Advancing Pre-exposure Prophylaxis (PrEP) Access in Pharmacies to Improve PrEP Uptake in Disadvantaged Areas
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: Emory University

Study Protocol 
 
Title: Advancing Pre-exposure Prophylaxis (PrEP) Access in Pharmacies 
to Improve PrEP Uptake in Disadvantaged Areas 
 
NCT Number: NCT04393935 
 
Modified Protocol Date: January 18, 2023 

Version: January 18, 2023
Full title: 
Advancing pre-exposure prophylaxis (PrEP) access in pharmacies to improve PrEP uptake in 
disadvantaged areas” (1R34 MH119007-01)
Investigator’s Names:
Natalie D. Crawford, PhD (Principal Investigator)
David Holland, MD
Donald Klepser
Aaron Siegler
Patrick Sullivan
Henry Young
Sponsor’s Name:
National Institute on Mental Health
Date:
January 18, 2022

Version: January 18, 2023
1. Background
1.1 Specific aims of the study 
Black men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United 
States1,2.  The most recent statistics indicate that BMSM are 550% more likely to be diagnosed with HIV 
than white MSM (WMSM)1,2. Pre-exposure prophylaxis (PrEP) reduces risk of HIV infection by 92%3, yet 
profound racial disparities in the uptake of PrEP persist. In 2015, among those offered PrEP, only 10% of 
blacks compared to 75% of whites used PrEP4. Low PrEP uptake in BMSM is driven by: poor access to 
PrEP including inconvenient locations of PrEP-prescribing physicians5-10 and distrust of physicians and 
stigma, which limit communication about PrEP and its side effects6,11. According to Cohen’s structural 
theory improving access to PrEP will improve PrEP uptake12. Since HIV among BMSM is largely clustered 
in high poverty, racial minority neighborhoods13,14, we can improve access by directing PrEP delivery to 
these areas. Pharmacists in these neighborhoods have strong rapport with the residents15 and as a 
trusted source for health information, could effectively inform BMSM about PrEP. Our work indicates 
that offering HIV prevention services in pharmacies located in high poverty, racial minority 
neighborhoods is feasible16 and can reduce stigma because pharmacies offer a host of less stigmatized 
health services (e.g. vaccinations)18. Moreover, preliminary data among BMSM show strong support for 
obtaining PrEP in pharmacies.
The purpose of this study is to develop a culturally appropriate pharmacy PrEP delivery model for 
BMSM who live in high poverty, racial minority neighborhoods. Pharmacies have proven to be a 
feasible source for offering PrEP for WMSM17,18, but have failed to reach the most at-risk, vulnerable 
population – BMSM19. State regulations limit pharmacists’ ability to screen and prescribe PrEP in 21 
states, so many pharmacies use nurse practitioners (NPs) instead18. But, pharmacies in high poverty, 
racial minority neighborhoods often lack NPs. Thus, we have designed a multi-level intervention that 
does not rely on pharmacists or NPs to screen BMSM for PrEP. Increasing PrEP access and uptake will 
reduce HIV incidence and racial inequities in HIV, two NIH HIV/AIDS high priority areas. This protocol 
describes the aims of this study, which are to:
Aim 1. Develop a pharmacy PrEP delivery model by evaluating the barriers to and facilitators of 
integrating PrEP into existing pharmacy practice among key stakeholders (pharmacists, 
technicians, PrEP-prescribing physicians and BMSM).
Aim 2. Evaluate eligibility and willingness to receive PrEP in pharmacies among BMSM and collect 
data on customer engagement with PrEP delivery information from pharmacy staff during 
COVID-19. 
Aim 3.  Pilot test the pharmacy PrEP delivery model and examine its feasibility, acceptability and 
safety, and gather early evidence of its impact and cost with respect to PrEP uptake at 
baseline and at 3-months (the clinically suggested follow-up period) among pharmacy client 
participants.
1.2 Background and preliminary studies that support this stage of research
BMSM bear the highest burden of HIV in the US. Between 2005 and 2014, HIV diagnoses increased 22% 
for BMSM but declined 19% for WMSM1,2. In Georgia, blacks make up less than 40% of the population 

Version: January 18, 2023
but represent 74% of new AIDS diagnoses. And almost two-thirds of incident HIV infections were among 
blacks via male-male sex20. 
PrEP is the single most effective HIV prevention strategy yet under-utilized among BMSM. When taken 
every day PrEP can prevent up to 92% of HIV infections3,19. Studies estimate that 48-70% of BMSM are 
willing to use PrEP5,21. Yet, uptake among blacks remains low (~10%)4. Lower insurance rates among 
blacks compared to whites22 may be a barrier to PrEP. But, evidence of comparable insurance rates 
among BMSM and WMSM23, as well as prescription payment programs that cover most or all of the 
costs of PrEP do not completely explain significant disparities in PrEP uptake24. Indeed, limited access to 
PrEP, distrust of physicians and stigma are noted as critical barriers to PrEP that must be improved to 
reduce HIV5,21. 
Neighborhood residence shapes BMSM HIV exposure and access to HIV prevention resources13. A recent 
study showed that 60% of prevalent HIV cases were located in one central Atlanta cluster14.  Census 
tracts with high HIV had 20% higher poverty and 200% larger MSM populations. High poverty 
neighborhoods also have the fewest HIV physicians10,25,26. While most census tracts are within 15 
minutes of an HIV physician by car, residents in HIV prevalent areas have low rates of car ownership and 
commute time more than doubles when traveling by public transportation10, which is unavailable in 
some areas. 
There is a strong scientific premise for increasing PrEP delivery in pharmacies for BMSM. About 95% of 
Americans live within 5 miles of a pharmacy; pharmacies have flexible hours and pharmacists have high 
credibility with community members15. Studies have shown pharmacies can engage with high risk 
populations including people who inject drugs (PWID) to reduce HIV risk behaviors27-30 and provide 
primary prevention services including immunizations31, blood pressure screenings32 and HIV testing16,33-
35. PrEP has also been sustainably offered in a Seattle pharmacy, but mostly to white MSM (85%). 
Nevertheless, almost 100% initiated PrEP and 75% followed up for continued PrEP17. Following this, 188 
Walgreens across the US have offered PrEP through their existing clinics18,36. 
Existing pharmacy PrEP models have limited potential for reaching BMSM. In Seattle, state regulations 
give pharmacists authority to administer biological screenings (HIV, STI and creatinine) and prescribe 
PrEP19. Many states do not have legislation that expand pharmacists’ purview in service delivery37,38. 
Walgreens has overcome this regulatory limitation by using nurse practitioners to screen and prescribe 
PrEP in their existing clinics18. While Collaborative Practice Agreements between pharmacists and 
physicians are another route to deliver services through pharmacies39,40, they are time-consuming and 
thus infeasible for community pharmacists in high morbidity neighborhoods who already have a hectic 
workflow; and for chain pharmacies these partnerships are determined on a corporate rather than 
individual pharmacy level40-43. 
1.3 Significance/ justification for the current study
The contribution of the proposed research is expected to be a sustainable, pharmacy PrEP delivery 
model that can be implemented without regulatory barriers to increase PrEP access in high poverty, 
racial minority neighborhoods for BMSM who have the highest need. This contribution will be significant 
because it will lay the foundation for making PrEP available in pharmacies specifically for populations 
that are disconnected from HIV prevention resources.  
2. Design

