriate. 
 
10.3 
Statistical Analysis Plan 
 
10.3.1 Specific Aim 1:  
 
Specific Aim 1 is to test whether a smartphone application (app) intervention (HMP Stigma) that 
promotes user-generated content and engagement to address intersectional stigma is associated 
with successful engagement in care as compared to an information-only control arm consisting 
of online informational articles and resources curated for YBLMT. Clinical and demographic 
characteristics will be described for the entire sample, and by treatment group. These will be 
compared between treatment groups using ANOVA or Kruskal-Wallis test for continuous 
variables, and chi-square tests for categorical variables. We will conduct primary analyses of our 
successful engagement in care outcome using logistic regression analyses to compare each 
active treatment group to the control in pairwise comparison tests at an adjusted significance level 
of 0.017 to reduce Type-I errors in our 3-arm trial. This approach allows us to also test for 
differential efficacy between the two intervention conditions (i.e., Does peer-referral HMP 
outperform the researcher-created HMP arm?).  
 
Logistic regression analyses will be stratified by serostatus. The regression will be run with group 
assignment only in the model.  Among HIV-positive participants, we will examine how intervention 
conditions influence YBLMT’s likelihood of consistent VS over 12 months. We will also test 
intervention effects on retention in care per IOM guidelines (i.e., proportion of HIV-positive 
participants who obtain at least 2 viral load tests (at least 3 months apart) within 12 months).  For 
HIV-negative YBLMT, we will compare the proportion of participants who obtain at least 2 HIV 
tests (at least 3 months apart) within 12 months across arms. Estimates will be calculated and 
presented with corresponding 95% exact binomial confidence intervals. In secondary outcome 
analyses, we will compare arms across other HIV care continuum outcomes, as well as stigma-
related (e.g., reduction in HIV-related stigma) outcomes, using a logistic regression with group 
assignment on the model assuming no imbalances due to successful randomization. 
 

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10.3.2 Specific Aim 2:  
 
Specific Aim 2 is to explore whether user engagement, as measured by paradata, mediates the 
intervention effects observed in stigma and HIV care outcomes.  
 
10.3.2.1 Quantitative Analyses 
Building our theoretical framework, we will use structural equation modeling (SEM) to test whether 
engagement with stigma content predicts changes in stigma-related outcomes over time (e.g., 
decreases in anticipated HIV stigma), and changes in HIV care outcomes over time (e.g., repeat 
HIV testing; consistent VS). In these HIV-stratified analyses, we will use latent class analysis to 
characterize users’ engagement in the app. We will estimate the independent contributions of 
passive and active engagement on both stigma and HIV outcomes, as well as how cumulative 
engagement in stigma-related discussions influences these outcomes. Key sociodemographic 
predictors will be included as covariates (e.g., age, time since diagnosis). We will also examine 
the contribution of specific mediators (e.g., social support) in these models by decomposing the 
total effects into direct and indirect effects. In exploratory analyses, we will use multigroup SEM 
analyses to test whether these proposed models differ based on latent classes of users (e.g., 
active forum contributors vs. lurkers; low, moderate, high engagement). Multigroup analyses allow 
us to compare the strength and direction of the effect sizes in our models and their overall fit 
across these engagement groups. Ideal models will have values of .90 or higher among fit indices 
and values of .06 or lower for RMSEA as acceptable indicators.85 The proposed study has 
sufficient power to carry out these subsample analyses in our model identification and model 
testing stages. MacCallum et al.220 show that power of .80 is achievable with alpha=.05 and 30 
degrees of freedom in cross-sectional analyses with a sample of 366 for a close model fit (for 
df=100 the minimum sample size is 178). Thus, we have ample power for these SEM analyses, 
even when dividing the sample by HIV status or engagement profile. 
 
