mLab App Plus: A Randomized Controlled Trial of an mHealth Intervention for Increasing Access to HIV and Syphilis Testing and Care Among Young Men
Phase: NA
Conditions: HIV Infections, Sexually Transmitted Diseases, Viral, Syphilis
Sponsor: Columbia University

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Protocol Number: AAAU1706 
Version 3.4 02.14.24
NCT06059443 
mLab App Plus: 
A randomized controlled trial of an mHealth intervention for increasing 
access to HIV and syphilis testing and care among young men 
Sponsored by: 
National Institute of Nursing Research 
Principal Investigator (PI): 
Rebecca Schnall 
Co-Investigator: 
Thomas Scherr, PhD 
Final Version 3.4 
02.14.2024 

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Protocol Number: AAAU1706 
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Table of Contents 
PROTOCOL TEAM ROSTER ........................................................................................................................... 4 
Principal Investigator ...................................................................................................................................... 4 
Co-Investigators ............................................................................................................................................. 4 
LIST OF ABBREVIATIONS ............................................................................................................................... 5 
SCHEMA ........................................................................................................................................................... 6 
1.1 
INTRODUCTION .................................................................................................................................... 6 
1.2 
Background Information and Prior Research ...................................................................................... 6 
1.3 
Prior Research ................................................................................................................................... 8 
1.4 
Rationale .......................................................................................................................................... 10 
2.1 
STUDY OBJECTIVES .......................................................................................................................... 10 
2.2 
Primary Objectives ............................................................................................................................ 10 
3.1 
STUDY DESIGN ................................................................................................................................... 11 
3.2 
Randomized Control Trial ................................................................................................................. 11 
3.3 
Study Randomization ........................................................................................................................ 11 
4.1 
Study Population ................................................................................................................................... 11 
4.2 
Inclusion Criteria for Aims ................................................................................................................. 11 
4.2.1 
Considerations of Age for Inclusion Criteria ............................................................................... 12 
4.2.2 
Considerations of PrEP Use for Inclusion Criteria ..................................................................... 12 
4.3 
Exclusion Criteria for Aims ................................................................................................................ 12 
4.4 
Co-enrollment Criteria ....................................................................................................................... 12 
4.5 
Recruitment Procedures ................................................................................................................... 12 
4.5.1 
Recruitment Limitations, Anticipated Problems and Alternative Solutions .................................. 13 
4.6 
Screening Procedures....................................................................................................................... 13 
4.7 
Informed Consent.............................................................................................................................. 13 
5.1 
Study Procedures ................................................................................................................................. 14 
5.2 
Enrollment Procedures ...................................................................................................................... 14 
5.3 
Locator/Contact Information .............................................................................................................. 14 
5.4 
Randomization Procedures ............................................................................................................... 14 
5.5 
Intervention/Investigation Procedures ............................................................................................... 15 
6.1 
Study Evaluations and Measures ......................................................................................................... 16 
6.2 
Study Outcomes and Measures ........................................................................................................ 17 
7.1 
Data Collection and Site Monitoring .................................................................................................. 17 
7.2 
Data Records .................................................................................................................................... 17 
7.3 
Data Quality Control and Quality Assurance ..................................................................................... 17 
8.1 
Participant Tracking and Clinical Management ..................................................................................... 18 
8.2 
Tracking Participants Follow-up ........................................................................................................ 18 
8.1.1 
Retention ................................................................................................................................... 18 
8.3 
Intervening on “Social Harm”............................................................................................................. 18 
8.4 
Acquisition of HIV and/or Syphilis Infection while on Study ........................................................... 18 
9.1 
Statistical/Analytic Considerations ........................................................................................................ 18 
9.2 
Size Considerations and Power Estimates ....................................................................................... 19 
9.3 
Data and Safety Monitoring ............................................................................................................... 19 
9.3.1 
Training on Human Subjects and Data and Safety Monitoring .................................................. 19 
9.3.2 
Data Management and Data Quality.......................................................................................... 19 
9.3.3 
Data Monitoring ......................................................................................................................... 19 
9.3.4 
Data and Safety Monitoring Board ............................................................................................. 19 
9.4 
Adverse Events ................................................................................................................................ 20 
9.4.1 
Adverse event assessment ........................................................................................................ 20 
9.4.2 
Adverse event reporting ............................................................................................................. 20 

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9.5 
Data Analysis Plan ........................................................................................................................... 21 
9.6 
Missing Data ..................................................................................................................................... 21 
10.1 
Human Subjects Protections................................................................................................................. 22 
10.2 
Informed Consent.............................................................................................................................. 22 
10.3 
Vulnerable Subjects: Protecting Against/Minimizing Potential Risk .................................................. 22 
10.4 
Risks ................................................................................................................................................. 22 
10.4.1 
General risks ........................................................................................................................ 22 
10.4.2 
Loss of confidentiality ............................................................................................................... 23 
10.4.3 
Venipuncture .............................................................................................................................. 23 
10.5 
Benefits ............................................................................................................................................ 23 
10.5.1 
Potential Benefits of the Proposed Research to Research Participants and Others ................. 23 
10.5.2 
Importance of Knowledge to be Gained .................................................................................... 23 
10.6 
Participant Privacy and Confidentiality .............................................................................................. 23 
10.6.1 
Access to individually identified private information about human subjects ............................... 23 
10.6.2 
Confidentiality of the App ........................................................................................................... 24 
10.6.3 
Confidentiality and privacy of the study data .............................................................................. 24 
10.6.4 
Plan for privacy and data security .............................................................................................. 24 
10.7 
Unexpected and Serious Adverse Event Reporting .......................................................................... 25 
10.8 
ClinicalTrials.gov .............................................................................................................................. 25 
11.0 References ........................................................................................................................................... 25 

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PROTOCOL TEAM ROSTER 
 
 
Principal Investigator: 
Rebecca Schnall, RN, PhD 
Columbia University School of Nursing 
212-342-6886 
rb897@columbia.edu 
School of Nursing 
Columbia University 560 
West 168th Street New 
York, NY 10032 
 
Co-Investigators: 
Thomas Scherr, PhD 
Vanderbilt University 
thomas.f.scherr@vanderbilt.edu 
Department of Biomedical Engineering 
2201 West End Avenue 
Nashville, TN, 37235 

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LIST OF ABBREVIATIONS 
 
CDC 
Centers for Disease Control 
CFR 
Code of Federal Regulations 
CUIMC 
Columbia University Irving Medical Center 
DSMB 
Data Safety and Monitoring Board 
FDA 
Food and Drug Administration 
GLMM 
Generalized linear mixed model 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
IRB 
Institutional Review Board 
ISO 
Information Security Office 
mHealth 
Mobile Health 
MSM 
Men who have sex with men 
MTF 
Male to female transgendered individual 
NIH 
National Institutes of Health 
NYC 
New York City 
PI 
Principal Investigator 
PrEP 
Pre-Exposure Prophylaxis 
RCT 
Randomized Control Trial 
REDCap 
Research Electronic Data Capture 
SAE 
Serious adverse event 
SAS 
Statistical Analysis System 
STI 
Sexual Transmitted Infection 
TGW 
Transgender women 
US 
United States 
YMSM 
Young men who have sex with men 
YTGW 
Young transgendered woman 