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To accomplish these aims, we will conduct a four-phase study: 
(1) formative phase of in-depth interviews and workflow assessments among 40 key stakeholders 
to inform phase two.
(2) intervention development phase to integrate formative data with input from an existing 
advisory board to develop a culturally relevant pharmacy PrEP delivery model. 
(3) transitional pilot phase to assess customer eligibility and willingness to receive PrEP in 
pharmacies during COVID-19.
(4) pilot test phase to test the model in two pharmacies in high poverty, racial minority 
neighborhoods, where we have existing relationships. 
For the remainder of the protocol, we will describe the methods according to each phase of the 
study.
2.1 Sample
This study will include various participant groups across each phase of the study. For clarification in 
terminology of each type of participant, here we provide definitions of each group:
Pharmacist – Pharmacist participant 
Technician – Pharmacy technician participant
Pharmacy staff – Pharmacist, pharmacy technician and pharmacy clerk participant
Client – Pharmacy client participant who patronizes pharmacy enrolled in the study
In the formative phase, we will collect data from key stakeholders: 10 pharmacists, 10 technicians, 10 
PrEP-prescribing physicians and 10 black men who have sex with men (BMSM) via in-depth interviews. 
Interviews will assess support for PREP screening, referral and monitoring in pharmacies, pharmacy-level 
policies influencing PrEP provision, potential barriers to the delivery of an intervention in a pharmacy, 
existing interactions between pharmacists and physicians, advocacy resources, knowledge of 
epidemiologic data on HIV, sexual behavior, drug use and PREP, and sustainability through pharmacy-
physician-community collaboration. We will also perform workflow assessments among pharmacists, 
technicians and PrEP prescribing physicians to examine the facilitators and barriers to PrEP 
implementation. 
In the intervention development phase, there are no pharmacy staff or client participants, thus no data 
protections are needed. In this phase of the study the investigative team and advisory board will use 
the data analyzed from the formative phase to develop the pharmacy PrEP delivery model to be 
implemented in the pilot study.  We will also iteratively revise the protocol over the course of the 
study to ensure its feasibility, acceptability, and safety. We will debrief about the study activities 
every month of the pilot study to refine the protocol for immediate implementation in the study 
activities. Each proposed change will be assigned a subject matter expert from the co-I’s on the grant. 
The subject matter expert and at least two other co-I’s will be asked to vote on whether the change 
will be made immediately, revoked or followed through the next monthly meeting. Any change that 
requires the recruitment, protocol or survey instruments to be revised will be submitted to the IRB for 
approval. Meticulous records of the development and revision process of the pharmacy PrEP delivery 
model will be kept throughout the study.

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In the transitional pilot phase, two pharmacies will be chosen to estimate how many pharmacy client 
participants would be eligible for the pilot phase. Among those who would be eligible, we will assess 
their willingness to receive PrEP in pharmacies. In order to recruit a sample of pharmacy client 
participants, pharmacy staff participants will place flyers in pharmacy client participants’ medication 
delivery packages and hang posters in their pharmacies. Given the COVID19 pandemic, many client 
participants are opting for medication delivery versus in-person pick up. The flyers and posters will 
contain information about the pharmacy-based PrEP delivery study. A QR code will allow client 
participants to be directly linked to the eligibility screener. After taking the eligibility screener, client 
participants will be eligible for the social and behavioral survey if they are: 1) male or trans male, 2) 
had any types of sex in the past 6 months, 3) engaged in unprotective sex in the past 6 months, 4) 
had protected and/or unprotected sex with HIV positive partners in the past 6 months, and 4) 
injected any drugs in the past 6 months. We will ask pharmacy staff to insert flyers into patient 
medication deliveries over a 3-month period and during this time we will assess pharmacy staff 
barriers and facilitators of engaging with client participants  regarding the study.
In the pilot test phase, two pharmacies will be chosen to pilot test the pharmacy PrEP delivery model. 
We will recruit pharmacy staff participants who work in each pharmacy and pharmacy client 
participants that patronize these pharmacies. Pharmacy staff participants will complete a pharmacy-
based HIV prevention training to equip them with the tools needed for optimal PrEP delivery. Since 
the pharmacies selected to be a part of the study are located in racial minority neighborhoods, we 
anticipate that most client participants will be racial minorities. We will be collecting both qualitative 
and quantitative data to assess the impact of the pharmacy PrEP intervention on the pharmacy 
environment, personnel, and business flow. Among the pharmacy client participants, we will assess 
feasibility, acceptability and safety of the intervention activities, satisfaction with the activities and 
participation in activities without stigmatization, discomfort, or harm.
Pharmacy client participants will be considered eligible for the social behavioral survey if they:

Consent to participate in the online screener

Are 18 years or older

Can speak and read English without any help 
In accordance with current CDC guidelines, Pharmacy client participants will be considered eligible for 
HIV testing if answers from the social behavioral survey indicate that: 

They consent to participate in the social behavioral survey

They are willing to be tested for HIV today
Respond “yes,” “don’t know,” or “prefer not to say” to one or more of the following conditions:

Identify as male, trans female, gender-non-conforming,” or “other” and reports having sex with 
men within the past 3 months 

Having vaginal or anal sex without a condom within the past 3 months 

Having ever used injectable drugs 
Pharmacy client participants will be considered ineligible for HIV testing if they do not consent to 
partake in the social behavioral survey, do not consent to be tested for HIV, or answer “yes” to both of 
the following conditions:

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
Reports no vaginal or anal sex without a condom within the past 3 months and identifies as a 
woman or trans male who has not had sex without a condom within the past 3 months

Has never used injectable drugs 
Pharmacy client participants will be eligible for a 30-day supply of PrEP from the pharmacy if they:

Test negative for HIV 

Agree to receive medication from the pharmacy 
2.2 Setting
Formative phase
All interviews will be conducted in a private setting identified either by the researcher or the key 
stakeholder (i.e., personal office). The researcher will arrange a private office in a convenient location 
for the interview to be conducted.
Intervention Development Phase
The investigative team and the advisory board will work together to develop the pharmacy PrEP delivery 
model. 
Transitional Pilot Phase
The transitional pilot phase will take place in two pharmacies that are located in high poverty and racial 
minority neighborhoods. We will provide pharmacy staff participants with flyers to disseminate to their 
pharmacy clients to take an eligibility screener and social and behavioral survey. Posters advertising 
the survey will also be placed throughout the pharmacy in case any client participants who visit the 
pharmacy in-person are interested.  
Pharmacy staff participants will complete a short orientation to learn the study activities. The study 
activities are as follows: place study flyers in client participants’ medication delivery packages; hang 
posters in their pharmacies about the study; and direct any questions that client participants may have 
about the study to our research team. Given that the study will ask sensitive questions about HIV and 
PrEP, pharmacy staff participants will receive two Continuing Education (CE) credit by participating in a 
training on understanding HIV in the community and mobilizing community pharmacies to improve 
access to PrEP. The orientation and training will take place online on Zoom.
Pharmacy staff participants will participate in a one-hour phone interview at baseline and 3-month of 
the intervention. 
Pharmacy client participants who are made aware of the study by the pharmacy staff participants, and 
are interested will take a 3-minute eligibility screener. Eligible participants will then be prompted to 
complete a 20-minute social and behavioral survey. The screener and survey will be administered online 
using links for Survey Gizmo. The screener and survey, similar to self-administered online surveys, will 
not require the presence of the research or pharmacy staff. During the survey, we will inquire about 
sensitive subjects (mental, sexual and behavioral health). If needed, pharmacy client participants may 
be offered linkages to community services to meet their healthcare needs.  Pharmacy client participants 
may refuse to participate in the study or to receive additional referrals at any time.

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Pilot Phase
The pilot phase will take place in two pharmacies that are located in high poverty and racial minority 
neighborhoods. All pharmacies will have a large, private space where client participants/patients who 
agree to be screened and linked to PrEP can have privacy. If necessary, we will provide additional wall 
partitions/ screens, noise machines and noise-cancelling curtains to enhance privacy.
Pharmacy staff participants will complete a thorough training via the Canvas platform to learn the study 
activities. Our Canvas site will link trainees to privately posted YouTube videos that contain training 
material. Additionally, pharmacy staff participants will complete a module in HIV Prevention and 
Counseling. During training, pharmacy members will complete a pre-post survey about HIV Care and 
Prevention using Alchemer software. These trainings will take place virtually. 
Pharmacy staff participants will participate in a one-hour interview at baseline, 3-month and 6-month of 
the intervention. These interviews will take place in a private office in the pharmacy. 
Pharmacy client participants who are recruited into the pilot study will complete a 20-minute social and 
behavioral screener using Alchemer on an easy to use, touch screen tablet in a private room in the 
pharmacy. Trained pharmacy staff will set up these interviews in the private area of the pharmacy but 
will not administer the survey.  In the event that a participant has a physical or intellectual disability that 
renders the m unable to use the tablet, a study team member will orally administer the survey. The 
screening survey, similar to the self-administered online surveys, will not require the presence of the 
research or pharmacy staff participants outside of them showing them to the tablet in a private room. 
Potential pharmacy client participants may complete the screener using the QR code found on 
recruitment flyers, complete it on study iPads if recruited by staff, or (if needed) be screened orally by 
a team member. If eligible, pharmacy client participants may be offered a free HIV test. If pharmacy 
client participants accept, then the HIV test will be completed in the same private area of the 
pharmacy. Pharmacy client participants may refuse to participate at any time or if they have time 
constraints, they can schedule the test at a later date. If they are uncomfortable completing the 
screening in the pharmacy, we will also provide them with a referral for a PrEP prescribing physician.
2.3 Recruitment and enrollment
Formative Phase
To enroll pharmacists (n=10) and technicians (n=10), we will identify all pharmacies in the highest HIV 
zip code in Atlanta as shown by AIDSVu. AIDSVu is an online, interactive display of HIV prevalence across 
the US.  Using an existing list of all pharmacies in the state of Georgia obtained from the Georgia Board 
of Pharmacy, we will generate a list of pharmacies from high HIV zip codes and then randomly contact 
each pharmacy to determine whether pharmacists or technicians are interested in participating in the 
study. Preliminary studies have indicated a sampling frame of about 43 pharmacies. 
To enroll PrEP prescribing physicians (n=10) we will randomly select, and call physicians located in (or 
near) high HIV zip codes in Atlanta who have registered with PrEP locator (PrEPlocator.com). PrEP 
locator is an online, Emory maintained database of physicians who offer PrEP across the US, which was 
developed by co-investigator (co-I) Siegler. 
To enroll BMSM we will rely on referral of the population by NAESM, our community partners. NAESM 
hosts large HIV testing drives at sites frequented by BMSM (i.e., bars, clubs’ college events). They will 
inform men of our study and will schedule interviews with interested men at pre-specified dates on our 

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behalf.
Intervention Development Phase
The investigative team and advisory board are identified on this IRB protocol. These are experts in HIV 
prevention, rather than study participants. Thus, no recruitment will occur during this phase.
Transitional Pilot Phase
To enroll pharmacies, we will choose two pharmacies located in high poverty, racial minority 
neighborhoods will be selected from a sampling frame of about 43 pharmacies. In order for the 
pharmacy to participate, consent will have to be obtained from at least 1 pharmacist participant and 
2-3 technician participants (n=4 per pharmacy). 
To enroll pharmacy client participants, trained pharmacy staff will discreetly place flyers in clients’ 
medication delivery packages to inform men about the eligibility screener and the social and 
behavioral survey. Pharmacy client participants will be directed online where they can privately 
consent to the study and complete the screener and survey. Pharmacy client participants who 
complete the eligibility screener will receive a $1 pharmacy coupon regardless of their eligibility or 
willingness to participate in our study. Eligible pharmacy client participants who are willing to 
complete the social and behavioral survey will be compensated  $25 for their time. Pharmacy client 
participants will be informed during the informed consent process that the information they provide 
will be used to determine their HIV risk, and they may be offered referrals for STIs/HIV testing and 
PrEP. 
Pilot Phase
To enroll pharmacies, we will choose two pharmacies to pilot test the pharmacy PrEP delivery model. 
Pharmacies that are located in high poverty, racial minority neighborhoods will be selected from a 
sampling frame of about 43 pharmacies. In order for the pharmacy to participate, consent will have to 
be obtained from at least 1 pharmacist participant and 2-3 technician participants (n=4 per pharmacy). 
Pharmacy staff participants will discreetly inform their pharmacy clients about the study.  If the 
pharmacy client is interested and willing to learn more about the study, the pharmacy staff participant 
will direct them to an area where they can privately provide electronic informed consent and 
complete the electronic screener. If they are unwilling or do not have time, they will be encouraged to 
return to the pharmacy when they have time. Pharmacy client participants who agree to complete the 
social and behavioral screener will be compensated $25 for their time regardless of their eligibility or 
interest in being clinically screened for PrEP. Participants will be informed during the informed consent 
process that the information they provide will be used to determine their HIV risk and they may be 
offered a free HIV test.
2.4 Procedures
Formative Phase
Procedures for qualitative in-depth interviews
1.
Initial contact and invitation to participate in an in-depth interview about PrEP screening and 
referral in pharmacies for MSM will be performed over the phone.
2.
An appointment will be made with individuals who are willing to participate in the interview.
3.
We will conduct individual in-depth qualitative interviews with two different kinds of key 
informants: 1) interactor participants (pharmacists, technicians and PrEP prescribing 

