eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
Phase: NA
Conditions: HIV Infections
Sponsor: Brown University

Official Title: eTest: Real-time, Remote Monitoring System for Home-based HIV Testing 
Among High-risk Men Who Have Sex With Men 
NCT Number: NCT03654690 
Document Date: 10/01/2018 

BROWN UNIVERSITY 
INSTITUTIONAL REVIEW BOARD 
HUMAN RESEARCH PROTOCOL 
 
Protocol Title:  eTest: 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. 
Department: Center for Alcohol and Addiction Studies 
Funding Source (if no external funding for the project, enter "University"):  University 
 
If externally funded, Coeus Institute Proposal # for the project:       
 
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Date:  __04/03/18______  
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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; Lenadro Mena, MD, James Brock, MD; 
Jeffrey Klausner, MD; Jack Needleman, Ph.D. 
 
A. Lay Person Summary 
HIV disproportionately affects men who have sex with men (MSM) in the United States, 
and new infections continue to increase particularly among African American (AA) and 
Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections 
originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV 
testing can produce reductions in incidence when implemented on a broad scale by facilitating 
earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L 
MSM, and innovative approaches to encourage testing may help address high incidence in these 
men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the 
number of MSM who are aware of their status by overcoming key barriers to clinic-based 
testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-
suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low 
testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently 
connect users with critical post-testing resources, such as confirmatory testing and care among 
those who test positive, and that these limitations may result in delayed linkage to care. Existing, 
FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who 
seek it, but few users do, and this “passive” approach may miss critical opportunities to engage 
with MSM for further prevention services.  
To address these challenges, we developed a mobile health platform (“eTEST”) that uses 
internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, 
allowing us to provide timely, “active” follow-up counseling and referral over the phone after 
they do so. In a pilot study, we show that providing HBST by mail at regular intervals boosted 
rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing 
reminders. Moreover, those who received follow-up phone counseling after HBST were more 
likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to 
initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered 
efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV 
incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not 
tested for HIV in the last year will be recruited from MSM-oriented “hook-up” mobile apps, and 
assigned to receive either (1) HBST with post-test phone counseling/referral (“eTEST” 
condition), (2) “standard” HBST without active follow-up, or (3) reminders to get tested for HIV 
at a local clinic (“control” condition) at three month intervals over the course of 12 months. We 
will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, 
receipt of additional HIV prevention services, and PrEP initiation, compared with standard 
HBST or clinic-based testing reminders alone. We will also explore the cost effectiveness of the 

 
 
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eTEST system under various scenarios compared with relying on traditional, clinic-based testing 
alone. 
 
B. Protocol Narrative 
B.1 Significance and Specific Aims of Project 
Significance. Although overall HIV incidence in the US has remained stable in recent years, new 
infections continue to increase in certain groups of men who have sex with men (MSM)1. In 
2014, MSM accounted for 67% of all new HIV infections2, a rate that has steadily risen in recent 
years30. New infections are especially high among African American (AA) and Hispanic/Latino 
(H/L) MSM. Recent surveillance data suggests that, if current incidence trends continue, 1 in 2 
AA MSM, and 1 in 4 H/L MSM will be diagnosed with HIV in their lifetimes31.  
One source of new HIV infections stems from those who are aware they have HIV but 
who are not virally suppressed. However, another major source is the estimated 20% of MSM 
who are infected but unaware of their status32. Past studies suggest that this scenario accounts 
for up to 50% of new infections5; 6, prompting calls to increase the access and availability of 
HIV testing33. Despite their elevated risk, less than 60% of MSM report having been tested in 
the last 12 months, and only 20% have been tested more than once in the past year34; 35. AA 
and H/L MSM are also twice as likely as White MSM to have never tested in their lifetime34.  
Testing is a cornerstone of HIV prevention efforts, since it can facilitate early diagnosis 
and treatment (i.e. “test and treat”)36. Studies show that this approach can reduce HIV incidence 
when implemented broadly37-39, in part by reducing the time between infection and diagnosis, 
which averages 2.6 years in some areas40. Expanding testing is a particularly important step in 
reducing new infections among AA and H/L MSM, since those who are unaware of their 
infection are key drivers of incidence in these groups3; 4. These findings suggest that innovative 
approaches to expanding testing are needed, particularly among AA and H/L MSM.  
Use of gay-oriented “hookup” apps to meet sexual partners is nearly ubiquitous among 
single MSM, with >90% reporting sex with a partner met online in their lifetimes41, and 70-85% 
having met their most recent partner online41-44. Young MSM are a particularly high-risk 
group2, and may be more likely to meet partners this way45-48. Studies also suggest that online 
sexual partnerships are frequently sources of new HIV and STI infections49; 50. Our past work 
showed that 60% of MSM newly diagnosed with HIV met partners online in the past year49. The 
increasing number of MSM who meet partners online has raised concerns about the difficulties 
this may pose for engaging MSM through traditional prevention efforts (e.g., in-person outreach 
and clinic-based testing)43; 51; 52. At the same time, use of dating apps/websites by a vast 
majority of high-risk MSM suggests that prevention programs may be able to reach more of 
these men now than ever before through online outreach62; 63, including subgroups that often 
evade in-person outreach, like AA and H/L MSM and MSM that do not identify as gay. 
However, to capitalize on the opportunity, new strategies are needed to link these men with HIV 
testing and other prevention services that go beyond clinic-based testing.  
In July 2012, the first rapid, home-based self-test for HIV (HBST) was approved by the 
FDA (OraSure® Technologies, Bethlehem, PA). This test uses oral fluid sampling, produces 
results in 20 minutes, and can be completed entirely by consumers. As a compliment to clinic-
based testing, HBST has the potential to reach more high-risk MSM who test infrequently. Past 
studies show that the most prominent obstacles to clinic-based testing among MSM were 
concerns about confidentiality and inconvenience (e.g., travel, wait times)53; 54. Others show 

 
 
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that the vast majority of MSM, and especially young MSM and those who have never tested, 
would prefer HBST and feel they would test more often with HBST7-9; 53; 55-57. Further, 
HBST may be particularly well-suited to increase testing among AA and H/L MSM, given that 
stigma and distrust of traditional medical services are key obstacles to clinic-based testing for 
these men58-60. These findings underscore HBST’s potential for overcoming barriers to testing 
and for encouraging those who test infrequently to do so more often. Using HBST to encourage 
more frequent, regular HIV testing could facilitate earlier diagnosis and linkage to care, thereby 
improving disease outcomes61 and reducing onward transmission62. For these reasons, the 
World Health Organization has recently recommended HBST for high-risk populations, and 
suggested that it may be key to reaching its target of diagnosing 90% of those who have HIV63.  
One strategy for increasing HIV testing among high-risk MSM involves providing free HBST 
through the apps/sites they already use. Our past studies15; 18; 64 show that using these apps to 
inform users about HBST, conduct a brief risk assessment, and send an HBST through the mail 
is acceptable and feasible. Moreover, Elliot et al.65 also demonstrated that sending HBST to app 
users successfully detected new HIV infections, with 77% of new diagnoses made at CD4 counts 
>350 cells/μL, suggesting that HBST might facilitate early diagnosis. Together, this work shows 
that providing high-risk MSM who use hookup apps with HBST could be an effective way to 
encourage them to test and may detect new infections earlier. However, these efforts have 
primarily been designed to encourage a single test. Mobile/web prevention tools could be an 
effective way to seamlessly connect with high-risk MSM via the hookup apps/sites they already 
use and to keep them engaged over time by encouraging them to test regularly and linking them 
with other prevention resources afterward.  
In exploratory work supported by NIMH (R21MH109374), we used Internet-of-Things 
(IoT) and mobile technologies to develop a “smart” HBST kit that monitors when recipients 
open the kits, enabling an HIV test counselor to reach out to provide timely follow-up phone 
counseling/referral. The system (called “eTEST”) uses a Bluetooth low energy beacon (Estimote 
LocationTM beacon) with an ambient light sensor that is placed inside each test kit’s enclosure 
(see Figure 1). Smartphone applications (both iOS and Android) installed on recipients’ phones 
then monitor the proximity of the beacon to the phone and the amount of light reaching it (>1 
lux) to automatically determine whether the recipient has opened the test enclosure. When these 
conditions are met, the app then updates a Structured Query Language (SQL) database on a 
central server and sends push notifications to users reflecting that they should expect a call from 
a counselor. The SQL database also issues notifications to a team of paraprofessional HIV test 
counselors, who place follow-up phone calls to users to conduct post-test counseling and provide 
referrals to users for other services (e.g., STI testing, PrEP consultation). The system requires no 
intervention from users to work, and successfully detects kit opening events even when the app is 
in the background, has been “killed,” or the user’s device is in sleep mode. “Pings” to the central 
server from the eTEST app also allow the HIV test counselors to monitor whether specific users 
have the app on their devices. See Fig. 2 for eTEST system flow.  
 
