Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)
Phase: NA
Conditions: HIV
Sponsor: Brown University

STUDY PROTOCOL  
Title: Exploring Use of a Real-time, Remote Monitoring and Follow-up System for 
Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)  
NCT#: NCT02876926 
Date of document: Last reviewed and approved by Brown IRB on 9/15/18 

Project Title:   
Real-time, remote monitoring system for home-based HIV 
testing among high-risk men who have sex with men 
 
Principal Investigator: 
Tyler B. Wray, Ph.D. 
Co-Investigators: 
Philip Chan, MD; Don Operario, Ph.D. 
 
A. Lay Person Summary 
Rates of new HIV infections continue to increase among men who have sex with men 
(MSM), despite stability or decline among other risk groups. While a large proportion of these 
new HIV transmissions originate from among MSM who are aware of their infection but not 
engaged in care, up to 50% of infections may be transmitted by individuals who are unaware of 
their status. Home-based self-HIV testing (HBST) offers considerable promise for increasing the 
number of MSM who are aware of their status by overcoming many prominent obstacles to 
clinic-based testing, such as concerns about confidentiality and inconvenience. Studies suggest 
that many MSM who have never tested would prefer to do so at home and feel they would test 
more often with HBST. HBST may also be uniquely well-suited for connecting particularly high-
risk, “hard to reach” segments of MSM with testing. MSM who meet partners online and via 
mobile apps are among these, and an extensive body of research has shown clear relationships 
between meeting partners online and higher HIV-risk behavior. Despite the promise of HBST for 
expanding access to testing among these high-risk and “difficult to reach” MSM, prominent 
concerns prevent their widespread integration into prevention programs. Among the most vital of 
these are concerns that HBST users may not be adequately linked with post-testing resources, 
such as counseling, confirmatory HIV testing, testing for other sexually-transmitted diseases 
(STIs), and other prevention resources (e.g., pre-exposure prophylaxis). As a result, HBST users 
may delay seeking care. OraSure’s® OraQuick, the only FDA-approved HBST available, offers 
a free, 24-hour helpline that provides these services to users who seek it, but few users do and 
this “passive” approach may miss critical opportunities to engage with “hard to reach” 
populations. Coupling existing and ubiquitous technologies with the delivery of HBSTs can 
enable a more “active” system for engaging with HBST users after testing to offer timely follow-
up and post-test counseling remotely. Monitoring HBST use in real-time and providing prompt 
follow-up could be an intervention-in-itself that increases the likelihood of future testing and the 
number of users who are successfully linked with care and other prevention services. Given these 
gaps in HBST service delivery, the goals of this exploratory research are to: (1) refine 
technology that enables real-time, remote monitoring of HBST kits, allowing timely delivery of 
post-test counseling and referrals to HBST users over the phone (“Enhanced HBST”), and (2) 
test whether this “enhanced HBST” increases the likelihood of any testing, repeat testing, and 
successful linkage to other prevention services compared to standard HBST in a sample of high-
risk MSM who meet partners online. Findings can inform whether proactively following-up with 
HBST users is feasible, acceptable, and useful, and can encourage future research exploring 
optimal methods for providing follow-up.  
 
B.  Proposal for Funding 
 
See attached.  
 
C. Study Protocol 
(C.1) Significance and Specific Aims of Project 

(C.2) Participant Population 
(C.3) Recruitment Procedures 
(C.4) Design and Methods 
 
C.1  Significance and Specific Aims of Project 
 
Overall estimates of new HIV infections in the United States have remained steady in the last 
decade1, reflecting considerable advances made in treatment and prevention using combination 
biomedical, behavioral, and social approaches2. However, annual HIV incidence continues to 
rise among men who have sex with men (MSM). MSM accounted for 63% of all new infections 
in 20103,4 and this rate is expected to climb 3% each year5. Despite these increases, modeling 
studies suggest that nearly 90% of new infections can be prevented using tools that already 
exist6. However, for this goal to be realized, innovative strategies are needed to speed the 
proliferation of these tools and increase their uptake among at-risk and “hard to reach” groups.   
 
While studies suggest that many new HIV transmissions originate from those who are aware 
of their infection but not engaged in care, up to 50% of new infections may originate from those 
who are unaware of their infection7,8. As such, exploring ways to expand access to HIV testing 
and encourage frequent and regular testing among at-risk groups is key to reducing the spread of 
HIV and could have a profound impact on the epidemic. In 2012, the first home-based, rapid 
self-administered HIV test (HBST; OraSure® Technologies, Bethlehem, PA) was approved by 
the FDA and made publicly available for sale. HBST offers many advantages over clinic-based 
testing, including the potential to reach more individuals who are at-risk for HIV infection and 
encourage them to test more often. Past studies suggest that the majority of MSM, including 
MSM who have never tested15,16, would prefer to test at home, and many felt they would do so 
more often with HBST11,13,14. Among the most prominent obstacles to traditional testing include 
difficulty seeking testing during work hours and the inconvenience of attending clinics (e.g., 
travel, wait times) 11,12. HBST may also be well-suited for connecting particularly high-risk, 
“hard to reach” segments of MSM with testing. MSM who meet partners on mobile apps are 
among these. An extensive body of research has shown clear relationships between meeting 
partners online and higher HIV-risk behavior9. Although few studies are available, some 
evidence suggests that these individuals are less likely to have ever had an HIV test and may be 
more likely to use HBST versus clinic-based testing10. Together, these studies suggest that HBST 
could overcome many of the most common barriers to testing, and that it may be useful for 
engaging high-risk MSM who meet partners online.  
 