10.3.2.2 Qualitative Analyses 
Using our latent class analysis of users’ engagement profiles (e.g. high/low users, lurkers), we 
will select a subsample of up to 45 enrolled participants (approximately 5 from control and 20 per 
each intervention arm) across different sociodemographic and user engagement profiles to 
complete qualitative evaluation interviews (described above in section 5.4.5)  Study staff, under 
the guidance of Dr. Muessig, will create a codebook of a priori and emergent themes including 
operational definitions of all codes and sample quotations to illustrate how to apply each code. 
Two study team members will use the codebook to independently code the data while a third team 
member will review these coded sections and resolve discrepancies. We will use Dedoose and 
Excel matrices to assist with theme identification, coding textual data, and describing relationships 
among codes (via code co-occurrence and memoing functions).221 Analysis results will be used 
in conjunction with participants’ survey responses, biological outcomes, and usage profiles to 
present a mixed methods intervention results analysis.  
 
10.3.3 Specific Aim 3:  
 
Specific Aim 3 is to examine whether changes in intersectional stigma and YBLMT’s 
improvements across the HIV care continuum differ based on the network structure underlying 
user engagement in the two versions of HMP Stigma. To understand the role of social network 
dynamics between the two intervention conditions, we will compute social network parameters 
(e.g., size, density, centrality) for each version using the statnet and igraph packages in R.222 
Paradata indicators of active engagement (e.g., forum replies/likes) and passive engagement 

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(e.g., reading forum posts) will be used to model threaded engagement networks between users.  
We will use these structures to describe types of users (e.g., discussion starters, contributors, 
lurkers), their location within the network (e.g., centrality), the frequency of exchanges between 
users (e.g., reciprocity), and presence of subgroups (e.g., cliques). Core social network metrics 
will be computed at the participant-level (e.g., centrality; popularity), as well as by stigma-related 
topic (e.g., trending, liked). We will use these network parameters to model (1) user engagement 
in HMP and (2) changes in HIV care continuum outcomes. We will use the general framework of 
generalized linear mixed models101–103 (GLMM) to model these longitudinal outcome 
trajectories.110–112 Given that some of our outcomes are binary, some count and some continuous 
traits they will be treated differently (identity for continuous outcome, logit for binary outcome and 
natural log for count outcomes). We will use the estimated network parameters as covariates in 
our models, measuring how network characteristics are associated in differences in outcomes 
across the two treatment groups. In addition, GLMM also allows us to link YBLMT’s individual 
trajectories with social network changes by adding them as time-varying covariates. For example, 
one analysis will examine how changes in networks’ characteristics effect changes in YBLMT’s 
VS, after adjusting for changes in stigma. These follow a network autocorrelation metric, whereby 
a term is added to the general model to captures a (weighted) average of peers’ outcomes.  
Exploratory analyses will determine if random effects should be included. Maximum likelihood 
estimation will be used for fixed effects. To ensure robustness, we will also apply an exchangeable 
working correlation structure to its corresponding generalized estimating equation  model.104  
 
Note: Any deviations from the analysis plans outlined above or in the sections that follow will be 
documented and justified in the Statistical Analysis Plan developed for this protocol. 
 
10.4 
Missing Data 
Several procedures will be used to conduct data analysis when data for either outcomes or 
covariates are missing. The first step will be to assess the extent and pattern of missing data. If 
data are missing for only a few cases, then data analysis will be conducted only on study 
participants with complete data. However, when such a strategy would result in loss of data from 
a substantial proportion of participants, or if this approach would lead to biased or inaccurate 
results, then some form of imputation will be performed. The form of imputation used will depend 
on the nature of the data that are missing. For example, data that are collected repeatedly might 
be imputed using the “last value carried forward” method; and in some instances, interpolation 
between neighboring points might also be used.  
 
When the primary endpoint is missing, one data analysis will be conducted using only cases with 
the endpoint. Subsequent analysis will be done where missing endpoints are imputed. Hot-deck 
imputation or regression imputation may also be used in this context. 
 