In our small pilot study, we enrolled 73 participants, 92% of which have been retained to 
date. Response rates to online surveys have been excellent, with an average monthly completion 
rate of 94% (SD=4.3, 86%- 100%). Of those in the eTEST group, 75% have kept the app 
downloaded on their phones over the average of 5 months they have been enrolled so far. All but 
two of these participants were contacted and successfully re-downloaded the app to continue the 
study. The eTEST system has successfully detected 91% of opening events among eTEST 

 
 
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participants so far. Follow-up counseling/referral phone calls were successfully placed for all 
detected openings and only four were not reached within 24 hours. All participants successfully 
reached for follow-up reported having taken the test minutes after opening it, suggesting that 
monitoring the kit’s opening serves as a reasonable marker of when they took the test. Figure 3 
shows study outcomes to date. These data show that 96% of those in the eTEST group have 
tested for HIV at some time during the study period, compared with 90% for standard HBST, 
and 62% for control. Among the 63% of participants who have completed Month 5 of the study, 
repeat testing rates (reporting testing during both of the first two 3-month periods) were 92% in 
eTEST, 54% in standard HBST, and 46% in control. Rates of testing for other STIs were 
modestly higher in the HBST conditions, but this difference is difficult to interpret due to the 
small sample size and may not be meaningful.  
Over 72% of eTEST participants received risk reduction counseling during the study 
period (control=18%, standard HBST=15%). While PrEP was not an explicit focus of the follow-
up phone calls, 25% of eTEST participants reported having consulted with a physician about 
PrEP and 10% reported having started PrEP as a result, compared with 4% who sought 
consultation and started PrEP in the control group. While AA and H/L participants comprised 
only 21% of this sample, over 75% of those assigned to HBST conditions tested for HIV at some 
point during the study period, compared with 43% in the control condition. Moreover, 67% 
reported testing during both the first two quarters of the study so far, compared with 33% in the 
control condition.  
 
Together, these studies suggest that providing HBST at regular intervals could be a 
promising tool for increasing HIV testing rates and frequency, especially among particularly 
high-risk populations of MSM, such as those who meet partners online and those who test 
infrequently. Our preliminary data further suggests that offering more active, phone-based 
counseling and referral services alongside HBST could help encourage these men receive other 
key prevention services. However, no fully-powered studies have explicitly tested these 
hypotheses to date. While our pilot work on eTEST has begun to explore these issues, limitations 
in the size, scope, and location of this study precludes firm conclusions about the utility and 
impact of HBST and eTEST as a potential component of community testing initiatives. (1) The 
results above are from a pilot project in which it was only feasible to recruit a small, local sample 
with a shorter study period (7 months) than is likely realistic. As such, the next steps are to test 
this promising approach as part of a full efficacy trial that involves following a much larger 
sample over a more realistic timeframe. (2) Programs encouraging regular HIV testing may also 
have the most impact in regions/populations that are highly affected by HIV74, such as those 
with larger populations of AA and H/L MSM. Our pilot sample, recruited exclusively in 
Providence, consisted of only 21% AA and H/L MSM. As such, it is critical to extend this work 
to explore the effects of eTEST and HBST in areas/populations with high HIV incidence, such 
the Deep South and West Coast, where large populations of AA and H/L MSM reside74. (3) 
Finally, to provide the most realistic picture, it is also critical to examine eTEST’s effects when it 
is deployed in a manner consistent with its goal: To provide users of online “hookup” apps a 
pathway for testing more regularly, by providing them the ability to test on their own, without in-
person meetings. Thus, another important next step involves developing an architecture for 
linking users of online hookup sites/apps directly to the eTEST system (see Section 3C.2.).  
 

 
 
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Importantly, our pilot data also shows that connecting with high-risk MSM through eTEST 
may be a key opportunity to also link them with PrEP. Daily oral PrEP is now recommended for 
MSM who are at high risk for HIV acquisition75, given strong evidence of its efficacy for 
preventing infection76-78. Despite its promise as a prevention tool, uptake in the US has been 
slow79, likely due to barriers such as limitations in awareness, access, and trust80-83. Uptake of 
PrEP among AA and H/L MSM has been especially slow, with racial/ethnic disparities emerging 
across the PrEP care continuum83; 84. In our pilot, all participants met risk criteria for PrEP, 
since all reported CAI with a casual partner in the last six months75. While post-test follow-up 
calls did not include discussion of PrEP, many participants asked about it during these calls, and 
several later consulted with medical providers about starting PrEP. Given this, we believe that 
follow-up calls could facilitate ongoing discussions about PrEP with participants while on the 
eTEST program, and provide opportunities to ask questions, consider its benefits/risks, and 
connect users with PrEP providers. In another study we conducted, a substantial portion of MSM 
who were educated about PrEP were lost to follow-up before initiating it19. Increasing contact 
with MSM who are candidates for PrEP may improve their engagement with PrEP care. A more 
personal approach that involves establishing trust and encourages two-way communication may 
also be especially important for engaging AA and H/L MSM, since mistrust of medical care is a 
key barrier in these groups that likely contributes to existing racial and ethnic disparities in PrEP 
use85; 86. Past studies also showed that awareness and willingness to use PrEP is particularly 
low among AA MSM who test infrequently83, suggesting that offering PrEP counseling 
alongside HIV testing may reach a critical subgroup. 
Specific Aim 1: To test whether the eTEST intervention results in higher rates of (a) initial 
and follow-up HIV testing, and (b) receipt of additional prevention services after testing (e.g., 
STI testing, risk reduction counseling, safer sex supplies) compared with standard HBST and 
reminders for clinic-based testing among MSM in three US regions with large AA and H/L 
MSM populations. As an exploratory aim, we will also examine whether receiving HBST helps 
detect more infections during the study period and reduces the time to diagnosis among those 
receiving reactive results, compared with clinic-based testing alone.  
Specific Aim 2: To test whether providing focused information/counseling about PrEP 
during eTEST contacts results in more participants (a) consulting with medical providers about 
PrEP and (b) initiating PrEP. We will define a PrEP care continuum, including the number of 
MSM who meet clinical indications for PrEP, the number who are interested in and are linked to 
care, the number who are prescribed PrEP, and the number who initiate PrEP in each condition.  
Specific Aim 3: To assess the cost-effectiveness of the eTEST system for improving rates of 
HIV testing compared with clinic-based testing alone. We will use mathematical models to 
estimate whether the eTEST system (and HBST) can be cost effective under various scenarios 
(e.g., testing intervals).  
The proposed research will provide a robust test of the feasibility, efficacy, and value of 
home-based testing programs with post-test follow-up in communities with large populations of 
AA and H/L MSM that are highly affected by HIV. It is also among the first studies in the US to 
leverage HBST to engage difficult-to-reach populations in care. Results can also inform efforts 
to seek high-risk MSM and engage them in PrEP services.  

 
 
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Overview of Research. Given these issues, the proposed research involves conducting a fully-
powered efficacy test of HBST and the eTEST system’s effects on rates of any/repeat HIV 
testing, use of other prevention services (e.g., STI testing, HIV risk reduction counseling), and 
PrEP linkage/initiation, compared with “standard” HBST and reminders for clinic-based testing, 
among high-risk MSM in three regions in the US: The Deep South (Jackson, MS), West Coast 
(Los Angeles), and Northeast (Providence/Boston). High-risk MSM (N=2000, N=666 per metro) 
who have not tested in the last year will be recruited online using an interactive web application. 
Participants will be randomly assigned to one of three arms that involve receiving one of the 
following at baseline, 3, 6, and 9 months: (1) HBST with phone follow-up (eTEST condition), 
(2) standard HBST (no follow-up), or (3) reminders for clinic-based testing only (control). Only 
enhanced eTest participants will be provided with the eTEST app, which will monitor the status 
of HBST kits and facilitate phone follow-up.  Control participants will receive text messages at 
quarterly intervals, reminding participants to get tested in a clinic. Participants in the standard 
HBST condition will receive their HBST in the mail when it is time for their quarterly tests. All 
study participants will have access to information that may be generally helpful (e.g., 
information about HIV, testing, and a testing clinic locator) and are already publicly available. 
Throughout the study, all participants will complete online questionnaires assessing key 
outcomes each quarter, which will be confirmed by reviewing clinical records in each local area 
when possible. Analyses will assess eTEST’s efficacy within and across regions, as well as the 
cost-effectiveness of these strategies compared with relying on clinic-based testing alone. 
 