Despite HBST’s promise for expanding testing in this high-priority population, many salient 
concerns remain about its use in real-world settings. Among the more critical of these is that 
HBST users may not be adequately linked with vital resources after testing, which may result in 
critical delays in seeking care and additional resources, such as confirmatory testing, testing for 
other sexually-transmitted infections (STIs), and other prevention resources (e.g., pre-exposure 
prophylaxis [PrEP], risk reduction counseling)11.Others have also expressed concern about the 
lack of post-test counseling in HBST12,13. Currently, OraSure® offers a 24-hour helpline that 
provides test counseling and referrals to local HIV prevention/care services13, but this approach 
is passive and relies on users to “reach out” for these services. Coupling existing and ubiquitous 
technologies with the delivery of HBSTs can enable a more “active” system for engaging with 
HBST users after testing to offer prompt follow-up and post-test counseling over the phone. In 
this “enhanced HBST” system, a mobile monitoring sensor detects when HBST kits are opened, 
triggering an alarm on dedicated mobile phones carried by qualified HIV test counselors 

(QHTC), prompting them to follow up with users over the phone within 24 hours. Conducting 
active follow-up through “enhanced HBST” may increase the number of HBST users who 
receive follow-up counseling and are referred/linked with care, confirmatory testing, and 
additional services. Providing timely follow-up counseling via enhanced HBST could also be an 
intervention-in-itself that increases the likelihood of future testing. To address this gap in service 
deliver, this proposal aims to: 
 
Specific Aim 1: Refine technology that enables real-time, remote monitoring of HBST kits, 
allowing delivery of post-test counseling and service referrals to HBST users over the phone 
(“Enhanced HBST”). This will be accomplished using an iterative developmental process 
informed by qualitative methods with target group members to produce a feasible and acceptable 
system for conducting “active” follow-up after HBST. 
 
Specific Aim 2: Explore whether “enhanced HBST” results in higher rates of (2a) any and 
repeat testing, (2b) receipt of post-test counseling, and (2c) follow up for additional services 
(e.g., STI testing, PrEP) versus standard HBST.  
 
Secondary Aims: We will also explore potential within- and between-subject effects of 
Enhanced HBST versus standard HBST on positive/negative affect, social support, sex risk 
behavior, and health empowerment.  
 
Overview of the research: During a “start-up” period of 6 months, we will use qualitative 
methods (focus group [N=8], individual interviews [N=10]) to inform ongoing consultation with 
Devicix (an electrical and software engineering firm) on refining a mobile technology for 
monitoring HBST use, ultimately preparing it for deployment. Then, during the “study phase,” 
40 high-risk MSM in the Providence, RI area will be randomly assigned to one of two 
conditions: An “enhanced” HBST condition (N=20) or standard HBST (N=20). In both 
conditions, 3 HBST kits will be sent by mail at 3-month intervals over the course of 6 months 
(baseline, 3-months, 6-months). We chose to deliver HBSTs by mail given recent evidence that a 
majority of MSM prefer this method of receiving kits (as opposed to pharmacy pickup or 
vending machines)50,51. In the “enhanced” HBST condition, mailed test enclosures will be 
equipped with a mobile monitoring sensor (see Section 3C.3.1.) that triggers an alarm on 
dedicated mobile phones carried by qualified HIV test counselors (QHTC). QHTCs will then 
conduct a follow-up call to the user within 24 hours. In the HBST alone condition, test kits will 
simply be mailed to participants with contact information for local HIV care, confirmatory 
testing, STI testing, and PrEP. All participants will be oriented to the study during a baseline, in-
person appointment at Brown University. Then, participants will complete monthly assessments 
online over the course of 7 months while on the study (see Fig. 1 for a timeline). To complete the 
project within the 2-year period, 4 participants per month will be recruited on a rolling basis 
(beginning in month 6 of year 1), allowing all participants to finish the study by month 10 in 
Year 2.  
 
C.2 Participant Population 
 
The research has three phases: (1) Focus group phase [N = 8], (2) individual interview 
phase [N = 10], and (3) pilot study phase [N = 40]. All participants (regardless of which phase 
they are participating in) will meet the same criteria.  
 
