Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs Among MSM
Phase: PHASE4
Conditions: HIV, STI
Sponsor: Emory University

Title: Parrying the Pitfalls of PrEP: Preventing Premature PrEP 
Discontinuation and STIs Among MSM
Date: 11/21/2024
NCT# NCT05072093

Protocol Title:  Element 2
Page 1 of 51
Protocol Version: Version 12  11/21/2024
PROTOCOL TITLE: Element 2 (Project PEACH)
PRINCIPAL INVESTIGATOR: 
Name: Patrick Sullivan, DVM, PhD
Department: Epidemiology
Telephone Number: 
Email Address: 
EXTERNAL (NON-EMORY) COLLABORATORS
Rob Stephenson, PhD, Professor, Biologic and Behavioral Health, University of Michigan. 
Institution’s IRB will not review. Rob will oversee the development of the motivational 
interviewing (MI) intervention which will be used to avert PrEP discontinuation through early 
identification of risk factors for stopping.  He will train study staff on implementing MI and will 
also be responsible for related quality assurance activities. Rob will also contribute to the fidelity 
evaluation.
Ellen Caniglia, Assistant Professor, Population Health, New York University. Institution’s IRB 
will not review. Ellie will lead the analysis of uncontrolled studies with historical controls and 
the target trial emulation which aim to estimate the causal effect of the intervention components
on the incidence of PrEP discontinuations.
VERSION: 12.0
FUNDING SOURCE: National Institutes of Health 
REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
1
3-25-21
Edits include a section on provisions to monitor the data for 
safety monitoring, testing of nasal swabs with S. aureus for 
doxycycline resistance among STI PEP users, delineation 
of primary and exploratory outcomes, clarifications on the 
mobile app requested by IRB.
2
5/14/21
Edited main study consent process to be in-person with 
participant signature. Clarified some terms in the main 
study consent.  Uploaded BAA with Survey Gizmo
3
8/6/21
Edited screening and main consent and some study 
procedures including visit structure, nasal swab addition, 
removal of separate consent for second rectal sample, 
updated incentive amounts, sharing of PII with laboratories, 

Protocol Title:  Element 2
Page 2 of 51
Protocol Version: Version 12  11/21/2024
pharmacies, and treatment providers; asking for consent to 
save screening and contact info for future studies.
4
9/3/21
Edited Main Study Consent to provide option for 
participants to have their contact information saved for 
future studies, changed number of blood tubes to be 
collected for laboratory testing from 2 to 3 tubes, changed 
timeline for incentive payments from first week of the 
following month to the second week of the following 
month. Additional mock ad attached. 
5
9/22/2021
Changed amount of blood sample to be collected for 
laboratory testing to 2 tablespoons. Added Cisgender Male 
to the inclusion criteria.
6
5/11/2022
Added introduction of new FDA approved long-acting 
injectable PrEP (cabotegravir extended-release injectable 
suspension, Apretude), two new arms of study (Injectable 
PrEP and Injectable PrEP & STI PEP), linkage to Injectable 
PrEP providers. Changed incentive amounts for Baseline, 
12mo, and 24mo visits to $125, $100, $100 respectively. 
Offering $20 Gift Cards to participants to share our IRB 
approved ad on their social media. Offering $5 incentive at 
in-person recruitment events to take study screener. 
Additional mock ads attached. Expanded eligibility criteria 
to MSM: ages 18-45, all races, all ethnicity, those currently 
on PrEP. 
7
7/26/2022
Changed incentive amount for the CASI Surveys at Month 
4, 7, and 19. Changed it from $20 to $40 to improve 
retention.
8
9/8/2022
Based on participant feedback, changed frequency of 
follow up for Motivational Interviewing (MI) to address 
monthly triggers for Daily PrEP users. Participants 
expressed frequent follow up for MI was not necessary for 
some triggers because they felt the trigger was not affecting 
their PrEP use. 
9
10/21/2022
After communication with NIH, changed enrollment target 
to 240 participants (enrolled prospectively).
10
12/12/2022
Changed incentive amount for second sample collection to 
conduct GC Resistance Testing to $100. It takes 
participants a few hours to coordinate their trip to PRISM 
clinic for second sample collection and then to an outside 
clinic for treatment. Additionally, as inflation rates continue 
to increase, providing a higher incentive for participants’ 
time is necessary. 
11
5/10/2023
Stopping collection of second sample for GC Resistance 
Testing due to low yield in isolating N. gonorrhoeae 
culture. 

Protocol Title:  Element 2
Page 3 of 51
Protocol Version: Version 12  11/21/2024
12
11/21/2024
Study funding ends 3/31/2025 before all participants 
complete their 24 Month Visit. As a result, we will Study 
Stop some participants early (by 1/31/2025) in order to 
have adequate time for study close-out procedures.

Protocol Title:  Element 2
Page 4 of 51
Protocol Version: Version 12  11/21/2024
Table of Contents
1.
Study Summary ........................................................................................................................3
2.
Objectives.................................................................................................................................3
3.
Background ..............................................................................................................................4
4.
Study Endpoints .......................................................................................................................9
5.
Study Intervention/Investigational Agent ................................................................................9
6.
Procedures Involved...............................................................................................................10
7.
Data and Specimen Banking ..................................................................................................18
8.
Sharing of Results with Participants ......................................................................................19
9.
Study Timelines......................................................................................................................19
10.
Inclusion and Exclusion Criteria ........................................................................................19
11.
Vulnerable Populations.......................................................................................................20
12.
Local Number of Participants.............................................................................................20
13.
Recruitment Methods..........................................................................................................20
14.
Withdrawal of Participants .................................................................................................21
15.
Risks to Participants ...........................................................................................................21
16.
Potential Benefits to Participants........................................................................................23
17.
Data Management and Confidentiality...............................................................................23
18.
Provisions to Monitor the Data to Ensure the Safety of Participants .................................27
19.
Provisions to Protect the Privacy Interests of Participants .................................................28
20.
Economic Burden to Participants .......................................................................................28
21.
Consent Process..................................................................................................................29
22.
Setting.................................................................................................................................29
23.
Resources Available ...........................................................................................................30
24.
Multi-Site Research when Emory is the Lead Site.............................................................30
25.
References...........................................................................................................................31

Protocol Title:  Element 2
Page 5 of 51
Protocol Version: Version 12  11/21/2024
1. Study Summary
Study Title
Parrying the Pitfalls of PrEP: Preventing Premature 
PrEP Discontinuation and STIs among MSM
Study Design
Prospective cohort with counterfactual comparison 
group serving as control 
Primary Objective
Using historical data on reasons for PrEP 
discontinuation, identify men at elevated risk for 
discontinuing PrEP before they discontinue and, for 
those with reported risk for discontinuation, use an 
early motivational interviewing (MI) approach and 
consultation with PrEP clinicians to support PrEP 
persistence.
Secondary Objective(s)
Offer on-demand PrEP for men who do not accept 
daily oral PrEP or who plan to stop PrEP because of 
infrequent risk or other reasons.
Offer long-acting injectable PrEP through referral to 
outside providers for men who are not interested in 
daily oral PrEP or on-demand PrEP.
Offer STI post-exposure prophylaxis (STI PEP) to all 
MSM in the cohort as a strategy for decreasing 
bacterial STI infections.
Research 
Intervention(s)/Interactions
In-person and virtual study visits with survey and lab 
testing; online surveys; mobile app for PrEP/STI PEP 
use brief surveys, scheduling study visits, providing 
lab results, and engaging with peer navigator for 
motivational interviewing.
Study Population
MSM ages 18-45 in Atlanta
Sample Size
240
Study Duration for 
individual participants
2 years
Study Specific 
Abbreviations/ Definitions 
PrEP: Pre-exposure prophylaxis
PEP: Post-exposure prophylaxis
STI: Sexually transmitted infection
MSM: Men who have sex with men
MI: Motivational interviewing
Funding Source (if any)
National Institutes of Health
2. Objectives

Protocol Title:  Element 2
Page 6 of 51
Protocol Version: Version 12  11/21/2024
AIM 1: Use historical data on reasons for PrEP discontinuation to identify men at 
elevated risk for discontinuing PrEP before they discontinue and, for those with reported 
risk for discontinuation, use an early motivational interviewing (MI) approach and 
consultation with PrEP clinicians to support PrEP persistence.
AIM 2: Offer on-demand PrEP for men who do not accept daily oral PrEP or who plan to stop 
PrEP because of infrequent risk. 
AIM 3: Offer long-acting injectable PrEP through referral to outside providers for men who are 
not interested in daily oral PrEP or on-demand PrEP.
AIM 4: Offer STI post-exposure prophylaxis (STI PEP) to all MSM in the cohort as a 
strategy for decreasing bacterial STI infections. 
Our scientific premise is that we can increase PrEP uptake and persistence and reduce 
STI incidence in MSM through novel offerings of prevention tools to this population. 
3. Background
The US HIV epidemic continues to disproportionately impact men who have sex with men 
(MSM), who comprise 2% of the US population but account for about two thirds of all new HIV 
diagnoses in the United States.1 Epidemic modeling studies2-4 and our National HIV/AIDS 
Prevention Strategy5 emphasize the critical role of pre-exposure prophylaxis (PrEP) in the 
national HIV prevention response. PrEP use is rising among men, but current estimates of 
coverage of PrEP among PrEP-eligible MSM (in 2016, about 13% of PrEP-eligible men reported 
ever using PrEP in their lifetime; in 2017 in Atlanta, less than 11% of PrEP-eligible MSM took 
PrEP) falls well short of the sustained 30%-50% coverage of PrEP among MSM2, 3 that would be 
required to produce substantial decreases in new HIV infections. Increasing rates of sexually 
transmitted infection (STI) diagnoses independent of and concurrent with higher PrEP use6 lead 
to concerns that men using PrEP may abandon condom use, contributing to greater increases in 
STIs in both PrEP-using MSM and other MSM. 
The impact of PrEP is currently limited by three important issues: the need to help more men 
benefit from PrEP protection; challenges with PrEP persistence for men who initiate PrEP; and 
high rates of sexually transmitted infections (STIs) in both PrEP-using men and in other MSM. 
Finding novel ways to address these concerns is critical to realizing the full potential of PrEP for 
HIV prevention. Multiple epidemic models have reached a consistent conclusion that PrEP 
uptake by 30-50% of PrEP-eligible MSM is predicted to decrease HIV incidence among MSM 
by 25%.3, 4, 9 Although PrEP usage has increased dramatically through 201710, less than one in 6 
PrEP-eligible MSM report ever using PrEP11, and uptake among Black MSM has not kept pace 
with the epidemic burden of this highly impacted group.12, 13 Further, rates of PrEP 
discontinuation are high: in two samples of MSM who had used PrEP, 28%14 and 33%15 had 
discontinued PrEP, with 4 in 5 men who discontinued PrEP not speaking with their PrEP 
provider before stopping.15 We recently concluded an observational cohort of young (18-29) year 
old HIV-negative Black MSM (EleMENt) in which we studied relationships of substance use to 
risk behaviors and HIV incidence (R01DA038196). Data from our study supports these other 
studies’ findings: we experienced 52 men at risk for HIV permanently discontinuing PrEP (40% 

Protocol Title:  Element 2
Page 7 of 51
Protocol Version: Version 12  11/21/2024
of the 131 who started PrEP), many of whom discontinued PrEP without talking to our PrEP 
clinicians. Half of men who discontinued PrEP reported having infrequent risk behavior or not 
wanting to take a medication daily. 
On-demand PrEP, prescribed to be taken the day of sex and for the following two days, reduced 
HIV incidence by 86% in French MSM, and could be most useful for MSM at infrequent sexual 
risk or who dislike daily dosing. On-demand PrEP is used in practice in some European countries 
and is endorsed by IAS-USA with an evidence rating of A1a16, but has not yet been 
recommended by CDC in the United States.17 In a sample of US MSM, on-demand PrEP was 
ranked as the most preferred mode of PrEP among 9 possible routes of PrEP administration, and 
men reported statistically significantly higher intention to use on-demand oral PrEP than to use 
daily oral PrEP.18 On-demand PrEP has both pros and cons: it offers the potential to provide 
PrEP protection to men who have less frequent or episodic sexual risks, but is limited in that men 
need to use upcoming sex as a cue for pre-sex dosing (rather than habituating to daily pill 
taking), and men do not always know in advance when sex will occur.19 Given the heterogeneity 
of sex frequency, risks and preferences, choice in PrEP is important.
STIs in the United States have been persistently increasing since PrEP was licensed as an 
indication for TDF/FTC in the United States.20 Against a backdrop of rising STI diagnoses from 
2012-2017 (especially syphilis, with a 76% increase), the burden of STIs in the United States is 
not evenly distributed.21-23 STI rates are higher among MSM compared to both MSW and 
women.24 Syphilis diagnosis rates for MSM rose 151% from 2010-2015.25 There is geographic 
disparity in STI incidence, with the South accounting for the highest burden of infections. 
Georgia ranks 5th, 3rd, and 4th highest for incidence of chlamydia, gonorrhea, and syphilis among 
all US states. STIs are detrimental to health in multiple ways; one salient concern for MSM is 
that rectal STIs increase the risk of acquiring HIV through rectal mucosal inflammation, 
accounting for up to 15% of new HIV infections in MSM.26, 27 However, there are also exciting 
new approaches to STI prevention for MSM; in the IPERGAY trial of on-demand HIV PrEP, a 
subset of participants were offered the chance to use post-exposure prophylaxis for STIs (STI 
PEP). A regimen of STI PEP, 200 mg of doxycycline taken after sex, was associated with a 
reduced hazard of acquiring chlamydia and syphilis (70% and 73% reductions).8 More data on 
side effects, usage patterns and acceptability are needed, and no data on STI PEP have been 
published from US MSM. 
Since the debut of PrEP, concerns have been raised regarding the potential for risk compensation 
and the possibility of subsequent increases in STIs among PrEP users.28 A systematic review and 
meta-analysis of PrEP demonstration projects and cohort studies showed an overall increase in 
the odds of an STI after starting PrEP (pooled odds ratio 1.25, 95% confidence interval 0.99-
1.54).29 The magnitude of association between PrEP use and increased STI incidence was 
stronger when restricted to more recent studies. The 2017 update to the CDC PrEP guidelines 
suggest an increase in STI testing to every three months.30 Although it is too early to evaluate if 
this increased testing frequency will lead to less STI transmission, there is evidence that 
laboratory testing in real-world PrEP users is suboptimal.31 

Protocol Title:  Element 2
Page 8 of 51
Protocol Version: Version 12  11/21/2024
Black MSM, especially young Black MSM, are a heavily impacted group for whom PrEP is 
essential. In our InvolveMENt cohort of HIV-negative Black and white MSM in Atlanta, the 
youngest (18-24 year-old) Black MSM experienced the highest race-specific HIV incidence: 
10.9%/year, compared to 0.9%/year for their white counterparts. Black men ages 18-29 years old 
(matching our proposed study age range) experienced an 8.9%/year incidence in the cohort. 
Despite this excess risk of infections, there is limited uptake of PrEP among Black MSM.13, 32 
Using data from our InvolveMENt cohort, we developed a PrEP continuum model, and tested its 
components for HIV-negative Black and white MSM in Atlanta.12 We found that although 
awareness and willingness to take PrEP were similar for Black and white MSM, access to 
healthcare and current PrEP eligibility criteria meant that Black MSM may be a third less likely 
to achieve PrEP protection than white MSM12, even though the HIV infection risk of Black 
MSM was three times greater than that for white MSM.33 Further, the CDC criteria for PrEP 
eligibility in MSM are less sensitive for predicting HIV infection risk in Black than white 
MSM.34,35 In addition, young Black MSM in both cohorts experienced high rates of STIs: in the 
InvolveMENt cohort, incidence of rectal CT (10.8%/year) and rectal GC (9.4%/year) among 
Black MSM were 2-3 times higher than rates for white participants.26 In our EleMENt cohort of 
young Black MSM, the rate of new STI diagnosis was 30.2%/year (men on PrEP: 52%; men not 
on PrEP: 27%, p=0.008). 
For our EleMENt cohort, because we had observed alarmingly high rates of new HIV infections 
among Black MSM in our InvolveMENt cohort, we felt it appropriate to offer all participants in 
the EleMENt, regardless of self-reported behavioral risks, the opportunity to start PrEP. Notably, 
this was not a PrEP demonstration project – men were enrolled without regard to their interest in 
PrEP initiation. PrEP information and opportunities to start PrEP were provided in our clinic at 
baseline, and at 3, 6, 12, 18 and 24 months. Over time, the clinic supported 131 of the 300 cohort 
members to start PrEP (defined as taking the first dose). However, there were significant lags 
between PrEP interest and PrEP start; the median time from expressing interest to PrEP start was 
about 4 months.36 The delays in starting and drop-off between PrEP interest and PrEP initiation 
was mostly attributed to structural barriers (e.g. health insurance, transportation to 
appointments).36 Achieving >40% PrEP uptake in our cohort has been associated with a 
reduction in HIV incidence among 18-29 year old Black MSM from 8.9% in InvolveMENt to 
6.2% in  EleMENt – a 30% reduction in incidence compared to the historical controls. This 
difference is not likely attributable to increases in viral suppression among MSM living with 
HIV over the period, because viral suppression has not declined significantly among PLWH in 
Georgia over this period.37, 38 However, 6.2% incidence of HIV among this group of vulnerable 
men is still unacceptable, and we must take further steps to realize the full benefits of PrEP.
Of the 131 young Black MSM who took a first dose of PrEP in the EleMENt study, 91 stopped 
PrEP at least once, and 52 permanently discontinued PrEP. The reasons for PrEP discontinuation 
vary, and some are appropriate. For example, 18 of the 52 permanent PrEP “stoppers” decided to 
hold or stop PrEP based on the recommendation of their study PrEP provider. Reasons included 
adverse events or having a positive HIV test result while prescribed PrEP. However, the other 
reasons for discontinuation were less clearly appropriate. Among the 34 men who initiated 
discontinuation on their own, half felt that they were no longer at risk or were at infrequent risk, 
a quarter cited concerns about side effects, and another quarter were unwilling to take a pill daily 