B.2 Participant Population 
Eligible participants will be (1) biological males, who (2) report any of the following in 
the past six months: anal sex without condoms outside of a monogamous partnership with a 
recently tested, HIV-negative male, having been diagnosed with an STI, or being in an ongoing 
sexual partnership with an HIV-positive male, and who (3) are not currently on PrEP. We chose 
to focus our study on male participants because epidemiological evidence suggests that MSM are 
disproportionately affected by HIV, and thus in need of tailored interventions for increasing HIV 
testing30; 102. These criteria are inclusive of transgender women, however. While we realize 
that there may be too few transgender participants to facilitate subgroup analyses, we elected to 
be inclusive because of the clear public health relevance of these individuals103. Risk criteria 
were chosen to align with DHHS’s PrEP criteria104 to allow comparisons with other PrEP 
studies. Eligible participants will also (4) have not tested for HIV in the last 12 months, (5) have 
a stable residence in one of the site metros where they can securely receive packages, (6) use an 
iOS/Android smartphone with a data plan or home wifi, and (7) be fluent in either English or 
Spanish. We will strive to recruit AA and H/L MSM at rates similar to each site’s general 
population, but will also implement procedures specifically to attract/retain AA and H/L MSM, 
including consulting with local ethnic/minority community advisors about recruitment, targeting 
apps catering to AA and H/L MSM (e.g., Jack’d), matching race/ethnicity in ad materials, 
emphasizing participants’ rights and community benefits in informed consent, and recruiting AA 
and H/L staff/counselors105; 106. 
 
B.3 Recruitment Procedures 

 
 
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Ads will be placed with several MSM-oriented “hookup” apps (e.g., Grindr, Scruff, 
Jack’d) to recruit participants into the study. Ads will display to users who login to the apps 
within 30 miles of each metro. Clicking on the ad will direct users to a landing page for the 
eTEST study, where users can learn about the study and its requirements. A brief questionnaire 
will assess eligibility criteria, and those eligible will then be directed to register for the study, 
which will involve providing informed consent, basic personal information, and baseline 
questionnaire data (see Human Subjects for more details about online informed consent). The 
web app will then randomize participants to one of the three arms. Finally, the web app will then 
walk participants through downloading the eTEST app from the Google Play or iTunes stores 
only if they were assigned to the enhanced eTest condition. Access to the eTEST app will be 
restricted to users registered in the eTEST web portal who are directed specifically from that site. 
Participants will also be encouraged to keep the app downloaded on their phone throughout the 
study period and will be encouraged to register any changes in their mailing address or 
smartphone information (number, phone OS) as soon as possible, either through the eTEST app, 
web portal, or by notifying study staff. 
Once users have registered, staff will conduct a brief introductory call with all 
participants to ensure that their information is correct and that they understand the study’s 
requirements. After successfully completing this call, study staff will mark these participants as 
‘fully enrolled,’ activating them in the study database. 
B.4 Design and Methods 
In the study phase, 2000 high-risk MSM who have not tested in the last year will be 
recruited from three metro areas, Providence/Boston, Jackson, MS, and Los Angeles, CA, using 
ads on MSM-oriented, geolocation-based mobile “hookup” apps. They will be randomized to 
receive one of the following at three month intervals over the course of a year: (1) HBST with 
remote monitoring and post-test phone counseling/referral (eTEST condition), (2) standard 
HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic, delivered 
via text messages (control condition). We chose a three month retesting interval 
(HBST/reminder) to align with the CDCs most stringent recommendations for high-risk MSM98. 
During the study period, participants will complete quarterly surveys online. At 12 months, 
participants will be asked to present to a local clinic to provide a blood sample for HIV testing, 
to facilitate exploratory analyses comparing the number of infections successfully detected in 
each group and the “time to diagnosis” in each condition (see 3C.3.5.2 for more detail). 
Experimental Conditions 
Only enhanced eTest participants will download the eTEST app. For these participants in the 
eTEST group, four HBST kits will be fit with BLE sensors and sent to participants. Follow-up 
calls will be made to these participants within 24 hours of opening their test to provide post-test 
counseling, referral for services, and a focused discussion on PrEP. In the standard HBST 
condition, four standard HBST kits will be sent at the same intervals, but will not be monitored 
and no follow-up calls will be provided. Standard participants will have a list of local resources 
(in Boston/Providence, L.A., or Jackson) depending on where participants are located included in 
the box with their test kit. This list of resources includes HIV/STD testing clinics, alcohol/drug 
and mental health treatment referrals, and the number for the national suicide prevention hotline, 

 
 
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as well as study staff contact information. These kits also, include a 24 hour helpline that 
participants can call with any questions or needs. In the control condition, participants will be 
reminded to get tested at a local clinic via text messages. Texts will link to the list of local clinics 
near them that conduct HIV testing, as well as their contact information/hours. 
Measures 
After enrolling, participants will complete a baseline questionnaire assessing demographics, 
language barriers, immigration status, past HIV/STI testing history, recent use of other 
prevention/sexual health services, recent sexual behavior107-114, alcohol/drug use108; 115, and 
mental health116. These data will be useful for exploring barriers to testing, and changes in these 
variables over the study period.  
 
Quarterly online questionnaires.  
Participants will also complete online questionnaires each quarter during the 12-month 
study period, which will be staggered and assigned one month after each testing interval to 
minimize possible conditioning effects. These surveys will assess HIV testing since the last study 
assessment, including whether they tested, how/where they tested, what their results were, 
whether each test was associated with PrEP care, or reasons for not testing. This approach will 
allow us to track contamination across conditions, or the extent to which those assigned to the 
control condition used a HBST or those in HBST conditions tested at a clinic. Questionnaires 
will also assess whether participants were referred for additional prevention services (e.g., STI 
testing, HIV risk reduction counseling), and whether they received these services since the last 
survey. Items will also assess whether participants consulted with a medical provider about PrEP 
in the last month, and if so, their provider’s information and whether they were prescribed PrEP. 
Finally, as a compliment to passive app data, questionnaires will also assess app usage.  
These surveys will also assess constructs relevant to the behavioral, emotional, and social effects 
of HBST, including sexual risk behavior (online Timeline Follow Back106-114; 125), emotional 
health (PANAS-X116), health empowerment117; 118, and social support119. Finally, these 
surveys will also assess financial strain120, insurance121, housing instability122, stigma100; 
101, and medical mistrust123, given evidence that these factors may be barriers to testing124-
128. 
 
Clinic-based HIV/STI testing. 
At the end of the 12-month study period, all participants in all conditions will be asked to 
present to designated clinics for in-person HIV testing in exchange for a bonus payment ($50). 
Encouraging participants in this way can help ensure that we have at least one accurate HIV test 
result for each (since some may elect not to test at all during the study period, regardless of 
condition). Results will allow us to more confidently estimate the number of new infections that 
were successfully detected or missed with HBST versus clinic-based testing reminders. For those 
who test positive, basic data from the sample (e.g., viral load, CD4 count at the time of 
confirmatory testing) will be collected from the medical records of each participant, provided 
they have signed a release. These data will permit us to estimate the “time since infection” for 
each participant diagnosed with HIV129, allowing us to address our exploratory hypothesis that 
HBST could facilitate earlier diagnosis compared with encouraging clinic-based testing alone.  
 
Clinic records. 

 
 
11 
 
We will also review clinical data for each participant to compare with self-report data on HIV 
testing, STI testing, and PrEP uptake. We will obtain a signed HIPAA release to review the 
records of area clinics where participants reported receiving these services. Data on verified 
service use will be compared across conditions to explore potential differences. While we realize 
that this data may be incomplete (especially given that some may elect to test at certain sites 
anonymously), we believe that collecting as much corroborating data as possible will serve as an 
important compliment to self-report data. Data collected is limited to: 
• 
Date of HIV test 
• 
Viral load 
• 
CD4 cell count 
• 
Type of HIV test (blood vs. antibody) 
• 
HIV status 
• 
Whether the patient received counseling to reduce their risk for HIV 
• 
Date of each STD test 
• 
STD tested 
• 
Test results 
• 
Whether the patient spoke to a provider about PrEP 
• Whether the patient was prescribed PrEP 
 
*Data Use Agreements will be put in place to allow staff at each study site access to the study 
database (saved on Brown’s servers) in order to verify service use and enter data collected.  
 