Inclusion criteria are as follows: 
 
1. 
Biologically male 
 
2.  
Aged 18 or older 

 
3. 
Have not been tested for HIV in the last year 
4. 
Report unprotected anal sex (or anal sex without a condom or having taken PrEP 
that day) with a casual male partner at least once in the past 6 months 
5. 
Sex with a partner met online in the past year 
6. 
Stable residence 
7. 
Use of an Android smartphone with service contract and data plan 
8. 
Fluent in English 
 
 
Exclusion criteria:  
 
1. 
Individuals who are HIV-positive 
 
2. 
Individuals who participated in other phases of the research 
3. 
Individuals who report being coerced to participate 
 
C.3 
Recruitment Procedures 
 
We will recruit participants using ads in social networking mobile apps and websites that 
gay men often use to meet partners (e.g., Grindr, Jack’d, Adam4Adam). App users who click on 
an ad will be directed to a webpage that provides more information on the study. If they are 
interested in participating, a link an online screening survey will be made available at the bottom 
of the page. Participants will provide their informed consent prior to answering questions on the 
screen. The screening questionnaire will be collected using Qualtrics® survey software. 
Screening items will only address eligibility criteria (see Appendix B, Section I.). Participants 
determined to be eligible based on this brief screening will be contacted by email and phone to 
provide more information about the study. Participants who are interested in participating in the 
full study will then schedule an appointment to come to the research offices at Brown.  
 
 
C.4 
Design and Methods 
Phase I: Start-Up and Qualitative Research 
 
 
Focus groups. At the start of the project period, we will conduct a focus group with 8 
participants from the target group in which we will present the proposed monitoring and follow-
up system, and solicit participant feedback. Key questions to be addressed include the 
desirability of “active” follow-up after HBST, when and how participants would like to receive 
follow-up, and what users would like follow-up calls to address. $50 will be paid to focus group 
participants.   
 
Individual interviews. After test versions of the technologies are available, we will recruit 10 
high-risk MSM to use the system and provide their feedback. We will recruit participants who 
are “willing to take a home HIV test” online and meet similar eligibility criteria to that of the full 
study (see 3C.4.2). Those eligible will be asked to come to the research offices, where the study 
will be explained. Consenting participants will then download study software onto their 
smartphones, and research assistants (RAs) will provide them with an HBST kit equipped with a 
BLE sensor, asking them to use the test within 1 week. They will be informed that a QHTC will 
contact them by phone within 24 hours of opening the test. During calls, QHTCs will conduct the 
normal follow-up procedures (e.g., post-test counseling, referral for services, see Section 
3C.4.4), and a brief, 20-minute qualitative interview about their experience using the system. 
Interviews will also inquire about participants’ preferences for receiving follow-up (e.g., when 
and how follow-ups are conducted) and other aspects they would like QHTCs to address during 
calls. Participants will be paid $30. 

 
Analysis and study set-up. Recordings of focus groups and individual phone interviews will 
be collected and transcribed. Themes about important considerations for conducting follow-up, 
(e.g., how long after testing to do so, issues to address during contacts) and issues with the 
monitoring system will be extracted and used to inform iterative changes in the monitoring 
hardware/software prior to the study phase. This data will also inform the process of providing 
monitoring and follow-up during the study phase. This 6-month start-up phase will also be used 
to refine manual data entry systems needed to conduct the proposed research, such as a front-end 
that can be used by study staff to enter data into the study database (e.g., RAs pairing beacons 
with participants, QHTCs entering data about whether post-test counseling and specific referrals 
provided during follow-up calls). Devicix has provided assurance that the prototype can be 
refined for implementation in the proposed project within the allotted timeframe (see Letter of 
Support).  
 
Phase II: Pilot Study Phase 
 
Experimental conditions. In this 7-month longitudinal study, 40 participants will be 
randomized to receive either “enhanced” HBST (N=20) or standard HBST (N=20). All will have 
3 OraSure® test kits shipped to their homes 1-week after baseline, 3-months, and 6-months. 
Those in the “enhanced” HBST condition will receive follow-up calls within 24 hours after 
opening their tests. Those in standard HBST will be provided contact information for local 
services in their test kits, in addition to the information provided by OraSure®.  
 
Measures. Demographics, past HIV testing history, sexual behavior, and other relevant 
variables will be collected at baseline. Throughout the 7-month study period, participants will 
complete online assessments each month inquiring about whether they used a study-provided 
HBST kits in the last month and what the result was. Items will also assess whether they were 
provided referral to a local agency for additional prevention services (e.g., additional HIV 
testing, STI testing, PrEP consultation, HIV risk reduction counseling) by a professional in the 
last month, and whether they sought each service over the last month. Participants will also 
complete Timeline Follow Back (TLFB55,56) assessments of their sexual behavior over the past 
month. The TLFB has proven to be one of the more reliable and valid assessments available for 
sexual behaviors57-64, and recent evidence suggests that optimal accuracy in reporting may be 
achieved with short follow-up periods (e.g., 30 days)52. Monthly online assessments will also 
measure general positive/negative affect over that time using the positive and negative affect 
scales of the PANAS-X65, a 20-item scale that asks participants to rate various emotion words 
according to the extent they have “felt this way over the past month,” on a 1 (very slightly) to 5 
(extremely) scale. These subscales have excellent psychometric properties when used to measure 
trait affect65. Health empowerment will be measured each month using the Patient Activation 
Measure (PAM-1366), and social support will be assessed with 3 subscales of the Received 
Support Scale (Emotional, Informational, Satisfaction). Both measures have excellent 
psychometric properties66-69.  