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mLab App Plus 
SCHEMA 
 
Purpose: 
The purpose of this research study is to assess the feasibility of the 
“mLab App Plus,” which provides an imaging algorithm that 
incorporates a duplex HIV/syphilis point-of-care (POC) test. 
Design/ 
Evaluation: 
We will conduct a randomized control feasibility trial (RCT) of 
participants randomized to two study arms: 1) the mLab App Plus 
and 2) standard of care (SOC). 
Intervention: 
• 
mLab App Plus 
• 
HIV/syphilis point of care test (DPP® HIV-Syphilis) 
Study Duration: 
This will be a 3-month study. 
Population: 
Men who have sex with men (MSM) and transgender women 
(TGW) who have sex with men ages 18-39 in New York City (NYC) 
Sample Size: 
40 YMSM and TGW (18-39 years) 
Participating 
Sites: 
Columbia University School of Nursing (Washington Heights, NYC) 
Data Collection: 
We will use self-report surveys to measure demographics, knowledge, 
attitudes, skills, and behaviors. We will measure testing uptake with data 
collected from the app and through survey collection. 
Summary 
MSM, especially young MSM (YMSM), and TGW have some of the highest rates of HIV and 
syphilis diagnoses in the United States. The goal of this proposed feasibility study is to pilot the 
mLab App Plus to assess YMSM’s and YTGW’s abilities to perform and interpret self-tests for 
HIV and syphilis and consequently increase the number of YMSM and YTGW who initiate self- 
testing for HIV and syphilis. 
 
1.0 INTRODUCTION 
 
1.1 Background Information and Prior Research 
 
From 2018 to 2019, the rate of syphilis increased by 11.2% (1) It has increased steadily since 
2000 especially among men, in which MSM bear a disproportionate majority of cases (47% of 
all cases were among MSM in 2019) (2, 3). 
 
HIV and syphilis rates continue to rise among YMSM (2, 3). While MSM account for only about 
2% of the US population (4), they are most affected by HIV, constituting 56% of PLWH (2). 
Moreover, the rate of syphilis among MSM is profoundly elevated, at least 100 times higher than 
that in men who have sex with women and even higher among YMSM (5, 6). Importantly, syphilis 
makes it easier to both acquire and transmit HIV, and about half of MSM who have syphilis are 
co-infected with HIV (5). 

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The risk of syphilis and HIV continues to rise in YMSM in New York City, the study site (6). Given 
these epidemiologic risk factors for HIV and syphilis, there is a strong scientific premise for this 
pilot study that proposes to test innovative and effective HIV and STI testing, prevention, and 
treatment models. Given that approximately 17% of MSM living with HIV in the U.S. are unaware 
of their status and significant comorbid syphilis in that population, both pathogens may be 
simultaneously transmitted (7). The increasing number of syphilis diagnosed in MSM 
highlights the importance of STI control in this population, not just for the health of the patient, 
but also for prevention of HIV and syphilis in uninfected persons. 
 
The number of youths living with HIV continues to rise, and they are disproportionately 
represented at each stage of the care continuum. Most relevant to this application, it is 
estimated that less than half of HIV-infected youth in the US have been diagnosed with HIV, 
and AIDS-related deaths among youth have increased over the past decade despite decreased 
death rates among all other age groups. Simply stated – youth unaware they are 
HIV+ cannot get the treatment they need to stay healthy and may infect others without knowing 
it. Thus, increasing access to HIV testing is a critical component to engaging and identifying 
YMSM and YTGW with undiagnosed HIV, linking them to care, and lowering forward HIV 
transmission (7-9). 
 
YMSM and YTGW, and specifically Blacks and Latinos, are disproportionately infected with 
HIV. To illustrate, in 2015, youth comprised 22% of all new cases of HIV (10). Of these youth, 
81% of infections occurred among YMSM (10). Among YTGW under the age of 29, limited 
data exists, but community-based samples suggest an HIV prevalence from 5% to 20% in 
this population (11). These numbers are exacerbated in racial/ethnic minorities. Black men 
who have sex with men (MSM) have more HIV diagnoses than any other racial/ethnic group 
of MSM (38%) and Black YMSM comprise 39% of these HIV diagnoses (10). Latino MSM 
comprise 27% of HIV diagnoses among MSM (7) and 7 out of 10 new HIV diagnoses among 
Latinos. YTGW have also been disproportionately affected by HIV with the highest 
percentage of HIV+ test results of any gender category (9). 
 
There are a number of behavioral and social factors that likely account for the high rates of 
new and undiagnosed HIV infections among youth, and specifically YMSM and YTGW. 
Engaging in receptive anal intercourse and a higher likelihood of having partners who may be 
at increased risk for HIV are some of the behavioral factors that potentiate the HIV epidemic in 
youth (6, 12, 13). Moreover, having never witnessed the devastating effect of HIV/AIDS in the 
early years of the epidemic, youth may perceive themselves to be at lower risk of HIV (12). 
Social factors including stigma, homophobia, and racism may compound those factors; many 
YMSM and YTGW feel rejected, isolated, and/or lack social support (12, 14). Healthcare system 
factors also contribute to the low HIV testing rates in youth. Many youths avoid contact with 
providers who offer HIV testing and care due to lack of health insurance, discomfort with 
facilities and services, fear of stigmatization, and concerns about confidentiality (15-17). For 
these reasons, many YMSM and YTGW avoid HIV testing services, making them unaware 
that they may be infected with HIV (7). 
 
Outreach is needed among YMSM and YTGW to engage them in HIV testing, which remains 
an important tool in the fight against HIV (18, 19). There are large disparities in HIV testing rates 
in youth and ethnic and racial minorities. Among those HIV-infected, only 49% of YMSM aged 
18-24 years compared to 66% of adults knew of their infection, highlighting the need for 
improved outreach for testing among high-risk youth (7, 20). Among all MSM, 54% of 

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Black/African American men knew of their infection, compared with 63% of Hispanic/Latino 
men and 86% of white men (2, 7, 19). This data reflects major racial and ethnic disparities and, 
therefore, the need for our proposed study that targets enrollment of Black and Latino YMSM 
and YTGW (NIMHD priority area) (21, 22). Transgender women (TGW) of all ages are also 
immensely burdened by HIV. In one study, TGW were shown to have a lower prevalence of 
ever having been tested (35.6%) or having been tested in the past year (10.0%) for HIV 
compared to cisgender gay and bisexual men (61.8% ever tested; 21.6% tested in past year) 
(9). TGW have consistently low HIV testing rates and a resultant high percentage of 
undiagnosed infection in comparison to the general population, pointing to the need for 
interventions to increase the uptake of HIV testing in this population (23-25). YMSM and YTGW 
do not have adequate access to HIV prevention and testing (9, 19) and they have poorer 
access to healthcare, in general (15, 16). The healthcare system is failing to test youth, 
contributing to the high percentage of youth with undiagnosed HIV; this is especially true for 
YMSM and YTGW who are often overlooked by the current healthcare system (15-17). As a 
result, more Black and Latino men end up being tested in non-clinical settings than White 
men, pointing to the need for expanding non-clinical options, such as self-testing, especially 
among racial and ethnic minorities (18, 21, 26). 
 
Though HIV self-testing may supplement gaps in healthcare provision, there are concerns 
regarding its potential to reduce contact with care providers or in healthcare settings where 
more sensitive tests may be warranted and other prevention approaches, such as pre- 
exposure and post-exposure prophylaxis, might be delivered (27, 28). Another concern 
frequently cited about the HIV self-test is that individuals who receive a reactive or 
preliminary positive test result may be less likely to seek or to receive a confirmatory test and 
be linked to appropriate care (29). Findings from a recent RCT suggests that when supported 
through a helpline, individuals with HIV that was identified through self-testing were 
adequately and appropriately linked to care (27). Perhaps most importantly, there were no 
serious adverse events described in this study or in other HIV self-testing studies (27, 30). 
While HIV self-testing kits can be purchased over the counter, we acknowledge that there 
has been low uptake of HIV self-testing among YMSM in the US, pointing to the need for 
technologies, such as the one proposed in this study, to promote the uptake of the HIV self- 
test (OraQuick test ) (31). 
 