11.0 
HUMAN SUBJECTS 
This study will be conducted in compliance with the protocol, International Conference on 
Harmonization Good Clinical Practice guidelines, and 45 CFR Part 46. 
 
11.1 
Participants’ Confidentiality 

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All laboratory specimens, questionnaires, evaluation forms, reports, and other records will be 
identified by a coded number only, to maintain participant confidentiality.  All records with 
personally identifying information will be kept in a locked, limited access area (such as a locked 
file cabinet).  All computer entry and networking programs will be done with coded numbers only.  
Clinical information will not be released without written permission of the participant (and parent 
or legal guardian, when applicable), except as necessary for monitoring by the NIMHD. 
 
Every effort will be made to ensure that study participants are protected from risks. The main 
risk is breach of confidentiality.  
Further risks may be specific to each project and these details can be found in the human 
subjects section accompanying each research project.  
Breach of Confidentiality 
A potential risk to participants is violation of confidentiality. We will take the utmost caution to 
protect the confidentiality of all responses. We will minimize this risk by maintaining 
confidentiality and discretion throughout all research procedures and data management and 
analysis.  
 
Participants may be concerned about the security of their data, particularly since it is collected 
and stored electronically. Our research team has significant experience developing security 
protocols for Internet-based studies, and we will take a variety of steps to ensure participant 
security, including using a dedicated server behind a firewall, encryption of data, separation of 
identifiers from responses, and password-protected access to data. Therefore, we believe that 
this risk will be minimal.  
Certificate of Confidentiality  
This research specifically targets a vulnerable population, children (YBLMT ages 15-17). We will 
take every available step to minimize the risk of identifying/linking data being subpoenaed, 
stolen, or inadvertently released. First, this study will receive a Certificate of Confidentiality from 
the NIH. Second, all research staff members are required to complete ethical clearance 
certification regarding protection of human’s subjects through their relevant IRBs. Third, this 
study will have documented procedures to safeguard against the risk of the linking information 
being stolen by keeping such information in a locked spaces to which only essential study 
personnel who have completed CITI certification for human subjects research ethics training 
(http://citiprogram.org) will have access.  
 
A Certificate of Confidentiality for this project will be sought prior to enrolling participants. As 
noted on the NIH website (http://grants.nih.gov/grants/policy/COC/faqs.htm#187), a Certificate 
of Confidentiality will help the research team “...avoid compelled ‘involuntary disclosure’ (e.g., 
subpoenas) of names and other identifying information about any individual who participates as 
a research subject (i.e., about whom the investigator maintains identifying information) during 
any time the Certificate is in effect.” We have applied for and received Certificates of 
Confidentiality for other NIH-funded research projects, and given the sensitive nature of the data 
collected for this project, do not foresee difficulty securing one for this study.  
11.2 
Participants’ Confidentiality 
11.2.1 Risks 

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The measurements that are involved in this study require finger pricks to collect blood samples. 
This procedure may cause local discomfort, bleeding, or bruising. This measurement should not 
be condisered greater than minimal risk in and of itself given its routine use in general health care 
delivery.  
 