 
Procedure. See Figure 3 for study timeline. Interested participants will be screened online, 
and those eligible will be contacted by a research assistant (RA), who will schedule an in-person 
appointment to begin the study. At this appointment, participants will complete baseline 
measures and be oriented to the study. In the “enhanced” HBST condition, participants will be 
informed that sensors will 
accompany their HBST kits 
and to expect a call from 
study QHTCs within 24 
hours after opening them, 
should they choose to test. 
Study software will then be 
downloaded onto the 
participant’s phone, and 
they will be instructed to 
keep their Bluetooth feature 
enabled at all times and to 
keep their phone near them as much as possible over the 7-month study. They will also be 
instructed to inform study staff as soon as possible should they lose their phones, change phones, 
or their current service contract lapses. One week after the initial appointment, an HBST kit will 
be sent to participants’ verified addresses. Shipment tracking will be used to record data about 
when HBST participants receive their tests. In “enhanced” HBST, participants, opening their 
mailed test enclosure will trigger an alert on the study database, which is monitored regularly by 
staff QHTCs. These alerts will instruct QHTCs to conduct a follow-up call with participants. 
QHTCs will be CAAS postdoctoral trainees with Ph.D.’s in clinical psychology who have 
completed additional training in HIV testing counseling (offered by Dr. Chan), suicide 
prevention intervention (offered by nearby Lifespan Hospital), and study-specific follow-up 
procedures. QHTCs will take turns placing follow-up calls. QHTCs will conduct calls while in 
private offices on Brown University’s campus. As such, they will be able to access the study 
database while conducting the calls, so as to allow check-ins about previous referrals and data 
entry during calls. QHTCs will follow up with participants within 24 hours after the test is 
opened. During follow-up calls, QHTCs will verify whether the participant has completed the 
test, what the result was, and ask whether the participant would like to receive counseling, 
entering this data into the study database. For reactive results, QHTCs will facilitate 
appointments for confirmatory testing. For non-reactive results, QHTCs will inquire about 
participants’ interest in other prevention services (e.g., STI testing, counseling). QHTCs will also 
screen for suicidality and record this information using the data entry forms, providing 
intervention/referral if needed. If participants indicate they have not taken the test yet but plan to 
do so, QHTCs will ask when they plan to take the test and whether there is a better time to 
contact them again. If a participant cannot be reached during the 24-hour post-test window, the 3 
additional follow-up attempts will be made over the following 72 hours. This process will repeat 
for tests sent at 3 and 6 months. To facilitate monthly study assessments, participants will receive 
an email with a link to an each assessment specific to that participant and time period. 
Participants will be asked to complete these on a desktop computer within 2 days of receipt, and 
failing to do so within that time will prompt the RA to follow up via phone and email to 
encourage adherence. Once the study is complete, the RA will follow-up with participants over 
the phone to conduct a 30-minute qualitative interview. This interview will assess participants’ 
Figure 3. Timeline of study assessments 

perceptions of “enhanced” HBST or HBST alone, additional procedures/services they might 
have preferred. Those in the “enhanced” condition will be asked about their impressions of 
counseling over the phone and the usability of the monitoring method. Participants will be paid 
$20 for completing the baseline in-person appointment and $15 per monthly assessment ($105 
total), with a $55 bonus for completing all assessments on time (within +/- 5 days of being 
assigned). 
 
Planned Analyses/Power Considerations. As this is a preliminary study, the primary goal is to 
explore evidence for the feasibility, acceptability, and utility of “active” monitoring and follow-
up with HBST, as well as its effects on testing likelihood and frequency compared with usual 
HBST. As such, data analysis will be primarily descriptive. To address Aim 1, we will explore 
the number of successful phone contacts with those in the “enhanced” HBST condition, whether 
contacts involved counseling and/or referral, and qualitative data/ratings of acceptability, 
feasibility, and preferences. To address Aim 2a, we will compare the overall number of 
participants reporting any HBST use and the mean number of tests used across the conditions 
over the study period. To address Aim 2b/c, we will also compare the number of participants 
receiving HIV test counseling, referral for additional prevention services, and the number who 
successfully followed-up with these services. Finally, to address the secondary aims, we will 
compare mean frequencies of unprotected anal sex (condomless or without having taken PrEP 
that day) and mean levels of positive/negative affect, health empowerment, and social support by 
condition and testing status. We are aware of the limitations of relying on small scale studies for 
generating broad conclusions about the efficacy and/or effect sizes of interventions96. As such, 
we are primarily interested in examining the pattern of results, rather than definitively testing 
hypotheses. We believe a sample size of 40 should allow some exploration of the direction of 
effects, while remaining within the scope of an exploratory project.  
 