Protocol Title:  Element 2
Page 9 of 51
Protocol Version: Version 12  11/21/2024
or were talked out of taking PrEP by a partner or parent.  In a multivariable analysis of factors 
associated with PrEP discontinuation, discontinuation was more likely among men who were 
younger, less educated, without insurance, had used cannabis, or had an STI diagnosis (aHR 
1.75, CI: 1.04-2.93).   Some men on PrEP reported that when they received an STI diagnosis, 
they decided to stop PrEP in favor of 100% condom use. PrEP discontinuations sometimes result 
in new HIV infections: we observed 23 new HIV infections among men offered participation in 
the PrEP program. Six of those seroconversions were among men who had started PrEP in the 
EleMENt PrEP program and had subsequently discontinued PrEP, only to go on to acquire HIV 
in the months after stopping PrEP.39 
Improving PrEP impact for Black MSM is an implementation problem, and we need to identify 
effective strategies to support these men at the right time with the right supports. Achieving high 
levels of PrEP protection for young Black MSM is a critical priority. We have demonstrated 
through our EleMENt PrEP program that we can support substantial uptake of PrEP in this 
critical group; integrated client-centered care coordination has also shown models for achieving 
PrEP uptake for Black MSM.40 However, maximizing PrEP impact will require that Black MSM 
at risk for acquiring HIV are linked to PrEP care, start PrEP, persist in PrEP care for the duration 
of their vulnerability, and avoid increased STIs. 
Developing approaches to prevent PrEP discontinuations and avert STI diagnoses is critical. 
However, there has understandably been more substantial early programmatic focus on recruiting 
eligible MSM to PrEP care and on developing adherence approaches41 than on developing 
systems to mitigate PrEP discontinuations and prevent STI infections for MSM on PrEP. There 
is a need for implementation-focused studies on how to holistically prevent premature PrEP 
discontinuations and avert STIs. The holistic focus relates importantly to implementation 
because of our understanding that the barriers to persisting on PrEP are both structural (e.g., 
distance to provider for follow-up visits, health insurance, reimbursement mechanisms) and 
socio-relational (e.g., attitudes of friends and family, relationship status, perception of 
vulnerability to HIV). The barriers to starting PrEP (e.g., lack of awareness of PrEP, barriers to 
care entry, stigma, doubts about the efficacy or safety of PrEP) are not the same as the barriers to 
PrEP persistence (e.g., lapse of insurance or assistance program, difficulties with long-term 
adherence, changing sexual partners, frequency or networks, negative influence of friends or 
family, concerns about new STIs). 
Questions about substance use and HIV risks and prevention are interwoven in questions about 
PrEP uptake and persistence.  The prevalence of substance use in the EleMENt cohort was also 
high (marijuana: 68%; cocaine: 14%; non-prescribed opioids: 8%; stimulants: 18%; risk alcohol 
use: 30%).  HIV risk behaviors have been long associated with substance use.43-45.  Yet, in our 
previous cohort, marijuana use was associated with lower likelihood of starting PrEP and higher 
risk of discontinuing PrEP once initiated.   Further, “chemsex”, or using sex while concurrently 
using drugs, is associated with high levels of risk behaviors.46, 47  On-demand PrEP might be 
especially relevant to men who use drugs during sexual encounters. Because we also propose to 
measure both self-reported and laboratory-confirmed substance use and to measure co-
occurrence of drug use and sex, we will also be able to characterize how substance use relates to 
choices about mode of PrEP (on-demand versus daily oral) and persistence.

Protocol Title:  Element 2
Page 10 of 51
Protocol Version: Version 12  11/21/2024
Our study is guided by the Andersen Model of Healthcare Utilization.48 The theory addresses 
factors that influence the appropriate uptake of healthcare services (in this study, PrEP uptake 
and persistence, choice of PrEP options and utilization of STI PrEP). The use of these services 
relies on decisions of our participants to seek the sustained use of appropriate services including 
medical services, pharmacy services, adherence support services, and prophylactic medications 
that, in their utilization, positively influence the prospects for sexual health and reduce risks of 
HIV and STI infection. Andersen further identifies three broad areas of factors that might 
influence the use of health services as: Predisposing factors (e.g., stigma, race, sexual 
orientation, marginalization, lower economic opportunity), Enabling factors (having to do with 
the logistical aspects of obtaining healthcare, like proximity of services, travel systems, regular 
source of care, waiting times, lower pill burden, and access to providers), and Need factors 
(having to do with perceived or evaluated needs for services, like sexual risks, mental health 
concerns, or STI diagnoses).48 The Andersen model has been applied to retention in antiretroviral 
therapy for persons living with HIV, and may be used to guide PrEP care retention.42
Table 1. Interventions, eligible populations, approaches, outcomes, and Andersen factors 
addressed
Intervention
Eligible 
Population Intervention Approach
Primary 
Outcome
Exploratory 
Outcome
Andersen Factors
Averting PrEP 
discontinuation 
through early 
identification 
and 
Motivational 
Interviewing 
(MI)
MSM not 
currently 
taking daily 
oral PrEP
Monthly screener 
surveys delivered 
through study app to 
assess for PrEP side 
effects; PrEP stop 
intentions; change in 
relationship status; 
change in perceived 
risk for HIV infection; 
change in insurance 
status or concerns 
about upcoming 
change; negative 
feedback from friends 
or family about PrEP; 
adherence concerns; 
MI from peer navigator 
and clinician 
consultation
Rate of PrEP 
discontinuation
Predisposing: Stigma
Enabling: travel systems, 
PrEP care provider, 
regular source of care, 
access to adherence tools, 
insurance navigation
Need: clarification of 
ongoing risks
On-demand 
PrEP
MSM who 
decline 
daily PrEP 
TDF/FTC fixed dose 
combination, 
directions to take 2 
doses 2-24 hrs before 
sex and single dose 24 
and 48 hours after first 
dose
Uptake of on-
demand PrEP
Usage patterns 
of on-demand 
PrEP
Enabling: proximity of 
care resources, 
streamlining pill burden42
Need: Clarification of 
ongoing risks
Injectable PrEP
MSM who 
decline 
daily oral 
PrEP and 
on-
demand 
PrEP
Apretude (Cabotegravir 
injection) every two 
months (to be 
obtained outside 
study)
Uptake of 
injectable PrEP
Usage patterns 
of injectable 
PrEP
Enabling: proximity of 
care resources, 
minimizing pill burden
Need: Clarification of 
ongoing risks

Protocol Title:  Element 2
Page 11 of 51
Protocol Version: Version 12  11/21/2024
Andersen describes different facilitators of utilization as being variably malleable.48 We use the 
model (Table 1) to emphasize intervention on those aspects of utilization which are amenable to 
intervention (e.g., malleable Andersen enabling factors48). For example, we focus on mitigating 
barriers to care/promoting enabling factors by offering commute-free options for discussing 
PrEP discontinuation decisions with a PrEP counselor before stopping PrEP. Some factors, such 
as PrEP-related stigma or negative messages about PrEP from friends or family might be a 
classical Andersen predisposing factor. However, ready access to our motivational interviewing 
(MI)-based counseling (a study-provided enabling factor) may help men put experiences of 
stigma in perspective. Thus, the MI counseling intervention might mitigate the effects of stigma 
or peer pressure to stop PrEP. For STI PEP, pre-dispensing doxycycline promotes the enabling 
factor of ready access to medication when it is needed. For all groups, offering multiple means of 
obtaining support (telephone call, video counseling, or clinic visit with app-based request for 
transportation assistance) promote enabling factors of minimizing time needed for visits and 
adequate transportation systems.
Our study is innovative in several ways. First, we use empirical data from a past cohort of young 
Black MSM in Atlanta to proactively identify men at high risk of discontinuing PrEP before they 
discontinue and intervene promptly. Second, we offer on-demand PrEP as an option to increase 
the proportion of YBMSM using PrEP and to mitigate PrEP discontinuations in the substantial 
group of men whose primary reason for stopping is the requirement to take pills daily or that 
they perceive their risks to be infrequent. Third, with the FDA approval of Apretude 
(cabotegravir extended-release injectable suspension) on 12/20/2021, we offer injectable PrEP as 
an alternative to daily oral PrEP or on-demand PrEP. Participants who elect injectable PrEP will 
be referred to local providers to access the medication; as part of our study, we will monitor their 
use through monthly surveys. Participants will have the option to switch prevention options at 
any point during the study by indicating their interest during monthly surveys or contacting study 
staff directly. Study clinicians will develop transition plan based on clinical indications. Fourth, 
we are offering STI PEP in the same service setting as we are offering HIV PrEP, which 
decreases STI infections including rectal Chlamydia -- thereby averting the increased biological 
susceptibility of rectal mucosa to HIV infection49 and concerns about MSM on PrEP about STI 
risk. Fourth, we have developed a design that is responsive to our understanding that we need to 
learn about the best ways to increase utilization of efficacious services.  Randomized clinical 
trials have shown on-demand PrEP and STI PEP to be efficacious.8, 50 Therefore, rather than 
randomizing young Black MSM at risk for HIV to no intervention, we have specified a target 
trial for emulation51 and we will use a just-completed study of young Black MSM in Atlanta as a 
counterfactual comparison group to understand the impact of our intervention on PrEP 
discontinuations and STI incidence, using methods already used for trial emulation by our 
Need: Clarification of 
insurance coverage issues
STI PEP
All men in 
cohort
Doxycycline 100 mg, 
directions to take 2 
capsules within 24 (no 
more than 72) hours 
after sexual risk
STI diagnoses at 
12 and 24 
months
Prevalence of 
doxycycline 
resistance 
among all STI 
PEP users and 
STI PEP 
participants 
diagnosed with 
NG
Enabling: proximity of 
care resources, 
minimizing pill burden
Need: Clarification of 
ongoing risks

Protocol Title:  Element 2
Page 12 of 51
Protocol Version: Version 12  11/21/2024
team52. Lastly, we will offer participants the opportunity to engage in study visits remotely 
through the use of telehealth and home testing methods to provide flexibility and ease concerns 
related to COVID-19.  
4. Study Endpoints 
Primary endpoints include: Rate of PrEP discontinuations, uptake and usage patterns of 
on-demand PrEP, STI diagnoses
Secondary endpoints include: HIV diagnoses
Primary safety endpoints include: PrEP adverse reaction; doxycycline adverse reaction
Secondary safety endpoints include: Doxycycline resistance among STI PEP users and 
participants diagnosed with GC (exploratory)
5. Study Intervention/Investigational Agent
The three study interventions include the following: (1) offering MI and PrEP clinical consults to 
reduce PrEP discontinuations; (2) offering on-demand PrEP to increase PrEP uptake and 
persistence; (3) offering long-acting injectable PrEP through referral to outside providers; and, 
(4) offering STI PEP to decrease STI incidence.  
PrEP discontinuation intervention- Men taking daily oral PrEP (Truvada) will receive a monthly 
screener through the mobile app.  If answers to screener questions indicate a participant is at risk 
for PrEP discontinuation, then a peer navigator will deliver a motivational interviewing 
intervention and a clinician will consult with the participant if needed. These efforts are intended 
to avert PrEP discontinuation. Participants will receive Truvada through local pharmacies. 
Offering of on-demand PrEP- For men who are not interested in daily PrEP or plan to 
discontinue daily PrEP, we will offer on-demand PrEP (Truvada) which will allow them to take 
it immediately before/after a sexual encounter. It is hoped that this will serve as an alternative to 
daily PrEP use that is desirable for some people. Participants will receive Truvada through local 
pharmacies.
Offering of injectable PrEP- For men who are interested in injectable PrEP, they will be referred 
to local providers to access the medication and for clinical monitoring. In the study, their use of 
the medication will be monitored through monthly surveys during which they have the option to 
indicate interest in switching to oral PrEP. 
Offering of STI PEP- All men in the cohort will be offered STI PEP (doxycycline) to use after 
condomless sex with the goal of averting STI diagnoses. We plan to partner with the Emory 
Investigational Drug Service (IDS) to dispense doxycycline to consenting participants at a 
dosage of 200 mg to be taken in a single dose ideally within 24 hours of possible exposure (e.g. 
condomless anal sex) and no later than 72 hours after exposure. Participants will be dispensed 
enough pills to allow for up to 3 weekly doses of 200mg doxycycline (i.e. 6 pills/week) for 3 
months (the interval between STI testing visits). Clinical study staff will write a prescription for 

Protocol Title:  Element 2
Page 13 of 51
Protocol Version: Version 12  11/21/2024
doxycycline and fax to the IDS along with a Fed Ex air bill for shipment of the drug directly to 
the participant. We obtained an IND waiver for investigational use of doxycycline, through the 
Emory Investigational Drug Service, to prevent STI infections.
6. Procedures Involved
Design: The study will be a prospective cohort of MSM who are followed prospectively 
for 2 years either in-person at our PRISM Health Research Clinic and/or virtually with 
remote study visits.  Follow-up visits will occur as frequently as every 3 months, or as 
appropriate to clinical needs of HIV PrEP or STI PEP (Figure 1). We will enroll men 
who are not on PrEP at study initiation and who may decide to start or stop PrEP, change 
from daily oral PrEP to on-demand PrEP or from on-demand PrEP to daily PrEP, and/or 
start or stop STI PEP at any point in the study period (Figures 1,4).  If we have trouble 
enrolling men who are not currently on PrEP we will expand our enrollment criteria to 
include men currently on PrEP.  All men will be provided with the study’s mobile smart 
phone app to support early identification of risks for PrEP discontinuation, to provide 
information about STI PEP and document usage patterns of on-demand PrEP and STI 
PEP, and to support easy linkage to support services for PrEP counseling and addressing 
concerns or questions about STI PEP. With the advent of newly FDA approved Apretude 
(cabotegravir extended-release injectable suspension), participants will now have the 
option of starting long-acting injectable PrEP through a local provider. Participants will 
be given a list of local providers to initiate the medication on their own. If participants 
elect both Injectable PrEP and STI PEP, STI clinical follow-up will be done through the 
study and administration of the injection will be done through a local provider. The local 
provider will also be responsible for all applicable clinical monitoring of the injection. If 
participants elect only Injectable PrEP, all clinical follow-up will be done by the local 
provider who administers the medication; we will monitor participant use of the 
medication through monthly surveys. The monthly surveys will provide an option to 
indicate interest in switching to oral PrEP; if indicated, participants will be able to access 
oral PrEP through the study. 
Figure 1: Study Procedures

Protocol Title:  Element 2
Page 14 of 51
Protocol Version: Version 12  11/21/2024
Eligibility: Eligible participants will: be male at birth, self-identify as cisgender male, 
ages 18-45 years, have had ≥1 male anal sex partner in the 12 months before the baseline 
interview, able to complete the survey instruments in English, live in the Atlanta MSA 
and not planning to move from it over the next 2 years, provide ≥ 2 means of contact, 
own a cell phone with data service, willing to download and use a health-related study 
app on cell phone, not be currently enrolled in another HIV prevention clinical trial, and 
have a confirmed HIV-negative status at the baseline visit. 
Recruitment: Our goal is to enroll 240 MSM using the most efficient methods, while 
minimizing opportunities for bias. We will use two recruitment methods that draw on the study 
team’s strengths. We will recruit MSM who are not known to be living with HIV from 2 sources. 
The venue-based method is a modified venue-day-time screening approach implemented by 
CDC for behavioral surveillance under PI Sullivan’s leadership.131 We have tracked the 
recruitment data for each recruitment venue and day from past studies, and will use those 
historical data to oversample venues that historically had high numbers of MSM who were HIV-
negative. We will also offer $5 incentive to take the study screener at in-person recruitment 
events. The second method is recruitment via dating apps and social media. This involves 
targeting advertisements to adult men in Atlanta who are using Grindr or other dating apps, who 
use social media channels such as Instagram and Snapchat, or whose Facebook profiles connote 
an interest in men. We will also offer $20 gift cards to current participants to share our IRB 
approved study ads on their social media. The goal is for participants to simply share this 
information with their social networks on a voluntary basis. Their participation in the study will 