The implementation of HIV self-testing for YMSM also provides an opportunity for self-testing of 
another STI prevalent in the MSM community: syphilis. MSM comprise approximately 46% of 
cases of concurrent HIV and syphilis infection in the US (3). The biological nature of syphilis 
infection, specifically syphilitic ulcer proliferation, facilitates transmission of HIV, making it highly 
dangerous for PLWH. Syphilis infections in PLWH were also associated with higher HIV viral 
load and lower CD4 cell counts, and therefore worsen the severity of HIV-related symptoms (32). 
Considering the increased harm caused by coinfection with syphilis amongst PLWH, there is a 
need for increased concurrent testing for HIV and syphilis. One study showed that uptake of 
concurrent HIV-syphilis testing in a healthcare setting was highest amongst people between the 
ages of 25-34, suggesting a strong acceptability of concurrent testing amongst youth (33). 
Moreover, the study acknowledged the social barriers to concurrent HIV-syphilis testing 
acceptance within the healthcare setting and called for the development of interventions that 
circumvent decision-making burden between providers and high-risk patients (33). 
 
 
1.2 
Prior Research 
 
In response to the need for interventions to increase HIV testing in youth, our study team developed 

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the mLab App, which affords advantages over existing self-test options to support the potential for 
higher uptake of the HIV self-test. The mLab App is a mobile app on a phone that is accessible using a 
login name and password. The app provides HIV prevention information, push notification reminders for 
testing, step-by-step instructions for using the OraQuick HIV tests, and an image upload function so 
individuals can send an image of their OraQuick HIV test to the study team. Individuals enter the results 
of the OraQuick test in the app. By using the app, we are asking individuals to help test the app's   
ability to interpret the results of the OraQuick tests. Individuals are not able see the results of this 
interpretation on the existing mLab application. If an individual tests HIV positive by the OraQuick HIV 
test, the mLab app provides information on how to set up follow-up confirmatory testing within the 
following 24 hours. All information that they provide within the app is stored on a secured server. The 
mLab App is derived from extensive participatory based research (focus groups, design sessions, 
usability testing) with young men (CDC U01 PS003715) (described in detail in APPROACH: preliminary 
study #1) (33-35). Building on this extensive user-centered design work and the engineering work of Dr. 
Scherr (Co-I; see APPROACH: preliminary study #3), who developed the automated image processing 
algorithm to provide real-time interpretation of smartphone camera images of a lateral flow assays for 
malaria, (36) the mLab App extends the algorithm to interpret the HIV self-test (OraQuick). 
 
The mLab App addresses many of the current barriers to self-testing kits through the 
integration with a smartphone to overcome ambiguous test interpretations, provides 
immediate results reporting, and helps support linkage to care. In addition, the mLab user 
interface promotes a holistic diagnostic experience because it provides step by step error- 
checking with clear picture directions. While in principle, rapid tests, such as the OraQuick, 
seem simple to interpret (37) with weak positive bands or weak control lines, it is all-too-often 
difficult for users to accurately interpret the test results, which we found in our own research 
on the OraQuick home test (31). Beyond diagnosis, the mLab App provides information 
facilitating linkage to care for those who test HIV-positive and educates users on the 
importance of follow-up testing and prevention services for those who test HIV-negative. 
 
We conducted preliminary studies to support the usage of this intervention for young men: 
 
1) Dr. Schnall led a CDC cooperative agreement (U01 PS004975) using critical iterative 
end-user feedback to design a mobile app for promoting HIV prevention behaviors in 
high-risk MSM (35). The methodological details, associated findings, and final Design 
Document have been widely disseminated (38). Findings from this study guided the 
content of the mLab App, which is being refined in this proposed study. 
Dr. Schnall conducted a study using in-depth interviews, observations, and a think- 
aloud protocol to understand high-risk young adults' use of the rapid (HIV) self-test. Our 
study incorporated a performance record to carefully identify competency in self- 
administration of the test (31). This study provided evidence of the perceived usefulness 
of the self-test by young adults, especially in light of their concerns about lack of privacy 
in medical settings. Notably, only one (of 21) participant followed all of the instructions 
for using the test. The policy implications of this finding are important since the Food & 
Drug Administration (FDA) Requirements for labelling and packaging are critical for the 
safe use of devices, but at the same time, end-users’ abilities to understand and use 
these package inserts, especially in stressful situations, must be better considered (31). 
To address this need, we developed the mLab App which provides step by step 
instructions on the smartphone screen and also an imaging algorithm for interpretation 
of test results so that the participants can be less burdened by the interpretation of fuzzy 
red lines, a common and well-known limitation to the self-test. 
 
2) Dr. Scherr’s team published its work on smartphone integration of a number of existing 

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technologies as an attractive tool for standardized detection and reporting of infectious 
diseases. Dr. Scherr demonstrated that using an unmodified mobile phone to 
photograph rapid detection lateral flow assays is superior to visual interpretation by 
inexperienced users. In short, the photo imaging algorithm has been successfully used 
with lateral flow assay tests for malaria with untrained users in non-clinical settings (36). 
Dr. Scherr’s work demonstrated that an automated image processing algorithm has an 
improved limit of detection over a commercially available lateral flow reader and reduced 
reporting errors inherent in visual test interpretation. 
 
To understand high-risk YMSM and YTGW’s plans for using the mLab App, barriers to use, 
and feasibility of using the imaging algorithm (the mLab), Drs. Schnall and Scherr conducted a 
mixed methods observational study among 18 YMSM and YTGW (mean age 24) who have all 
engaged in high-risk sexual behavior (unprotected anal sex) in the past 3 months. Participants 
used the mLab App and then completed a follow-up survey and an in-depth interview. 
Participants completed the Health-ITUES survey and rated the mLab App as Impact on health 
(4.3 out of 5), Useful (4.4 out of 5) and Easy to Use (4.4 out of 5). We collected paradata as part 
of our pilot study and collected time stamps, pages accessed, test image, type of Internet 
browser, operating system, and the smartphone device. Following the survey, we conducted in- 
depth interviews to understand high-risk youth’s plans for using the mLab App and barriers to 
use. All of the participants reported this would be a very useful tool for high-risk youth and 
thought most youth would want to use the mLab App. They also all indicated they would seek 
follow-up care if they themselves tested positive and saw the principal advantages of the mLab 
App as being convenient and portable and an enabler for promoting uptake of HIV testing. In 
particular, participants noted that the mLab would be especially helpful to youth who did not 
have a close relationship with a provider or were concerned about potential stigma from a 
provider regarding their sexual behavior. Participants also provided useful feedback on the user 
interface with suggestions (39). 
 
1.3 
Rationale 
 
In response to the mLab App study and the scientific evidence of need for at-home syphilis 
POC testing among YMSM and YTGW, we propose to implement the mLab App Plus to 
assess YMSM’s and YTGW’s abilities to perform and interpret self-tests for HIV and syphilis 
and consequently increase the number of YMSM and YTGW who initiate self-testing for HIV 
and syphilis. 
 