 
Individual interviews. 
RAs at each site will contact participants via phone at the end of the study to conduct a 
30-minute individual interview about their experience using the eTEST app and HBSTs (if 
applicable). Interviews will inquire about the strengths/drawbacks of HBST versus clinic-based 
testing, their perceptions of the app and its features, and their preferences for follow-up/referral. 
Procedure 
Ads will be placed with several MSM-oriented “hookup” apps (e.g., Grindr, Scruff, 
Jack’d) to recruit participants into the study. Ads will display to users who login to the apps 
within 30 miles of each metro. Clicking on the ad will direct users to a landing page for the 
eTEST study, where users can learn about the study and its requirements. A brief questionnaire 
will assess eligibility criteria, and those eligible will then be directed to register for the study, 
which will involve providing informed consent, basic personal information, and baseline 
questionnaire data (see Human Subjects for more details about online informed consent). The 
web app will then randomize participants to one of the three arms. Finally, for participants 
assigned to the enhanced condition, the web app will walk participants through downloading the 
eTEST app from the Google Play or iTunes stores. Access to the eTEST app will be restricted to 
users registered in the eTEST web portal who are directed specifically from that site. Participants 
will also be encouraged to keep the app downloaded on their phone throughout the study period 
and will be encouraged to register any changes in their mailing address or smartphone 

 
 
12 
 
information (number, phone OS) as soon as possible, either through the eTEST app, web portal, 
or by notifying study staff. 
Once users have registered, staff will conduct a brief introductory call with all 
participants to ensure that their information is correct and that they understand the study’s 
requirements. After successfully completing this call, study staff will mark these participants as 
‘fully enrolled,’ activating them in the study database. For control group participants, test 
messages will be sent to remind users when they are due to test. Tests will include a link to a 
web service listing nearby clinics offering HIV testing, as well as their location, phone number, 
hours, and cost. For standard HBST group participants, staff will send an HBST kit to their 
confirmed shipping addresses. These participants will receive no phone-based follow-up, but can 
use OraSure’s provided 1-800 number for questions or needs. We will follow the same steps for 
eTEST participants, except that each test kit will be fit with an EstimoteTM beacon. Beacons will 
automatically detect when each kit is opened and relay this information to a central study 
database, which triggers an email notification sent to counselors. Within 24 hours of opening the 
kit, an HIV test counselor will call eTEST participants to conduct post-test counseling and refer 
them to other needed services, including PrEP (see Section 3C.3.6.1.). HIV test counselors will 
be bachelor’s-level staff who are certified as HIV test counselors and will have crisis 
intervention training. Clinical assessment and analysis of mental health will remain a 
responsibility of the licenses study clinician. At least one HIV test counselor will also be fluent 
in Spanish. Counselors will record data during each call in the study database. In each condition, 
participants will receive these interventions every three months over the course of the study 
period: at baseline, 3, 6, and 9 months. 
Online surveys will use Qualtrics and will be hosted on Brown University servers. On 
each quarterly survey’s due date, the study database will automatically send participants an email 
with language-specific instructions and links to the surveys. Participants will be asked to 
complete these within two days, and reminder emails will be sent every other day for seven days 
after the due date. If participants have not completed the survey within a week of their due date, 
site-specific RAs will contact participants by phone, text message, and email to encourage 
adherence. For all participants, those who fail to complete two consecutive quarterly assessments 
will be considered to have withdrawn from the study. After participants complete their final 
online survey, they will be asked to present to designated clinics for in-person HIV testing to 
finish the study. Site RAs will conduct follow-up calls with participants to ensure adherence to 
this procedure. Study payments will be issued via a reloadable debit card that will be mailed after 
participants are activated in the study. Participants will earn $25 for the baseline survey and each 
of the five quarterly surveys they complete, with a $50 bonus for completing all within a week of 
their assignment. They will also earn an additional $50 for completing the in-person HIV test 
after the study is finished, for a possible total of $250. 
Focused information/counseling on PrEP. PrEP education and counseling will take place 
at each post-test phone call with participants in the eTEST condition. During the first call, HIV 
test counselors will provide a brief PrEP education session, covering indications for PrEP 
eligibility, a description of the medication used for PrEP, and an overview of common side 
effects and clinical follow-up (every three months). In our past work, we have employed an 
effective, five minute PrEP education session during in-person HIV testing that resulted in 
greater PrEP awareness among MSM131, and this will guide the education delivered during HIV 
test counselor phone contacts. Following the education content, participants will asked whether 
they are interested in making an appointment with a medical provider for PrEP consultation. 

 
 
13 
 
Interested participants will be provided with contact information for the local clinical sites where 
PrEP is provided. During subsequent phone calls, HIV counselors will re-assess PrEP interest 
and provide additional information upon request. Those indicating interest in PrEP at a prior call 
will be asked whether they made an appointment, initiated PrEP, and have attended follow-up 
appointments, which will be corroborated by reviewing medical records.  
 
Design Considerations. We designed this study to approximate (as closely as possible) what the 
eTEST program might look if it were implemented in real-world settings, while also balancing 
the need to collect thorough and valid data on the program’s effects over time. Given this, these 
procedures balance being as “hands off” as possible with conducting follow-ups that allow us to 
understand the program’s effects thoroughly and accurately. This guided our decisions to (1) 
allow participants to consent and enroll remotely (2) use online surveys and (3) offer phone 
counseling to eTEST participants who test both positive and negative. First, while our pilot study 
required an in-person meeting for participants to enroll, the proposed research enables 
participants to provide consent and enroll remotely, because we believe one of HBST’s key 
strengths is its potential to reach high-risk MSM who do not otherwise engage with traditional, 
“brick-and-mortar” services7-9. Thus, to reach these high-risk MSM, we believe it is important 
to allow them to test more regularly without the inconvenience and stigma of a face-to-face 
appointment. We realize that this may present  
difficulties in terms of ensuring that participants are valid. However, to address this issue, 
multiple entries from the same IP or device will be blocked, and participants must verify their 
email addresses when registering, as well as other contact information via a call with staff after 
enrollment. Second, we chose to assess key self-report outcomes using quarterly online surveys 
to minimize participant burden, to minimize conditioning effects, and to allow a more accurate 
and “hands off” view of each conditions’ effects. Since requiring in-person visits could 
artificially inflate adherence to key outcomes (e.g., HIV testing), we opted to use less 
burdensome online surveys. Third, the most important benefit of using the eTEST system is 
likely its ability to efficiently link those who test preliminary positive via HBST with 
confirmatory testing and care. As such, we considered several potential ways of providing phone 
follow-up with only these high-priority users (e.g., asking users to submit images of their test96). 
However, some authors have noted that another key limitation of HBST is the lack of follow-up 
and referral for other services (e.g., STI testing, PrEP) for those who test negative11; 12. We 
believe that arriving at best practices for how to offer post-test follow-up with HBST and with 
whom are key questions that are best addressed after its effects are first well understood among 
all participants. That is, we believe it is important to first understand whether offering follow-up 
in both of these scenarios confers an appreciable benefit beyond standard HBST. Finally, we also 
realize that requiring eligible participants to have a smartphone with a data plan or home wifi 
may exclude an important subset of MSM who may be at high risk for HIV, including those with 
financial difficulties or unstable housing132; 133. However, this criterion is consistent with our 
focus on MSM who use “hookup” apps. Of the 1,269 participants screened from Grindr for the 
pilot study, 97% reported having a smartphone with a data plan. Recent data also shows that 60-
80% of unstably housed individuals, including minority youth, had smartphones with data 
plans134; 135. Nevertheless, this requirement is a limitation of this study. Future work should 

 
 
14 
 
address this limitation by exploring other ways of providing monitoring/ follow-up after HBST, 
such as text messaging or by providing low-cost devices to users. 
Planned Analyses 
Analyses will be conducted in Year 5. To evaluate Aim 1(a), we will use factorial logistic 
regression to test whether rates of having completed any HIV test over the 12 month study period 
(assessed via self-report and/or clinic records) differ by study condition. Condition, study site 
(and their interaction) and other relevant covariates will be entered as predictors, allowing us to 
explore whether each condition’s effects differ by study site. To explore the effects of study 
condition on regular HIV testing, we will use a generalized estimating equation (GEE)136; 137 
for repeated, binary outcomes, specifying whether participants tested during each 3-month study 
period as the focal outcome. A logit link function and independent correlation structure will be 
specified, with study condition, site, and relevant covariates as predictors, to test whether the 
odds of testing differ across time period, condition, and site. GEEs are a fitting approach for 
studies in which correlations between repeated measures variables are to be controlled, rather 
than a central focus of the analysis136; 137. For all models of HIV testing outcomes, a covariate 
reflecting whether a given participant had initiated PrEP (and when, for longitudinal models) will 
be added to each model, since these individuals are required to test for HIV quarterly as a part of 
ongoing PrEP care. Doing so will allow us to estimate the effects of study arm on HIV testing 
among those who did not initiate PrEP. Given that we have proposed collecting 54 more 
participants per site (162 total) than is required to estimate our most complex model (see Model 
1b in Section 3C.3.10), we believe we will be fully powered to test this model, even with a high 
rate of PrEP adoption. While contamination of the control group in our pilot study was rare (only 
one control participant reported using a HBST), we will also track where each participant tested 
(at home, in person) in quarterly surveys. If contamination is significant, we will employ 
methods aimed at reducing this bias, including adding indicators of contamination as covariates 
or bootstrapping138; 139. To evaluate Aim 1(b), we will generate variables reflecting whether 
participants received testing for other STIs or risk reduction counseling during each of the four 
3-month intervals of the study period. Similar GEE models will be estimated for these outcomes 
with time period, condition, and site as predictors, to test whether the odds of receiving each 
service differ across these factors. To evaluate Aim 2, we will code variables indicating whether 
participant reports or clinic records reflect participants having consulted with a medical provider 
about PrEP and/or received a PrEP prescription any time across the study period. Factorial 
logistic regression with study site, condition, and their interaction will be entered as predictors of 
this outcome, to test whether the odds of having received consultation and/or a PrEP prescription 
differ across each of the study sites and conditions. Overall, data from those who drop out or 
withdraw from the study will be used in these analyses, in intent-to-treat (ITT) fashion140. 
Similarly, we will assume values of zero for all outcomes (i.e., non-receipt of testing or services) 
when quarterly assessments are missing but participants are retained in the study. Depending on 
the degree of missing assessments, we will use multiple imputation for these values141, since 
data from missing assessments will likely be missing not at random.  
 