Protocol Title:  Element 2
Page 15 of 51
Protocol Version: Version 12  11/21/2024
not be affected in any way should they volunteer to share study information. They will not be 
referring individuals, rather simply share information that has been approved by IRB. 
Considering the current social climate, our target demographic gets most of their information 
online. As a result, social media advertising is the most effective way to get information out to 
intended audiences. Men who click on the online ads are referred to a brief introduction script 
and a self-administered online screening form. Analyses of our InvolveMENt data show few 
differences exist in behaviors, HIV/STI infection, and retention between MSM recruited by VDT 
and subset recruited via Facebook.61 
Eligibility Screening: Men who click on ads or who are approached in-person will be given the 
opportunity to complete a screening consent and then an eligibility screening survey.  
Enrollment and baseline procedures: Building on successful protocols from InvolveMENt, 
EngageMENt and EleMENt studies, our staff will contact screening respondents who were 
initially eligible and will schedule an enrollment (baseline) visit at our PRISM Health Research 
Clinic, which is in a central location in Decatur and 1.5 blocks from a major MARTA rail 
station. To minimize selection bias for study enrollment, we will offer Uber rides to the clinic or 
to a convenient MARTA station for men who have limited transportation options or long 
commutes (minimizing bias). The enrollment visit will consist of informed consent, a computer-
assisted self-interview (CASI) behavioral survey, HIV and STI testing, training on using the 
study app, and a counseling session to include pre- and post-test HIV prevention information and 
a discussion about PrEP and STI PEP options (see figures 2 and 3) with participants given the 
option to initiate either or both of these following the baseline visit.   The 1-hour CASI survey 
will assess demographics, HIV and STI testing history, sex and drug use behaviors, anxiety and 
depression, stigma, and questions about past PrEP use and experience.  Men who have a new 
HIV diagnosis either at baseline or during the study will be helped with accessing HIV care and 
treatment services and will not proceed to the prospective study or their study participation will 
terminate upon HIV diagnosis. All men will be referred to other indicated services (e.g., sexual 
or mental health, housing assistance) based on needs identified during post-test counseling.  
Respondents who complete an enrollment visit will be compensated $125, whether or not they 
participate in the prospective study. 
Daily PrEP offering: All participants will be offered daily PrEP (Figure 2) at baseline and at the 
12-month follow-up visit. Men who are not taking daily PrEP will also have the opportunity to 
indicate interest in it with each of the CASI surveys at months 4, 7, 12, and 19 and also with the 
3-monthly clinical monitoring for STI PEP and/or on-demand PrEP. Men can also request an ad-
hoc PrEP or STI PEP initiation visit at any time in the study app. Using the protocol established 
in our EleMENt cohort for PrEP offering and insurance navigation, we will show participants a 
short informational video about daily oral PrEP. Men who are interested in starting PrEP can talk 
to a counselor at the visit; if they are interested in starting daily PrEP, we will perform a 
commercial 4th generation HIV test as well as test for Hepatitis B surface antigen and creatinine 
(liver function) level in addition to the HIV and STI testing already being conducted for all study 
participants. Participants will either be prescribed Truvada as a fixed-dose combination of 300 
mg TDF/200 mg FTC or Descovy as a fixed-dose combination of 25 mg TAF/200 mg FTC.  
Decisions about which PrEP medication will be prescribed will be made by the study clinicians. 
We will help with navigating insurance concerns or applying for patient assistance programs to 

Protocol Title:  Element 2
Page 16 of 51
Protocol Version: Version 12  11/21/2024
help cover the costs of PrEP. Daily PrEP users will be sent an at-home specimen collection kit 
every 3 months to clinically monitor them for HIV and STIs.  Preliminary data on PrEP offering: 
In EleMENt, we offered PrEP to 300 young Black MSM, of whom 125 initiated daily oral PrEP 
using similar processes and materials proposed for this study36. Participants will receive Daily 
PrEP through local pharmacies.
On-Demand PrEP Offering: If men are interested in PrEP but do not accept daily oral PrEP, we 
will offer on-demand PrEP (see Figure 2) which will also be described in the video participants 
watch about the prevention options. Men who initiate on-demand PrEP will receive the same 
laboratory testing as men who initiate daily oral PrEP (e.g., HIV 4th gen Ag/ Ab testing, 
Hepatitis B surface antigen, creatinine). Men who choose on-demand PrEP will be prescribed 
Truvada as a fixed-dose combination of 300 mg TDF/200 mg FTC or Descovy as a fixed-dose 
combination of 25 mg TAF/200 mg FTC Participants will be directed to take two pills 2-24 
hours before sex, and to take an additional pill 24 hours after the first pill and a final dose 24 
hours after that (“2-1-1”).50 To support appropriate dosing, the mobile app will allow participants 
to record their first (pre-sex) dose, and receive non-specific reminders (“remember to take your 
pill!”, or a participant-chosen message92,135) 24 and 48 hours later. On-demand PrEP users will 
be sent an at-home specimen collection kit every 3 months to clinically monitor them for HIV 
and STIs. Participants will receive On-Demand PrEP through local pharmacies.   
Injectable PrEP Offering: If men are interested in injectable PrEP, we will provide referrals to 
local providers. They will be given a list of local providers to initiate the medication on their 
own. Men who initiate injectable PrEP and STI PEP will receive the same laboratory testing as 
men who initiate only STI PEP, which includes HIV/STI screening. Clinical monitoring of 
injectable PrEP will be done by the local provider who administers the injection. If they elect 
only injectable PrEP, all clinical follow-up will be conducted by the provider who administers 
the injection; we will only monitor their use of the medication and HIV testing status through 
monthly and periodic surveys. Men will also have the option of changing prevention options at 
any point during the study by indicating their interest during their monthly surveys or simply 
contacting us directly through the study phone, text or email.

Protocol Title:  Element 2
Page 17 of 51
Protocol Version: Version 12  11/21/2024
Figure 2: PrEP Offering Algorithm
 
STI PEP Offering: All men in the cohort will be offered STI PEP (Figure 3) per the published 
IPERGAY protocol.8 We will use the same model to introduce STI PEP as we have used to 
introduce HIV PrEP in our current cohort: participants will be shown a short video introduction 
to STI PEP, instructed on use and possible side effects, and will be offered initiation on STI PEP 
on the day of the baseline visit or at all subsequent study interactions. Men will also be offered 
the option to initiate STI PEP on each of their CASI surveys at months 4, 7, 12, and 19 as well as 
at a potential 3-monthly visit for PrEP users. Men may also schedule an appointment between 
regular study visits to initiate STI PEP. A licensed clinician, overseen by Dr. Kelley, will 
prescribe all STI PEP, using doxycycline at a dosage of 200 mg to be taken in a single dose 
ideally within 24 hours of possible exposure (e.g. condomless anal sex) and no later than 72 
hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly 
doses of 200mg doxycycline (i.e. 6 pills/week) for 3 months (the interval between STI clinical 
monitoring testing). Doxycycline will be provided by the Emory Investigational Drug Service 
Pharmacy that will mail out initial and renewal prescriptions. The weekly STI PEP monitoring 
surveys will assess how a participant’s STI PEP use has gone, ask about STI symptoms, side 
effects or concerns, and confirm whether the participant wants to continue using STI PEP and 
needs a refill. Additionally, STI PEP users will be sent an at-home specimen collection kit every 
3 months to clinically monitor them for HIV and STIs.  If a participant ever has side effects or 
questions about STI PEP, they will be able to contact the provider through the HIPPA-compliant 
messaging system, by phone, or by telehealth video chat. GI side effects were common in 
IPERGAY. We will pay special attention to educating participants and eliciting GI side effects.

Protocol Title:  Element 2
Page 18 of 51
Protocol Version: Version 12  11/21/2024
Figure 3: STI PEP Offering Algorithm
Prospective follow-up: 
Prospectively-enrolled participants will be followed for two years (Figure 4). Depending on what 
services are used, some participants will receive additional app-based assessments to document 
risks for PrEP discontinuation and use of on-demand PrEP, injectable PrEP or STI PEP (Table 
2). Oral PrEP initiators and STI PEP initiators will receive brief weekly surveys ($5 incentive for 
each) for the first 2 weeks after they start their new regimen to identify side effects or other 
barriers to use as early as possible. After this period, all daily PrEP users will receive monthly 
short surveys for risk factors for PrEP discontinuation administered through the study app ($10 
incentive for each).  Injectable PrEP users will receive monthly short surveys ($10 incentive for 
each) to measure PrEP use and assess risks for discontinuation. Participants who start on-demand 
PrEP or STI PEP will continue weekly short surveys ($5 incentive for each) to measure PrEP 
and/or STI PEP use and assess risks for PrEP discontinuation (on-demand PrEP); the frequent 
follow-up intervals will reduce recall bias (minimizing bias). Participants will be compensated 
for all weekly and monthly assessments during the second week of the following month. All 
participants will complete CASI surveys at months 4, 7, 12, 19 and 24 months, attend in-person 
follow-up visits at 12 and 24 months ($40/4,7,19 months; $100/12 month survey and study visit; 
$100/24 month survey and study visit) and additional telehealth or in-clinic visits if risk for PrEP 
discontinuation is identified by surveys. Daily or on-demand PrEP users will have 3-monthly 
HIV/STI home-testing for clinical monitoring of their PrEP use 36, 132, and STI PEP users will 
have the same home testing to clinically monitor their STI PEP use (Figure 4). For injectable 
PrEP users, all clinical monitoring will be done outside the study by a local provider of the 
participants’ choosing.
Participants will be study stopped early when funding ends. The budget for this study will end on 
3/31/2025. Participants will complete all study activities by 1/31/2025 to provide adequate time 
for study close-out procedures. At this point, some participants will have completed their 24 
Month Visits. Others will be study stopped, before they complete their 24 Month Visit. All 
participants will be provided refills for medications, when applicable, and linkage resources to 
continue their health journey.  

Protocol Title:  Element 2
Page 19 of 51
Protocol Version: Version 12  11/21/2024
Table 2. Schedule of Added Interim Surveys for Men on PrEP/STI PEP
Regimen
Initial Check-in Frequency
Maintenance check-in frequency
Daily PrEP
Monthly
On-Demand PrEP
Weekly
STI PEP
Weekly for first 2 weeks
Weekly
Injectable PrEP
None
Monthly
Mobile app to support participant management, on-demand PrEP, injectable PrEP and STI PEP 
usage, and weekly/monthly screeners: We will build on our extensive experience in designing 
and evaluating mobile apps for MSM76, 92, 98, 133, and the SMaRT (Study Management and 
Retention) system developed by the Emory CFAR. The SMaRT system is a study management 
platform that allows for participant management (reminders, scheduling, survey administration, 
and communication by email and text messaging). It includes a companion mobile app that study 
participants install on their smart phones that supports several key functions of study 
participation: notifications of surveys/screeners available, administration of surveys, messaging 
center, appointment scheduling for in-person or telehealth visits, HIPPA-compliant uploading of 
documents and return of laboratory results, and HIPPA-compliant telehealth video meetings. 
We will modify the SMaRT system and participant app to deliver weekly/monthly surveys 
assessing risk factors for PrEP discontinuation and on-demand PrEP/injectable PrEP/STI PEP 
use, scheduling for assessment visits and other prevention services, telehealth meetings with 
trained peer navigators, and messaging systems to request transportation assistance (e.g., Uber 
ride to clinic or nearest MARTA station). Given the robust SMaRT platform, we estimate that 
initial production of the tailored version will take 6 weeks. Preliminary data for mobile app 
platform: We have developed several mobile apps for HIV prevention for MSM and documented 
our process of piloting and getting feedback from communities and end-users.92, 98, 134, 135 The 
SMaRT system is currently used for 14 NIH-supported HIV prevention studies41, 98, 99, 136-141 (all 
supported by Emory staff) and is available as a CFAR service from the Emory CFAR Prevention 
Sciences Core.
Identification of risk factors for PrEP discontinuation through monthly surveys: We will “push” 
a survey notification through the study app monthly to all participants on Daily PrEP. The survey 
will include several items to identify common concerns that have led to PrEP discontinuation 

Protocol Title:  Element 2
Page 20 of 51
Protocol Version: Version 12  11/21/2024
among previous participants (See Table 1 for sample indicators) and participants can schedule an 
appointment to discuss PrEP questions or concerns, if they choose to. Appointments may be 
scheduled through the app for a telephone call, a video call, or an in-person clinic visit. If 
transportation assistance is needed for an in-clinic visit, it can be requested through the app at the 
time of scheduling. This brief monthly survey is 7 questions in length and will be completed 
securely within the HIPPA-compliant app. When a participant endorses ≥1 risk factor for PrEP 
discontinuation, study staff will be notified by a secure electronic message and the participant 
will be asked immediately to schedule a motivational interviewing (MI) session with a peer 
navigator in the mode/location of his choice, and offered available times to schedule through the 
app. If the participant does not self-schedule within 72 hours, we will communicate with the 
participant through the secure messaging features in the app to establish a time for a call, in 
which study staff will explain that we would like the participant to have a telehealth or in-person 
visit with a PrEP peer navigator. Frequency of follow up on monthly triggers for MI session will 
vary based on the needs and experience of each participant. After an initial MI session for each 
indicated trigger, participants will have the opportunity to express which triggers are relevant to 
their PrEP experience and thus require future follow up when indicated. Based on participant 
feedback, peer navigators will tailor frequency of follow up for each indicated trigger. 
Injectable PrEP users will receive monthly short surveys to measure PrEP use, HIV testing 
status, and assess risks for discontinuation. They will have the option to indicate interest in 
switching their prevention option within the survey.
PrEP discontinuation intervention: If answers to the monthly screener questions indicate a 
participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational 
interviewing (MI) intervention and a clinician will consult with the participant if needed. These 
efforts are intended to avert PrEP discontinuation. When a participant reports any of the risk 
factors, they will be invited to schedule a discussion with a peer navigator. Triage sessions will 
be client-centered, using an approach grounded in MI. By focusing on the last time the client was 
confident about being on PrEP (e.g., think back to when you were taking your medication every 
day. What was going on in your life? Where were you living? Who were you dating?), the peer 
navigators will be able to understand the holistic context of the current risk factor – for example, 
changes in willingness to take a daily medication might arise from changes in housing situation 
or relationship patterns. Based on this comprehensive understanding of needs and the monthly 
screening data, trained peer navigators will use MI tools to help participants problem solve based 
on the needs identified and will work with them to develop a plan to address those concerns 
while maintaining PrEP, if appropriate. For example, if a participant says they plan to stop PrEP 
because they have a new partner who they feel committed to, the counselor might talk to the 
client about HIV and STI testing with the partner before discontinuing PrEP or using Couples 
HIV Testing and Counseling145 services to discuss mutual decisions about PrEP, condom use, 
and other prevention tools. Clinical concerns (e.g., side effects) will be referred to a PrEP 
clinician for discussion. 
Injectable PrEP users will receive monthly short surveys to measure PrEP use and assess risks 
for discontinuation. They will have the option to indicate interest in switching their prevention 
option within the survey. However, an MI intervention and clinical consultation will not be 
provided as part of the study based on their survey answers. Our goal will be to simply monitor 

Protocol Title:  Element 2
Page 21 of 51
Protocol Version: Version 12  11/21/2024
the use of injectable PrEP and HIV testing status among our participants. If they elect to switch 
to oral PrEP at any point during the study, then the above interventions will apply. 
Computer assisted self-interview (CASI): Participants will complete online CASI surveys on a 
HIPPA-compliant survey platform at baseline, 4, 7, 12, 19 and 24 months (Figure 4).  Surveys 
will either be done remotely or at our research clinic. The CASI will assess updated contact 
information, recent sex and drug-using behaviors, psychosocial factors, use of PrEP and STI 
PEP, and HIV and STI testing outside the study and self-reported results since the previous visit. 
For PrEP and STI PEP users, more frequent (weekly and/or monthly) assessments of daily PrEP, 
on-demand PrEP, injectable PrEP and STI PEP use will be administered through the study app. 
Preliminary data - CASI: We have employed secure, online CASI with 4,503 follow-up surveys 
in previous cohorts. Most men (80%) chose to take follow-up surveys from home, using their 
own computers.
Laboratory testing procedures: Laboratory testing (Figure 4) will be done at the research clinic or 
remotely by the participant at home using self-collection specimen methods. If specimens are 
collected at the clinic, we will use INSTI, a CLIA-waived HIV rapid test, to confirm self-
reported negative HIV infection status at baseline. INSTI will also be used for HIV testing at the 
12 and 24-month study visits. If the rapid test is positive or indeterminate, or if someone is 
initiating PrEP/STI PEP, we will send a blood sample to Quest for commercial fourth generation 
testing.  If specimens are collected remotely, we will have the participant use a dried blood spot 
card and have MTL laboratories perform commercial fourth generation HIV testing.  Regardless 
of whether participants attend a remote or in-person study visit, they will self-collect urine, rectal 
and pharyngeal samples to test for the presence of C. trachomatis (CT) and N. gonorrhea (NG) 
using the Abbott Real Time CT/NG assay.  Serum samples for an FDA-approved syphilis rapid 
plasma reagin (RPR) test and titers will either be collected in-person at the clinic by a 
phlebotomist or remotely via participant fingerstick blood sample. STI samples will either be 
sent to MTL (self-collected) or Quest (in-person) for testing.  Oral PrEP candidates will also 
receive creatinine testing at baseline, 12 and 24 months, Hepatitis B screening at baseline or 
whenever PrEP is initiated, and periodic testing of tenofivir-diphospate (TFVdp) levels using a 
dried blood spot card. Blood samples for these tests will either be self-collected and sent to MTL 
or phlebotomist-collected and sent to Quest with the exception of all TFVdp testing being done 
by MTL. Injectable PrEP users will receive the same laboratory tests as everyone for baseline, 12 
and 24 month visits. They will not have 3-monthly clinical monitoring through the study unless 
they also elect STI PEP. If they elect STI PEP, they will receive HIV/STI screening every 3 
months to monitor STI PEP use. Clinical monitoring of injectable PrEP use will be done by the 
local provider who administers the medication.
Any positive test results will be provided to participants over the phone by a study staff member 
who can refer participants to study-paid treatment for STI infections at a local community-based 
health clinic, or participant-paid treatment through a provider of their choosing. Negative tests 
will generally be delivered through the HIPPA-compliant study app. To minimize bias in self-
report data on substance use, we will conduct urine drug screening (UDS) in our onsite CLIA-
waived laboratory at baseline, 12 and 24 months using the Ten Panel Integrated EZ Split Key 
Cup Drug Test (minimizing bias).