We propose the following Specific Aims: 
 
1: Examine the feasibility of using the DPP® HIV-Syphilis test as a self-test to improve 
uptake and access to STI testing. 
 
2: Estimate the effect sizes for the mLab App Plus for improving testing uptake in YMSM and 
YTGW. 
 
2.0 
STUDY OBJECTIVES 
 
2.1 Primary Objectives 
The primary objective of this study is to pilot the use of added syphilis testing to mLab and 
determine its feasibility among YMSM and YTGW for further use and study, recruiting 40 
YMSM and YTGW into the RCT. We will assess demand and a limited effect size to predict 

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usefulness for a larger study of the application. Because DPP® HIV-Syphilis tests are not yet approved by 
the FDA for self-administration, participants will complete their self-tests at our clinic in Washington Heights 
under the supervision of a trained clinician. The clinician will be qualified to use the device according to the 
approved Instructions for Use (IFU) and will complete the test in a manner consistent with the point of care 
(POC), non-CLIA waived label of the test. Thus, we will also be assessing participants’ abilities to self- 
administer and interpret DPP® HIV-Syphilis tests. If participants are unable to self-administer, apprehensive, 
or incorrectly use the DPP® HIV-Syphilis test as per the IFU, the clinician will intervene and conduct the test 
on the participant. 
3.0 
STUDY DESIGN 
 
3.1 
Randomized Control Trial 
 
We will conduct a small-scale digital RCT to evaluate the feasibility of the mLab App Plus 
and testing/linkage to care uptake as compared to the control arm (receiving SOC). We will 
enroll 40 YMSM and YTGW (ages 18-39) who report being negative for HIV and syphilis, or 
whose statuses are unknown, and randomize them into the intervention or control condition. 
The trial includes screening, a baseline appointment, and a 3-month follow-up   
appointment. 
 
Intervention Condition: Participants randomized to intervention will be provided with the mLab 
App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab 
Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (1st test) and 3-month follow- 
up (2nd test) appointments in the clinic (more details in section 5.4 Intervention/Investigation 
Procedures). 
 
Control Condition: Participants randomized to standard care will be sent an email with links 
to mobile-optimized online prevention information, including PrEP and HIV/STI testing 
information found on the CDC website, and a box of condoms (40). 
 
 
3.2 
Study Randomization 
 
After providing informed consent, participants will be randomized to study arms in a 1:1 
ratio of intervention to control arms. To reduce opportunities for selection bias, we will use 
a variable permuted randomization block design where block size itself is randomly 
selected (i.e., blocks of four to eight). The advantage of a permuted block design is that 
treatment assignment is pre-determined before the trial begins and assignment remains 
static throughout the trial. Both groups will receive standard care HIV/STI testing-related 
risk reduction counseling, a box of condoms, and PrEP assessment. The intervention 
group will self-administer their first DPP® HIV-Syphilis Test under the supervision of a 
trained clinician at baseline and again at their 3-month follow-up. No control group 
participant will be offered HIV or Syphilis testing in order to observe intervention outcome. 
 
4.0 
Study Population 
 
4.1 Inclusion Criteria for Aims 
 
Individuals who meet the following initial criteria are eligible to proceed to the confirmatory 
study screening: 
• 
18-39 years of age (see justification below) 
• 
Assigned male sex at birth and identify as (1) a man or (2) a trans woman 

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(e.g., MTF, YTGW) 
• 
Understand and read English or Spanish 
• 
Self-identify as any race or ethnicity 
• 
Substantial risk for acquiring HIV infection per CDC guidance (e.g., Sexual partner with HIV 
and/or recent bacterial STD and/or high number of sexual partners and/or history of inconsistent 
or no condom use and/or commercial sex work) (1, 2, 41) 
• 
All participants must report having sex with a man/men 
• 
Smartphone ownership 
• 
Self-report being HIV-negative or unknown status 
• 
Self-report being negative for syphilis or unknown status 
• 
Not having been tested for HIV or syphilis in the past 3 months (e.g., therefore 
being somewhat outside of the current CDC testing recommendations for high-risk 
populations – see below) 
• 
Understand the limitations of the duplex lateral flow test and the mLab App Plus (e.g., a 
confirmatory test is needed and self-test must be performed in the presence of a qualified clinician) 
 
4.1.1 
Considerations of Age for Inclusion Criteria 
 
The proposed inclusion ages of 18-39 captures the upper range of the greatest increase in 
new infections (42), and the youngest age is the average age when sexual initiation begins 
(43, 44). 
-54). 
 
4.2 
Exclusion Criteria for Aims 
 
Individuals who meet any of the following criteria will be excluded from the study: 
• 
Persons who have a known diagnosis of HIV and/or syphilis 
• 
Persons for whom the investigators determine that participation may be detrimental 
to the participant or to the study (e.g., severe cognitive deficit) 
• 
Persons diagnosed with Systematic Lupus Erythematosus, as their medical 
condition could affect the results of the DPP HIV-Syphilis test 
• 
Persons who are unable or unwilling to provide consent for study participation 
 
4.3 
Co-enrollment Criteria 
 
Participants are ineligible for participation if they are currently enrolled in any other HIV or 
syphilis testing-related research study. 
 
4.4 
Recruitment Procedures 

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We will likely employ a multi-modal recruitment strategy. The research team has extensive 
experience recruiting YMSM and YTGW of color into research studies, including the pilot 
study of the mLab App, in which 12/18 participants (67%) were non-white and the 
preliminary study in which 70% were non-white (CDC U01 PS004975). 
 
We have used a variety of recruitment venues for other similar studies and maintain strong 
working relationships with online advertising vendors and local community-based 
organizations. Although online venues are constantly evolving, in the past major categories of 
recruitment have included social network sites (e.g., Facebook, Instagram, Twitter); online 
sexual networking apps (e.g., Grindr, Scruff); and banner advertisements on other websites 
frequented by MSM (e.g., POZ). We will recruit young men through posting flyers and 
promoting the study through community partners. Those recruited through these flyers will be 
directed to an online web survey (e.g., REDCap) for eligibility screening. 
 
4.4.1 
Recruitment Limitations, Anticipated Problems and Alternative Solutions 
 
Limitations 
Some limitations or anticipated problems with recruitment may involve the efficacy of the 
utilized ads. In addition, participant interest may vary from population to population. There  
is always the possibility of restricted recruitment as it pertains to accessing and promoting 
studies in public spaces (i.e., schools, parks, etc.). We will also inform the study participants 
upon enrollment that the goal of the mLab App Plus is for self-testing and NOT for      
partner testing/sero-sorting. In order to ensure that DPP® HIV-Syphilis Tests are used only 
on the study participants themselves, participants will not be given DPP® HIV-Syphilis tests 
to take home. Participants will receive a test at our clinic in Washington Heights where a 
provider will be present and watch them self-administer the test. Because the DPP® HIV- 
Syphilis tests are not yet FDA approved as self-tests, it is possible that participants will be 
unable to perform the test on themselves, and will need the clinician to administer it for 
them. 
 
Alternative Solutions 
Some alternative solutions to participant recruitment may include, but are not limited to email 
blasts, posted flyers, and in-network recruitment. With regard to partner testing, we will 
suggest that participants who have partners who are interested in testing should contact the 
study team for more information on HIV testing. If participants are apprehensive about self- 
administering the DPP® HIV-Syphilis test, they will have the option to ask the clinician to 
administer it for them. 
 