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physicians) who interact with BMSM on a day to day basis and will be able to provide 
information about how the pharmacy and medical systems works at a practical level; and 2) 
BMSM participants who will describe their interactions with and perceptions of pharmacists 
and PrEP prescribing physicians, their receptiveness to pharmacy-based interventions, as well 
as their interactions with and attitudes towards the legal, public health and HIV prevention and 
care systems. 
4.
The interview process will be semi-structured and the interview guide will be targeted to the 
type of key informant. Topic guides will be used to guide the interview.
5.
Qualitative data collection will assess barriers and facilitators of pharmacy PrEP delivery and 
discuss ways to support a sustainable pharmacy PrEP delivery model. Moreover, with each 
participant, we will describe the preliminary PrEP model for specific feedback on each step with 
respect to advertising, recruitment of BMSM, costs and other concerns. The interviews will also 
cover a range of topics within four domains: general public health and HIV/AIDS policy, 
pharmacy utilization of health services, pharmacy-based HIV prevention services including 
PREP, and pharmacy-physician partnerships. Specific questions will address: support for PREP 
screening, policies influencing PrEP delivery, referral and monitoring in pharmacies, potential 
barriers to the delivery of an intervention in a pharmacy, knowledge of epidemiologic data on 
HIV, sexual behavior, drug use and PREP, and sustainability through pharmacy-physician 
collaboration. 
6.
All interviews will be recorded for transcription and data analysis.
7.
Interview recordings and paper notes will be stored in a locked cabinet in a lock office.
8.
All of the data (transcripts) and analysis related to this study will be stored on network drives 
only available to the investigator and research assistant. The data will be anonymized, and the 
identity of the participants will be kept in a separate network drive, only available to the study 
investigator.
Procedures for workflow assessments
1.
Direct observation of the pharmacy (for pharmacists and technicians) or physician office (for 
PrEP prescribing physicians) will be performed to understand routine and non-routine 
activities44. 
For pharmacists and technicians, the research assistant will focus on the door-to-door 
patient experience of obtaining a prescription as well as the process implemented behind the 
counter for filling a prescription. We will also pay particular attention to the pharmacist and 
technician procedures for patients obtaining a primary prevention service such as an 
immunization in the pharmacy. We will take note of the procedures performed to prepare for 
the immunization (i.e., authorization calls, collection of all materials, privacy partition set up) 
and following the administration of the immunization (i.e., logging of service performed, 
department of health reporting) including the time taken to perform each of these procedures. 
For PrEP-prescribing physicians, researchers will focus the workflow assessment on the 
administrative process performed before and after seeing patients. In consideration of patient 
privacy, research assistants will not sit in on patient visits. Rather they will shadow the 
physicians once a patient visit is complete to understand how patient prescriptions are filled and 
how interaction occurs between the pharmacist and physician.
2.
Research assistants will monitor the day-to-day procedures in each environment during a 
morning or afternoon work shift; whichever is most convenient for the participant. Observations 
will be made from a non-intrusive area. As time allows, open-ended questions will be asked to 
clarify observations.
3.
Workflow diagrams for the pharmacy and physician offices will be created and patterns will be 

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examined across each environment to create an overall description that best represents a 
typical prescribing encounter44.  
Intervention Development Phase
1.
The investigative team will review and analyze the data from the qualitative interviews and 
work-flow assessment.
2.
All of the data will be reviewed, summarized and shared with the advisory board to assist 
with the development of the pharmacy PrEP delivery model.
3.
The investigative team will develop 2-3 simulations of the potential pharmacy PrEP delivery 
model and present those step-by-step to the advisory board.
4.
The advisory board will provide feedback on the study protocol, pharmacy trainings, 
pharmacy recruitment brochure, survey instruments and other materials as needed.
5.
Using the adaptive protocol method, we will iteratively revise the protocol over the course of 
the study to ensure its feasibility, acceptability, and safety45,46.
6.
We will debrief about the study activities every month of the pilot study to refine the 
protocol for immediate implementation in the study activities.
7.
 Proposed changes will be assigned to subject matter experts from the co-I’s on the grant.
8.
Subject matter expert and other co-Investigators will vote on whether the change will be 
made immediately, revoked or followed through the next monthly meeting.
9.
Agreed upon changes will be submitted to the IRB for approval.
10. Meticulous records of the development and revision process of the pharmacy PrEP delivery 
model will be kept throughout the study.
Transitional Pilot Phase
Pharmacy eligibility, enrollment and data collection
1.
Two pharmacies that are located in high poverty, racial minority neighborhoods will be chosen 
to evaluate eligibility and willingness of BMSM to receive PrEP in pharmacies.
2.
We will obtain consent from at least 1 pharmacist and 2-3 technicians at each pharmacy to 
participate in the study.
3.
Pharmacy staff participants will earn 2 CE credit at an online Pharmacy Training Seminar to 
teach them how to mobilize community pharmacies to improve PrEP access.
4.
Pharmacy staff participants will also participate in a short orientation to learn the study 
activities. The study activities are as follows: place study flyers in pharmacy client participants’ 
medication delivery packages; hang posters in their pharmacies about the study; and answer 
any questions that client participants may have about the study.
5.
Research staff will provide each pharmacy with flyers, posters, and information in case client 
participants need to be referred to third-party organizations for health services.
6.
One-hour in-depth interviews will be administered to pharmacy staff participants at baseline 
and 3-month of the transitional pilot study.
7.
Pharmacy client participants will receive information about the study from flyers or pharmacy 
posters.
a.
Pharmacy client participants will use the QR code on the flyers or posters to access the 
eligibility screener.
b.
After taking the screener, eligible pharmacy client participants will be prompted to 
take the social and behavioral survey.
c.
Pharmacy client participants will receive electronic compensation at the end of the 
eligibility screener and/or social and behavioral screener.