Protocol Title:  Element 2
Page 22 of 51
Protocol Version: Version 12  11/21/2024
Figure 4: Timeline of study visits, activities, and labs
Staphylococcus aureus nares resistance testing: A recent Canadian study of daily doxycycline 
use to prevent STIs among MSM on PrEP found doxycycline resistance in nasal carriages of S. 
aureus over the study’s duration. Over the course of our study, we will collect a total of 2-4 nasal 
swabs at in-person study visits from all participants to assess the prevalence of doxycycline 
resistance among persons taking STI PEP versus those who are not. The swabs will be banked 
for later analysis by Sarah Satola’s Emory Investigational Clinical Microbiology Core lab for 
testing. 
Preliminary data for laboratory: We previously performed HIV rapid testing for 1,668 
participants in our cohort studies. In total, we performed STI testing with the same study team 
and CFAR laboratory colleagues for 3,102 STI measurements in MSM in Atlanta.122 We have 
completed 2,913 UDS results in previous studies, and have published data on using UDS to 

Protocol Title:  Element 2
Page 23 of 51
Protocol Version: Version 12  11/21/2024
characterize and adjust for misclassification bias from self-report.126 Dr. Kelley has extensive 
experience in studying the rectal microbiota in MSM.62, 68, 144
Retention activities: Several activities will be developed to maximize retention, building on the 
experiences and expertise of the study team. Our past cohort studies and clinical trials have 
employed a sophisticated participant management database (SMaRT) and successful retention 
coordination activities that will also be used for this study. An Emory staff person will be 
allocated exclusively to retention activities. The SMaRT mobile app customized for this study 
can schedule/reschedule/receive reminders of/cancel study appointments, communicate securely 
with study staff, and update contact information from within the HIPPA-compliant app. 
Participants will be prompted every 3 months to review and update their contact information in 
the SMaRT app. At enrollment, we will ask permission for several means of contacting 
participants. Retention contacts will be customized based on participants’ contact preferences 
(email, text, call, US mail) and organized by SMaRT. Participants will be reminded about their 
follow-up visits through the app messaging system or through their preferred means of contact 4 
weeks before the scheduled follow-up date. If we lose contact with participants (missed surveys 
or appointments and non-responsive to contact requests), we will have obtained consent to use 
for-fee public-use databases (e.g., Lexis-Nexis) to locate participants; this has been used by us in 
previous studies to relocate participants lost to follow-up. For participants who cannot be 
contacted, after IRB approval, staff will attempt to link the identities of participants to registries 
of known decedents using a statewide dataset (vital records) and a nationwide dataset (National 
Death Index). 
Intervention training and quality assurance 
Training and QA protocols will be developed and supervised by Consultant Stephenson; 
management of QA record selection and evaluation will be coordinated by the Study 
Coordinator. Our team has a wide range of experience training and monitoring 
intervention staff in behavioral clinical trials. Training: Training will encompass the 
intervention approach and procedures, PrEP information/education, general health and 
mental health issues, and research ethics. Specific techniques for adhering to a 
manualized intervention while allowing for flexibility to address individual participant 
needs will be taught, role-played and supplemented by instructional readings. QA 
procedures of intervention delivery across peer navigators and over time during the 
course of the study have been developed from the team’s prior trials94, 96 and the relevant 
literature and include: (1) development of detailed manuals for the intervention; (2) 
intensive training; (3) incorporation of mock training sessions that enable us to ensure all 
facilitators meet performance criteria for intervention delivery, leading to certification of 
peer navigators based on common performance standards; (4) digital recording of 
sessions, with 20% of all files randomly selected among facilitators for QA ratings. QA 
checklists will be developed and will provide the structure for review; ratings will be 
contingent upon >80% inter-rater reliability; and (5) QA feedback will be incorporated 
into routine project supervision. Over the course of the proposed trial, it is therefore 
anticipated that up to 50 hours of intervention delivery will be monitored for QA 
purposes, reflecting 20% of sessions. Additional monitoring will continue for staff whose 

Protocol Title:  Element 2
Page 24 of 51
Protocol Version: Version 12  11/21/2024
QA ratings fall below pre-designated thresholds until performance improves or, if 
necessary, the staff member is replaced.
Study Medications
The study medications include Truvada or Descovy for daily and on-demand PrEP and 
doxycycline for STI PEP.  All three medications are FDA approved. The study qualifies 
for an IND waiver for the investigational use of doxycycline to prevent STI infections.  
Side effects of PrEP include nausea/vomiting, diarrhea, abdominal pain, high creatinine 
level, bone fracture, proteinuria, glycosuria, elevated alanine aminotransferase.  Side 
effects of doxycycline include nausea/vomiting, diarrhea, abdominal pain, high creatinine 
level, proteinuria, glycosuria, elevated ALT concentrations. Participants can access 
Apretude (cabotegravir extended-release injectable suspension) through a local provider 
of their choosing, this medication will not be provided through the study. Side effects of 
injectable PrEP include: pain, tenderness, hardened mass or lump, swelling, bruising, 
redness, itching, warmth, loss of sensation at the injection site, abscess, discoloration, 
diarrhea, headache, fever, tiredness, sleep problems, nausea, dizziness, passing gas, 
stomach pain, vomiting, muscle pain, rash, loss of appetite, drowsiness, back pain, or 
upper respiratory infection.
 
Safety and Risk Minimization
Throughout the study, we will minimize risks to participants and monitor their safety by 
engaging with them frequently through study visits, surveys, and telehealth appointments 
and assessing side effects and other clinical and/or behavioral issues that need addressing. 
Clinical staff, as well as the peer navigator, will intervene when issues are identified to 
minimize potential harm to the participant and ensure safe use of study medications.  
7. Data and Specimen Banking 
Additional data analyses besides those described in this protocol will be performed. Data 
will be stored in accordance with the description outlined in section 17.0 “Data Analysis, 
Management and Confidentiality.” Participants will be asked during the consent process 
if they consent to release certain data to Emory for use in the study. No data will be 
collected after all research procedures are completed.
A second set of rectal samples collected at in-person study visits will be stored for 
possible future analyses to examine perturbations in the microbiota associated with daily 
or on-demand PrEP and/or STI PEP. Specimens will be stored in a freezer at The Hope 
Clinic of Emory University for no longer than 20 years for use in future microbiome 
research.  Nasal swab samples collected at in-person study visits will also be frozen and 
banked for no longer than 20 years for future analyses of doxycycline resistance to staph 
aureus in nasal carriages. 
Data associated with banked specimens will include participant ID, date of collection, test 
results and date, and PrEP/STI PEP use at time of specimen collection.

Protocol Title:  Element 2
Page 25 of 51
Protocol Version: Version 12  11/21/2024
The data and specimen release process will include completion of a data request form, 
review and approval by a subset of study investigators, and monitoring for appropriate 
use and dissemination.  
8. Sharing of Results with Participants
Results from all diagnostic and routine monitoring tests will be shared with participants 
either in person (i.e., rapid HIV test done at in-person study visits), over the phone or 
through the HIPPA-compliant study app. Any positive non-rapid test results will be 
provided to participants over the phone by a study staff member who can refer them to 
treatment. Negative tests will generally be delivered through the HIPPA-compliant study 
app. 
9. Study Timelines
Individual participants will be in the study for 2 years. Full study enrollment is 
anticipated to take one year. Primary analyses are estimated to be completed by the end 
of year 5 (April 2025).
10. Inclusion and Exclusion Criteria
Inclusion Criteria

Male at birth

Self-identify as Cisgender Male

Ages 18-45 years

≥1 male anal sex partner in the 12 months before the baseline interview

Live in the Atlanta MSA

Owns cell phone with data service

Willing to download a health-related app to their cell phone as part of the research study

Able to provide ≥ 2 means of contact

Not currently enrolled in another HIV prevention clinical trial

Confirmed HIV-negative at baseline visit
Exclusion Criteria:

Female at birth

Do not self-identify as Cisgender Male

Individuals < 18 years of age or > 45 years of age

HIV positive status

No male anal sex partner in the 12 months before the baseline interview

Does not own mobile phone with data service

Not willing to download a health-related app to their cell phone as part of the research 
study

Protocol Title:  Element 2
Page 26 of 51
Protocol Version: Version 12  11/21/2024

Live outside the metro Atlanta MSA and/or planning to move from Atlanta area 
in the next 2 years

Currently enrolled in an HIV prevention or treatment clinical trial
We will also exclude all of the following:

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners 
Data informing new eligibility/inclusion criteria: There is a substantial literature about risks 
and PrEP use and intentions to use during the COVID pandemic. Many MSM who were using 
PrEP stopped using it, in the US South (154, 155) and globally (156, 157). Visits for PrEP 
initiation were lower in US practice settings (158), and increases in chlamydia and syphilis 
diagnoses during the pandemic (159) suggest lower levels of risk behaviors were occurring. As a 
result, while maintaining our original scientific aims, we are expanding our eligibility criteria. 
Surveillance data and data from our own research in Atlanta show that MSM, especially MSM in 
the South, face substantial risk of HIV infection through their 40s. We originally enrolled 
exclusively young MSM because HIV risk is even higher in that group; we will now broaden our 
criteria to include MSM through age 45.
We also will broaden our eligibility criteria to include men other than Black MSM.  HIV risk and 
PrEP indications are high for all MSM in the US South.  We originally focused on Black MSM 
based on a relatively higher risk for HIV compared to other groups; however, the COVID 
pandemic especially impacted Black Americans and Black Atlantans face more substantial 
challenges to traveling to HIV prevention and care (160-162). We will address this challenge for 
participants by expanding support for transportation and increasing study incentives.  We will 
also enroll other MSM  to meet the scientific objectives of understanding the patterns of PrEP 
usage as more PrEP modalities are available. Though some of our background information cites 
previous outcomes among Black MSM, we are expanding our eligibility criteria to include all 
races and ethnicities based on similar risk factors for HIV as well as indicated changes in PrEP 
use and risk behaviors as a result of COVID.  
Our group has a long history of research with minority communities. The design of this study is 
based on prior research by our group, including qualitative data, aimed to increase PrEP 
persistence in people at increased risk of HIV acquisition. We will be using self-reported race 
during the study. Race and/or ethnicity may be used for descriptive statistics or in explanatory 
model. Differences in HIV acquisition, PrEP use, and PrEP persistence are known to occur 
across demographic factors. While these demographic factors are a surrogate for other social 
determinants of health (e.g. poverty, lack of access to healthcare, structural racism), they remain 
a standard of measurement in epidemiologic studies and in CDC reporting of HIV incidence and 
PrEP use. Race will be used as a proxy for social determinants of health. 

Protocol Title:  Element 2
Page 27 of 51
Protocol Version: Version 12  11/21/2024
Up until May 2022, we have enrolled MSM who were not currently taking PrEP, to observe 
initial choices.  Given our scientific objectives to avert PrEP discontinuations by making more 
PrEP choices available, we will include men already taking PrEP, and offering them monitoring 
for risks for PrEP discontinuation, the same range of PrEP options, and STI PEP.  
We have also analyzed the PrEP choices of our participants to date, to inform our 
consideration of whether we might be able to accomplish our scientific objectives with a 
lower total sample size.  We found a more even distribution of initial PrEP choices than 
we had anticipated. When we proposed this project, we had essentially no prior data 
about what initial PrEP choices might be, and our sample size was proposed based on 
confidence intervals around changing PrEP modalities.  We proposed a higher sample 
size to be able to have some reasonable estimates of use, even for modalities that might 
have lower uptake. However, our experience with our first 114 participants suggests that 
we have a broad variety of PrEP modalities being chosen. Further, we powered our STI 
PEP aim based on an anticipation of 25% uptake of STI PEP, and we have observed 
nearly 73% uptake to date.  We had anticipated that up to a third of participants might not 
choose to start PrEP immediately, but only 11% have chosen not to start PrEP. Based on 
these data, we will reduce our total sample size to 240.  With the observed distribution of 
STI PEP uptake and assuming 30/100 PY rate of diagnosis of STIs, we would have 85% 
power to detect  a 70% reduction in STI diagnoses (compared to 80% power to detect a 
70% reduction in the original design.
Individuals will be screened for eligibility through a self-administered online screener 
that will either be done in-person on a tablet device during a recruitment event or online 
after clicking on a link in a recruitment ad.  Those men found eligible will then be invited 
to an enrollment (baseline) visit.  At the enrollment visit they will be re-screened for 
eligibility by a study staff and will be tested for HIV to confirm the required HIV 
negative status for prospective study enrollment. 
Results from the study will be shared with participants and the broader community they 
represent through study newsletters, publication announcements, and community 
meetings. Additionally, a peer navigator, who will be part of the study staff, will 
represent the community of MSM in Atlanta and be involved in the study design and 
implementation.
11. Vulnerable Populations
N/A
12. Local Number of Participants
We plan to enroll 240 study participants for the prospective study. It is expected that a 
small number of men (<20) will be deemed ineligible at the baseline appointment due to 
a positive HIV status and/or not meeting other eligibility criteria. 
13. Recruitment Methods

Protocol Title:  Element 2
Page 28 of 51
Protocol Version: Version 12  11/21/2024
Our goal is to enroll 240 MSM using the most efficient methods, while minimizing 
opportunities for bias. We will use two recruitment methods that draw on the study 
team’s strengths. We will recruit MSM who are not known to be living with HIV from 2 
sources. The venue-based method is a modified venue-day-time (VDT) screening 
approach implemented by CDC for behavioral surveillance under PI Sullivan’s 
leadership.131 We have tracked the recruitment data for each recruitment venue and day 
from past studies, and will use those historical data to oversample venues that historically 
had high numbers of MSM who were HIV-negative. Venues includes bars, nightclubs, 
gyms, parks, gay pride events, etc. We will also offer $5 incentive to take the study 
screener at these in-person recruitment events. The second method is recruitment via 
dating apps and social media. This involves targeting advertisements to adult men in 
Atlanta who are using dating sites such as Grindr and Adam4Adam, and who use social 
media channels such as Instagram and Snapchat, or whose Facebook profiles connote an 
interest in men. We will also offer $20 gift cards to current participants to share our IRB 
approved study ads on their social media. The goal is for participants to simply share this 
information with their social networks on a voluntary basis. Their participation in the 
study will not be affected in any way should they volunteer to share study information. 
They will not be referring individuals, rather simply share information that has been 
approved by IRB. Considering the current social climate, our target demographic gets 
most of their information online. As a result, social media advertising is the most 
effective way to get information out to intended audiences.
Men recruited through venues or online will read a brief introduction of the study, sign 
the screening consent (if interested in participating), complete an online eligibility 
screener, and leave their first name, phone number and email for follow-up, if eligible for 
study participation.  Staff will in turn reach out to eligible men to schedule them for a 
baseline visit. Analyses of our InvolveMENt data show few differences exist in 
behaviors, HIV/STI infection, and retention between MSM recruited by VDT and subset 
recruited via Facebook.61  
Respondents who complete an enrollment visit will be compensated $125, whether or not 
they participate in the prospective study. Participants who complete the in-person survey 
and study visit at 12 months will receive $100 and those completing the 24-month survey 
and study visit will also be compensated $100. Daily PrEP users, on-demand PrEP users 
and STI PEP users will be paid $5 for each weekly survey they complete, as appropriate.  
After the first two weeks of initiating PrEP, daily PrEP users will receive monthly short 
assessments for risk factors for PrEP discontinuation administered through the study app 
and will be paid $10 for each survey. All participants will take online surveys at months 
4, 7, and 19 and these will be compensated at $40 each. If a participant needs to return to 
the clinic for a blood draw or other specimen collection outside of their study visit 
schedule, they will be paid $20.
Participants will be offered transportation assistance such as an Uber ride to the research 
clinic or to the nearest Marta station for all in-person visits including the enrollment one. 
14. Withdrawal of Participants

Protocol Title:  Element 2
Page 29 of 51
Protocol Version: Version 12  11/21/2024
Study investigators may withdraw participants from the study in order to protect 
participant or staff safety. Investigators have a right to stop their participation in the study 
without their consent if:
•
They believe it is in their best interest;
•
They were to object to any future changes that may be made to study procedures;
•
Other factors related to their eligibility change during the study;
•
Or for any other reason.
It is anticipated that some participants will voluntarily withdraw from the study and, 
when this occurs, we will document on a study withdrawal form the circumstances 
necessitating the action. If they withdraw, the study information they provided will 
remain with Emory University and will be used in analyses.
15. Risks to Participants
Following are anticipated risks to participation, and procedures to reduce risk.