4.5 
Screening Procedures 
 
Interested participants will be sent a RedCap link to the mLab App Plus screener to fill out 
online. If found eligible, they will then have a visit at our clinic in Washington Heights with 
one of our investigators to answer questions and consent to enroll in the study. After 
receiving written consent, the study team will randomize participants to one of the two arms. 
After signing the consent and being randomized, they will be considered to be “enrolled” 
into the study. 
 
4.6 
Informed Consent 
 
We will be using electronic online informed consent procedures for enrolling YMSM and 

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14 
YTGW into the study. Interested participants will verbally consent to screening. If screened as 
eligible, participants will complete a consent form for enrollment into the study at the beginning 
of their baseline session. Prior to randomization, participants will read and sign the consent 
form provided to them by study staff onsite. The informed consent form provides details     
of the study procedure, risks, benefits, site contact information, and the nature of 
confidentiality and voluntary participation. The consent process also covers information on the 
study and compensation for time. The same consent form will be given to all study 
participants. Participants consent to be randomized to any of the two aims for study purposes. 
Before a participant signs the informed consent forms, staff will review the forms, ask 
if the participant understands the content of the consent forms, and answer any questions. 
Participants will be given a copy of the informed consent forms for their records. 
5.0 
Study Procedures 
5.1 
Enrollment Procedures 
After successfully providing consent, the participant will be randomized to a study arm and 
then complete a computer self-administered baseline survey (further described in section 
5.4). After completing the baseline survey, both groups will receive standard care HIV/STI 
testing-related risk reduction counseling, a box of condoms, and PrEP assessment. 
Participants who are randomized to the intervention arm will be given a DPP® HIV-Syphilis 
Test at their baseline appointment, which they will self-administer in the presence of a 
qualified clinician. 
5.2 
Locator/Contact Information 
At the participant’s baseline study visit, participants will be asked to provide contact 
information for follow-up assessments: this information will be entered into REDCap. We will 
collect each participant’s cell phone number, email address, as well as encourage them to 
share their social media handles (e.g., Snapchat, Instagram, Twitter Facebook, WhatsApp, 
and/or Skype usernames). Participants will be asked if it is okay to mention the name of the 
project and method(s) of study communication preferred when sending reminder (e.g., text 
messaging, email, phone call, leave voicemail). Study staff will not send messages or leave 
voicemail messages unless explicitly permitted to do so by the participant. If permission is 
given to leave voice messages, site staff will assure participants that messages left will not 
include any protected health information or information related to study participation. Contact 
information will be maintained using the same confidential data management practices used 
for all study data. 
5.3 
Randomization Procedures 
After providing informed consent, participants will be randomized to study arms in a 1:1 
ratio of intervention to control arms. To reduce opportunities for selection bias, we will use 
a variable permuted randomization block design, where block size itself is randomly 
selected (i.e., blocks of four to eight). The advantage of a permuted block design is that 
treatment assignment is pre-determined before the trial begins and assignment remains 
static throughout the trial (55). No control group participant will be offered HIV or Syphilis 

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15 
testing in order to observe intervention outcome. 
5.4 
Intervention/Investigation Procedures 
See Table 1 for baseline and 3-month follow-up schedule of events. 
Table 1. Schedule of Events 
Intervention Arm 
Control Arm 
Baseline 
3-Months 
Baseline 
3-Months 
Standard-of-Care 
Counselinga 
X 
X 
Online Survey 
X 
X 
X 
X 
mLab App Plus 
X 
DPP® HIV-Syphilis 
Test 
X 
X 
a: Receipt of standard-of-care HIV/STI testing-related risk reduction counseling, box of condoms, PrEP 
assessment, and referral information for clinics that provide PrEP. 
Baseline Visit 
The baseline survey will include questions on demographics, health literacy (52), sexual risk 
behaviors including number of men (and other genders) they engaged in anal or oral sex with, 
condomless anal intercourse, and HIV/STI testing history and opinions regarding HIV/STI 
testing. The baseline survey will also include questions on PEP/PrEP use and adherence, 
drug and alcohol use, (51) and HIV Risk Index (54). We are using REDCAP, a web-based survey 
software package with several benefits that have been cited including data being captured 
directly in electronic format and interactive data capture checks (56). This approach will be 
especially beneficial in a multi-site study. REDCap is a secure web-based system that 
provides an intuitive interface, audit trails, and automated export. REDCap is a service offered 
through CUIMC Information Technology. Staff at Columbia University will have a link to the 
secure web-based data collection survey tool and will be present to assist the participant in 
completing the survey. Staff will be accessible during survey completion to address any 
technical problems or to answer questions participants may have. Staff may periodically 
check-in with the participant to inquire about any difficulties that may arise in completing the 
survey. However, to ensure privacy, the staff person will not directly observe the full process of 
completing the survey unless requested by the participant. Both the baseline and 3-month 
follow up surveys will be conducted in-person. 
At the baseline study visit, following consent and completion of the baseline questionnaire, 
participants randomized to the intervention group will be instructed on how to use the mLab 
App Plus by the investigator, who will create an account for them during baseline. Next, 
they will verbally complete a DPP® HIV-Syphilis testing assessment so that study staff 
ensures they are aware of the functions and limitations of the test. Participants will be taken 
to the CUIMC Nurse Practitioners clinic where they will be instructed to self-administer their 
first DPP® HIV-Syphilis test under the supervision of a trained clinician. The clinician will 
ensure that the DPP® HIV-Syphilis test is administered correctly and test results are 
accurately interpreted. The participant will use the mLab App Plus and the DPP® HIV- 
Syphilis testing instructions to guide them through the DPP® HIV- Syphilis testing process 
and to help them understand their test results. Participants will be provided with all 
necessary materials to complete the test by the on-site clinician. In the event that the 
participant feels uncomfortable or unable to perform the DPP® HIV-Syphilis test as a self- 

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test, they may ask the clinician to administer the test for them. 
Testing with a DPP® HIV-Syphilis kit requires that the participant obtain a small drop of blood 
using a sterile lancet and sample loop and insert it into the SampleTainer Bottle. Participants 
will then drop the blood sample on the test strip per the DPP® HIV-Syphilis test instructions. 
The participant will then attach the DPP Micro Reader, a device which interprets the test 
results, to the test strip. Once the DPP Micro Reader has finished running the test, 
participants will take a picture of the DPP Micro Reader display screen through mLab App 
Plus, which is then processed through automated image processing software. Participants 
then see their results on their smartphone screen. The test will likely take around twenty 
minutes to complete. For step-by-step instructions, please refer to the mLab App Plus 
Workflow. The mLab App Plus is unique in that it allows a person to test themselves. 
However, because DPP® HIV-Syphilis tests are not yet approved by the FDA as self-tests, 
participants will be required to complete the self-testing process at our clinic in Washington 
Heights, under the supervision of a qualified clinician. Test results are then stored on the 
participants’ smartphones and also securely transmitted and stored on the REDCap Server. 
This will contribute to the validity of findings as participants’ reports of testing themselves can 
be confirmed through this device. In addition, the mLab App Plus user interface can promote 
a more holistic diagnostic experience, particularly in self-testing because the interface 
provides step-by-step picture directions, and information on linking to follow-up testing and 
prevention services, as appropriate. 
Upon receiving a test result, participants will be directed to another screen on their 
smartphone informing them that a study team member will be in contact with them shortly to 
discuss their test results. The study team member will meet with the participant at the clinic, 
immediately after they have completed their DPP® HIV-Syphilis test. They will discuss with 
the participant what their test result means and what it does NOT mean. In the event of a 
positive test result, the study team member will offer support and help the participant set up 
an appointment at our clinic for confirmatory testing. Participants will receive reminders on 
mLab App Plus for their next visit prior to the 3-month follow up visit. 
3-Month Follow Up Visit 
The 3-Month Follow Up survey will include questions on demographics, health literacy (52) 
sexual risk behaviors including number of men (and other genders) they engaged in anal or 
oral sex with, and condomless anal intercourse, as well as questions on PEP/PrEP use and 
adherence, drug and alcohol use (51), and HIV Risk Index (54). Participants randomized to 
both the control arm and intervention arm of the study will all participate in the questionnaire 
at the 3-month time point. The survey will also inquire about participants’     
opinions towards HIV/STI testing since the baseline visit and their experiences using the 
mLab App Plus, if they are randomized to the intervention arm. 
Following completion of the survey, intervention arm participants will once again 
self-administer the DPP® HIV-Syphilis test at the clinic in the presence of a 
clinician. They will follow the same testing procedure as they did at baseline and a 
study team member will meet with them to discuss results and set up confirmatory 
testing, if necessary, once they have completed their DPP® HIV-Syphilis test. 
Results are stored on their smartphone through the mLab App Plus and securely 
transmitted and stored on the REDCap Server. 
6.1 
Study Evaluations and Measures 