C.5. 
Human Subjects Involvement, Characteristics, and Design 
Participants will be 40 males who are 18 years of age or older, who report having sex 
with a partner met online in the past year, and who have not received an HIV test in the last year. 
Focusing recruitment toward these individuals will allow us to examine whether remote 
monitoring and follow-up after HBST are helpful specifically among those who rarely test and 
may be “hard to reach” with more traditional HIV prevention services. Eligible participants will 
also report having had unprotected anal sex (anal sex without a condom or having taken PrEP 
that day) with a casual male partner at least once in the last 6 months. This criterion will ensure 
that the research is conducted among MSM who are at high risk for HIV. Since the research 
involves receiving HBST kits by mail, eligible participants will also be required to have a secure 
and stable residence to minimize the potential that tests may be stolen or diverted. This criteria 
was informed by past qualitative studies suggesting that most high-risk MSM prefer to receive 
tests by mail50; 51, as opposed to other delivery avenues (e.g., vending machine, pharmacy 
pickup). However, future research should address methods for providing “active” follow-up after 
HBSTs that are delivered via these routes, since many at highest risk may not have stable 
residences. Next, to be eligible, participants must currently have an Android smartphone with a 
data plan. If successful, we hope to extend this technology to iPhone users, since they constitute 
a large share of the overall smartphone market. However, acquiring approval for iPhone-
compatible software is an extensive process that often takes months. The Android platform is 
open source, allowing flexibility in deployment, so the current study will focus on Android users. 

Finally, eligible participants will also be required to be fluent in English. While many of the 
study’s materials could be easily translated into Spanish (or other languages), hiring bilingual or 
Spanish-speaking QHTCs that are able to conduct follow-ups would be prohibitive for a study of 
this scope. No special or vulnerable populations, as defined by 45 CFR Part 46 (e.g., prisoners, 
pregnant women, fetuses) are involved. 
Participants will be recruited from the community using ads in popular gay social 
networking mobile apps (e.g., Grindr, Jackd, Scruff). Participants expressing interest in the study 
will be screened online. Those meeting eligibility criteria will be contacted by phone and email 
to schedule an in-person appointment to begin the study. Next, participants will complete 
baseline measures online. Then, participants will be randomized to a condition. For those in the 
“enhanced” condition, RAs will inform participants about the study’s purpose and guide them in 
downloading study software onto their smartphones. Although participants will not need to 
actively provide any input through the app, RAs will instruct participants to keep the app 
installed, their Bluetooth sensor enabled, and their phones near them throughout the 7-month 
study. RAs will also ask participants to notify them as soon as possible if they lose their phone or 
get a new one, their data is erased, or if their service plan changes. Next, RAs will inform all 
participants that they should expect to receive an email each month with a unique link, and that 
clicking this link will allow them to complete their monthly assessments. They will also be 
informed that HBST kits will be mailed to them 1 week after their appointment, and then again 
in 3 months and 6 months, which they can choose to take or not. However, should they choose to 
do so, those in the “enhanced” condition will be told that they should expect a call from a QHTC 
associated with the study  within 24 hours after opening their test, and that these calls are 
intended to provide counseling and referrals after taking the test (which participants can refuse). 
Finally, participants will be asked to complete a 30-minute follow-up interview about the study 
via phone after completing the study. They will be informed that they can pick up payments for 
completing study assessments at the research offices anytime during or after the study.  
Those in the “enhanced” HBST condition will receive follow-up calls within 24 hours 
after opening their tests. These calls will be made by CAAS Postdocs who have Ph.D.’s in 
clinical psychology and who will receive training in HIV test counseling (provided by Dr. Chan) 
and suicide prevention intervention (provided by behavioral health staff at The Miriam Hospital). 
Training by Dr. Chan will involve modeling counseling interactions, role playing with QHTCs, 
and direct observation during clinic-based testing conducted at the Miriam Immunology Clinic. 
Dr. Chan will also provide ongoing supervision to these QHTCs throughout the study. Follow-up 
calls will follow the CDC’s guidelines for HIV counseling, testing, and referral80, and as such, 
will involve the same post-test counseling procedures offered by paraprofessionals and service 
providers in clinic- and community-based settings worldwide. Participants will be screened for 
suicidality during these calls, and if necessary, intervention will be provided according to 
National Suicide Prevention Lifeline procedures81,82. Referrals will be offered to local, LGBT-
friendly agencies for additional HIV/STI testing, additional HIV prevention services (PrEP, risk 
reduction counseling), substance abuse treatment, mental health treatment, and primary care. 
During 3- and 6-month follow-up calls, QHTCs will also assess whether referral for these 
specific services was provided during the previous call, and if so, whether the participant sought 
these services (questions also assessed via monthly online assessments). For participants testing 
positive, participants will be assured that an initially reactive result is not a confirmed positive 
result, and will be scheduled for an appointment to conduct confirmatory testing at The Miriam 

Immunology Clinic (MIC) as soon as possible. The MIC has standard procedures for providing 
newly diagnosed patients ongoing HIV care.  
All study procedures, including data collection, will be conducted by research staff, the 
PI (Dr. Wray) or Co-Investigators (Dr. Chan and Dr. Operario). Research staff will receive 
intensive training in all study procedures from Dr. Wray, Dr. Chan, and Dr. Operario.  
 