Persons may learn they have HIV or an STI, and this may be upsetting. To minimize 
this risk, we will have counselors who have attended a HIV counseling and testing 
training course and a passed a proficiency panel assessment.

Persons may be uncomfortable with some survey questions. To minimize this risk, we 
will offer participants the option in the survey to not answer any question that makes 
them uncomfortable. Participants who find the questionnaire to be generally 
uncomfortable can choose to discontinue participation in the study.

Persons may have bruising or a local infection at the site of venipuncture. This is a 
typical risk of having blood drawn in any setting. We will employ experienced 
phlebotomists who have a certificate of training from a program that meets the core 
national standards for training, and who have at least 40 hours of experience as a 
phlebotomist. We will also provide schematics for participants self-collecting their 
specimens at home to help minimize the risk of bruising and infection.

Persons who take Truvada or Descovy for PrEP may have adverse reactions to the 
drugs. These adverse reactions are uncommon and include gastrointestinal symptoms, 
allergic reactions, and kidney and liver problems. The safety of Truvada and Descvoy 
has been established through multiple clinical trials and are FDA approved and 
indicated for HIV prevention. The study will provide all required clinical monitoring 
to ensure that the medications are being used as safely as possible and the study 
physician will discontinue or modify the participant’s use to ensure safety. Side 
effects that will be monitored for include: nausea, vomiting, diarrhea, abdominal pain, 
headache, weight loss, abnormal blood tests (creatinine, glycosuria, proteinuria, 
elevated ALT concentration).  

Protocol Title:  Element 2
Page 30 of 51
Protocol Version: Version 12  11/21/2024

Persons who take Apretude (cabotegravir extended-release injectable suspension) 
may have adverse reactions to the drug. These adverse reactions are uncommon and 
include allergic reactions, liver problems, and depression or mood changes. The 
safety of Apretude has been established through multiple clinical trials and is FDA 
approved and indicated for HIV-1 prevention. Clinical monitoring to ensure 
medication is being used safely will be done by the local provider where the 
participant initiates injection. The local provider will discontinue or modify use of 
Apretude to ensure safety. The local provider will also monitor all common side-
effects such as: pain, tenderness, hardened mass or lump, swelling, bruising, redness, 
itching, warmth, loss of sensation at the injection site, abscess, discoloration, 
diarrhea, headache, fever, tiredness, sleep problems, nausea, dizziness, passing gas, 
stomach pain, vomiting, muscle pain, rash, loss of appetite, drowsiness, back pain, or 
upper respiratory infection.

Persons may have their study information compromised. We describe procedures for 
data security below. All study staff will have training in confidentiality policies, and 
will sign a confidentiality agreement annually. We use SSL encryption for transfers 
of information online, and SurveyGizmo has a business partner HIPAA agreement 
with Emory. SurveyGizmo’s servers are HIPAA compliant. 

Additional protections for children (aged 16-21): According to 46 CFR subpart D, 
children are defined for the purpose of that section as “persons who have not attained 
the legal age for consent to treatments or procedures involved in the research, under 
the applicable law of the jurisdiction in which the research will be conducted.” 
We will not be enrolling men ages 16-17. In Georgia, persons aged 13-21 have 
attained the legal age of consent for HIV/STI services, including HIV testing, care 
and treatment. However, we are aware that the consequences of disclosure of one’s 
HIV status, or of having male sex partners, may be particularly difficult for younger 
men (ages 18-21) in our cohort. For all participants, we will specifically ask when 
contact information is requested if there are any special instructions or considerations 
for contact, for example if the participants live with parents or other family who 
should not be made aware of the participant's enrollment in the health study.  
There are unique privacy-related concerns for youth ages 18-21 given their likelihood 
of residing with and/or being dependent on parents, guardians, and others.  Special 
considerations will be taken to discreetly schedule and remind participants of study 
appointments to ensure privacy is maintained.  This will include asking participants 
for their preferred method of study reminder communication, such as personal mobile 
phone texts or private email, avoiding the use of mailings to home addresses or 
landline phones. 
16. Potential Benefits to Participants
Participants will learn their HIV and STI status and, as needed, be linked to care and 
treatment for HIV, STIs, mental health and substance abuse treatment services. Free 

Protocol Title:  Element 2
Page 31 of 51
Protocol Version: Version 12  11/21/2024
treatment for STIs at a community clinic will be offered to all participants during their 
study duration.  Additionally, participants will be supported by study staff in getting free, 
or minimal cost, Truvada or Descovy (PrEP), and free STI PEP (doxycycline) through 
the Emory Investigational Drug Service. Participants who take PrEP may significantly 
lower their chances of acquiring HIV and participants taking STI PEP may lower their 
chances of acquiring a bacterial STI. 
17. Data Management and Confidentiality
Data Analysis 
Aim 1
The primary analytic goal of Aim 1 will be to estimate the causal effect of the 
intervention components on the incidence of PrEP discontinuations. To rigorously 
specify the analysis, we articulate a target trial design as described by Hernan et al.51  
Target trial emulation recreates a randomized control trial (RCT) using a secondary data 
source (in this case our prior cohort) when a contemporary control condition is not 
available. 
We recognize that the target trial is subject to selection bias, because some men will not 
initiate PrEP during the trial and will be excluded from the analysis. To account for 
possible differences in the composition of the cohorts by factors related to risk of PrEP 
discontinuation, we will use inverse probability weights to create a synthetic for which 
the baseline covariates are independent of treatment assignment.148  We will include 
items related to PrEP attitudes and intentions (e.g., how confident are you that PrEP will 
provide protection from HIV infection) asked in the historical cohort and asked in the 
new cohort, as a way of adjusting for the effects of potential secular trends in PrEP 
attitudes on discontinuation. We will construct adjusted Kaplan Meier estimates for 
survival until PrEP discontinuation149 and truncate weights to avoid instability150. The 
results will indicate marginal, rather than conditional probabilities, which is appropriate 
to our analytic question.151  Power: Based on an estimated rate of PrEP discontinuations 
of 31/100 person-years (based on preliminary data) and 50% PrEP uptake overall, we 
would have 80% power to detect a 30% reduction in PrEP discontinuation in the 
intervention cohort (rigor; calculations in PS software152 using α=0.05, power=0.80, 
n=150 PrEP users, m1=220, A=365, F=730, m=1¬). 
Secondary analyses: In this implementation-focused study, we will characterize rate of 
identification of risk factors for PrEP discontinuation (source: monthly screening survey 
data); the prevalence of discontinuation at the time of identification of risk factors 
(source: CRFs from peer navigator sessions); and the utilization of different modes of 
accessing support (telephone call, video call, clinic visit) for men at risk for PrEP 
discontinuation. Confidence intervals for these proportional outcomes are as follows: 
initially selected mode of PrEP: ± 5%; rate of risk factors: ± 0.7%; prevalence of stops at 
risk factor identification: ± 11%; utilization of mode of access: ± 9% (rigor).
Aim 2
The primary analytic goal of Aim 2 will be to estimate the proportion of men who choose 
to start intermittent PrEP after declining daily oral PrEP, the proportion of men with risks 

Protocol Title:  Element 2
Page 32 of 51
Protocol Version: Version 12  11/21/2024
for discontinuing daily oral PrEP who switch to on-demand PrEP, and the patterns of 
usage of on-demand PrEP among those who choose it. Analyses will be descriptive, 
reporting proportions of outcomes of interest for starting on-demand PrEP (data source: 
visit records and PrEP counseling CRFs). We will also depict the patterns of use of on-
demand PrEP by visualizing the dates of self-reported use and by calculating the rate of 
self-reported use. Data for these analyses will come from the study mobile app, which 
will ask men on intermittent PrEP to report at least weekly to document use and to 
minimize recall bias (minimizing bias). Power: Given our sample size, the proportions of 
men starting or changing to on-demand PrEP will be estimated as proportions +/- 5%, 
given 30% uptake (rigor). 
Aim 3
The primary analytic goal of Aim 3 will be to estimate the proportion of men who choose 
to start injectable PrEP after declining oral PrEP, the proportion of men with risks for 
discontinuing daily or on-demand PrEP who switch to injectable PrEP, and the patterns 
of usage of injectable PrEP among those who choose it. Analyses will be descriptive, we 
will depict the patterns of use of injectable PrEP by visualizing the dates of self-reported 
use and by calculating the rate of self-reported use. Data for these analyses will come 
from the study mobile app, which will ask men on injectable PrEP to report their use of 
injectable PrEP on a monthly basis. Power: Given our sample size, the proportions of 
men starting or changing to injectable PrEP will be estimated as proportions +/- 5%, 
given 30% uptake (rigor). 
Aim 4
The primary analytic goal of Aim 3 will be to estimate the causal effect of the 
intervention components on STI incidence. Participants in the proposed study (i.e., 
‘intervention group’) will be compared to an historical control group derived from an 
existing cohort of age-matched, HIV-negative MSM in Atlanta. The primary outcome of 
interest will be diagnoses of any STI (rectal, urethral or pharyngeal gonorrhea or 
chlamydia, syphilis) at the 12- to 24-month study visits with STI testing. To assess the 
effect of the intervention, we will calculate the standardized incidence ratio (SIR) for 
STIs between the current cohort and historical cohort. The expected number of STI 
diagnoses will be determined based on the risk of diagnoses at 12- and 24-month visits 
from the historical cohort. To account for possible differences in the composition of the 
cohorts by factors related to risk of STI, we will adjust for factors that are found to be 
associated with STI (if any) in the historical cohort, to be analyzed after the historical 
cohort ends in 2019. Secondary analyses: We will calculate a secondary incidence 
comparison based on the STIs for which doxycycline is expected to be efficacious 
(chlamydia and syphilis). In this implementation-focused study, we will characterize the 
rate of interest in discussing STI PEP (source: weekly screening survey data); the 
proportion of men who accept STI PEP (source: CRFs from STI PEP counselors); and the 
self-reported patterns of STI PEP use (source: mobile app weekly brief surveys). Power: 
Based on an estimated rate of STIs (30/100 p-y) and 25% STI PEP uptake overall, we 
would have 80% power to detect a 70% reduction in STI diagnoses (as observed by 
Molina for syphilis and gonorrhea8; rigor).

Protocol Title:  Element 2
Page 33 of 51
Protocol Version: Version 12  11/21/2024
Data Security: 
Data will be stored on a SQL server in the "trusted zone" (HIPPA compliant) of the 
Rollins School of Public Health computing service. Daily backups of the entire dataset 
will be performed. All participants will be assigned a unique identification number for the 
study. A master list linking these numbers and identifying data will be stored on the SQL 
server, and access to these confidential files will be managed by the Study Director and 
Principal Investigators. Documents with identifying information (name, contact 
information) such as study forms, consents, prescription logs, etc. will be stored in a 
separate SQL database from all other de-identified data. Access to the identifying 
information will be on a role-based system: access to identifying information will be 
restricted to those who need access to perform their work function. Thus, access to 
identifying information will be restricted to the Principal Investigators, the Retention 
Coordinator, who must contact participants to schedule visits; the Study Director and 
Coordinator who may assist with notification of test results or as a backup for visit 
scheduling; counselors and peer navigators providing support to participants; and, 2-3 
graduate research assistants who will enter the identifying information into the data 
system. Access will be controlled by business rules on the SQL server based on the login 
ID. Paper forms will be stored in a locked cabinet in a locked room in PRISM’s research 
clinic. The locks for the room and cabinet require different keys/codes. Access to the 
room and cabinet will be limited to the PIs, Study Director, Data Manager; Graduate 
Research Assistants who perform data entry, and other study staff responsible for filing 
forms in study binders. Once all study data are collected, all identifiers will be removed 
from study data.
The main sources of possible data entry errors will lie with any manual entering of study 
data however we expect this to be minimal as most data collections systems will be 
automated. For app- and survey-based data, the participant identifiers are associated with 
the electronic record automatically, so the chance of problems with attribution of 
responses to the incorrect participant is very small. 
We will follow regulations for mandatory reporting of breaches in confidentiality or 
adverse events. There is a statement in the consent form notifying participants of this 
possibility. All study personnel will have completed CITI training and attended a 
confidentiality training and signed an associated agreement. Any additional personnel 
who join the study after initial launch will have to complete this training before they 
handle any subject data. Issues regarding confidentiality will be reinforced prior to each 
data collection with study personnel.
All study staff will be trained to recognize, document, and report any unusual events or 
circumstances that occur during data collection immediately to the PIs and to Emory IRB. 
If an adverse event appears to be research-related, it will be reported to the OHRP and the 
funding institution project officer, along with summaries of discussions concerning the 
event. The funding institution project officer will be informed of any IRB action taken 
concerning any adverse event. The Principal Investigators and Study Director will 
monitor staff closely. Staff deficient in any aspect of performance will be re-trained, 
closely monitored for proficiency, and if not adhering to established protocols and 
procedures, will be terminated.

Protocol Title:  Element 2
Page 34 of 51
Protocol Version: Version 12  11/21/2024
SurveyGizmo: When data are collected via Survey Gizmo, they are automatically 
encrypted, with the coded access only available to the Data Manager, Study Director and 
the PIs. This procedure increases the security of the data, as commercial survey providers 
(e.g., SurveyMonkey, SurveyGizmo, etc.) store the data in their own servers. 
Furthermore, all web survey data will be secured using an SSL 256-bit encryption. SSL 
encryption is the standard for all web-based transactions that include any identifiable 
information, including names, addresses, and credit card numbers. 
Once data are downloaded from the server, we will expunge them from the server. 
Survey and intervention data files will be identified using numeric study participant ID 
numbers, assigned by study staff, which will be unrelated to the participant’s name or 
email address. All online survey data will be collected using SurveyGizmo, a secure, 
encrypted electronic platform with which the Emory site team has established a business 
associate agreement to ensure HIPAA-compliance. Study data stored by Survey Gizmo 
are maintained on a dedicated secure server, with no co-mingling of study data with other 
SurveyGizmo customer data, or between Emory projects administered by Survey Gizmo. 
Data collected through the SMaRT app will be stored on a HIPPA-compliant server 
housed at Emory University; data will be stored within the Emory AWS platform. The 
SMaRT system and app went through a security review and were approved by Emory 
LITS in 2020. They were not created specifically for this study. We will not send 
individual results from this study to the mobile app with the exception of laboratory 
results that participants will receive through the app. App data will be encrypted at rest. 
All data will be stored in an Emory AWS RDS database using in-box AWS database 
encryption. Data in transit will be encrypted with TLS 1.2. The study team will not be 
able to access participants’ mobile device activity, they will only be able to see their 
completion of some activities in the study app through its admin web portal. They will be 
required to log in to the application with a username and password as an additional app 
security measure. All app screens are covered by authorization. Data are stored on the 
server and not locally in the app. Per HIPAA requirements, sessions expire after several 
minutes and require users to log back in. When participants finish the study, we will help 
them remove the app from their mobile device and they will no longer be able to log in to 
the app.
Describe how data or specimens will be handled study-wide:

What information will be included in that data or associated with the specimens?
Specimens will be labeled with the participant’s unique study identifier or name 
depending on the laboratory testing the specimens and their associated requirements 
to use names and DOB.  

Where and how data or specimens will be stored?
Specimens from in-person study visits will be stored in a locked laboratory with 
only limited staff access until they are picked up or delivered to the lab for testing. 
Laboratory results will be returned electronically and associated files will be stored 

Protocol Title:  Element 2
Page 35 of 51
Protocol Version: Version 12  11/21/2024
on the SQL server reserved for study documents with identifying information and 
with restricted access by study staff. All data files will have SSL encryption and 
strong password protection. Participant survey data will be stored by 
SurveyGizmo.com on a secure, HIPAA-compliant webserver until downloaded by 
Emory. 
Molecular Testing Lab (MTL) will receive the name and address of the participants 
for the purpose of shipping specimen collection kits to them. Test results will be 
stored in MTL’s HIPPA-compliant database used for clinical laboratory reporting.
The PIs will provide oversight of all study procedures and quality assurance checks. 
All printed records pertaining to the study will be securely stored in locked file 
cabinets within locked offices at the PRISM research clinic and will be monitored 
for access by the PIs and Study Coordinator. Only designated staff will have access 
to the data. The Principal Investigators and Co-Investigators will be responsible for 
dissemination of study findings through presentations and publications. The 
Principal Investigators will also be solely responsible for handling any requests 
from other investigators to examine the data collected during this study.