To minimize the risk of participants feeling uncomfortable about answering personal questions, 
we will use Computer Assisted Self Interview (CASI) methods for the study's surveys. In CASI, 
participants read and respond to survey questions on a laptop, tablet, smartphone.  
To minimize risks to confidentiality, we will secure study data with all appropriate physical, 
electronic and operational protections. Data will be stored in a physically secure environment. 
All data files will have encryption and strong password protection. Any identifiable data will 
either be stored on University of Pennsylvania or UNC-CH’s secure servers or will be on fully 
encrypted laptops. CASI surveys and online eligibility screening will take place on an encrypted 
commercial survey website, Qualtrics. This site has been used by the investigators for 
numerous online surveys with MSM with no data security breaches. Access to data will be on a 
role-based standard; only those study staff who require access to each type of data to complete 
their study-related roles will be allowed access. All study staff will be trained in security and 
confidentiality procedures, and will sign a confidentiality agreement before receiving access to 
any participant data.  
We will also develop procedures to minimize indirect disclosure that a participant is participating 
in an HIV-related research study, or a study that enrolls MSM and transgender women. No 
study-related messages will ever mention HIV prevention or the nature of the research study. 
Additionally, all scripts for email, text message, and telephone contact with participants will be 
reviewed and approved by the University of Pennsylvania’s IRB before being used for contact 
with participants (see “HMP SOP-Communications.docx”).  
We use SSL encryption for transfers of information online. Qualtrics uses Transport Layer 
Security (TLS) encryption (also known as Hypertext Transfer Protocol Secure (HTTPS)) for all 
transmitted data.  Survey data are protected with passwords and HTTPS referrer checking.  The 
data is hosted by third party data centers that are Statement on Standards for Attestation 
Engagements (SSAE)-16 Service Organization Control (SOC) II certified.  All data at rest are 
encrypted, and data on deprecated hard drives are destroyed by U.S. Department of Defense 
methods and delivered to a third-party data destruction service. 
 
Qualtrics deploys the general requirements set forth by many Federal Acts including the Federal 
Information Security Management Act (FISMA) of 2002.  They meet or exceed the minimum 
requirements as outlined in Federal Information Processing Standards (FIPS) Publication 200.  
All client data are considered confidential, and treated as such. 
 
Related to HIPAA, Health Information Technology for Economic and Clinical Health Act (HITECH) 
are updated assessment rules to ensure that data are properly protected and best security 
practices are followed.  By using secure and certified data centers, Qualtrics ensures the highest 
protection and testing as per HITECH requirements. We will use Dedoose software to perform all 
qualitative analyses. Dedoose is a web-based application for organizing and analyzing textual, 
audio, and video data (qualitative) along with outstanding functionality for their integration with 
survey, test score, ratings, and demographic data (quantitative). Dedoose employs the highest 
levels of data encryption available for a web application in all data storage, back up, and 

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transmission. Dedoose allows for project specific encryption feature. When using this feature, 
only Dr. Muessig or her designee will hold the additional encryption key needed to be entered in 
order to view the project. This gives Dr. Muessig exclusive control over who can view the project 
under any circumstances.  
In addition to a Certificate of Confidentiality, we will protect participants in the following ways 
(which correspond to the potential risks described in 8.3):  
1) Breach of confidentiality: We will take every precaution to minimize risks to study 
participants. All research staff members are required to complete ethical clearance 
certification regarding protection of human subjects through UNC-CH or U. Penn. We 
also have a strong data and safety monitoring plan in place to protect participants. 
Adverse events will be reported to the U. Penn IRB, individual research PI institutional 
IRBs using Adverse Event Reporting Forms created by the research team. Reports will 
be sent within 24 hours of notification by the PIs. Annual updates on enrollment and 
retention will also be sent to the IRBs.  
All study personnel names on this application have completed training and received certification 
in Human Subjects Research Protection (CITI Program) and HIPAA regulations. They will 
continue to renew this training in compliance with institutional policies.  
 
11.2.2 Benefits   
The risk to individual participants is small and the potential benefit to both the individual and 
society is substantial. The main benefit of the proposed study to society is the development of a 
potentially feasible and acceptable mobile platform that reduces intersectional stigma and 
improves individuals’ adherence to the HIV care continuum (i.e. increased testing for YBLMT 
without HIV; adherence to treatment for YBLMT living with HIV). Participants may experience 
improvements in their own experiences with stigma, thereby potentially reducing their risk for 
HIV infection, transmitting HIV, and the associated risks and costs to society. Therefore, the 
risk/benefit ratio is favorable. Study participants will be compensated for their time. 
 