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Pilot Phase
Pharmacy eligibility, enrollment and data collection
8.
Two pharmacies that are located in high poverty, racial minority neighborhood will be chosen to 
pilot test the pharmacy PrEP delivery model.
a.
All pharmacies will have a large, private space where pharmacy clients who agree to 
be screened and linked to PrEP can have privacy. If necessary, we will provide 
additional wall partitions/ screens, noise machines and noise-cancelling curtains to 
enhance privacy.
9.
We will obtain informed consent from at least 1 pharmacist and 2-3 technicians at each 
pharmacy to participate in the study.
10. Pharmacy staff participants will participate in a virtual Pharmacy Training Seminar that will 
take approximately 1.5 hours to complete. The training will follow the guidelines of the 
Pharmacy Staff Training Manual for all participating pharmacies.
11. During the virtual Pharmacy Training Course, pharmacy staff participants will participate in a 
HIV Prevention and Counseling module to learn post-test HIV counseling.
12. One-hour in-depth interviews will be administered to pharmacy staff participants at baseline, 3-
month and 6-month of the pilot study.
Pharmacy training seminars
1.
The objective of the pharmacy training seminar is to equip participating pharmacy staff with 
the tools needed for optimal PrEP delivery. While pharmacy staff participants will not be 
required to provide care to pharmacy client participants, our goal is to assess pharmacy staff 
participants increase in HIV knowledge over time. 
2.
The investigators will provide pharmacy staff participants with a training manual to help 
pharmacy staff participants understand the specific challenges of the BMSM population with 
respect to HIV prevention and PrEP. The sections of the training manual will be as follows: 
pharmacy staff as public health providers, the scope of the problem with HIV in the community, 
understanding cultural challenges and barriers of BMSM, research ethics, patient eligibility for 
PrEP, PrEP payment options, training services that will be offered in the pharmacy (i.e. PrEP 
delivery, HIV testing), the importance of PrEP in HIV prevention, PrEP safety, the availability of 
PrEP locally in the community and relevant contact information, and other PrEP and HIV services 
available in the community that may be important to know about (e.g., medical/healthcare 
services, prevention, mental health services, support groups for HIV positives, etc.).
3.
Research assistants will undergo extensive training to ensure standardization of the pharmacy 
training protocol in both pharmacies.
a.
Research staff will practice role-playing strategies to suggest various techniques for 
engaging client participants.
4.
Pharmacy staff participants will receive virtual training via Canvas and walk-through the 
intervention activities including engaging client participants, providing the social and 
behavioral survey, offering the biological screening kit, interpreting the results and linking to 
PrEP.
5.
Pharmacy staff participants will be required to complete a HIV Prevention and Counseling 
module through the virtual Canvas training course to equip them with HIV counseling 
concepts, basic counseling skills, HIV prevention counseling and how to conduct the six-step 
HIV prevention counseling protocol.
Pharmacy-based PrEP delivery
1.
Pharmacist participants will be asked to stock generic PrEP medication to ensure that eligible 

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participants are provided with 30-days of PrEP medication. Pharmacies will be compensated 
by the research team for the cost of the medication and receive a $50 dispensing fee for each 
prescription dispensed. 
2.
Pharmacy staff participants will provide a pharmacy brochure highlighting that they offer 
pharmacy PrEP delivery tailored to the Atlanta area and for those who patronize the pharmacy. 
Pharmacy posters normalizing PrEP and HIV will be carefully tailored to the community of the 
pharmacy. These posters will be designed to appeal to the general customer base and be 
placed inside and outside of the pharmacy. These posters will be placed with other health 
literature to avoid singling out HIV-related services that may inadvertently add stigma.
3.
Pharmacy staff participants will discreetly inform pharmacy clients (n=60) about the study. 
Pharmacy clients who are interest and willing will complete an electronic eligibility screener. 
a.
In cases of long lines in the pharmacy and privacy is not possible, we will discourage 
pharmacy staff from delivering detailed information (at this particular visit) to protect 
anonymity of their customer; this will be done consistently across each pharmacy. 
4.
Pharmacy client participants who agree to participate will be directed to an area where they 
can privately provide electronic informed consent and complete the eligibility screener. They 
will be informed at the end of the survey if they are eligible for the 20-minute social and 
behavioral survey via an electronic prompt. Eligible pharmacy client participants can 
immediately complete the social and behavioral survey or return to the pharmacy at a later 
time to do so. and their customer visit will be logged.
5.
The consent form and survey will be self-administered via an electronic tablet so it will NOT 
require the presence of the pharmacy staff participants outside of them directing them to the 
private room where the tablet is set up. To circumvent potential literacy issues, the participant 
will listen to questions via headphones and mark their answers using the touch screen 
computer. If the participant has a physical or mental condition that renders them unable to 
use the tablet, the survey will be administered orally by a study team member. Audio 
recordings of the questions will be utilized throughout Alchamer wherever possible in case of 
literacy barriers.
a.
The electronic survey platform, Alchemer, will allow us to automatically identify 
individuals who are behaviorally appropriate for PrEP.  A password-protected 
document will be automatically generated to inform the pharmacy staff participants 
if the individual is eligible for the clinical PrEP screening. The pharmacy staff 
participants will not know what behaviors were reported by the pharmacy client 
participant to deem eligibility. They will just have an affirmative or non-affirmative 
response that indicates the pharmacy client participants eligibility.
b.
Pharmacy client participants who complete the eligibility screener will receive $1 and 
$25 for the social and behavioral survey regardless of their eligibility or interest in 
being clinically screened for PrEP.
6.
The pharmacy client participants will inform the pharmacy client participant if they are eligible 
to participate in the clinical screener. 
7.
Pharmacy client participants who are eligible and agree to the HIV test will be provided with a 
pre-packaged kit of a self-administered test for HIV and directed back to the private area of 
the pharmacy to perform their screenings. A recent “PrEP-at-home” pilot study conducted by 
co-I Siegler showed high levels of comfort and efficacy of MSM self-administering HIV tests at 
home without supervision47. 

Version: January 18, 2023
a.
Video and visual instructions will be provided on the tablet and paper to guide 
pharmacy client participants through the process of each test. Pharmacy client 
participants will also be able to reach an Emory staff member via phone or 
videoconference for questions about specimen collection.
b.
We expect that 90% of pharmacy client participants will be able to complete these 
tests in a private area47. Our community partners at NAESM also conduct self-testing 
at their community center and have high levels of participation. 
4.
We will ask pharmacy client participants who decline to be screened for PrEP to complete a 1-
2-minute survey to explain their reasoning for declining the HIV test. 
8.
Pharmacy client participants will be asked to return the screening tests to the pharmacy staff 
participants. While their tests are being processed, we will ask them to complete an electronic 
post clinical screener survey that collects their follow-up information (phone number, email, 
address and contact for someone who can reach them) and ascertains their experience 
performing the self-screening tests in the private area.
a.
They will be assured that we will only use this information to follow-up with them 
about the study and their information nor personal data will be shared with anyone 
other than themselves.
9.
The pharmacy staff participants will process/ interpret the results of the rapid HIV test first in 
case a treatment referral needs to be set up.  
10. Pharmacy client participants who test HIV negative will be provided with their results and be 
given a 30-day prescription for PrEP, culturally appropriate PrEP counseling and a follow-up 
appointment with co-I Holland or another PrEP prescribing physician identified through 
PrEPlocator.org, whichever is closest.
a.
A PrEP prescribing physician will be available via phone during the testing process to 
provide participants with a prescription of 30-day PrEP. 
b.
We will inform the individual that a 30-day PrEP prescription will be required to 
achieve protection from HIV but in order to sustain protection, they need to continue 
PrEP beyond the 30-day period.
11. Pharmacy client participants may refuse to participate at any time or if they have time 
constraints, they can schedule the clinical screening at a later date. If they are 
uncomfortable completing the screening in the pharmacy, we will also provide them with a 
referral for a PrEP prescribing physician.
12. Pharmacy client participants who test HIV positive will receive post-test counseling from the 
pharmacy staff, who underwent intensive post-test counseling. Pharmacy client participants 
will be immediately sent for confirmatory testing and linkage to treatment at our community 
partner (NAESM) or co-I Holland.
a.
If needed, we will provide transportation for those who test positive to the clinic (if 
physically open pending COVID-19) and a research assistant from Emory or NAESM will 
be available to accompany the participant. 
13. Pharmacy client participants who have an inconclusive HIV test will be told that their test is 
inconclusive and will be referred to our community partner, NAESM, for a confirmatory HIV 
test. 
14. Once the pharmacy client participant completes the study activities they will be thanked for 
their time. In case of inclement weather, a research team member will offer to order an Uber 
or Lyft for the participants.