How long the data or specimens will be stored? 
Specimens will only be stored for as long as it takes the labs to process the samples. 
All personally identifiable information will be destroyed when all study data are 
collected and the study is complete. Specimens for possible future analyses to 
examine perturbations in the microbiota associated with daily or on-demand PrEP 
and/or STI PEP will be stored for no longer than 20 years however no identifying 
information will be stored with the specimens. Similarly, nasal specimens will also 
be stored in a freezer at The Hope Clinic of Emory University for up to 20 years for 
future analyses of doxycycline resistance to staph aureus found in nasal carriages. 
Data associated with specimens will include participant ID, date of collection, test 
result and date, and PrEP/STI PEP use at time of specimen collection.

Who will have access to the data or specimens?
All electronic files and records will be stored in a firewall-protected, encrypted 
server at Emory University. Access to printed or electronic data will be on a role-
based standard; only those study staff who require access to identifying data to 
complete their study-related roles will be allowed access. All study staff will be 
trained in security and confidentiality procedures. Laboratory staff will be the only 
study personnel handling the specimens from in-person study visits and ensuring 
their pick-up/delivery for testing. Participants self-collecting their specimens at 
home will be responsible for packaging their specimens in a study-provided 
shipping box and either arranging pick up of the box or dropping it at a USPS drop 
box.  

Who is responsible for receipt or transmission of the data or specimens?

Protocol Title:  Element 2
Page 36 of 51
Protocol Version: Version 12  11/21/2024
MTL and Quest Diagnostics will be responsible for the laboratory specimens’ 
receipt, handling and transmission of test results. SurveyGizmo will be responsible 
for the receipt and transmission of screening questionnaires, consents and survey 
data to Emory study staff.   Emory University will be responsible for the 
management of data collected through the SMaRT app.

How data or specimens will be transported?
Specimens collected in-person will either be transported to Quest Diagnostics by a 
lab staff or picked up by a Quest courier.  Home collected specimens will be 
transported to MTL via US mail. 
18. Provisions to Monitor the Data to Ensure the Safety of Participants
Quality Assurance Data Monitoring
Emory study staff, including the Co-Principal Investigators, will monitor data periodically for 
data quality and protocol compliance. Twice yearly, study staff will conduct a systematic review 
of study data using the Emory University-Self-monitoring Tool available at 
http://www.ctac.emory.edu/clinical_trial_resources/Audit%20Tools.html. 
Adverse Events 
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject 
administered a pharmaceutical product regardless of its causal relationship to the study 
treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of a medicinal 
(investigational) product. 
Any AE that is reported to either the investigators or their designated research associates by a 
study subject or by medical staff caring for the subject and which meets the criteria will be 
documented in the participant’s chart.  The reporting period for participant AEs begins at 
enrollment and continues until the subject either completes or withdraws from the study. 
All AEs and laboratory abnormalities will be graded according to the Division of AIDS Table for 
Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), 
Version 2.1, July 2017, which can be found on the DAIDS RCC Web site: http://rcc.tech-
res.com/tox_tables.htm. 
    
Each AE will be assessed for relatedness to study product. Study investigators will determine 
AEs to be either definitely related, probably related, possibly related or not related to study 
product. If the adverse event is, in the investigator’s opinion, possibly, probably, or not related to 
study drug or procedures, then an alternate etiology will be provided by the investigator. 
Related AEs ≥ Grade 3 will be included in the summary reports provided to the Medical Monitor 
of the study. Exceptions to expedited reporting are detailed below.  

Protocol Title:  Element 2
Page 37 of 51
Protocol Version: Version 12  11/21/2024
This study uses FDA approved drugs with known common side effects (please refer to the risk 
section of the protocol for common side effects).  The following side effects will not be reported 
as an EAE unless it increases in severity or becomes prolonged.
Nausea: Report if severity is a Grade 3 or higher 
Vomiting: Report if severity is a grade 3 or higher 
Diarrhea: Report if severity is a Grade 3 or higher 
Serious Adverse Events
A SAE is an adverse drug experience that results in any of the following outcomes: 
1. Death. 
2. Life-threatening situation - The subject was at risk of death at the time of the adverse 
event/experience.  It does not refer to the hypothetical risk of death if the AE were more 
severe or were to progress. 
3. Inpatient hospitalization or prolongation of existing hospitalization. 
4. Persistent or significant disability/incapacity - Any AE having an outcome that is 
associated with a substantial disruption of the ability to carry out normal life functions, 
including the ability to work.  This is not intended to include transient interruption of 
daily activities. 
5. Congenital anomaly/birth defects - Any structural abnormality in subject’s offspring that 
occurs after intrauterine exposure to treatment. 
6. Important medical events/experiences that may not result in death, be life threatening, or 
require hospitalization may be considered a serious adverse event/experience when, 
based upon appropriate medical judgment, they may jeopardize the subject and may 
require medical or surgical intervention to prevent one of the outcomes listed above, i.e., 
death, a life-threatening adverse event/experience, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant disability/incapacity, 
or a congenital anomaly/birth defect. Examples of such medical events/experiences 
include allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or 
the development of drug dependency or drug abuse. 
The reporting period for participant SAEs begins at study enrollment and continues until the 
subject either completes or withdraws from the study. All SAEs will be reported to the Medical 
Monitor within 24 hours of site awareness and reported to the IRB per its policies. 
 
It should however be noted that a severe adverse event/experience is not necessarily serious, as 
the term severe is a measure of intensity while a serious adverse event (SAE) is determined 
based on the aforementioned regulatory criteria. 
Data Safety Monitoring
AEs ≥ Grade 3 or 4 and targeted AEs will be reviewed in real time by study investigators.  
Medical Monitor

Protocol Title:  Element 2
Page 38 of 51
Protocol Version: Version 12  11/21/2024
A medical monitor will be assigned to this study for the purpose of safety oversight. The 
medical monitor will be notified of all SAEs within 24 hours of site awareness and 
receive quarterly summary reports of all AEs meeting the previously described criteria.
19. Provisions to Protect the Privacy Interests of Participants
The following procedures will be used to protect the privacy interests of those involved in 
this research:
Participants’ contact information and any pieces of study data containing identifying 
information will be stored on a HIPPA-compliant server with access controls on the data 
files. Additionally, all files with identifying information will be password protected. Six 
months after study completion, participant contact information and all links between 
study data and contact information will be destroyed. The study will use SSL encryption 
for transfers of information online and survey data will be stored in the secure, HIPAA-
compliant servers of SurveyGizmo. The Emory team maintains a business partner 
HIPAA agreement with SurveyGizmo. Participants attending a baseline visit who are not 
eligible will be thanked for their time, and although we will retain screening data, no 
identifying information will be collected. Individuals will not be informed of why they 
were ineligible to avoid unintentional disclosure and to protect against fraud.
Only those study staff who require access to identifying data to complete their study-
related roles will be allowed access. All study staff will be trained in security and 
confidentiality procedures and will sign a confidentiality agreement before receiving 
access to any participant data.
Procedures will be developed to minimize indirect disclosure that a participant is 
participating in an HIV/STI prevention research study. Contact preferences will be 
solicited from participants at baseline and at follow-up study visits to ensure that we are 
reaching out to them in their preferred way for all types of study communication 
(appointment reminders, test results, etc.). We will never reference HIV/STI in our 
messaging to protect participants’ privacy. The SMaRT app will not reference HIV/STI 
in its name.
Participants will be reminded before an online survey begins to only take the survey in a 
private area, where they will not be observed. Participants will also be provided with 
detailed instructions for how to self-collect specimens at home so that they can plan for 
what they will need, both materials and privacy-wise. 
Study participant data, including limited personally identifiable information (PII), may be 
shared with the Georgia Department of Public Health, for the purpose of reportable 
disease notification. 
Study participants will interact with staff and clinical providers in person or through 
telehealth sessions. Data will be collected via paper and online forms, through surveys, 
and through the SMaRT app. Should participants feel uncomfortable filling out surveys 
or attending in-person visits, their concerns and questions will be addressed by a member 
of the study staff with effort made to place the participant at ease. 

Protocol Title:  Element 2
Page 39 of 51
Protocol Version: Version 12  11/21/2024
20. Economic Burden to Participants
The participants will have no foreseen economic costs associated with this study.
21. Consent Process
Consent to be screened for study eligibility will occur online and participants will read a 
brief introduction to the eligibility screener before checking a box indicating whether or 
not they consent to be screened. Participants will then consent for the main study at their 
in-person baseline visit. They will be provided with a paper copy of the consent and will 
be asked to take their time reading and signing the consent. The consent will incorporate 
the options to start or stop PrEP and/or STI PEP at any time. Study counselors will be 
trained to answer any questions individuals have regarding the consent and participants 
will be given a paper copy of the consent to keep if they choose. 
The electronic informed consent for the screening process will be administered through a 
secure online portal, SurveyGizmo.com, with whom Emory has established secure and 
HIPAA-compliant business practices. 
We will inform participants that they will be given the option of allowing the study to collect and 
store their current contact information (i.e. name, phone number, email address) in a confidential 
database for contact about participation in future PRISM Health research studies. The consent 
will clarify that authorization to store their contact information is completely optional, does not 
affect their involvement in any other part of the study, and can be withdrawn at any time. 
Participants will be given the option in the main study consent of selecting yes or no for their  
contact information to be saved for possible participation in future PRISM Health studies.    
Non-English-Speaking Participants: N/A
Participants who are not yet adults (infants, children, teenagers): N/A
Cognitively Impaired Adults N/A 
Adults Unable to Consent N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception): N/A
We are not including persons who do not speak English given the significant cost of 
having a bilingual staff and all study materials and resources in another language. 
22. Setting
The research will be conducted in the Atlanta MSA.  Depending on the study visit and 
participants’ optional decision to take PrEP and/or STI PEP, some study visits will take 
place at the research clinic in downtown Decatur and some at a participant’s home.  
Participants will have the option to meet with clinical and study staff either in-person or 
virtually through HIPPA-compliant videoconferencing platforms.  Laboratory testing will 
take place either at Quest Diagnostics (for specimens collected at in-person study visits) 
or at Molecular Testing Lab in Vancouver, Washington (self-collected 

Protocol Title:  Element 2
Page 40 of 51
Protocol Version: Version 12  11/21/2024
specimens). Recruitment will take place via physical venues such as bars and restaurants, 
and online through social media/dating sites such as Facebook and Jack’d. 
We will form a Clinical PrEP Advisory Board (CPAB) to gain provider input on 
implementation strategies from the outset, and to speed dissemination of implementation 
lessons learned into practice.
23. Resources Available

We routinely recruit large cohort samples of people through venue- and web-
based recruitment with great success. There is a large population of MSM ages 
18-45 who reside in the Atlanta MSA and who are accessible for both in-person 
and online recruitment methods. We recruited 300 participants from this 
population for our EleMENt study with few challenges and we expect a similar 
process for this study. 

We expect to commit multiple full-time and part-time staff, faculty and clinicians 
to this study with oversight by Drs. Sullivan and Kelly, the Multiple Principal 
Investigators. 

The research will be conducted in our research clinic located in downtown 
Decatur as well as virtually over HIPPA compliant videoconferencing platforms.  
Staff will work remotely from home work stations as well as in the research clinic 
offices. 

There are minimal risks to this protocol.   We will provide the name, phone 
number and email address for a study staff member in case the participants have 
questions or concerns.  Clinicians will be available to meet in-person or via 
telehealth to discuss clinical concerns related to PrEP and STI PEP.  We will also 
have a resource directory that can be used to help link participants to medical, 
mental health, substance abuse treatment, housing and other ancillary services 
identified as needed. 

We will have extensive training of all staff prior to initiating recruitment 
including review of standard operating procedures, interventions to be delivered 
such as Motivational Interviewing, and respective roles and expectations for each 
study component. 
24. Multi-Site Research when Emory is the Lead Site 
N/A

Protocol Title:  Element 2
Page 41 of 51
Protocol Version: Version 12  11/21/2024
25. References
1.
Centers for Disease Control and Prevention. Diagnoses of HIV Infection in the United 
States and Dependent Areas, 2016; vol. 28. 
http://www.cdc.gov/hiv/library/reports/surveillance/index.html. Published November 
2017. Accessed December 27, 2017.
2.
Jenness, S.M., et al., Impact of the Centers for Disease Control's HIV Preexposure 
Prophylaxis Guidelines for Men Who Have Sex With Men in the United States. J Inf Dis, 
2016.
3.
Sullivan, P.S., et al., Successes and challenges of HIV prevention in men who have sex 
with men. Lancet, 2012. 380(9839): p. 388-99.
4.
Brookmeyer, R., et al., Combination HIV Prevention among MSM in South Africa: 
Results from Agent-based Modeling. PLoS One, 2014. 9(11): p. e112668.
5.
Office of National AIDS Policy.  National HIV/AIDS Strategy for the United States: 
Updated to 2020 [online national strategy document].  2015.  Available at: 
https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf (last 
accessed November 1, 2015)
6.
Montano, M.A., et al., Changes in sexual behavior and STI diagnoses among MSM using 
PrEP in Seattle, WA. Age, 2017. 30: p. 8.7.
7.
Serota, D.P., et al., Beyond the Biomedical: PrEP Failures in a Cohort of Young Black 
Men who have Sex with Men in Atlanta, GA. Clin Infect Dis, 2018.
8.
Molina, J.-M., et al., Post-exposure prophylaxis with doxycycline to prevent sexually 
transmitted infections in men who have sex with men: an open-label randomised substudy 
of the ANRS IPERGAY trial. 2018. 18(3): p. 308-317.
9.
Jenness, S.M., et al., Impact of the Centers for Disease Control's HIV Preexposure 
Prophylaxis Guidelines for Men Who Have Sex With Men in the United States. J Infect 
Dis, 2016. 214(12): p. 1800-1807.
10.
Sullivan, P.S., et al., Trends in use of oral emtricitabine/tenofovir disoproxil fumarate for 
pre-exposure prophylaxis against HIV infections, United States, 2012-2017. Annals 
Epidemiol, 2018 (in press).
11.
Sullivan PS, Zlototzynska M.,, Sanchez T.  Trends in awareness, willingness and use of 
oral pre-exposure prophylaxis (PrEP) among serial national samples of US men who have 
sex with men: 2013-2016.  International Workshop on HIV Observational Databases, 
Malaga, March 2018.
12.
Kelley, C.F., et al., Applying a PrEP Continuum of Care for Men who Have Sex with Men 
in Atlanta, GA. Clin Infect Dis, 2015.
13.
Eaton, L.A., et al., Minimal awareness and stalled uptake of pre-exposure prophylaxis 
(PrEP) among at risk, HIV-negative, black men who have sex with men. 2015. 29(8): p. 
423-429.
14.
Holloway, I., et al., PrEP Uptake, Adherence, and Discontinuation among California 
YMSM Using Geosocial Networking Applications. Journal of acquired immune 
deficiency syndromes (1999), 2017. 74(1): p. 15-20.
15.
Morgan, E., et al., High Rate of Discontinuation May Diminish PrEP Coverage Among 
Young Men Who Have Sex with Men. 2018: p. 1-4.