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6.2 
Study Outcomes and Measures 
The primary outcome is the number of participants who are able to self-administer the 
DPP® HIV-Syphilis test with mLab App Plus (Table 2). A successful self-test is defined 
as having completed the DPP® HIV-Syphilis test by themselves and having accurately 
identified and interpreted their HIV and Syphilis statuses as determined by the 
supervising clinician. In the event that the clinician, rather than the participant administers 
the DPP® HIV-Syphilis test, the test is not recorded as a successful self-test. Secondary 
outcomes are also listed in Table 2, including information about linkage to health care 
and other support services. 
Table 2. Outcome Data for Aim 3 
# YMSM/YTGW who completed testing for HIV/syphilis at Baseline and 3-Month Follow-up 
# YMSM/YTGW who self-administered the DPP® HIV-Syphilis test at Baseline and 3-Month Follow- 
up 
# negative/positive results 
# YMSM/YTGW referred for HIV/STI services (participants with HIV and/or syphilis only) 
# YMSM/YTGW linked to (attend one appointment) HIV/STI prevention or care services 
# YMSM/YTGW attending other HIV/STI prevention service appointments 
# YMSM/YTGW accessing HIV/STI prevention or social service appointments (e.g., PEP, PrEP, STI 
testing, mental health counseling, drug treatment, job assistance, education services, job skills 
training, housing assistance) 
Outcome indicator data disaggregated by race/ethnicity, age, testing history and geographical 
area 
Additional HIV-associated health outcomes (e.g., sexual behaviors associated with HIV transmission) 
7.1 
Data Collection and Site Monitoring 
7.2 
Data Records 
All electronic data will be stored on a certified environment. The recordings will be stored 
securely after the data have been analyzed and the findings disseminated. The smartphone 
that is connected to the mLab App Plus will require a password. Data will be coded. The PI 
and Project Manager will have access to the identifiable data. Study data will be encrypted 
and stored on secure HIPAA- compliant servers at the CUIMC campus. mLab App Plus data 
will be stored at Vanderbilt University. All study data will be kept in password-protected 
computers or file cabinets in locked offices and will be maintained in a completely secure 
and HIPAA-compliant environment. All CUIMC servers have HIPAA-compliant security. 
7.3 
Data Quality Control and Quality Assurance 
Routine data quality control assessments will identify and resolve data errors in both data 
collection (e.g., surveys) and study documentation (e.g., visit logs). Data quality resolutions 
will be documented for reference. As determined necessary by the PI, the study Data Safety 
Monitoring Board will advise resolutions for data quality concerns during Board meetings. 
Data validation tools available through the REDCap platform will be leveraged to ensure data 
quality assurance in study data collection and documentation such that data is checked 
against validation standards at the time of input. Quality assurance measures will be routinely 
reviewed with new measures added as necessary to address emerging data quality 

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concerns. 
8.1 
Participant Tracking and Clinical Management 
8.2 
Tracking Participants Follow-up 
Contact (phone calls, text, email, or note as preferred by the participant) will be made by the 
site study staff 3 days and 1 day prior to the follow-up visit to confirm or reschedule an 
appointment. Participants in the intervention arm will also receive a 3-month follow-up visit 
reminder through the mLab App Plus. The discrete contact will thank the participants for being 
in the program, remind them of the date and time of their follow-up appointment, and note the 
telephone number that can be called if rescheduling is necessary. Participants who do not 
respond and cannot be located during the acceptable 1-month window period are coded as a 
missed assessment and attempts to contact them will resume for the next assessment. We 
will contact participants until they express the desire to be dropped from the study. These 
extensive procedures will be used to promote participant attendance at the follow-up visits and 
have been successful in previous HIV prevention studies conducted by our study team. 
8.1.1 
Retention 
Participants will be asked at the end of the screening what would be the best way for us to 
remind them of the appointment (voice phone, text, e-mail). Participant retention during the 
intervention will be enhanced in several ways. We will offer multiple reminders via text, 
email, calls, or mLab App Plus, for participants randomized to the intervention arm. We will 
use several approaches that have shown success at reducing barriers, including: 1) clearly 
explaining the duration of the study; 2) collecting multiple contact points (phone number, e- 
mail, social media username) based on participants’ preferences; and 3) implementing 
consistent study staff follow-up with participants to build rapport. 
8.2 
Intervening on “Social Harm” 
If a study participant reports severe depressive symptoms or suicidal ideation, we will refer the 
participants to the local emergency room or mental health referral facility. 
8.3 
Acquisition of HIV and/or Syphilis Infection while on Study 
If a participant receives a reactive or indeterminate result from the DPP® HIV-Syphilis test 
for their HIV and/or Syphilis status during the course of the study, the study team will link 
them to confirmatory testing on site at the clinic. 
To facilitate these tasks, study staff must complete the HIV/Syphilis Confirmation Testing 
instrument in REDCap which should be updated with the information around the preliminary 
positive, confirmatory test, and linkage to care information as it is updated. Once HIV and/or 
syphilis status has been confirmed as positive, participants will be withdrawn from study. 
9.1 
Statistical/Analytic Considerations 