Cost-effectiveness analyses (CEA). To examine the cost effectiveness of each condition under 
various scenarios (e.g., population prevalence/incidence, with/without follow-up for specific 
users, retesting intervals, purchase price), we will use mathematical models similar to those used 
in past CEA studies of HIV testing strategies142; 143. In CEA, a strategy is considered cost-

 
 
15 
 
effective if the gains in health justify the resources needed to implement the program144; 145. 
The basic element of CEA is the incremental cost-effectiveness ratio, or the difference in the 
total costs associated with a given testing program versus an alternative, over the difference in 
incremental health improvement conferred by each program, generally measured in Quality 
Adjusted Life Years (QALYs)146. While HIV testing programs can lead to increased costs 
because treatment can begin earlier and continue for longer, these costs can be offset by lower 
rates of hospitalization and treatment for opportunistic infections, and more QALYs. To evaluate 
Aim 3, we will calculate the total annual costs associated with providing each HBST condition 
(standard and eTEST), including the costs of tests, postage, sensors, web 
development/maintenance, counselor resources, training, and supervision. Some of these costs 
depend on flexible aspects of the program, including the retesting interval (3 mos., 6 mos.), 
follow up strategy (only positive tests versus all tests) and purchase price. As such, we will 
estimate the marginal intervention costs under various scenarios to compare them with similar 
estimates for clinic-based, rapid HIV testing programs for MSM in high-prevalence areas from 
the literature142; 143; 147; 148. Potential health gains from testing programs include: Longer 
life, better quality of life, reduced risk of transmission to others among those with reactive results 
due to earlier awareness, diagnosis, and treatment entry, and reduced future infection risk among 
those testing negative by linking them with PrEP and other prevention services149-151. These 
also depend on outcomes for each program, like test acceptance, the number/timing of new cases 
detected, rates of linkage to care and treatment initiation, and rates of linkage to other prevention 
services among non-infected individuals. Gains conferred by these factors will be estimated 
using study data and available studies to compare them with existing programs125; 126. Overall, 
the goal of these simulations is to arrive at an estimate of the costs associated with each HBST 
program under various conditions per quality-adjusted life year (QALY) gained, so that they can 
be compared with similar estimates for clinic-based testing programs targeting similar 
populations. These estimates can then be used to evaluate whether providing low or no-cost 
HBST (with or without follow-up) can be cost effective when targeted toward certain high-
incidence populations, compared with existing clinic-based approaches.  
Exploratory analyses on new HIV cases and time to diagnosis. A key advantage of 
achieving more frequent testing through HBST could be the ability to detect more new infections 
and do so earlier, ideally before disease advances and others are infected. Given this, as 
exploratory aims, we will also examine whether more new cases are detected, and detected 
earlier on, using HBST compared to relying on clinic-based testing alone. To facilitate this, all 
participants will be tested in-person at the conclusion of the study, to ensure that HIV test results 
are available for most participants, even if they elected not to test using the study interventions. 
Among those who did not test during the study period, new cases detected through the post-study 
test will suggest that the interventions likely “missed” these cases. The proportion of cases 
detected with study interventions versus those missed can then be compared across conditions. 
Confirmatory testing in those who receive a reactive test at any time during the study, together 
with post-study testing for all participants, will also allow us to use CD4 counts and viral loads 
from positive blood tests to explore differences in estimated time to diagnosis among those 
infected during the study period, using methods described in past studies129; 152. These aims 
are secondary, however, since we acknowledge that there may be insufficient numbers of those 
infected with HIV during the study period in each group to conduct fully-powered tests. 
However, based on estimates of the rate of new infections among those without an HIV 
diagnosis in each study site’s area74, we estimate that at least 20 participants (6 per group) may 

 
 
16 
 
be diagnosed with HIV during the study period. This will allow some limited exploration of 
these aims.  
 
Power Considerations. We used past studies153; 154 and power estimation/ simulation 
packages in R, to determine the sample sizes necessary to detect significant effects in each of the 
models proposed in 3C.3.8. Relative risk ratios (RRs) were estimated for relevant outcomes (e.g., 
HIV testing, STI testing) across study conditions in our pilot data, and we used the smallest of 
these group differences for estimation so as to provide the most conservative estimate of required 
sample size. For each estimate, we assumed α=0.05, an observed power of .80, and a small but 
constant effect (1.2) for study site on each outcome, to ensure that any differences emerging 
between study sites could be detected. For GEE models, we assumed quarterly measurements (T 
= 4), with relatively independent relationships between repeated data (Φ=0.2). Table 2 
summarizes the models, outcomes, parameters, and sample size estimates for each aim. For 
GEEs, sample size gives the estimated number of participants needed to test condition effects 
within each site. The sample  
size required to detect the most complex model with the smallest effects is 246. To account for 
missing data, we propose collecting 300 MSM at each site. 
B.5 Human Subjects Involvement, Characteristics, and Design 
Participants will be 2000 males who are 18 years of age or older, not currently on PrEP 
and who have not received an HIV test in the last year. Focusing recruitment toward these 
individuals will allow us to examine whether the eTEST system and HBST increase testing and 
receipt of additional prevention services among those who rarely test and may be more difficult 
to reach with traditional prevention resources (i.e., clinic-based testing). Eligible participants will 
also report any of the following in the past 6 months: (1) anal sex (receptive or insertive) without 
condoms outside of a monogamous partnership with a recently tested, HIV-negative male, (2) 
having been diagnosed with an STI, or (3) having anal sex with an HIV-positive male. This 
criterion will ensure that the research is conducted among MSM who are at high risk for HIV 
and who meet DHHS criteria for pre-exposure prophylaxis. 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 criterion 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 other routes, since many at highest risk may not have stable residences. 
Next, to be eligible, participants must currently have an Android or iOS smartphone with a data 
plan or a wifi internet connection at home. This ensures that the eTEST app can detect HBST kit 
openings when participants use the test at home. Finally, eligible participants will also be 
required to be fluent in either English or Spanish. All research materials will be translated into 
Spanish, and at least one test counselor and the LA site research assistant will be fluent in 
Spanish. These steps will ensure that we can explore the program’s effects specifically among 
Spanish-speaking Hispanic and Latino MSM. 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 each community (Providence, RI/Boston, MA; Los 
Angeles, CA; Jackson, MS) using ads placed on popular geolocation-based, gay-oriented mobile 
apps and sites (e.g., Grindr, Scruff, Jack’d). After clicking on the ad, interested participants will 

 
 
17 
 
then be taken to a mobile-optimized, interactive web application that will provide more 
information about the study, assess eligibility criteria, and document informed consent. Since 
participants will provide informed consent entirely online, we will ensure that the key study 
requirements are easily visible and presented in lay terms. Participants will also be required to 
enter their initials to indicate their consent to key parts, as well as the consent as a whole (see 
Section B.1. for more detail). After providing informed consent, the web app will then collect 
registration information from participants (e.g., name, phone number, email, address) before 
guiding them through a series of simple screens designed to orient them to the study. 
Randomization to a study condition will take place after participants complete the study consent, 
and this will determine which “on boarding” (orientation) sequence participants are shown. 
Participants assigned to the eTEST condition will be “funneled” toward downloading the eTEST 
app, while those assigned to Standard HBST and Control conditions will not be directed to the 
app store.  
Once participants have completed this sequence, research staff will place a phone call to 
each participant within 24 hours to verify their contact information, ensure their understanding of 
the study requirements, and answer any questions about the study. Participants who do not 
complete this call within 72 hours of completing the orientation sequence will be considered ‘not 
enrolled,’ andthey will be considered as withdrawn from the study. Likewise, participants who 
do not recall basic information about the requirements of the study (e.g., that they are expected to 
complete quarterly surveys online, that they will receive letters or test kits in the mail every 3 
months) will similarly be considered ‘not enrolled’ and deleted from study databases. All eTest 
participants will be instructed to keep the app downloaded as much as possible during their time 
on the study. Since the SQL database associated with the app allows us to track when users 
uninstall it, we will contact participants who delete the app by phone and email to inquire about 
their interest in continuing with the study. We will also track data on app uninstalls (e.g., reasons 
for uninstalling and/or withdrawing) to continue examining the usability and burden of the app. 
eTEST participants who change their smartphones during the study period (due to an upgrade, 
change in service provider, or the phone being lost or stolen) will be able to re-download and 
login to the eTEST app from app stores appropriate to their operating system (iOS, Android). 
Minimal study data is stored on participants’ smartphones themselves; Instead, most data is 
stored on a centralized, secure database hosted on Brown University’s dedicated servers. This 
data is password protected and can only be accessed by essential study staff members. All 
participants will also be allowed to update their personal information at any time, either through 
the eTEST native app (for eTEST participants) or through a study web portal (for standard 
HBST and control participants). Quarterly surveys will also inquire about any changes in 
participants’ contact information (e.g., address, phone, email) each month.  
As in our pilot study, to avoid influencing the study results, participants in HBST 
conditions (eTEST and standard HBST) will not be given explicit instructions about whether or 
not to use the tests sent to them (except during eTEST follow-up calls, which will encourage re-
testing every 3 months). They will be informed that HBST kits will be sent to them 1 week, 3 
months, 6 months, and 9 months after initially signing up, and that they can choose to take these 
tests or not. For eTEST participants who choose to take the tests, they will be informed that they 
should expect a call from an HIV test counselor within 24 hours of opening it, and that these 
calls are intended to provide post-test counseling, information about HIV prevention, and 
referrals. Push notifications on participants’ smartphones will also notify participants at the time 
their test kits are opened that it was detected and that they should expect a call. Participants can 