Protocol Title:  Element 2
Page 42 of 51
Protocol Version: Version 12  11/21/2024
16.
Saag, M.S., et al., Antiretroviral drugs for treatment and prevention of HIV infection in 
adults: 2018 recommendations of the International Antiviral Society–USA Panel. 2018. 
320(4): p. 379-396.
17.
Molina, J., et al. On demand PrEP with oral TDF-FTC in MSM: results of the ANRS 
Ipergay trial. in Conference on Retroviruses and Opportunistic Infections. 2015.
18.
Hall, E.W., et al., Preexposure Prophylaxis Modality Preferences Among Men Who Have 
Sex With Men and Use Social Media in the United States. J Med Internet Res, 2016. 
18(5): p. e111.
19.
Volk, J.E., et al., Sexual frequency and planning among at-risk men who have sex with 
men in the United States: implications for event-based intermittent pre-exposure 
prophylaxis. J Acquir Immune Defic Syndr, 2012. 61(1): p. 112-5.
20.
New CDC analysis shows steep and sustained increases in STDs, in 2018 STD 
Prevention Conference. 2018, Centers for Disease Control and Prevention: Washington, 
DC.
21.
Stenger, M.R., et al., Increases in the Rate of Neisseria gonorrhoeae Among Gay, 
Bisexual and Other Men Who Have Sex With Men-Findings From the Sexually 
Transmitted Disease Surveillance Network 2010-2015. Sex Transm Dis, 2017. 44(7): p. 
393-397.
22.
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 
2016. 2017 10/2016 [cited 2017 08/04/2018]; Available from: 
https://www.cdc.gov/std/stats15/std-surveillance-2015-print.pdf.
23.
Grey, J.A., et al., Rates of Primary and Secondary Syphilis Among White and Black Non-
Hispanic Men Who Have Sex With Men, United States, 2014. J Acquir Immune Defic 
Syndr, 2017. 76(3): p. e65-e73.
24.
Sullivan, P., Practical Considerations for Implementing a New Syphilis Action Plan. 
Sexually transmitted diseases, 2018.
25.
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 
2015. 2016 10/2016 [cited 2016 11/17/2016]; Available from: 
https://www.cdc.gov/std/stats15/std-surveillance-2015-print.pdf.
26.
Kelley, C.F., et al., The effect of high rates of bacterial sexually transmitted infections on 
HIV incidence in a cohort of black and white men who have sex with men in Atlanta, 
Georgia. AIDS research and human retroviruses, 2015. 31(6): p. 587-592.
27.
Barbee, L.A., et al., New human immunodeficiency virus diagnosis independently 
associated with rectal gonorrhea and chlamydia in men who have sex with men. 2017. 
44(7): p. 385-389.
28.
Blumenthal, J. and R.H. Haubrich, Will risk compensation accompany pre-exposure 
prophylaxis for HIV? Virtual Mentor, 2014. 16(11): p. 909-15.
29.
Traeger, M.W., et al., Effects of Pre-exposure Prophylaxis for the Prevention of Human 
Immunodeficiency Virus Infection on Sexual Risk Behavior in Men Who Have Sex With 
Men: A Systematic Review and Meta-analysis. Clin Infect Dis, 2018. 67(5): p. 676-686.
30.
Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 
Update: a clinical practice guideline. 2017; Available from: 
https://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2017.pdf.
31.
Spinelli, M.A., et al., Provider Adherence to Pre-exposure Prophylaxis Monitoring 
Guidelines in a Large Primary Care Network. Open Forum Infect Dis, 2018. 5(6): p. 
ofy099.

Protocol Title:  Element 2
Page 43 of 51
Protocol Version: Version 12  11/21/2024
32.
Garnett, M., et al., Limited awareness of pre-exposure prophylaxis among black men who 
have sex with men and transgender women in New York city. 2018. 30(1): p. 9-17.
33.
Sullivan, P.S., et al., Explaining racial disparities in HIV incidence in black and white 
men who have sex with men in Atlanta, GA: a prospective observational cohort study. 
Ann Epidemiol, 2015. 25(6): p. 445-54.
34.
Chard, A.N., et al., Social Stressors and Intoxicated Sex Among an Online Sample of Men 
who have Sex with Men (MSM) Drawn from Seven Countries. Subst Use Misuse, 2017: p. 
1-9.
35.
Lancki, N., et al., Preexposure prophylaxis guidelines have low sensitivity for identifying 
seroconverters in a sample of young black MSM in Chicago. AIDS (London, England), 
2018. 32(3): p. 383-392.
36.
Rolle, C.P., et al., Challenges in Translating PrEP Interest Into Uptake in an 
Observational Study of Young Black MSM. J Acquir Immune Defic Syndr, 2017. 76(3): 
p. 250-258.
37.
CDC. Monitoring selected national HIV prevention and care objectives by using HIV 
surveillance data—United States and 6 U.S. dependent areas—2014. HIV Surveillance 
Supplemental Report 2015;21(No.4). Published October 2015.  Available at: 
https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-
supplemental-report-vol-21-4.pdf.  Last accessed: December 31, 2018.
38.
CDC. Monitoring selected national HIV prevention and care objectives by using HIV 
surveillance data—United States and 6 U.S. dependent areas—2014. HIV Surveillance 
Supplemental Report 2015;23(No.4). Published October 2018.  Available at: 
http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published June 2018. Last 
accessed: December 31, 2018.
39.
Serota, D.P., et al., Beyond the Biomedical: Preexposure Prophylaxis Failures in a 
Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia. 2018.
40.
Hucks-Ortiz, C., et al. HPTN 073: successful engagement of Black MSM into a culturally 
relevant clinical trial for pre-exposure prophylaxis. in JOURNAL OF THE 
INTERNATIONAL AIDS SOCIETY. 2016. INT AIDS SOCIETY AVENUE DE FRANCE 
23, GENEVA, 1202, SWITZERLAND.
41.
Hightow-Weidman, L.B., et al., University of North Carolina/Emory Center for 
Innovative Technology (iTech) for Addressing the HIV Epidemic Among Adolescents and 
Young Adults in the United States: Protocol and Rationale for Center Development. 
2018. 7(8).
42.
Holtzman, C.W., et al., Mapping patient-identified barriers and facilitators to retention 
in HIV care and antiretroviral therapy adherence to Andersen's Behavioral Model. AIDS 
care, 2015. 27(7): p. 817-828.
43.
Rietmeijer, C.A., et al., Sex hustling, injection drug use, and non-gay identification by 
men who have sex with men: Associations with high-risk sexual behaviors and condom 
use. Sexually transmitted diseases, 1998. 25(7): p. 353-360.
44.
Celentano, D.D., et al., Associations Between Substance Use and Sexual Risk Among 
Very Young Men Who Have Sex With Men. Sexually Transmitted Diseases, 2006. 33(4): 
p. 265-271.
45.
Mimiaga, M.J., et al., Walking the line: stimulant use during sex and HIV risk behavior 
among Black urban MSM. Drug and alcohol dependence, 2010. 110(1-2): p. 30-37.

Protocol Title:  Element 2
Page 44 of 51
Protocol Version: Version 12  11/21/2024
46.
Bourne, A., et al., Illicit drug use in sexual settings (‘chemsex’) and HIV/STI 
transmission risk behaviour among gay men in South London: findings from a qualitative 
study. Sex Transm Infect, 2015. 91(8): p. 564-568.
47.
Giorgetti, R., et al., When “chems” meet sex: a rising phenomenon called “chemsex”. 
Current neuropharmacology, 2017. 15(5): p. 762-770.
48.
Andersen, R.M., Revisiting the behavioral model and access to medical care: does it 
matter? Journal of Health and Social Behavior, 1995: p. 1-10.
49.
Vaughan, A.S., et al., An application of propensity score weighting to quantify the causal 
effect of rectal sexually transmitted infections on incident HIV among men who have sex 
with men. BMC Med Res Methodol, 2015. 15(1): p. 25.
50.
Molina, J.-M., et al., On-demand preexposure prophylaxis in men at high risk for HIV-1 
infection. New England Journal of Medicine, 2015. 373(23): p. 2237-2246.
51.
Hernán, M.A. and J.M. Robins, Using big data to emulate a target trial when a 
randomized trial is not available. American journal of epidemiology, 2016. 183(8): p. 
758-764.
52.
Caniglia, E.C., et al., Emulating a target trial of antiretroviral therapy regimens started 
before conception and risk of adverse birth outcomes. 2018. 32(1): p. 113-120.
53.
Caniglia, E.C., et al., Antiretroviral penetration into the CNS and incidence of AIDS-
defining neurologic conditions. Neurology, 2014. 83(2): p. 134-41.
54.
Caniglia, E.C., et al., When to Monitor CD4 Cell Count and HIV RNA to Reduce 
Mortality and AIDS-Defining Illness in Virologically Suppressed HIV-Positive Persons 
on Antiretroviral Therapy in High-Income Countries: A Prospective Observational Study. 
J Acquir Immune Defic Syndr, 2016. 72(2): p. 214-21.
55.
Cain, L.E., et al., Efavirenz versus boosted atazanavir-containing regimens and 
immunologic, virologic, and clinical outcomes: A prospective study of HIV-positive 
individuals. Medicine (Baltimore), 2016. 95(41): p. e5133.
56.
Caniglia, E.C., et al., Comparison of dynamic monitoring strategies based on CD4 cell 
counts in virally suppressed, HIV-positive individuals on combination antiretroviral 
therapy in high-income countries: a prospective, observational study. Lancet HIV, 2017. 
4(6): p. e251-e259.
57.
Caniglia, E.C., et al., Commonly Prescribed Antiretroviral Therapy Regimens and 
Incidence of AIDS-Defining Neurological Conditions. J Acquir Immune Defic Syndr, 
2018. 77(1): p. 102-109.
58.
Haaland, R.E., et al., Urine tenofovir and emtricitabine concentrations provide biomarker 
for exposure to HIV preexposure prophylaxis. AIDS, 2017. 31(11): p. 1647-1650.
59.
Kelley, C.F., et al., Applying a PrEP Continuum of Care for Men Who Have Sex With 
Men in Atlanta, Georgia. Clin Infect Dis, 2015. 61(10): p. 1590-7.
60.
Rolle, C.P., et al., Willingness to use pre-exposure prophylaxis among Black and White 
men who have sex with men in Atlanta, Georgia. Int J STD AIDS, 2017. 28(9): p. 849-
857.
61.
Hernandez-Romieu, A.C., et al., The comparability of men who have sex with men 
recruited from venue-time-space sampling and facebook: a cohort study. JMIR Res 
Protoc, 2014. 3(3): p. e37.
62.
Kelley, C.F., et al., The rectal mucosa and condomless receptive anal intercourse in HIV-
negative MSM: implications for HIV transmission and prevention. Mucosal Immunol, 
2017. 10(4): p. 996-1007.

Protocol Title:  Element 2
Page 45 of 51
Protocol Version: Version 12  11/21/2024
63.
Kelley, C.F., et al., Differences in expression of gut-homing receptors on CD4+ T cells in 
black and white HIV-negative men who have sex with men. Aids, 2016. 30(8): p. 1305-8.
64.
Kelley, C.F., et al., Measuring population transmission risk for HIV: an alternative 
metric of exposure risk in men who have sex with men (MSM) in the US. PLoS One, 
2012. 7(12): p. e53284.
65.
Kelley, C.F., et al., Prevalence of urethral Trichomonas vaginalis in black and white men 
who have sex with men. Sex Transm Dis, 2012. 39(9): p. 739.
66.
Kelley, C.F., et al., The Effect of High Rates of Bacterial Sexually Transmitted Infections 
on HIV Incidence in a Cohort of Black and White Men Who Have Sex with Men in 
Atlanta, Georgia. AIDS Res Hum Retroviruses, 2015.
67.
Okafor, N., et al., Disparities in herpes simplex virus type 2 infection between black and 
white men who have sex with men in Atlanta, GA. Int J STD AIDS, 2015. 26(10): p. 740-
5.
68.
Pescatore, N.A., et al., Short Communication: Anatomic Site of Sampling and the Rectal 
Mucosal Microbiota in HIV Negative Men Who Have Sex with Men Engaging in 
Condomless Receptive Anal Intercourse. AIDS Res Hum Retroviruses, 2018. 34(3): p. 
277-281.
69.
Rolle, C.P., M.D. Bolton, and C.F. Kelley, Use of a Prospective Sex Diary to Study Anal 
Lubricant and Enema Use Among High Risk Men Who Have Sex With Men-Implications 
for Human Immunodeficiency Virus Prevention. Sex Transm Dis, 2016. 43(8): p. 476-8.
70.
Sanchez, T.H., et al., Lack of Awareness of Human Immunodeficiency Virus (HIV) 
Infection: Problems and Solutions With Self-reported HIV Serostatus of Men Who Have 
Sex With Men. Open Forum Infect Dis, 2014. 1(2): p. ofu084.
71.
Sullivan, P.S., et al., Understanding racial HIV/STI disparities in black and white men 
who have sex with men: a multilevel approach. PLoS One, 2014. 9(3): p. e90514.
72.
Sullivan, P.S., et al., Explaining racial disparities in HIV incidence in black and white 
men who have sex with men in Atlanta, GA: a prospective observational cohort study. 
Ann Epidemiol, 2015.
73.
Kelley, C.F., et al., HIV-1 RNA rectal shedding is reduced in men with low plasma HIV-1 
RNA viral loads and is not enhanced by sexually transmitted bacterial infections of the 
rectum. J Infect Dis, 2011. 204(5): p. 761-7.
74.
Jones, J., et al., Acceptability and willingness among men who have sex with men (MSM) 
to use a tablet-based HIV risk assessment in a clinical setting. Springerplus, 2014. 3: p. 
708.
75.
Jones, J., et al., Assessing the Performance of Three HIV Incidence Risk Scores in a 
Cohort of Black and White MSM in the South. Sexually Transmitted Diseases, 2017. 
44(5): p. 297-302.
76.
Sullivan, P.S., et al., The Roles of Technology in Primary HIV Prevention for Men Who 
Have Sex with Men. Curr HIV/AIDS Rep, 2015. 12(4): p. 481-8.
77.
Weiss, K., A. Bratcher, P.S. Sullivan, and A. Siegler, Geographic Access To Prep Clinics 
Among Us Msm: Documenting PrEP Deserts.  Abstract 1006Presented at CROI 2018, 
March 4-7, 2018, Boston.
78.
Siegler, A.J., et al., Developing and assessing the feasibility of a home-based PrEP 
monitoring and support program. Clin Infect Dis, 2018. in press.

Protocol Title:  Element 2
Page 46 of 51
Protocol Version: Version 12  11/21/2024
79.
Siegler, A.J., et al., Location Location Location: An Exploration of Disparities in Access 
to Publicly Listed PrEP Clinics in the United States. Ann Epidemiol, 2018. in press, 
https://doi.org/10.1016/j.annepidem.2018.05.006.
80.
Serota, D.P., et al., Beyond the Biomedical: Preexposure Prophylaxis Failures in a 
Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia. Clinical 
Infectious Diseases, 2018: p. ciy297-ciy297.
81.
Bratcher, A., S. Schlueter Wirtz, and A.J. Siegler, Users of a National Directory of PrEP 
Service Providers: Beliefs, Self-Efficacy, and Progress Toward Prescription. JAIDS 
Journal of Acquired Immune Deficiency Syndromes, 2018. 78(4): p. e28-e30.
82.
Rolle, C.P., et al., Challenges in Translating PrEP Interest into Uptake in an 
Observational Study of Young Black MSM. J Acquir Immune Defic Syndr, 2017.
83.
Sullivan, P.S., et al., Trends in active prescriptions of emtricitabine/tenofovir disoproxil 
fumarate for pre-exposure prophylaxis against HIV infections, United States, 2012-2016. 
Annals of Epidemiology, 2018. in press.
84.
Siegler, A.J., et al., The prevalence of PrEP use and the PrEP-to-need ratio in the fourth 
quarter of 2017, United States. Ann Epidemiol, 2018. in press.
85.
Siegler, A.J., et al., Exploring repeat HIV testing among men who have sex with men in 
Cape Town and Port Elizabeth, South Africa. AIDS Care, 2015. 27(2): p. 229-34.
86.
Siegler, A.J., et al., Knowledge and awareness of acute human immunodeficiency virus 
infection among mobile app-using men who have sex with men: a missed public health 
opportunity. Open Forum Infect Dis, 2015. 2(1): p. ofv016.
87.
Siegler, A.J., et al., Elements of Condom-Use Decision Making among South African Men 
Who Have Sex with Men. J Int Assoc Provid AIDS Care, 2014. 13(5): p. 414-23.
88.
McNaghten, A., et al., Sibanye Methods for Prevention Packages Program Project 
Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men 
in South Africa. JMIR Res Protoc, 2014. 3(4): p. e55.
89.
Siegler, A.J., et al., The role of intent in serosorting behaviors among men who have sex 
with men sexual partnerships. J Acquir Immune Defic Syndr, 2013. 64(3): p. 307-14.
90.
Hernandez-Romieu, A.C., et al., Concordance of Demographic Characteristics, Sexual 
Behaviors, and Relationship Attributes Among Sex Dyads of Black and White Men Who 
Have Sex with Men. Arch Sex Behav, 2016. 45(6): p. 1463-70.
91.
Siegler, A.J., et al., Developing a Web-Based Geolocated Directory of HIV Pre-Exposure 
Prophylaxis-Providing Clinics: The PrEP Locator Protocol and Operating Procedures. 
JMIR Public Health and Surveillance, 2017. 3(3): p. e58-e58.
92.
Sullivan, P.S., et al., Usability and Acceptability of a Mobile Comprehensive HIV 
Prevention App for Men Who Have Sex With Men: A Pilot Study. JMIR Mhealth Uhealth, 
2017. 5(3): p. e26.
93.
Stephenson, R., et al., Intervention to Increase HIV Testing Among Substance-Using 
Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR 
Res Protoc, 2018. 7(4): p. e114.
94.
Stephenson, R., et al., Home-Based HIV Testing and Counseling for Male Couples 
(Project Nexus): A Protocol for a Randomized Controlled Trial. JMIR Res Protoc, 2017. 
6(5): p. e101.
95.
Stephenson, R., et al., Providing Home-Based HIV Testing and Counseling for 
Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial. 
JMIR Res Protoc, 2017. 6(11): p. e237.