C.5.1 Sources of Materials 
 
Self-report data collected from participants throughout the course of the study will be 
obtained using the following methods:  
1. Focus groups will be conducted in-person during the study’s start-up phase to 
solicit feedback about the mobile monitoring system. It will also solicit feedback 
about use and follow-up issues that will be used to refine the technology use 
(during the start up phase) and follow-up procedures (during the study phase). 
2. Individual interviews will be collected over the phone during the start-up phase to 
collect feedback from individual high-risk MSM about their experiences using the 
mobile monitoring system that inform further refinement of the system and 
procedures used during the study phase. Phone interviews will also be conducted 
at the conclusion of the study among all participants to address general usability 
of HBSTs, preferences for follow-up, and experiences using the “enhanced 
HBST” system (for those in this condition). Phone interview data will also be 
collected during follow-up calls placed during the study phase to those in the 
“enhanced HBST” condition, and will assess whether participants used their test, 
what the result was, whether they would like to receive post-test counseling, 
whether they would like to receive referrals, and whether they followed up on any 
referrals offered during the previous follow-up calls. 
3. Online questionnaires, will be used to collect screening, baseline, and monthly 
assessment data.  
4. Online web application, used to specifically collect TLFB data in monthly 
assessments 
 
Focus group data will be collected during in-person focus group meetings with members 
of the target population. These methods will produce qualitative data in the form of handwritten 
notes, digital recordings (collected using a digital voice recorder) and transcripts for analysis. 
Focus groups will be moderated by Dr. Operario, and will generate data in the form of written 
notes, voice recordings, and transcripts, none of which will contain participant identifiers. 
Contact data will be collected via online screening to facilitate scheduling focus groups, but will 
be deleted after focus groups are completed. We will use this data to inform both the refinement 
of the “enhanced HBST” system and how we conduct follow-ups after testing during the study 
phase.  
Individual interviews will be collected over the phone from a 10 participants from the 
target population during the start-up phase, and from all participants in the study phase after 
completing the study. These interviews will also be recorded, and will generate data in the form 
of written notes, digital recordings, and typed transcripts, all of which will contain no participant 
identifiers. Interviews will be conducted by a trained RA, with Dr. Operario providing 
comprehensive training and supervision. Interviews collected during the start up phase will 
inform both refinement of the “enhanced HBST” system and how we conduct follow-ups after 

testing during the study phase. Interviews conducted after “study phase” participants complete 
the study will focus on the unique experiences participants have using the “enhanced HBST” 
system over multiple tests delivered by mail and will inform further refinement of the system for 
use in future research and prevention.  
Online questionnaire data will be collected using Qualtrics© web survey software, which 
uses Transport Layer Security encryption for any data transmitted, protects surveys with 
passwords, and uses HTTP referrer checking. Data collected via Qualtrics© will only contain 
participants’ unique study ID codes and will be briefly stored via Qualtrics, but downloaded 
weekly to Brown University’s secure internal servers and password protected so that they are 
accessible only to essential research staff. TLFB data collected via online web application will be 
stored directly on Brown University’s servers and will be similarly encrypted and password-
protected.  
Finally, interview data collected during telephone contacts will be entered into a custom 
database that can be accessed by QHTCs while on the Brown University campus. This database 
will be hosted on Brown’s internal servers and will be password-protected. Post-study interview 
data will be stored separately from other study data, in secure, password-protected files.  
 
 
To facilitate remote monitoring and follow-up, the following data will be obtained, 
relayed, and stored without input from users:  
1.Bluetooth low energy (BLE) beacons, will transmit a unique code (UUID) and 
native sensor data about the state of the HBST kit enclosures when the sensor 
changes to “open.” 
2.Participant-side mobile application, will use the Bluetooth sensor on the 
participant’s smartphone to relay the unique code of the BLE and its state (open, 
closed) to a database hosted on Brown servers. 
3.Centrally-hosted database, which will store minimally-identifying data about 
participants that is needed to facilitate follow-up, links this information with BLE 
UUID’s via participants’ unique study ID numbers, and listens for changes in the 
state of these BLE UUIDs to “push” relevant information to the research-side 
mobile application. 
 
The BLE will only transmit its unique code (UUID) and the state of its sensor (open, 
closed) to the participant-side mobile app, and is not identifiable. The participant-side mobile 
app only “listens” for a change in the BLE’s state, and transmits this data and the beacon’s UUID 
to the centrally-hosted database. Given this, this data is also not identifiable, and will be stored 
only briefly via the device’s internal memory until it is relayed, and then erased. The app itself 
will only consist of a splash screen with the School of Public Health logo on it, and will be 
named “Test Helper.” The centrally-hosted database will use Filemaker, and will be used to 
store minimally-identifying data (e.g., unique study ID, first name, phone number) about 
participants for the purposes of conducting monitoring and follow-up. The database will also be 
used to link incoming data (UUIDs, sensor state) with participant data (via unique study ID 
numbers), and to provide notifications/scheduling to QHTCs who need to conduct follow up 
calls to participants. The database will also provide a front-end that facilitates data entry by 
QHTCs as they are conducting follow-up. This database will be hosted on Brown University’s 
secure servers and password protected, so that only essential research staff will have access.  
 