 
 
18 
 
refuse any part of the discussions with counselors at any time. All participants will also be 
informed that, should they indicate having tested positive using an HBST through the quarterly 
surveys, a test counselor will follow up with them within 24 hours to ensure that they have made 
an appointment at a local clinic for confirmatory testing and care, if needed. If not, counselors 
will facilitate scheduling this appointment during their calls with these participants.  
For eTEST participants that open their tests, counseling calls will be placed within 24 hours. 
These calls will be made by paraprofessional, Bachelor’s level staff members who are employees 
of the Brown University School of Public Health, work in a “call center” physically located at 
Brown University, and who have been certified as ‘Qualified HIV Test Counselors’ in Rhode 
Island. This training ensures that candidates have basic knowledge of HIV and other sexually 
transmitted infections, understand HIV testing and how to conduct the test, and are familiar with 
counseling strategies needed to address many of the issues that commonly arise in those being 
tested. The training is conducted each year by Dr. Chan (Co-PI). Counselors will also receive 
training in triaging crisis intervention, which is provided by behavioral health staff at Lifespan. 
Clinical assessment and analysis of mental health will remain a responsibility of the licensed 
study clinician.  
Additional study-specific training will involve principles of conducting phone-based 
counseling, role plays, and direct observation through recorded counseling sessions, as well as 
clinic-based testing conducted at Lifespan (supervised by Dr. Chan). Drs. Chan and Wray will 
also provide ongoing supervision to phone counselors throughout the study. Importantly, all 
follow-up calls will follow the CDC’s guidelines for HIV counseling, testing, and referral155, 
and as such, will involve similar post-test counseling procedures that are currently provided by 
paraprofessionals and service providers in clinic- and community-based settings worldwide.  
Participants who test positive with HBST (those in either the standard HBST or eTEST 
conditions) will be assured that an initially reactive result is not a confirmed positive result. 
Counselors will then assist participants in scheduling an appointment for confirmatory testing 
with specific designated clinics at each study site (Miriam STD/HIV Clinic or Fenway Health 
in Boston, MA/Providence, RI; OpenArms in Jackson, MS; or AHF Wellness Center in Los 
Angles, CA) via three-way calling while participants are on the line. Each of these centers/clinics 
has standard procedures for providing newly diagnosed patients ongoing HIV care. Site PIs 
maintain professional affiliations with each, so that site-specific research staff can 
ensure/confirm whether each participant successfully made their appointments. Test counselors 
will conduct follow-up calls after each participant’s scheduled appointments to ensure that they 
receive confirmatory testing. Participants with reactive test results will also be screened for 
suicidality during these calls, and if necessary, intervention will be provided according to 
National Suicide Prevention Lifeline procedures156; 157.  
For each study metro area, “primary referral” sites have been designated that provide 
comprehensive HIV/STI prevention and care services. Each of these sites also provides HIV/STI 
testing services on a walk-in basis, for free. Study staff and counselors will recommend these 
clinics to participants first, particularly for confirmatory testing and care for any who receive 
reactive tests while on the study. These clinics will also serve as the primary site of referral for 
clinic-based tests they are to receive at the end of their study period.  
 
Site PIs each have close connections with these clinics through their current clinical roles. 
Letters of Support have also been provided for each. However, each area also has several other 
options for HIV/STI testing, with locations that may be more convenient for some participants. 

 
 
19 
 
As such, a list of these clinics is provided through an HIV/STD test locator function of the app, 
and participants will be able to choose from these clinics, as well. Below is a list of primary sites 
(identified with *) and other HIV/STI testing sites, grouped by study metro:  
 
Jackson, MS  
• Open Arms Wellness Center*; 805 East River Place, Jackson, MS 39216. (601)-500-
7660. Walk-In Hours: Mon through Fri, 8:00 am to 5:00 pm. Cost: Free. Dr. Mena serves 
as medical director at this facility.  
• Crossroads Clinic – Hinds County Health Department; 350 W. Woodrow Wilson 
Avenue, Suite 2516, Jackson, MS. (601)-987-6728. Hours: Mon through Fri, 8:00 am to 
5:00 pm.  
• Jackson Medical Mall – Hinds County Health Department; 350 W. Woodrow Wilson 
Drive, Suite 411, Jackson, MS. (601)-364-2666. Mon through Fri, 8:00 am to 5:00 pm.  
• AIDS Healthcare Foundation: 766 Lakeland Dr #A, Jackson, MS 39216. Phone: (601) 
368-3440. Wednesdays, 1:00 pm to 5:00 pm  
• UMMC Adolescent and Young Adult Health Clinic: 350 W. Woodrow Wilson Avenue, 
Suite 459, Jackson, MS (601-815-3284) Mon, Tues and Fri, 8:00 am to 5:00 PM.  
• UMMC Adult Specialty Care Clinic; 350 W. Woodrow Wilson Avenue, Suite 510, 
Jackson, MS (601-815-3120). Mon through Fri, 8:00 am to 5:00 pm  
 
Los Angeles, CA  
• AHF Wellness Center*; 1300 N. Vermont Avenue, Los Angeles, CA. (866)-339-2525. 
Walk-In Hours: Mon, Wed, Thurs, & Fri, 5:30 pm to 8:30 pm; Sat 9:30 am to 4:30 pm. 
Cost: Free. Dr. Klausner serves as Lab Director at this facility.  
• APLA Wellness Center – Beverly Hills; 3743 South La Brea Avenue, Los Angeles, CA. 
(323)-329-9900. Hours: Mon and Wed, 8:30 am to 5:00 pm.  
• APLA Wellness Center – Long Beach; 1043 Elm Avenue, Suite 302, Long Beach, CA. 
(562)-432-7300. Hours: Tues, Thurs, & Fri, 8:30 am to 5:00 pm.  
• Hollywood-Wilshire Public Health Center; 5205 Melrose Avenue, Los Angeles, CA. 
(323)-769-7932. Hours:  
• Ruth-Temple Public Health Center; 3834 Western Avenue, Los Angeles, CA. (323)-730-
3576. Hours: Mon, Tues, Wed, 7:30 am to 10:30 am & 12:00 pm to 3:30 pm; Thurs, 
10:00 am to 12:30 pm & 2:00 pm to 5:00 pm. Fri, 7:30 am to 10:30 am.  
• Los Angeles LGBT Center – Hollywood Jeffrey Goodman Clinic; 1625 N. Schrader 
Blvd., Los Angeles, CA. (323)-993-7500. Hours: Mon through Fri, 11:00 am to 7:00 pm.  
• Los Angeles LGBT Center – West Hollywood; 8745 Santa Monica Blvd., 2nd Floor, 
West Hollywood, CA. (323)-993-7440. Hours: Mon through Fri, 11:00 am to 2:00 pm & 
4:00 pm to 7:00 pm.  
 
Providence, RI / Boston, MA  
• Miriam Hospital HIV/STD Clinic*; 1125 North Main Street, Providence, RI; (401)-
781-0665. Walk-In Hours: Wed, Thurs, Fri, 12:30 pm to 3:30 pm. Cost: Free. Dr. Chan 
serves as Director at this facility.  