Version: January 18, 2023
15. We will complete a 3-month follow-up phone call with pharmacy client participants who have 
test for HIV to assess linkages to PrEP/HIV care.
2.5 Quality Assurance
Due to COVID-19, research assistants will work remotely with pharmacies to complete the 
transitional pilot phase. Research staff will conduct a short online orientation with pharmacy staff 
participants to review the study activities. There are only two study activities for the transitional 
pilot phase: 1) place flyers in client participants’ medication delivery packages about the study; 2) 
place posters about the study in their pharmacies and be willing to refer client participants with 
questions about the study to our research staff.  
Research staff will proceed with the pilot phase of this study when in-person human interaction is 
favorable. Prior to the pilot phase, research assistants will undergo extensive training to ensure 
standardization of the pharmacy training protocol. Research staff will practice role-playing 
strategies to suggest various techniques for engaging client participants, which will be used during 
the pharmacy staff trainings. 
To check the consistency of pharmacy PrEP delivery by pharmacy staff participants, the research 
staff will conduct at least one “test-buy” without knowledge to the pharmacy staff at each 
pharmacy. At enrollment and during informed consent, pharmacy staff participants will be made 
aware that we will be evaluating their services at various times throughout the data collection 
period and that our staff will not identify themselves as Emory research staff. If inconsistencies 
are observed, additional one-on-one trainings will be performed. Pharmacy activities will also be 
assessed through bi-weekly check-in visits/phone calls and through semi-structured interviews. 
This will help inform potential changes and/or booster trainings that may need to take place. 
While pharmacy staff participants will have gone through extensive training on how to engage 
their client participants, our research staff will closely monitor the first couple of months to 
encourage the highest quality of service delivery.

PrEP Up Pharmacies IRB Protocol
2.6 Risks to participation
In terms of the key stakeholder surveys and workflow assessments completed for Aim 1, there are no 
psychological, social or biological risks involved.  
In the transitional pilot phase, research assistants will engage with pharmacy staff participants online 
through Zoom. Pharmacy staff participants will complete a short orientation of the study activities. 
Pharmacy staff participants will also earn 2 CE credit through an online training seminar to learn how to 
mobilize pharmacies to improve PrEP access. There are only two study activities for this phase. Firstly, 
pharmacy staff participants will place flyers within their client participants’ medication delivery 
packages. Secondly, pharmacy staff participants will hang posters about the study and the assessments 
in their pharmacies. 
With COVID-19 unabated, pharmacies primarily deliver medication to their client participants, which 
provide the opportunity to place study flyers in client participants’ medication delivery packages. 
Additionally, few pharmacy client participants still visit pharmacies. Pharmacy staff participants will 
place posters in their pharmacies to increase costumer engagements with the study information. The 
aforementioned study activities do not require pharmacy staff participants to perform duties outside of 
their current scope of practices.  Therefore, there are no additional psychological, social or biological 
risks involved.  However, there are minimal risks for pharmacy client participants who complete the 
eligibility and social and behavioral screeners to determine behavioral eligibility for PrEP. Pharmacy 
client participants may feel mild discomfort in answering personal and lifestyles questions.
In the pilot study phase, pharmacy staff participants will inform pharmacy clients about the study and 
will be trained on the importance of confidentiality and discretion with respect to the pharmacy client 
participants. Pharmacists have extensive experience working with patients for a host of health outcomes 
and are bounded by the Code of Ethics that are adopted by the American Pharmacists Association. The 
Code of Ethics promote covenantal relationship, respect, and confidentiality for every patient. 
Therefore, we do not foresee any problems with pharmacists’ ability to uphold fundamental principles 
of ethics when interacting with study participants48. 
We will, however, provide additional training to pharmacy staff participants on research ethics during 
the pharmacy training. There is a small possibility of other patrons in the pharmacy over-hearing 
pharmacy staff discuss the study with potentially eligible pharmacy client participants. To circumvent 
this, we will train pharmacy staff participants to engage pharmacy client participants during a discreet 
time when customer flow is low. Discussions of sensitive topics (i.e., drug and sex behaviors, PrEP, HIV, 
etc…) will be conducted in a private room or an area that we have created with partitions, noise 
cancelling curtains and a sound machine to muffle noise.  
There are minimal risks for pharmacy client participants who complete the social and behavioral 
screener to determine behavioral eligibility for PrEP. For those who are behaviorally appropriate for 
PrEP and agree to be clinically screened for PrEP (HIV testing), they may learn that they have a positive 
HIV diagnosis, which may result in emotional or psychological distress. The pharmacy staff participant, 
who will undergo intensive post-test counseling training, will counsel the patient. The pharmacy staff 
participant will immediately link the patient to confirmatory testing and HIV care through our 
community partners at NAESM (who have significant experience counseling and treating newly 
diagnosed patients) or co-I Holland who directs Atlanta’s Fulton County HIV clinic. We will provide 
transportation for those who test HIV positive to the clinic and research assistants from Emory and 