Protocol Title:  Element 2
Page 47 of 51
Protocol Version: Version 12  11/21/2024
96.
Stephenson, R., et al., Project Stronger Together: Protocol to Test a Dyadic Intervention 
to Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US 
Cities. JMIR Res Protoc, 2017. 6(8): p. e170.
97.
Winskell, K., et al., A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV 
Among Young Africans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth, 
2018. 6(8): p. e10482.
98.
Bauermeister, J., et al., Reducing HIV Vulnerability Through a Multilevel Life Skills 
Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized 
Controlled Trial. 2018. 7(7).
99.
Bauermeister, J.A., et al., A Multilevel Tailored Web App-Based Intervention for Linking 
Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a 
Randomized Controlled Trial. JMIR Res Protoc, 2018. 7(8): p. e10444.
100.
Khumsaen, N. and R. Stephenson, Adaptation of the HIV/AIDS Self-Management 
Education Program for Men Who Have Sex With Men in Thailand: An Application of the 
ADAPT-ITT Framework. AIDS Educ Prev, 2017. 29(5): p. 401-417.
101.
Goodreau, S.M., et al., Targeting Human Immunodeficiency Virus Pre-Exposure 
Prophylaxis to Adolescent Sexual Minority Males in Higher Prevalence Areas of the 
United States: A Modeling Study. J Adolesc Health, 2017.
102.
Jenness, S.M., et al., Individual HIV Risk versus Population Impact of Risk Compensation 
after HIV Preexposure Prophylaxis Initiation among Men Who Have Sex with Men. PLoS 
One, 2017. 12(1): p. e0169484.
103.
Jones J, Stephenson R, Sullivan PS.  An iPad-based tool for PrEP eligibility assessment 
in clinics: qualitative results.  [oral abstract].   Presented at Sex::Tech 2011, San 
Francisco California, April 1-2, 2011.
104.
Pingel, E.S., et al., It’s just not for me: exploring low prep uptake among young black 
men who have sex with men in the southern united states. Sexually Transmitted 
Infections, 2017. 93(Suppl 2): p. A4-A4.
105.
Sullivan P, Liu A, Fuchs J, Irby R, Tarver R, Buchbinder S.  (2011) Awareness of and 
intention to use PrEP: a post-iPrEX survey of US MSM. National HIV Prevention 
Conference; August 2011; Atlanta GA.
106.
Rolle, C.P., et al., Willingness to use pre-exposure prophylaxis among Black and White 
men who have sex with men in Atlanta, Georgia. Int J STD AIDS, 2016: p. 
956462416675095.
107.
Siegler, A.J., et al., Developing and assessing the feasibility of a home-based PrEP 
monitoring and support program. 2018.
108.
Siegler, A.J., et al., Developing a Web-Based Geolocated Directory of HIV Pre-Exposure 
Prophylaxis-Providing Clinics: The PrEP Locator Protocol and Operating Procedures. 
JMIR Public Health Surveill, 2017. 3(3): p. e58.
109.
Sullivan, P.S., et al., Time to first annual HIV care visit and associated factors for 
patients in care for HIV infection in 10 US cities. AIDS Care, 2011. 23(10): p. 1314-20.
110.
Khosropour CM and Sullivan PS.  At-home HIV testing of MSM Enrolled in an Online 
HIV Behavioral Risk Study. Oral presentation at 2011 National HIV Prevention 
Conference. Atlanta, Georgia. August 2011.
111.
Khosropour, C.M., et al., Enhancing retention of an Internet-based cohort study of men 
who have sex with men (MSM) via text messaging: randomized controlled trial. Journal 
of Medical Internet Research, 2013. 15(8).

Protocol Title:  Element 2
Page 48 of 51
Protocol Version: Version 12  11/21/2024
112.
Sullivan, P.S., et al., Safety and acceptability of couples HIV testing and counseling for 
US men who have sex with men: a randomized prevention study. J Int Assoc Provid AIDS 
Care, 2014. 13(2): p. 135-44.
113.
Rosenberg, E.S., et al., Understanding the HIV disparities between black and white men 
who have sex with men in the USA using the HIV care continuum: a modeling study. 
Lancet HIV, 2014. 1(3): p. e112-e118.
114.
Understanding Substance Use and Incident HIV/STI Among Young Black MSM 
(ele[men]t) [online research protocol].  Clinicaltrials.gov Identifier: NCT02503618.  
2015.  Available at: https://clinicaltrials.gov/ct2/show/NCT02503618.  Last accessed 
December 16, 2015.
115.
Ricca, A.V., et al., Factors Associated with Returning At-Home Specimen Collection Kits 
for HIV Testing among Internet-Using Men Who Have Sex with Men. Journal of the 
International Association of Providers of AIDS Care (JIAPAC), 2016: p. 
2325957416668579.
116.
Chapin-Bardales, J., E.S. Rosenberg, and P.S. Sullivan, Trends in racial/ethnic 
disparities of new AIDS diagnoses in the United States, 1984-2013. Ann Epidemiol, 
2017.
117.
Goodreau, S.M., et al., Sources of racial disparities in HIV prevalence in men who have 
sex with men in Atlanta, GA, USA: a modelling study. Lancet HIV, 2017.
118.
Jenness, S.M., et al., Incidence of Gonorrhea and Chlamydia Following HIV 
Preexposure Prophylaxis among Men Who Have Sex with Men: A Modeling Study. Clin 
Infect Dis, 2017.
119.
Sharma, A., et al., HIV and Sexually Transmitted Disease Testing Behavior Among 
Adolescent Sexual Minority Males: Analysis of Pooled Youth Risk Behavior Survey Data, 
2005-2013. LGBT Health, 2017. 4(2): p. 130-140.
120.
Warner L, Ghanem KG, Newman D, Macaluso M, Sullivan P, Erbelding EJ. Male 
circumcision and risk of HIV infection among heterosexual men attending Baltimore 
STD clinics: an evaluation of clinic-based data. 2006 Society for Epidemiologic Research 
Meeting, Seattle, WA, June 21-24, 2006.
121.
Zlotorzynska, M., P. Sullivan, and T. Sanchez, The Annual American Men's Internet 
Survey of Behaviors of Men Who Have Sex With Men in the United States: 2015 Key 
Indicators Report. JMIR Public Health Surveill, 2017. 3(1): p. e13.
122.
Sullivan, P.S., et al., Understanding Racial HIV/STI Disparities in Black and White Men 
who have Sex with Men: A Multilevel Approach. PLos ONE, 2014 (in press).
123.
Rosenberg, E. and P.S. Sullivan, A new online survey module to measure sexual 
partnership timing with results from a focus group of MSM, in Sex::Tech. 2010: San 
Francisco.
124.
Sanchez, T.H., et al., Lack of Awareness of HIV Infection: Problems and Solutions with 
Self-reported HIV Serostatus of Men Who Have Sex with Men. Open Forum Infectious 
Diseases, 2014.
125.
Sullivan, P.S., et al., Understanding Racial HIV/STI Disparities in Black and White Men 
Who Have Sex with Men: A Multilevel Approach. PloS one, 2014. 9(3): p. e90514.
126.
White, D., et al., Racial differences in the validity of self-reported drug use among men 
who have sex with men in Atlanta, GA. Drug and alcohol dependence, 2014. 138: p. 146-
153.

Protocol Title:  Element 2
Page 49 of 51
Protocol Version: Version 12  11/21/2024
127.
Hernández-Romieu, A.C., et al., How often do condoms fail? A cross-sectional study 
exploring incomplete use of condoms, condom failures and other condom problems 
among black and white MSM in southern USA. Sexually Transmitted Infections, 2014.
128.
Vaughan, A.S., E.S. Rosenberg, and P.S. Sullivan, Spatial Relationships Between Gay 
Stigma, Poverty, and HIV Infection Among Black and White Men Who Have Sex with 
Men in Atlanta. AIDS Res Hum Retroviruses, 2014.
129.
Peterson, J.L., et al., Social Discrimination and Resiliency Are Not Associated With 
Differences in Prevalent HIV Infection in Black and White Men Who Have Sex With Men. 
JAIDS Journal of Acquired Immune Deficiency Syndromes, 2014. 66(5): p. 538-543 
10.1097/QAI.0000000000000203.
130.
Understanding Substance Use and Incident HIV/STI Among Young Black MSM 
(Ele[MEN]t) [online research protocol].  Clinicaltrials.gov Identifier: NCT02503618, 
2015.  Available at: https://clinicaltrials.gov/ct2/show/NCT02067039.   (Archived by 
WebCite® at http://www.webcitation.org/6mTuL9BMi).
131.
MacKellar, D.A., et al., Surveillance of HIV risk and prevention behaviors of men who 
have sex with men - A national application of venue-based, time-space sampling. Public 
Health Reports, 2007. 122: p. 39-47.
132.
US Public Health Service.  Preexposure prophylaxis for the prevention of HIV infection 
in the United States - 2017 update. [Clinical Practice Guideline].  Available at: 
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf  Accessed: 
2018-09-03.
133.
Jones, J., et al., Acceptability and willingness among men who have sex with men (MSM) 
to use a tablet-based HIV risk assessment in a clinical setting. SpringerPlus, 2014. 3(1): 
p. 708.
134.
Goldenberg, T., et al., Preferences for a Mobile HIV Prevention App for Men Who Have 
Sex With Men. JMIR Mhealth Uhealth, 2014. 2(4): p. e47.
135.
Goldenberg, T., et al., Building a Mobile HIV Prevention App for Men Who Have Sex 
With Men: An Iterative and Community-Driven Process. JMIR Public Health Surveill, 
2015. 1(2): p. e18.
136.
Bauermeister, J., et al., Reducing HIV Vulnerability Through a Multilevel Life Skills 
Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized 
Controlled Trial. JMIR Res Protoc, 2018. 7(7): p. e10174.
137.
LeGrand, S., et al., Testing the Efficacy of a Social Networking Gamification App to 
Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): 
Protocol for a Randomized Controlled Trial. JMIR Res Protoc, 2018. 7(12): p. e10448.
138.
Biello, K.B., et al., A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for 
Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial. 
JMIR Res Protoc, 2019. 8(1): p. e10661.
139.
Biello, K.B., et al., A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing 
and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a 
Pilot Randomized Controlled Trial. JMIR Res Protoc, 2019. 8(1): p. e10694.
140.
Liu, A., et al., Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually 
Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have 
Sex With Men: Protocol for a Randomized Controlled Trial. JMIR research protocols, 
2019. 8(1): p. e10659.

Protocol Title:  Element 2
Page 50 of 51
Protocol Version: Version 12  11/21/2024
141.
Gamarel, K.E., et al., The Development and Testing of a Relationship Skills Intervention 
to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who 
Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a 
Randomized Controlled Trial. JMIR Res Protoc, 2019. 8(1): p. e10370.
142.
Centers for Disease Control and, P., 1998 guidelines for treatment of sexually transmitted 
diseases. Centers for Disease Control and Prevention. MMWR Recomm.Rep, 1998. 
47(RR-1): p. 1-111.
143.
Kirkcaldy, R.D.J.M.S.S., Neisseria gonorrhoeae antimicrobial susceptibility 
surveillance—the gonococcal isolate surveillance project, 27 sites, United States, 2014. 
2016. 65.
144.
Haaland, R.E., et al., Repeated rectal application of a hyperosmolar lubricant is 
associated with microbiota shifts but does not affect PrEP drug concentrations: results 
from a randomized trial in men who have sex with men. J Int AIDS Soc, 2018. 21(10): p. 
e25199.
145.
Sullivan, P.S., et al., Adaptation of the African couples HIV testing and counseling model 
for men who have sex with men in the United States: an application of the ADAPT-ITT 
framework. Springerplus, 2014. 3: p. 249.
146.
Sanchez T PR, Baral S, Puren A, Kose Z, Ahame E, Sokhela Z, Chibi B, Hoosain E, 
Valencia R, Zahn R, Sullivan P. An effectiveness-implementation trial for package of 
community and peer-based services to improve HIV treatment engagement and viral 
suppression among South African MSM.  AIDS IMPACT; Cape Town, South Africa 
2017.
147.
Sly, J.R., et al., Challenges to replicating evidence-based research in real-world settings: 
training African-American peers as patient navigators for colon cancer screening. 
Journal of Cancer Education, 2012. 27(4): p. 680-686.
148.
Rosenbaum, P.R., Model-based direct adjustment. Journal of the American Statistical 
Association, 1987. 82(398): p. 387-394.
149.
Xie, J. and C. Liu, Adjusted Kaplan–Meier estimator and log‐rank test with inverse 
probability of treatment weighting for survival data. Statistics in medicine, 2005. 24(20): 
p. 3089-3110.
150.
Lee, B.K., J. Lessler, and E.A. Stuart, Weight trimming and propensity score weighting. 
PloS one, 2011. 6(3): p. e18174.
151.
Austin, P.C., The use of propensity score methods with survival or time-to-event 
outcomes: reporting measures of effect similar to those used in randomized experiments. 
Statistics in Medicine, 2014. 33(7): p. 1242-1258.
152.
Dupont, W.D. and W. Plummer, PS: Power and sample size calculation. Control Clin 
Trials, 1997: p. 18-274.
153.
Grennan, T., Hull, M., Mohammed, S., Tattersall, T., Edward, J., Gupta, A., et al.  Daily 
Doxycycline in MSM on PrEP for Prevention of Sexually Transmitted Infections.  Science 
Spotlight presentation at Conference on Retroviruses and Opportunistic Infections. 
Virtual, March 2021.
154.Pampati S, Emrick K, Siegler AJ, Jones J. Changes in Sexual Behavior, PrEP Adherence, 
and Access to Sexual Health Services Because of the COVID-19 Pandemic Among a Cohort 
of PrEP-Using MSM in the South. J Acquir Immune Defic Syndr. 2021 May 1;87(1):639–
643. PMID: 33512848

Protocol Title:  Element 2
Page 51 of 51
Protocol Version: Version 12  11/21/2024
155.Hong C, Horvath KJ, Stephenson R, Nelson KM, Petroll AE, Walsh JL, John SA. PrEP use 
and persistence among young sexual minority men 17-24 years old during the COVID-19 
pandemic. AIDS Behav [Internet]. Springer Science and Business Media LLC; 2021 Aug 
13; Available from: http://dx.doi.org/10.1007/s10461-021-03423-5 PMCID: PMC8361406
156.Reyniers T, Rotsaert A, Thunissen E, Buffel V, Masquillier C, Van Landeghem E, 
Vanhamel J, Nöstlinger C, Wouters E, Laga M, Others. Reduced sexual contacts with non-
steady partners and less PrEP use among MSM in Belgium during the first weeks of the 
COVID-19 lockdown: results of an online survey. Sex Transm Infect. BMJ Publishing 
Group Ltd; 2021;97(6):414–419.
157.Chow EPF, Hocking JS, Ong JJ, Phillips TR, Schmidt T, Buchanan A, Rodriguez E, 
Maddaford K, Fairley CK. Brief Report: Changes in PrEP Use, Sexual Practice, and Use of 
Face Mask During Sex Among MSM During the Second Wave of COVID-19 in Melbourne, 
Australia. J Acquir Immune Defic Syndr. ncbi.nlm.nih.gov; 2021 Feb 1;86(2):153–156. 
PMCID: PMC7808277
158. Rogers BG, Tao J, Maynard M, Chu C, Silva E, Toma E, Nagel K, Napoleon S, Chan PA. 
Characterizing the Impact of COVID-19 on Pre-Exposure Prophylaxis (PrEP) Care. AIDS 
Behav. Springer; 2021 Nov;25(11):3754–3757. PMCID: PMC8191705
159. Pagaoa M, Grey J, Torrone E, Kreisel K, Stenger M, Weinstock H. Trends in Nationally 
Notifiable Sexually Transmitted Disease Case Reports During the US COVID-19 Pandemic, 
January to December 2020. Sex Transm Dis. ncbi.nlm.nih.gov; 2021 Oct 1;48(10):798–804. 
PMCID: PMC8459909
160.Goswami ND, Schmitz MM, Sanchez T, Dasgupta S, Sullivan P, Cooper H, Rane D, Kelly 
J, Del Rio C, Waller LA. Understanding Local Spatial Variation Along the Care Continuum: 
The Potential Impact of Transportation Vulnerability on HIV Linkage to Care and Viral 
Suppression in High-Poverty Areas, Atlanta, Georgia. J Acquir Immune Defic Syndr. 2016 
May 1;72(1):65–72. PMCID: PMC4837075
161.Dasgupta S, Kramer MR, Rosenberg ES, Sanchez TH, Reed L, Sullivan PS. The Effect of 
Commuting Patterns on HIV Care Attendance Among Men Who Have Sex With Men 
(MSM) in Atlanta, Georgia. JMIR Public Health Surveill. JMIR Publications Inc., Toronto, 
Canada; 2015 Jul;1(2):e10. PMCID: PMC4869235
162.Sharpe JD, Sanchez TH, Siegler AJ, Guest JL, Sullivan PS. Association between the 
geographic accessibility of PrEP and PrEP use among MSM in nonurban areas. J Rural 
Health [Internet]. Wiley; 2022 Jan 7; Available from: http://dx.doi.org/10.1111/jrh.12645 
PMID: 34997634