 
 
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• Fenway Health – Ansin Building*; 1340 Boylston Street, Boston, MA; (617)-927-6000. 
Hours: Mon, Tues, 12:00 pm to 4:00 pm; Wed, 4:00 pm to 7:00 pm; Thurs, Fri by 
appointment. Cost: Free. Dr. Chan and Dr. Wray have conducted past studies at this 
facility.  
• Rhode Island Free Clinic; 655 Broad Street, Providence, RI; (401)-274-6347; Hours: 
Mon, Wed, Fri, 8:00 am to 5:00 pm, Tues, Thurs, 8:00 am to 9:00 pm.  
• Planned Parenthood – Rhode Island (low-cost); 111 Point Street, Providence, RI; (401)-
421-9620. Hours: Call for appointment.  
• Boston STD Clinic; 725 Albany Street, Suite 9C, Boston, MA. (617)-414-4081. Hours: 
Mon Tues, Thurs, Fri, 8:30 am to 4:00 pm; Wed, 8:30 am to 4:00 pm.  
• Project Trust – Boston Medical Center; 721 Massachusetts Avenue, Boston, MA; (617)-
414-4495. Hours: Mon through Fri, 9:00 am to 4:00 pm.  
• Fenway Health – South End; 142 Berkeley Street, Boston, MA; (617)-247-7555. Hours: 
Call for appointment.  
• Massachusetts General Hospital – STD Clinic; 55 Fruit Street, 5th Floor, Boston, MA; 
(617)-726-3236. Hours: Tues, Thurs, Fri, 8:30 am to 11 am; Wed, 1:00 pm to 3:00 pm.  
 
Referrals will also be offered to local, LGBT-friendly agencies for substance abuse treatment, 
mental health treatment, and primary care, upon request. Lists of these clinics and services will 
be generated by site-specific study personnel (site PIs and RAs), updated as needed throughout 
the study, and will be provided to participants through the app, via text, and in every test kit 
package sent during the study.  
All study procedures, including data collection, will be conducted by research staff, Co-PIs (Drs. 
Wray and Chan) or site-PIs and Co-Investigators (Drs. Klausner, Mena, Brock, and Needleman). 
Research staff will receive intensive training in all study procedures from Drs. Wray and Chan. 
B.5.1 Sources of Materials Over the course of the study, data will be collected using the 
following methods:  
1. Custom study web/mobile applications will be used to collect initial screening and registration 
data, mobile app user data, and sensor data. The web application will also be used by test 
counselors to log data from post-test counseling phone calls.  
2. Online self-report questionnaires will be used to collect baseline and quarterly assessment 
data.  
3. Audiotapes of post-test counseling phone calls will occasionally be recorded for the purposes 
of supervising test counselors.  
4. Clinic records verifying service use will also be used to corroborate participants’ reports about 
appointments attended, services, sought/conducted, and results/lab values from HIV/STI tests 
conducted.  
 
B.5.1.1. Custom study web/mobile applications. Custom web and mobile applications have 
been developed specifically for this work with data safety and participant confidentiality in mind. 
Both elements have been used in this project’s pilot phase (see Section 3A.5.), but will be further 
refined during the proposed project’s start-up phase to meet the specific needs of this project. 
While the institutions involved in this research do not constitute ‘covered entities’ under HIPAA, 
guidance on data security issues provided through HIPAA/HITECH policies, workgroups, and 

 
 
21 
 
work statements provide useful guidance for ensuring the security of health-related data that is 
collected, stored, and transmitted using web-based tools. As such, we will ensure that all 
components are developed to comply with these requirements (including the HIPAA Security 
Rule) for electronic protected health information and other health data158. The web and mobile 
applications will be part of a complex web-based architecture in which all staging components 
(onboarding web app, participant-side web portal, administrator portal, and mobile app) interact 
with a centrally-hosted database. The web application will be used to collect self-report and 
registration data during the screening process (contact, login information). Registration data 
(current contact information and preferences) can be updated by participants at any time 
throughout the study by logging in to the secure web portal or the mobile app (for eTEST 
condition participants). An admin panel of the web application will also be used by study test 
counselors to log data from post-test counseling phone calls, including testing date, time, and 
results, referral information provided. The mobile application will be used to collect and relay 
sensor and device data, user preferences, to provide interactive information about prevention 
services (e.g., HIV testing, HBST, STI testing, safe sex, PrEP). Both applications are currently 
hosted locally (on Brown University’s servers), ensuring that they are protected by Brown’s 
strict security policies. These policies include server-specific firewalls, restricted access through 
a virtual private network, IP-specific verification, and encryption (both at rest and in transit). 
These servers are maintained by IT staff that also provide regular, secure backups, and control 
physical access via badge entry and sign-in with video surveillance. Together, these 
specifications ensure that only essential research staff have access to the data that are collected 
and stored by these tools.  
 
B.5.1.2. Online self-report questionnaires. Online questionnaires will be used to collect self-
report data as part of the baseline and quarterly follow-up assessments. These questionnaires will 
be developed and hosted using Qualtrics, which is a web application that affords custom 
development of web-based surveys. Qualtrics allows strict password protection and limited 
survey access which ensures that only essential research personnel at the study site will have 
access to the study data. For these reasons and others, Qualtrics can be used to collect many 
types of sensitive data, including 21 CFR Part 11, FISMA, and HIPAA data. Surveys can also be 
mobile-optimized within Qualtrics, allowing study participants to complete surveys on a variety 
of devices. Qualtrics is currently used by our research team. 
 
B.5.1.3. Audiotapes of post-test counseling phone calls. Phone calls between test counselors 
and eTEST condition participants will occasionally be recorded for the purposes of conducting 
supervision with test counselors. These tapes will be collected using electronic recording 
equipment and will be stored in digital files on Brown University’s servers. However, they will 
be stored only until the next supervision meeting (weekly) and will be deleted immediately 
afterward.  
 
B.5.1.4. Clinic records verifying service use. We will also review the records of area clinics to 
compare with self-report data for each of the proposed outcomes (e.g., HIV testing, STI testing, 
PrEP consultation, receipt of a PrEP prescription). To facilitate this, participants will be asked to 
sign and return a HIPAA release in the case that they tested outside of the site clinics. The study 
informed consent process will also specifically ask participants to consent to allowing us to 
release limited personal information that reveals their participation in the study to the clinics they 

 
 
22 
 
identify for the purposes of verifying service receipt and collecting limited clinical data (e.g., 
HIV/STI test results, and if positive, CD4 counts and viral loads). Quarterly online surveys will 
ask participants to name the specific clinics where they received each of the services that the 
questionnaires inquire about, and site-specific RAs will then request records from these clinics 
for these participants. Site-specific RAs will download participant data to explore service 
utilization and compile lists of participants who noted receiving services at each clinic. RAs will 
then contact each clinic that a participant utilized for HIV/STD testing. Once clinic data is 
received, site-specific RAs will code it using participants’ unique study ID numbers and store it 
in password-protected files on Brown University’s secure servers.  
We realize that not all services will be verifiable (e.g., anonymous HIV testing), and that some 
participants may not be comfortable signing broad releases for their medical information. We 
also acknowledge that requiring the release of personal medical data may serve as a barrier to 
enrolling for some participants. At the same time, we also believe it is important to collect more 
objective data that can serve as a compliment to self-report whenever possible. Given these 
considerations, returning a signed release will not be required in order to enroll in the study, to 
prevent this procedure from acting as an impediment to enrollment. Instead, we will verify 
clinical service information for those who return their releases and consent to this specific 
procedure. This approach will allow us to verify as much clinical service data as possible, while 
minimizing participant discomfort with the study’s procedures. While this likely means that data 
on clinical service use will be incomplete, we do not believe that incorporating this procedure 
undermines the importance of self-report data or the study as a whole. (See Section B4 for a full 
list of data collected from clinics.) 
 
*Data Use Agreements will be put in place to allow staff at each study site access to the study 
database (saved on Brown’s servers) in order to verify service use and enter data collected.  
 
 
C. Risks to Participants and Procedures to Protect Against Risk 
C.1 Adequacy of Protections against Risk 
We will make every attempt to minimize risks to participants throughout the study protocol, 
including loss of confidentiality or privacy and psychological discomfort. 
C.1.1 Recruitment and Informed Consent Procedures 
Recruitment. All participants will be recruited via geographically focused advertisements 
placed on MSM-oriented “hookup” mobile applications (e.g., Grindr, Scruff). These 
advertisements appear as ‘pop-ups’ within the apps when users log in within a specified radius of 
a given metro area. If users click on a ‘More Info’ button within these ads, they are directed to a 
‘landing page’ for the eTEST study, which represents the first portion of the web app’s user-side 
onboarding process. After selecting their desired language (English/Spanish), a sequence of 
screens will explain the study in very simple terms. Then, basic eligibility criteria will be 
assessed using a series of online forms (see Section 3.C.3.4.). “Ballot stuffing” prevention 

 
 
23 
 
measures will be deployed to ensure that participants do not complete the eligibility assessment 
multiple times (e.g., barring multiple entries from the same IP or device MAC address). 
Eligibility data will be discarded if participants do not meet criteria, and an error message will 
display notifying users that they are not eligible. Those who are eligible based on this data will 
be directed to create a user account in the web app before being directed to informed consent 
screens. 
Informed Consent. On the first informed consent screen, participants will be able to elect to 
either read (written), hear (audio), or watch (video) a plain-language explanation of all 
information included in the consent process. Consent information will be explained/written at a 
sixth-grade reading level and important concepts will be highlighted via bulleted text, 
highlighted text, and/or captions. Participants will be required to type their initials next to each 
key concept presented to ensure that they have seen and understand each, as well as to indicate 
their overall consent. A short, three question ‘quiz’ will assess whether participants understand 
what is being asked of them. Those that get less than three correct will be returned to complete 
the informed consent section again. Those who enter correct answers to these questions will 
move on to complete the study baseline questionnaire. Afterward, those assigned to the eTEST 
condition will be directed to download the app from the app store specific to their OS (i.e., 
Android/iPhone).  
Research staff and study test counselors will receive notifications, both via the 
administrator-side of the web app and via email, that a participant has completed their 
“onboarding” sequence. Staff will then conduct an introductory call with each participant. This 
call is designed to further emphasize the key points made by during the informed consent 
process, verbally assess participants’ understanding of the concepts, confirm contact information, 
and to stress the importance of adherence to the study. These calls will last approximately 10 
minutes. Based on this conversation, if staff/counselors have reason to believe that a participant 
is not aware of study requirements and/or may be unable to provide informed consent, he/she 
will notify the participant that they are ineligible. If staff/counselors believe the participant 
understands and can provide consent, they will be formally considered “enrolled” after all other 
information is checked and verified.  
 