PrEP Up Pharmacies IRB Protocol
NAESM will be available to accompany the patient if needed. NAESM and Dr. Holland have extensive 
experience working directly with patients who have HIV. They will be available to study participants who 
need referrals, are not linked to a regular health care provider and need health care treatment. We will 
also provide mental health referrals tailored to their needs and community.
2.7 Adequacy of Protection Against Risks
Recruitment and Informed Consent  
For the key stakeholder interviews and workflow assessments (Aim 1), written informed consent will be 
obtained at recruitment into the study. The data will be summarized within each key stakeholder 
subgroup without the inclusion of personal identifying information. 
For the transitional pilot phase, pharmacy staff participants will provide written informed consent once 
the pharmacy is recruited into the study. We will complete pre/post pharmacy training surveys as well 
as baseline and 3-month surveys throughout the period of the transitional study. These data will include 
personal identifying information as this will be used for tracking quality control and identifying areas 
where the pharmacy PrEP delivery model needs adjustment for the pilot phase.
Also, in the transitional pilot study, pharmacy client participants will provide electronic informed 
consent before initiating the eligibility screener and social and behavioral survey. Participants will 
receive links and given instructions to take surveys. The screener and survey will provide a brief 
statement regarding the purpose of the study.  Pharmacy client participants who take the eligibility 
screener will be compensated a $1 pharmacy coupon. Pharmacy client participants who are eligible and 
take the social and behavioral survey will be compensated $25 for their time. Before survey questions 
appear, pharmacy client participants will provide electronic consent, similar to online surveys. On the 
consent, pharmacy client participants are told that they may refuse to answer any question or to drop 
out of the study at any time they feel uncomfortable with the process. This wording will be bolded. 
Surveys will be administered privately through the use of Alchemer; we will have the participant select 
their answers using their mobile or other electronic devices.  Alchemer can be used on mini-computers, 
tablets, and phones (which increases privacy). They will be told that the information obtained will be 
summarized with information from others and only aggregate data will be reported; that in no case will 
individual information be released (except to the pharmacy who is liable under Health Insurance 
Portability and Accountability Act of 1996) without their written consent. Records of the consent, which 
include personal identifying information will be stored in locked files separate from data collection 
forms that have no personal identifying information but are noted with a unique study number.
For the pilot study, pharmacy staff participants will provide written informed consent once the 
pharmacy is recruited into the study. We will complete pre/post pharmacy training surveys as well as 
baseline, 3-month and 6-month surveys throughout the period of the pilot study. Pharmacy staff 
participants will also complete electronic logs of their recruitment efforts of the study population. These 
data will include personal identifying information as this will be used for tracking quality control and 
identifying areas where the pharmacy PrEP delivery model needs adjustment.
Also, in the pilot study, pharmacy client participants will provide electronic informed consent before 
initiating the social and behavioral screening survey. For pharmacy client participants who are interested 
in being in the study, pharmacy staff participants will escort the pharmacy client participant to a private 

PrEP Up Pharmacies IRB Protocol
area where they can begin the electronic informed consent process. On the consent, pharmacy client 
participants are told that they may refuse to answer any question or to drop out of the study at any time 
they feel uncomfortable with the process. This wording will be bolded. Surveys will be administered 
privately through the use of Alchemer we will have the participant listen to questions via headphones 
and mark their answers using the touch screen tablet computer. Alchemer can be used on mini-
computers and tablets (which increases privacy). They will be told that the information obtained will be 
summarized with information from others and only aggregate data will be reported; that in no case will 
individual information be released (except to the pharmacy who is liable under Health Insurance 
Portability and Accountability Act of 1996) without their written consent. Under Georgia State law, the 
researcher(s) will not maintain as confidential, information about known or reasonably suspected 
incidents of abuse or neglect of a child, elder, or vulnerable adult, including but not limited to physical, 
sexual, emotional, and financial abuse or neglect. If any researcher has or is given such information, he 
or she may be required to report it to the authorities. Records of the consent, which include personal 
identifying information will be stored in locked files separate from data collection forms that have no 
personal identifying information but are noted with a unique study number. Those records will be 
stored in a physically secure environment. All data files will have encryption and strong password 
protection. Any identifiable data will be stored on Emory University's secure servers. 
Protections Against Risk 
In terms of the key stakeholder surveys and the pharmacist/ technician surveys during the transitional 
pilot phase and pilot phase of the study, there are no psychological, social or biological risks involved.
Since in this proposed research plan, pharmacy client participants will be informed about the study by 
the pharmacy staff participants, the importance of confidentiality will be conveyed to all study 
pharmacy staff participants. To minimize the risk of pharmacy client participants feeling uncomfortable 
about answering personal questions, we will use an electronic survey platform, Alchemer, for the study's 
surveys. In Alchemer, participants will select answers to the survey questions. In the Alchemer survey, 
participants listen to questions via headphones and mark their answers using the touch screen tablet 
computer. During the transitional pilot phase, pharmacy client participants will self-interview using 
Alchemer. However, for the pilot phase, pharmacy staff will be available to assist participants with 
questions regarding technical difficulties on Alchemer. But, for questions specific to the pharmacy client 
participants data or survey instrument, the participant will be told that they can call or videoconference 
an Emory research assistant. Pharmacy client participants may refuse to answer any question that 
makes them uncomfortable. 
To minimize risks to confidentiality, we will secure study data with all appropriate physical, electronic 
and operational protections. Data will be stored in a physically secure environment. All data files will 
have encryption and strong password protection. Any identifiable data will either be stored on Emory 
University's secure servers or will be on fully encrypted laptops. Alchemer surveys will take place on an 
encrypted commercial survey website, SurveyGizmo (http://www.surveygizmo.com/survey-software- 
features/secure-link/). This site has been used by one of our Co-I for thousands of online surveys with 
MSM with no data security breaches. Access to data will be on a role-based standard; only those study 
staff who require access to each type of data to complete their study- related roles will be allowed 
access. All study staff will be trained in security and confidentiality procedures and will sign a 
confidentiality agreement before receiving access to any participant data. While we do not expect any 
problems, all adverse events and unanticipated problems will be promptly reported to the Emory IRB.

PrEP Up Pharmacies IRB Protocol
The investigators will provide a Certificate of Confidentiality for this study to further protect the 
individually identifiable protected health information from compelled disclosure during legal 
proceedings. Though we will not be collecting information on the identities of sexual partners, our study 
will be collecting detailed sexual behavior information from participants who may be HIV-positive. This 
protection will be important in Georgia because of past prosecutions of HIV- positive persons for lack of 
zero-status disclosure or hypothetical transmission of HIV to sex partners. 
Additional protections for children (aged 18-21): 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.” In Georgia, persons aged 18-21 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 positive HIV status or of having male sex partners may be particularly difficult for men in 
this age group. 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. 
2.8 Reportable events
All adverse events and unanticipated problems will be promptly reported to the Emory IRB and/or NIH 
program official in accordance with the NIMH reportable events policy for definitions and timeframes.
2.9 Benefits to subject or future benefits 
Although there are no direct personal benefits to the participants included in the study, the results of 
the study will lay the critical groundwork for understanding whether pharmacy PrEP delivery can be 
achieved for BMSM in high poverty, racial minority neighborhoods. This study will inform a future 
efficacy trial that is implemented to test the uptake of PrEP through pharmacies for BMSM. In addition, 
this model could be adopted for pharmacies across the country, in communities at high risk for HIV, and 
other underserved populations in the US without another point of access to PrEP in their communities.  
2.10 Compensation
Formative Phase
Pharmacists, technicians, PrEP-prescribing physicians, and BMSM will be compensated $50 for 1.5 hours 
for their time completing the interview. Pharmacists and/or PrEP-prescribing physicians will receive an 
additional $50 for their time if we perform a guided walk around of their office to assess their workflow. 
Transitional Pilot Phase
During the transitional pilot phase, each pharmacist participant will receive $250 for 3 months of 
participation in study activities as outlined in the pharmacist participant consent forms. Each 
pharmacy staff participant (we estimate 1 pharmacist and 3 technicians per pharmacy) will receive $25 
for the orientation session plus $25 for each semi- structured interview. We have noted that this 
amount of compensation for pharmacy staff has been sufficient in earlier work with pharmacies. 
Pharmacy client participants who agree to complete the eligibility screener and social and behavioral 
survey will be compensated $1 and $25, respectively, for their time regardless of their eligibility or 