Finally, a separate database containing participants’ full contact information (including address) 
and a unique linking ID number will be stored in a separate location on Brown’s internal servers. 
This database will be used by RAs to ship HBSTs to the addresses participants have provided. It 
will be password-protected and only accessible to essential research staff via computers 
physically located in the research offices. This database will contain no other study data, and can 
only be linked with other study data via a linking ID.  
 
D.  
Risks to Participants and Procedures to Protect Against Risk 
 
Participation in this study involves no physical risk above those ordinarily encountered in 
daily life. However, there may be several non-physical risks: 
 
1. There is a small risk of loss of privacy and confidentiality of data, including data that is 
sensitive (sexual risk-taking, psychological characteristics). We take this risk very seriously, 
and will take steps to protect participants’ confidential data and anonymity, as detailed in 
Section B2. We will ensure that personal identifiers are removed from any stored data after 
the study is completed, as well as any reports/publications arising from the study. Informed 
consent documents will bring confidentiality risks to participants’ attention.  
 
2. Participants may also experience psychological discomfort while in the study, as a result 
of completing HIV testing at home, receiving “reactive” results from these tests, or while 
completing study questionnaires, since these inquire about sensitive behaviors (e.g., sexual 
behavior, affect).   
 
D1.  
Adequacy of Protections against Risk 
 
We will make every attempt to minimize risks to participants throughout the study 
protocol, including loss of privacy or confidentiality and psychological discomfort.  
 
D.1.1. Recruitment and Informed Consent Procedures 
 
Recruitment. All participants will be recruited via advertisements placed on gay-oriented 
social networking mobile applications (e.g., Grindr, Scruff). Interested participants will be 
instructed to contact research staff via phone or email, and upon doing so, will be directed to an 
online screen that assesses the study eligibility criteria. A separate online survey will be used to 
collect contact information, and will be linked to participants’ screening responses using a 
unique ID code. Datasets containing screening data and contact information will be stored in 
separate locations on Brown University’s secure servers and password-protected. A single 
dummy variable will be used to identify eligible participants, who will be contacted by research 
staff to provide further details about the study and inquire about participants’ interest in 
enrolling. If interested, participants will be scheduled for an appointment to come to the research 
offices to complete baseline measures and be oriented to the study. Those recruited for focus 
groups will be asked to attend the group meeting, and will be shown the “enhanced HBST” 
system and asked for their feedback. During the individual interview phase of start-up, 
participants “interested in providing feedback after taking a home HIV test” will be recruited. 
They will be scheduled for an in-person appointment at the research offices, and provided with a 
beacon-monitored HBST kit, and told to expect a follow-up call 24 hours after opening their test. 
After conducting the normal follow-up call procedures (i.e., providing post-test counseling and 
referral, if desired), QHTCs will conduct a brief follow-up qualitative interview about 

participants’ experiences using the test. Those randomized to a study condition during the study 
phase will be mailed HBST test kits to their home addresses, which will be stored in a database 
hosted on Brown University’s secure internal servers, password-protected, and can only be 
accessed from computers physically located at the research offices. A unique link will also be 
emailed to participants each month over the course of the study to facilitate completion of 
monthly assessments. Screening, baseline, and monthly assessment data will be stored according 
to protocols for handling sensitive information, and we will destroy all identifying information 
after the study is completed. Participants will be compensated based on completion of study 
appointments, monthly assessments, and follow-up interviews. Focus group participants (N=8) 
will be paid $50. Individual interview participants (N=10) will be paid $30. Participants will be 
paid $20 for completing the baseline in-person appointment and $15 per monthly assessment 
($105 total), with a $55 bonus for completing all assessments on time (within +/- 5 days of being 
assigned). This compensation schedule is consistent with standard reimbursement amounts for 
research involvement at the Center for Alcohol and Addiction Studies at Brown University, thus 
posing little risk of coercion. Payments will be issued in cash. Recruitment and compensation 
procedures have been approved by the Brown University Research Protections Office IRB.  
 
 
Informed Consent. The informed consent process will be conducted by trained staff 
members that possess research experience working with the target populations and who are also 
trained in the ethical treatment of human subjects. Staff members will also be trained in more 
advanced research topics, such as protocol adherence, quality assurance, data management, and 
so on. The process of informed consent involves presenting a detailed verbal description of the 
study as it is described on the printed, IRB-approved consent form. Staff will emphasize that 
participation is voluntary, and that participants can refuse to answer any question and/or can 
discontinue participation at any time without penalty. Interviewers will ask whether participants 
have experienced any coercion to take part in the study; those that describe any pressure or 
coercion to participate will be excluded. Potential subjects receive an item-by-item reading of the 
consent form by the study staff. Participants will be informed of the procedures for ensuring their 
confidentiality, including: the use of unique non-personally identifying ID numbers instead of 
names on research materials, and maintenance of data on secure computers, devices, and servers. 
Compensation for participation will be explained. All participants will be given the contact 
numbers of the Principal Investigators and Research Protections Office to answer questions 
about the study or one’s rights as a human subject as well as a research site contact number. All 
consenting participants will be offered a copy of the informed consent form. 
 