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9.2 
Size Considerations and Power Estimates 
Due to the small sample size (n=40), results will not be powered enough to be representative 
of the greater population. Our goal is to examine feasibility among participants and estimate 
the effect size of the intervention for a future RCT. 
9.3 
Data and Safety Monitoring 
The Data and Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol 
approved by the Single Institutional Review Board (IRB) which will oversee the study 
activities. A Data and Safety Monitoring Board will be established after a Notice of Award is 
granted. 
9.3.1 
Training on Human Subjects and Data and Safety Monitoring 
All proposed staff have participated in the Department of Health and Human Services 
required trainings for conduct of studies that involve human subjects and any future study 
staff will do so upon hiring. Training for all staff includes (but is not limited to) Protection of 
Human Subjects, Informed Consent, Good Clinical Practice, Quality Management, 
Confidentiality, and Reporting of Adverse Events. If any study staff discovers any untreated 
condition (e.g., onset of physical or mental health condition), they will refer participants to 
appropriate treatment immediately. 
9.3.2 
Data Management and Data Quality 
Columbia University will be responsible for computerized survey programming and data 
capture, management, and analysis. All study information will be identified through the 
Participant Identification Number on all forms and computerized files. 
9.3.3 
Data Monitoring 
Biweekly reports for the study sites will be created by the data manager (i.e., data monitoring is done 
by both Columbia University staff and Vanderbilt University staff) to review relevant app engagement 
data, barriers with recruitment/enrollment and retention, laboratory and medical records, compliance 
with the protocol, and accuracy and completeness of the records. The investigative team will schedule 
biweekly conference calls, and these reports will be briefly reviewed by the team at these meetings. 
These regular reviews will ensure close communication between the research assistants, quickly 
identify missing data points, and ensure consistent management of any issues with the protocol across 
sites. Data quality will be examined before statistical analyses are conducted, including examination of 
missing data, assessment of distributional assumptions, and identification of outliers. In addition to data 
quality, the comparability between intervention and control groups will be carefully examined, including 
baseline balance and differential attritions at all waves of follow-up. 
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9.3 
Adverse Events 
9.3.1 
Adverse event assessment 
We anticipate that the Data and Safety Monitoring Board will define study-specific serious 
adverse events (SAE)s. While we do not anticipate any SAEs, we will carefully review safety 
and data security and study drop-out. 
9.3.2 
Adverse event reporting 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens 
in severity during the course of the study. Intercurrent illnesses or injuries should be regarded 
as adverse events. Abnormal results of diagnostic procedures are considered to be adverse 
events if the abnormality: 
•
results in study withdrawal
•
is associated with a serious adverse event
•
is associated with clinical signs or symptoms
•
leads to additional treatment or to further diagnostic tests
•
is considered by the investigator to be of clinical significance
Serious Adverse Event 
Adverse events are classified as serious or non-serious. A serious adverse event is any AE 
that is: 
•
fatal
•
life-threatening
•
requires or prolongs hospital stay
•
results in persistent or significant disability or incapacity
•
a congenital anomaly or birth defect
•
an important medical event
Important medical events are those that may not be immediately life threatening but are clearly 
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of major clinical significance. They may jeopardize the participant’s health and may require 
intervention to prevent one of the other serious outcomes noted above. For example, drug 
overdose or abuse, a seizure that did not result in in-patient hospitalization, or intensive 
treatment of bronchospasm in an emergency department would typically be considered serious. 
All adverse events that do not meet any of the criteria for serious should be regarded as non- 
serious adverse events. 
We will follow the guidelines of the IRB that require investigators to promptly notify the IRB 
(within 1 week from awareness of the occurrence) when an adverse event (AE) or serious 
adverse event (SAE) meets the definition of an Unanticipated Problem (UP). 
The IRB requires that any event that is unexpected, related or possibly related to the 
research intervention, and suggests that the research places subjects or others at a greater 
risk of harm (including physical, psychological, economic or social harm) than was previously 
known or recognized must be reported. Events that are unrelated to the research intervention 
do not have to be reported to the IRB; however, we will report these to the monitoringentity 
and Centers for Disease Control and Prevention (CDC). Risks that are described in the 
protocol and consent form do not have to be reported unless the expected event occurs more 
frequently or is more severe than expected. One exception to this rule is in the case of a 
death. All deaths must be reported whether or not the death was related to the research. 
An unanticipated adverse device effect (UADE) is defined as “any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects” (In accordance with 21 CFR 812.3(s)). 
In accordance with 21 CFR 812, UADEs will promptly be reported to the FDA and IRB, but no 
later than 10 working days after the investigator first learns of the event. 
9.4 
Data Analysis Plan 
All multivariate analyses will be preceded by standard descriptive bivariate analyses to 
describe the key variables and relationships among them. These analyses will include 
means, frequency tables, histograms, and examination of distributions. Frequencies and 
rates of HIV/syphilis tests, as well as corresponding confidence intervals, will be 
calculated for each arm (mLab App Plus vs. Standard of Care (Control)). Logistic 
regression models will be used to compare in the likelihood of having HIV/STI tests 
between the mLab App Plus arm and the standard clinic-based testing arm. 
9.5 
Missing Data 
Prior to performing any outcome analyses, we will evaluate the amount, reasons, and 
patterns of missing data. Missing data unrelated to the outcome of interest will be considered 
missing completely at random, and complete case analysis will still generate unbiased 
estimates. We will conduct sensitivity analyses to compare estimates of treatment effects with 
and without multiple imputation to assess the effect of missing data on statistical inference. 
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We propose a GLMM to analyze data, the main advantages being unbiased estimates when 
there are missing outcomes during the follow-up period if the probability of missing is not 
related to the outcome value. For the missing values at the baseline or partial baseline 
collected data, we will use a multiple imputation approach. Models will also be run on the raw, 
non-imputed data with full information maximum likelihood estimation. Inferences for the trial 
arm, wave, and interaction between trial arm and wave do not differ between the analyses of 
the raw and multiply imputed data. Rates of reduction will be calculated from population- 
averaged rates, which control for all other covariates in the multivariable model. Models will 
be calculated by using the GLIMMIX and MIANALYZE procedures in SAS, version 9.4, and 
model fit will be evaluated by diagnostic statistics and residual plots. 
10.0 
Human Subjects Protections 
10.1 
Informed Consent 
The informed consent of each participant will be obtained in accordance with 21 CFR Part 50 
and the Declaration of Helsinki before protocol-specified procedures are carried out. An 
investigator will obtain the participant’s written informed consent prior to any study-related 
procedures. Consent will be documented by the dated signature of the subject. The signature 
confirms that the consent is based on information that has been understood. Each participant's 
signed informed consent form will be kept on file by the investigators for possible inspection by 
regulatory authorities. 
The study plan, advertisements, or recruitment letters, lay description of the study, and all 
consent forms will be submitted to the IRB following proposal acceptance and prior to study 
initiation. Dr. Schnall will be responsible for obtaining IRB approval for this study. Recruitment 
for study participation will occur following IRB approval. The investigators will determine 
eligibility for inclusion, explain the purpose of the study, answer any questions, and obtain e- 
consent from the participants. Patients who agree to participate will sign a consent form. 
Potential risks and strategies for risk management will be carefully explained as part of 
informed consent procedures. All HIPAA requirements will be applied to this study. 
We will assure potential participants in these study activities that their willingness to 
participate and/or to complete the study activities will not have an impact on their participation 
in other aspects of the study or on their employment or student status at study sites. 
10.2 
Vulnerable Subjects: Protecting Against/Minimizing Potential Risk 
Ethnic and racial minority populations will be enrolled. While this group is considered a 
vulnerable population, the study team has considerable experience enrolling these 
participants. The study will be conducted according to Good Clinical Practice guidelines, the 
U.S. Code of Federal Regulations (CFR) Title 21 CFR (Part 50 – Protection of Human 
Subjects and Part 56 – Institutional Review Boards) and the Declaration of Helsinki. 
10.3 
Risks 
10.3.1 
General risks 
There may be risks or discomforts in participating in this study. Participants may feel uncomfortable 
with completing some questions in the survey. Participants may skip any HIV/STI information or 
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questions that may make them feel uncomfortable or stop the research procedure. People around may 
observe participants using the mLab App Plus. If participants are concerned about people seeing them 
use of mLab App Plus, it is important that they access the application in private location. 
10.3.2 
Loss of confidentiality 
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss 
of confidentiality or privacy means having personal information shared with someone who is 
not on the study team and was not supposed to see or know about your information. 
10.3.3 
Venipuncture 
There is a small risk of local hematoma or infection associated with blood sampling. On rare 
occasions, drawing blood can cause dizziness, presyncope, and even syncope. 
10.4 Benefits 
10.4.1 
Potential Benefits of the Proposed Research to Research Participants and Others 
The potential benefits to an individual participant in the study are not known. The potential 
benefits of the study to others could be considerable. If our hypotheses are true, this study 
will make a significant contribution towards preventing HIV and syphilis in YMSM. 
This study has not been designed for the direct benefit of its participants; however, there are 
several ways in which they may derive benefit. The proposed research will increase 
knowledge of HIV and syphilis testing among YMSM. The knowledge gained will contribute 
to the body of knowledge regarding the use of health information technology for improving 
the lives of MSM at risk for HIV and syphilis. The avoidance of HIV and syphilis through 
study participation will be a significant personal benefit to participants. 
10.4.2 
Importance of Knowledge to be Gained 
The knowledge gained from this research will enable the scientific community, clinicians, and 
high- risk populations to prevent new HIV and syphilis infections in the US. 
10.5 
Participant Privacy and Confidentiality 
10.5.1 
Access to individually identified private information about human subjects 
Access to individually identified private information about human subjects will be limited to 
research team members who collect and manage the data, study staff, site principal 
investigators and the Principal Investigator. Coded data will be accessible to all members of the 
research team involved in the data analysis. Our study team is extremely prudent in keeping 
participant data secure and confidential. All laboratory specimens, evaluation forms, reports, 
and other records will be identified by a unique coded number to maintain participant 
confidentiality. The material, records, and data obtained through participation in the study will 
be specifically for research purposes. Existing health records may be used with the permission 
of the participants. Materials will be obtained by trained clinical staff at each study site. Data will 
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be stored using Research Electronic Data Capture (REDCap) at each respective performance 
site, and then the completely deidentified data will be merged at CUIMC. All laboratory 
specimens will be identified only by the identification number. The code linking the participant 
identification number to participant identifying information (name, address, etc.) is maintained 
at the clinical sites through REDCap, and only authorized site personnel have access to the 
code. Limited individually identifiable private information is collected that is essential for 
processing participant payments and for analysis purposes. 
10.5.2 
Confidentiality of the App 
The App requires a password. All study data will be encrypted and stored on secure 
HIPAA- compliant servers at the CUIMC campus. All study data will be kept in password- 
protected computers or file cabinets in locked offices and will be maintained in a completely 
secure and HIPAA-compliant environment. All CUIMC servers have HIPAA-compliant 
security. Nonetheless, there is always the risk of a data breach, so we will make our study 
participants aware of this risk upon enrollment. 
10.5.3 
Confidentiality and privacy of the study data 
All study data will be stored in password-protected computers or file cabinets in locked offices. 
Audio recordings of interviews or focus groups will be destroyed once data are transcribed 
and analyzed. All research team members will pass the protection of human 
subjects and HIPAA research exams and sign a protocol-specific conflict of interest. Risks will 
be minimized by not including personal identifying information on the forms, when possible, 
and by conducting interviews and collection of personal information in a private setting. All 
data will be collected using unique patient identification codes. All laboratory specimens, 
evaluation forms, reports, and other records will be identified by a coded number to maintain 
participant confidentiality. All records will be stored in a locked file cabinet. Study data from 
both sites will be collected and managed using REDCap. REDCap is a secure web application 
designed to support data capture for research studies, providing user-friendly web- based 
case report forms, real-time data entry validation (e.g., for data types and range checks),  
audit trails, and a deidentified data export mechanism to common statistical packages   
(SPSS, SAS, Stata, R/S-Plus). REDCap data collection projects rely on a thorough study-
specific data dictionary defined in an iterative self-documenting process by all members of the 
research team. This iterative development and testing process results in a well- planned data 
collection strategy for individual studies. REDCap also includes a powerful tool for building 
and managing online surveys. The research team can create and design surveys      in a web 
browser and engage potential respondents using a variety of notification methods. 
REDCap is flexible enough to be used for a variety of types of research and provides an 
intuitive user interface for database and survey design and data entry. Lastly, clinical 
information will not be released without written permission of the participant, except as 
necessary for monitoring by the IRB or the CDC. 
10.5.4 
Plan for privacy and data security 
Beginning with the development process and throughout the research project, we will follow 
the privacy and security principles set forth at healthhit.gov. Our team is familiar with the 
importance of the privacy and security of personal health information to engender individual 
trust in the use of health IT applications. We have expertise and experience in this domain as 
we have developed several health IT systems funded through NIH and the Agency for 
Healthcare Research and Quality for persons living with HIV whose personal health 
information is usually held to higher security standards than traditional patients as HIV has 
historically been a stigmatized disease. We built the the mLab App Plus (NIMH 
25 