PrEP Up Pharmacies IRB Protocol
interest in being clinically screened for PrEP.
Pilot Phase
In this proposed study, each pharmacist participant will receive $2,500 ($1,250 for each pharmacist 
participant in the pharmacy) for 6-months of participation in study activities as outlined in the 
pharmacist participant consent forms. Each pharmacy technician participant (we estimate 3 
technicians per pharmacy) will receive $50 for the training session plus $25 for each semi- structured 
interview. We have noted that this amount of compensation for pharmacy technician participants has 
been sufficient in earlier work with pharmacies. Additionally, pharmacies will be compensated for the 
price of PrEP medication and be provided with a dispensing fee of $50 per bottle. 
Pharmacy client participants who agree to complete the social and behavioral screener will be 
compensated $25 for their time regardless of their eligibility or interest in taking an HIV test.
2.11 Data analysis
Formative Phase
Qualitative interviews will be taped and transcribed. Field notes from the workflow assessment will be 
transferred to electronic files. Two separate interviewers will double code the transcripts and workflow 
assessments for content and themes in order to identify emergent patterns49. As the domains are 
defined, we will construct a preliminary codebook, and coding scheme. Transcripts will be coded into 
Atlas.ti with open codes first in order to identify broad themes or patterns. Following open coding and 
broad thematic analysis, transcripts will be coded with axial codes, or more interpretive codes that will 
be used in order to identify core concepts. With coherent axial coding we will construct detailed 
narratives of the interviewees understanding of the pharmacy PrEP delivery model and how it can be 
implemented in the context of their current day-to-day activities. 
Intervention Development Phase
The advisory board will provide feedback on the study protocol, pharmacy trainings, pharmacy 
recruitment brochure, survey instruments and other materials as needed. We will also iteratively 
revise the protocol over the course of the study to ensure its feasibility, acceptability, and safety. 
Adaptive protocol development is recommended in early phase clinical trials since it allows for 
continued process improvement and time-savings from data as it is being collected45,46. We will 
debrief about the study activities every month of the pilot study to refine the protocol for immediate 
implementation in the study activities. Each proposed change will be assigned a subject matter 
expert from the co-I’s on the grant.  The subject matter expert and at least two other co-I’s will be 
asked to vote on whether the change will be made immediately, revoked or followed through the 
next monthly meeting. Meticulous records of the development and revision process of the pharmacy 
PrEP delivery model will be kept throughout the study.
Transitional Pilot Phase
Quantitative data will be transferred to analyses using analysis software (i.e., SAS) to derive descriptive 
statistics and quantitative profiles of customer data. Exploratory data analysis (EDA) will be conducted 
through data editing using SAS. EDA will include calculation of means, medians, percentages, 

PrEP Up Pharmacies IRB Protocol
proportions, standard deviations, and skewness/kurtosis as appropriate. If outliers or nonstandard 
distributions exist, variable transformations or standardized cut-points in the data will guide recoding of 
continuous variables. Externally validated standards will be used to recode the data if possible. The 
influence of outliers will be assessed and medians (or rank tests) used if required. Differences between 
two means (or medians) will be tested using t- tests or rank tests and categorical variables will be 
compared between groups using Chi-square tests, exact tests and/or with 95% confidence intervals to 
guide interpretation. Correlates of interest include health insurance, sexual behavior, substance use and 
HIV testing behavior. Other relevant mediators and/ or confounders will include variables such as 
previous and/ or consistent access to health care. We plan to separately examine the relationship 
between each confounder and outcome of interest using t-tests or rank tests on continuous measures 
and exact tests on categorized values if categorizations are used. Initial unadjusted comparisons will be 
made using exact tests. If significant bivariate associations are found, we will incorporate these 
exposures as covariates using linear regression for continuous variables and logistic regression for binary 
variables where sample size allows.
Pilot Phase
Pharmacist and technician participant data
Transcripts from the audio-recorded pharmacists and technician interviews will be loaded into 
Atlas.ti, a qualitative data analysis software package. Research assistants will enter the data 
immediately so that intervention activities and protocols can be altered during the study, if needed. 
Patterns of knowledge, beliefs, behaviors, and practices that point to practical barriers or facilitators 
of effective training of pharmacists, feasibility of intervention delivery and effective risk reduction 
will be identified. These data will include pharmacy-identifying information so that each pharmacy 
can be monitored for consistency of study activities. In terms of quality control, these data will also 
be used to inform the necessity of additional training for pharmacy staff.
For the data analysis, all interviews will be double coded by two different research assistants. Topic 
guides for the interviews will be used to establish preliminary codes for interpretation. Coding will 
begin with the first interview by creating open codes of broad themes found in the four SEIPS 
components of inquiry: person, organization, environment and tasks. More interpretive codes within 
those open codes will then be used to identify patterns of knowledge, beliefs, behaviors, and 
practices that point to practical barriers or facilitators of effective training of pharmacists, feasibility 
of intervention delivery and effective pharmacy PrEP delivery.
Pharmacy client participant data
Formation of new variables and collapsing variables will be done when exploring the proportion and 
correlates of feasibility, acceptance, safety and PrEP use at baseline and at 3-months among BMSM. 
Exploratory data analysis (EDA) will be conducted through data editing using SAS. EDA will include 
calculation of means, medians, percentages, proportions, standard deviations, and skewness/kurtosis 
as appropriate. If outliers or nonstandard distributions exist, variable transformations or 
standardized cut-points in the data will guide recoding of continuous variables. Externally validated 
standards will be used to recode the data if possible. The influence of outliers will be assessed, and 
medians (or rank tests) used if required. Differences between two means (or medians) will be tested 
using t- tests or rank tests and categorical variables will be compared between groups using Chi-

PrEP Up Pharmacies IRB Protocol
square tests, exact tests and/or with 95% confidence intervals to guide interpretation. Correlates of 
interest include health insurance, sexual behavior, substance use and HIV testing behavior. Other 
relevant mediators and/ or confounders will include variables such as previous and/ or consistent 
access to health care. We plan to separately examine the relationship between each confounder and 
outcome of interest using t-tests or rank tests on continuous measures and exact tests on 
categorized values if categorizations are used. Initial unadjusted comparisons will be made using 
exact tests. If significant bivariate associations are found, we will incorporate these exposures as 
covariates using linear regression for continuous variables and logistic regression for binary variables 
where sample size allows.

PrEP Up Pharmacies IRB Protocol
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PrEP Up Pharmacies IRB Protocol
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