Black/African American YMSM account for the highest number of new HIV diagnosis of all 
YMSM, followed by Hispanic/Latino YMSM.221 If successful, our intervention will improve these 
outcomes in our subject population. Given this high potential impact and low potential hazards 
to participants, we find that a clear examination of these research questions outweighs the 
previously mentioned risks. The effectiveness of a novel, scalable, technology driven 
intervention to address intersectional stigma is understudied with this population. Given the 
significant adverse health outcomes associated with HIV infections, and the paucity of 
intervention programs for this population of young adults, the knowledge to be gained from this 
research is significant. The risks to participants are reasonable in relation to the importance of 
the knowledge to be gained. 
 
11.3  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.   

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Written 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.  The informed consent/assent form is found in “Revised ICF-031320-clean.docx”. 
 
11.4 
Waiver of the Requirement for Parental Permission for Special Circumstances 
University of Pennsylvania IRB will request a waiver of parental permission to participate in this 
research study for youth participants under the age of (18).   
 
Under 45 CFR 46.408 (c), an IRB has the authority to waive parental permission if it determines 
that “a research protocol is designed for conditions or a subject population for which parental or 
guardian permission is not a reasonable requirement to protect the subjects” and “an appropriate 
mechanism for protecting the children who will participate as research subjects is substituted” and 
“that the waiver is not inconsistent with Federal, State, or local law.” 
 
Under 45 CFR 46.408 (c), an IRB has the authority to waive parental permission if it determines 
that “a research protocol is designed for conditions or a subject population for which parental or 
guardian permission is not a reasonable requirement to protect the subjects” and “an appropriate 
mechanism for protecting the children who will participate as research subjects is substituted” and 
“that the waiver is not inconsistent with Federal, State, or local law.” A waiver of parental 
permission for studies with lesbian, gay, bisexual, transgender, and questioning (LGBT) youth 
that do not involve greater than minimal risk is a common practice among researchers working in 
the area of gay and lesbian health/mental health. This is done to avoid the selection biases 
operating in only recruiting youth whose parents are both aware of and comfortable with their 
sexual orientation. Commonly these youth have explored their sexual orientation without their 
parents’ knowledge as the youth struggle with issues of disclosure and its consequences within 
the social, religious, and economic context of their families. A requirement for parental permission 
in this type of study could not only affect a person’s willingness to participate, but could also 
potentially impact the ability of researchers to engage in this type of research with sexual minority 
youth. Additionally, minors can often seek sexually transmitted infection (STI) and HIV prevention 
services without parental/legal guardian permission, depending on each site’s state laws. 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, 
then requiring parental permission for youth in these circumstances is not a reasonable 
requirement.  Additional privacy protections are provided in that all assessments, notes, reports, 
and other records will be identified by only a coded number to maintain participant confidentiality. 
These records and any forms that do contain identifying information will be kept in a locked, limited 
access area (such as a locked file cabinet) at the participating site. A waiver of signed consent 
will be requested from UNC-CH IRB.  
 
 
11.5 
Prisoner Participation 
NIMHD has concluded that this protocol does NOT meet Federal requirements governing prisoner 
participation in human subject research and should NOT be considered by local IRBs for the 
recruitment of prisoners. Subjects enrolled who subsequently become incarcerated or are placed 

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in detention may not continue study participation. Study visits cannot be conducted during the 
period of incarceration or detention.  
 
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) 
Both UNC-CH and the University of Pennsylvania are 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 NIMHD, UNC-CH, U Penn, or other 
government agencies as part of their duties to ensure research participants are protected.  
 
12.0 
PUBLICATION OF RESEARCH FINDINGS 
Any presentation, abstract or manuscript will be made available for review by the study 
sponsors prior to submission.   
 
13.0 
BIOHAZARD CONTAINMENT  
HemaSpot devices are not considered hazardous materials by USPS and may be shipped by 
standard mail if secured within a secondary container before placing inside the mailer. The 
HemaSpot device is considered the secondary container and renders the blood sample safe 
and secure after closing.  
 
 

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14.0 
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