D.2  
Procedures to Protect Against Risk 
 
Several measures will be implemented to protect against the loss of privacy and/or 
confidentiality. First, digital audio recordings from focus groups and phone interviews will be 
stored in a locked cabinet in a locked office until they are transcribed, which will take place no 
longer than a week after they are collected. No participant identifiers will be associated with 
these recordings, and prior to conducting the interviews/focus groups, participants will be asked 
to refrain from providing any information that could identify them. Once transcribed, original 
voice recordings will be destroyed, and any identifying information provided during the 
interview will be edited out of transcripts by RAs. Transcript files will be stored in secure, 
password-protected files on Brown University’s servers. Handwritten notes collected by staff 
during focus groups/individual interviews will also contain no identifying information, and will 

be stored briefly in a locked file cabinet in the Investigators’ offices until they can also be 
transcribed (no longer than a week after they are generated), and then destroyed.  
Screening, baseline, and monthly assessment data collected online will be stored briefly 
via Qualtrics© web survey software in de-identified format, before being downloaded weekly 
and stored in de-identified, password-protected files on Brown University’s secure servers. 
Participant identifying information will be kept in a separate database from study data, in a 
password-protected file that contains only their unique study ID. Data facilitating monitoring 
(e.g., participant first names, contact phone number) will be stored in a database that is centrally 
hosted on Brown University’s secure internal servers, and password-protected so that only 
essential study staff have access. Sensor and BLE ID numbers are not identifiable, and the 
participant-side mobile app will only be used to relay this information to the centrally-stored 
database on Brown’s servers. As such, the participant-side mobile application will not store any 
participant data. After being linked with participant IDs in the secure centrally-hosted database a 
notification and calendar event will be created to let QHTCs who regularly monitor the database 
know that they need to conduct a follow-up call with participants. These follow-up calls will be 
conducted in private offices available at Brown University. HBST test kits will be mailed to 
participants in discreet packaging and participants will be trained to look for these at 1-week, 3-
months, and 6-month intervals. They will also be provided with tips for allowing maximum 
privacy when opening and taking the test. Participants will also be instructed about how to 
properly dispose of any tests they take, and OraSure’s® test kit provides packaging for discreet 
and safe disposal. When conducting follow-up calls, QHTCs will first ensure that participants 
have adequate privacy to discuss the test over the phone, and if not, follow-up calls will be re-
scheduled. Finally, while monthly email notifications providing the link for monthly assessments 
will contain no identifying information or other data, participants will be instructed to delete 
these emails after they have completed their assessment.  
 
Several measures will also be employed to minimize psychological discomfort or distress 
as a result of the research. First, while participants may experience some discomfort while taking 
an HIV test at home, past research suggests that this risk is low 42-44, and OraSure’s clinical trial 
data suggests that HBST can be completed safely, resulting in minimal distress. The FDA has 
also deemed that this product can be used safely by the general public. Nevertheless, participants 
in either condition will be encouraged to report any distress they experience as a result of testing 
to study staff, who will provide referral to LGBT-friendly treatment providers in the local area. 
Second, while some participants may receive “reactive” results during the study, staff will 
prepare them for this during their orientation visit and encourage participants to interpret this 
merely as “reactive” (rather that “positive”), since further testing is needed to confirm “positive” 
results. Participants in either condition will also be encouraged to report receiving “reactive” 
results to study staff as soon as possible, and will be provided with contact information for doing 
so. These participants will then be scheduled for confirmatory testing appointments at MIC, 
which has established procedures for conducting follow-up testing and engaging these patients in 
care. Finally, the risk of distress or discomfort from study assessments is low, but participants 
will again be encouraged to report this to study staff as soon as possible. Staff will then provide 
referrals to local MSM-friendly treatment resources and emergency services. In addition, 
research staff will be trained in responding to adverse events, including participant distress. 
These events will be reported promptly to the Brown University IRB.  
Finally, to ensure that all participants are encouraged to seek follow-up testing and care 
after testing, participants indicating that they have taken a test on the monthly assessment (either 

provided by us or from another clinic) will be asked what the results of this test were. If it was 
reactive or positive, we will ask whether confirmatory testing has been completed or is pending 
and whether participants are currently under the care of a physician who is attending to these 
issues. For those noting having received a “reactive” result from a study test, who is not pursuing 
confirmatory testing and/or is not under the care of a physician who is aware of this issue, we 
will follow-up with these participants as soon as possible over the phone. The monthly 
assessment data will only contain participants’ unique study ID numbers, and will not be 
identifiable until it is downloaded and imported into the study databases. We will download and 
monitor the study monthly survey data every 48 hours, and for every participant with this 
constellation of responses, we will follow up with them over the phone to offer to make 
appointments with them for confirmatory testing and follow-up care.