Protocol Number: AAAU1706 
Version 3.4 02.14.24 
26 
 
 
 
R01MH118151) which is housed on the CUIMC IT servers. Study data from mLab App Plus 
will be stored on the CUIMC servers. The CUIMC servers are in a secure datacenter, with 
necessary redundancies. Currently the network can be accessed remotely via Virtual Private 
Network with a Citrix solution being developed. All servers have HIPAA compliant security. 
 
CUIMC has an Information Security Office (ISO) that facilitates all aspects of information 
security risk management at CUIMC, with a particular focus on threat management and 
HIPAA compliance. This includes administration and enforcement of information security 
policies on campus. 
 
The Information Security Office also provides guidance to CUIMC schools and departments 
regarding any information security concerns they may have. The ISO collaborates with the 
entire CUIMC community to protect the confidentiality, integrity, and availability of critical 
information and computer resources. The ISO strives to implement secure computing 
infrastructure and practices with sensitivity to CUIMC's educational and research 
environment. Columbia University has an information security charter which is the foundation 
of all the work carried out by Dr. Schnall and her research team. In specific, Dr. Schnall will 
work with the CUIMC IT server group and the information security office to protect the 
confidentiality, integrity, and availability of participants’ data. Confidentiality means that 
information is only accessible to authorized users. Integrity means safeguarding the accuracy 
and completeness of data and processing methods. Availability means ensuring that 
authorized users, such as research participants, have access to data and associated 
information resources when required. 
 
Prior to consent, study participants will be informed as to what data the App will collect. Data 
will be encrypted and stored securely on the CUIMC IT servers. As a starting point for 
ensuring privacy and security, all smartphones will be password–protected. In addition, there 
will be an additional password for the App so that only study participants will be able to open 
the App. 
 
 
10.6 
Unexpected and Serious Adverse Event Reporting 
 
A detailed monitoring plan will be included as part of the study protocol, submitted to the IRB, 
and reviewed and approved by the Centers for Disease Control and Prevention (CDC) before 
the study begins. Prior to initiation of the study, agreement about the data safety monitoring 
plan will be confirmed to ensure the safety of participants and the validity and integrity of the 
data. Study staff at each site will report serious adverse events (SAEs) that are unexpected 
and study-related immediately to the PI who will convey this information to the study team, 
IRB, and the CDC. All AEs and SAEs will be captured, reports will be completed, and 
information will be entered into the study database. A safety report will detail all serious and 
unexpected AEs or other unanticipated problems that involve risk to study participants or 
others and whether these appeared to be related to the study-based interventions or research 
assessment protocols. All SAEs will be reviewed every 6 months, or sooner, with 
the designated safety Data Safety and Monitoring Board. 
 
10.7 
ClinicalTrials.gov 
 
This study will be registered on ClinicalTrials.gov. 
 
11.0 
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