Payments. Participants will be compensated on the basis on their completion of quarterly 
assessments, as well as the follow-up appointment conducted at the study’s end. They will earn 
$25 for the baseline survey and each of the five quarterly assessments they complete, with a $50 
bonus for completing all assigned surveys within a week of their assignment. They will also earn 
an additional $50 for completing the in-person HIV test after the study is finished, for a total of 
$250. Participants will be paid for each survey immediately after completing it using a 
reloadable debit card that will be sent to each participant after enrolling. Study payments will be 
managed using the shared study database and issued by staff at Brown University. We 
successfully used this system, as well as a similar compensation schedule, in our pilot study (see 
Section 3.A.5.). Compensation amounts are consistent with payments provided for research 
participation at Brown and other institutions, thus posing little risk of coercion. 
C.2 Procedures to Protect Against Risk 

 
 
24 
 
C.2.1. Protections against the loss of data security, confidentiality, and privacy. Before 
beginning their work on the study, all members of the research staff will receive thorough 
training in procedures designed to maintain data security. Informed consent procedures have 
been specifically designed to ensure that participants are aware of the study’s potential risks to 
confidentiality and privacy. We have elected to conduct this consent process entirely online, 
because we believe that the eTEST system may be most appealing and beneficial for those MSM 
who may have been deterred from testing because of the face-to-face interaction that is normally 
required. However, the online informed consent process is thorough, and involves several steps 
designed to ensure that participants understand its key components, including: presenting key 
concepts in several formats (written, audio, video), condensing presented material to key points, 
requiring that participants initial each key point, and requiring that participants complete a short 
quiz to demonstrate their understanding. RAs will also call participants on the phone to verify 
their understanding of study procedures before considering them ‘enrolled.’ While some may 
have reservations about conducting and collecting informed consent online, we believe doing so 
offers participants a better opportunity to consider their participation in private and freely decline 
participation, if they so choose. We also believe that these steps for ensuring participants’ 
informed consent also actually exceed of those undertaken in many in-person consent 
procedures.  
(1) Data security. While collecting and storing participants’ personal information using web-
connected databases is unavoidable due to the nature of the study, a number of steps will be used 
to help secure and safeguard this data throughout the project. All elements of the proposed web 
architecture (web application, mobile application, database) will be hosted on Brown 
University’s secure internal servers. Hosting these elements locally has the benefit of allowing us 
to enforce a strict set of security and authentication rules and exercise more control over who has 
access to the data (i.e., to only essential research staff, and information technology staff directly 
involved in maintenance and oversight of the server). We can also require additional security 
measures for all authorized individuals, such as two-step verification (a password plus registered 
device), VPN-only access, and IP-specific firewall rules. Access to participant information will 
be restricted to essential research staff, and only after two-step verification. Given the sensitivity 
of some of the data collected as part of this project, servers running elements of the eTEST 
architecture will conform to ‘restricted-level’ server settings. In addition to more stringent virtual 
access controls, this designation also means more stringent physical access controls, and that 
Brown’s Computing and Information Services (CIS) staff performs continuous monitoring, 
emergency support/backup, and regular penetration tests. More details about server security 
designations at Brown is available at: http://brown.edu/go/serversecurity.  
Questionnaire data collected throughout the study will also adhere to similar server/data security 
measures, since these elements are also hosted on the same internal servers. Specifically, these 
surveys will be developed and hosted using Qualtrics, which allows researchers to create 
individualized surveys and host them on local servers, to ensure local control over security 
settings and access policies. By using Qualtrics, we can send online surveys to research 
participants that they complete on web applications hosted at Brown. These surveys can also be 
mobile-optimized, so that participants can easily complete them on their mobile devices.  
(2) Privacy when using mobile/online tools and assessments. Since participants will complete 
quarterly questionnaires online, and some questions asked will be sensitive, they will be 
specifically instructed to complete these in a private location when possible. Emails that are 
automatically sent to participants to remind them to complete the surveys will also remind them 

 
 
25 
 
to complete assessments in private. Reminder emails will also contain no identifying information 
(other than their email address) or references to HIV testing or other sensitive topics.  
All participants will have access to information about HIV and other sexually transmitted 
infections, testing, prevention, and referral information via the eTEST app. As such, they will be 
instructed to use their phone’s lock screen to prevent unauthorized access. They will also be 
instructed to access this information only in private locations. Users will receive push 
notifications from the app, either to inform them that they are due for their next test, or to inform 
them about the status of their next HBST kit (i.e., that it has been shipped, that it has been 
opened and a counselor will be reaching out soon). These notifications will be worded as 
innocuously as possible (e.g., “Looks like you opened your test!”), and test opening notifications 
in particular only register when the device is in close proximity to the beacon (≈50m), ensuring 
that they display only when participants are already in a location in which they are comfortable 
taking the HIV test. Still participants will be encouraged to use their devices’ native security 
settings (e.g., enabling a lock screen with code in order to access the phone) while they are in the 
study. No participants have expressed concerns about the privacy of the app in our pilot study. 
The Bluetooth low energy (BLE) beacons used in test kits do not collect or store any data. They 
only transmit information about the beacon and its state to nearby Bluetooth devices (e.g., 
smartphones).  
(3) HBST Packaging. If participants have been assigned to either the standard HBST or eTEST 
conditions, OraSure OraQuick® HBST kits will be sent to the verified physical addresses of 
participants throughout the study. To safeguard participant confidentiality, these packages will 
be sent with generic return addresses (i.e., Brown University) and in discrete packaging. An 
information card will also provide participants with tips for ensuring their privacy while taking 
the test at home and for disposing of the test collection swab. OraSure provides an envelope 
container that participants can use to confidentially dispose of the test collection swab after the 
test is complete.  
(4) Phone counseling/follow-up interviews. When conducting follow-up phone calls, counselors 
will first ensure that participants have adequate privacy to discuss the test over the phone, and if 
not, calls will be re-scheduled. Data from these calls will be manually entered by counselors into 
the study’s central, password-protected database. Occasionally, counseling phone calls will also 
be digitally recorded for training, supervision, and fidelity purposes. These recording files will be 
password-protected and stored on Brown University’s secure servers, in locations separate from 
participants’ identifying data. Digital audio recordings collected for supervision purposes will be 
deleted immediately after supervision meetings have occurred. Those used for training and 
fidelity will be stripped of any identifying information that may have been recorded, and deleted 
after they have been used for these purposes.  
C.2.2. Protections against psychological discomfort/distress. Several measures will also be 
employed to minimize psychological discomfort or distress as a result of the research. First, 
while participants may experience some nervousness or anxiety while taking an HIV test at 
home, past research suggests that this risk is low 159-161, and OraSure’s clinical trial data 
suggests that HBST can be completed safely and with minimal distress. Nevertheless, 
participants in either HBST condition (standard HBST, eTEST) 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, some participants may receive “reactive” 
results during the study, so this possibility will be addressed during their “onboarding” and 
consent process. This sequence will explicitly encourage participants to interpret HBST test 

 
 
26 
 
results as “reactive” (rather that “positive”), since false-positive results are possible and further 
testing is needed to confirm “positive” results. Participants in any condition will also be 
encouraged to report receiving “reactive” results to study counselors as soon as possible, and will 
be provided with contact information for doing so. When reporting a “reactive” result, study test 
counselors will aid these participants in scheduling an appointment for confirmatory testing at 
clinics specific to their areas and at which site PIs have existing relationships (see Section A.2. 
for a list of these and other referral sites). Each of these clinics have established procedures for 
conducting follow-up testing and engaging these patients in ongoing HIV 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/or 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 and the IRBs of the relevant site. Together, 
we believe that these procedures greatly reduce any risks associated with the research, both in 
terms of data security and possible emotional discomfort/distress.