Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study
Phase: NA
Conditions: HIV Prevention
Sponsor: University of Washington

PROTOCOL: Pharmacy PrEP Pilot – Kisumu 
 
                          January 19, 2022 
 
 
 
 
 
STUDY PROTOCOL: KISUMU 
 
 
 
Pharmacy delivery to expand the reach of PrEP in Kenya:  
 
Pilot study 
 
 
 
NCT04558554 
 
January 19, 2022 
 
 
 
 
Funding: 
 
United States National Institute of Mental Health (NIMH) and the Bill & Melinda Gates Foundation 
(BMGF) 

PROTOCOL: Pharmacy PrEP Pilot – Kisumu 
 
                          January 19, 2022 
 
 
PROTOCOL TEAM 
 
University of Washington, Seattle, USA 
 
Jared Baeten, MD, PhD (PI) 
 
Katrina Ortblad, ScD, MPH (Project Director) 
Renee Heffron, PhD, MPH (Co-investigator) 
Andy Stergachis, PhD, MS, BPharm (Co-investigator) 
Pamela Kohloer, PhD, MPH, BSN (Co-investigator) 
Stephanie Roche, MPH (Co-investigator) 
 
 
Jomo Kenyatta University of Agriculture and Technology Nairobi, Kenya 
 
Kenneth Ngure, PhD, MPH, MSc (Co-investigator)  
 
 
Kenya Medical Research Institute, Nairobi, Kenya 
 
Elizabeth Bukusi, MBChB, MMed, PhD (Site PI) 
Zachary Kwena, PhD, MSc (Co-investigator) 
Peter Mugo, PhD, MSc, BPharm (Consultant) 
Josephine Odoyo, MPH (Research coordinator) 
Kevin Oware, MA (Research coordinator) 
 
 
National AIDS & STI Control Programme, Nairobi, Kenya 
 
Mary Mugambi, BA (Consultant) 
 
 
University of Colorado School of Pharmacy 
 
Peter Anderson, PharmD (Co-investigator)  
 
 
 
 
Kelly-Ross Pharmacy 
 
Elyse Tung, PharmD (Consultant) 

PROTOCOL: Pharmacy PrEP Pilot – Kisumu 
 
                          January 19, 2022 
 
 
TABLE OF CONTENTS 
 
ABREVIATIONS ............................................................................................................................................................5 
PROTOCOL SUMMARY ................................................................................................................................................6 
LAY SUMMARY ................................................................................................................................ 8 
ABSTRACT ....................................................................................................................................... 8 
BACKGROUND ................................................................................................................................. 9 
METHODS ....................................................................................................................................... 22 
Study Objectives .............................................................................................................................................. 22 
Research Questions ......................................................................................................................................... 22 
Study Design .................................................................................................................................................... 22 
Setting .............................................................................................................................................................. 23 
Pilot pharmacies .............................................................................................................................................. 23 
Participant eligibility & recruitment - .............................................................................................................. 25 
Pilot procedures .............................................................................................................................................. 28 
Data Collection ................................................................................................................................................ 35 
Data Analysis & Outcomes .............................................................................................................................. 39 
Participant retention and withdrawal ............................................................................................................. 41 
Limitations ....................................................................................................................................................... 41 
SAFETY ........................................................................................................................................... 43 
PrEP .................................................................................................................................................................. 43 
Pregnancy ........................................................................................................................................................ 43 
Social harm considerations.............................................................................................................................. 43 
HUMAN SUBJECTS CONSIDERATIONS ....................................................................................... 45 
Study oversight ................................................................................................................................................ 45 
Risks ................................................................................................................................................................. 45 
Protection against risk ..................................................................................................................................... 45 
Benefits ............................................................................................................................................................ 46 
Care for persons identified as HIV infected ..................................................................................................... 46 
Benefits to the community .............................................................................................................................. 46 
Importance of the knowledge to be gained .................................................................................................... 47 
Treatment for injury ........................................................................................................................................ 47 
Study records ................................................................................................................................................... 47 
Confidentiality ................................................................................................................................................. 47 

PROTOCOL: Pharmacy PrEP Pilot – Kisumu 
 
                          January 19, 2022 
 
Dissemination Plan .......................................................................................................................................... 47 
TIMELINE ........................................................................................................................................ 48 
BUDGET ................................................................................................................................................................... 48 
BUDGET    JUSTIFICATION ........................................................................................................... 48 
REFERENCES ............................................................................................................................................................ 52 
 

PROTOCOL: Pharmacy PrEP Pilot – Kisumu 
 
                          January 19, 2022 
 
ABREVIATIONS 
 
3TC 
 
Lamivudine 
AIDS  
Acquired Immunodeficiency Virus 
AE 
 
Adverse Event 
ART 
 
Antiretroviral Therapy 
ARC 
 
AIDS Related Complex 
CCC 
 
Comprehensive Care Clinic 
CDC 
 
Centers for Disease Control and Prevention (US) 
CHCT  
Couples HIV testing and Counseling 
DAIDS  
Division of AIDS (NIH) 
DALY  
Disability-Adjusted Life Year  
DBS 
 
Dried Blood Spots 
EC 
 
Ethics Committee 
FDA 
 
Food and Drug Administration (US) 
FTC 
 
Emtricitabine 
FTC-TP 
Emtricitabine-triphosphate  
HIV 
 
Human Immunodeficiency Virus 
GEE 
 
Generalized Estimating Equations  
HTTP    
Hypertext Transfer Protocol (presentation of web data) 
ICER  
Incremental Cost-Effectiveness Ratios  
IRB 
 
Institutional Review Board 
KEMRI  
Kenya Medical Research Institute 
NACOSTI  
National Commission of Science, Technology and Innovation  
NIH 
 
National Institutes of Health (US) 
PEP                Post-exposure prophylaxis 
PrEP  
Pre-exposure prophylaxis 
SAS 
 
Statistical Analysis Software 
STI 
 
Sexually transmitted infection 
TDF 
 
Tenofovir 
TFV-DP 
Tenofovir diphosphate 
UNAIDS 
Joint United Nations Program on HIV/AIDS 
US 
 
United States 
UW 
 
University of Washington 
VCT 
 
Voluntary counseling and testing 
WHO  
World Health Organization 

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PROTOCOL SUMMARY 
Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for 
optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, 
PrEP is being added to an already-burdened public health infrastructure and the ability of the health 
systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility 
evaluations of PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, 
the costs of staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions. 
In Kenya, retail pharmacies fill an important gap in the health care system, providing access to 
treatment of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid 
prescription), monitoring of chronic conditions (e.g., blood pressure testing), and preventative care 
(e.g., contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV 
self-tests or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes 
that may be desirable for potential PrEP users, including convenience (as pharmacies outnumber 
clinics and have shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), 
and engagement (which may be greater for a preventative service at a pharmacy than at a clinic that 
prioritizes treating ill individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, 
and paying for a service could result in greater sustained consumer engagement. The core components 
of PrEP – including HIV testing, adherence and risk reduction counseling, assessment of side effects, 
and provision of refills – are within the scope of practice for pharmacists (including pharmaceutical 
technologists, common in sub-Saharan Africa), and one US model has demonstrated that PrEP can be 
provided by pharmacists, facilitated by oversight by a remote clinician.  
In the second half of 2019, we conducted formative work among pharmacy providers and clients in 
Kenya to assess the feasibility and acceptability of pharmacy-based initiation and continuation of PrEP. 
Overall, the pharmacy providers and clients in our formative study strongly supported the idea of 
pharmacy-based PrEP delivery and felt it would be feasible so long as client privacy could be ensured 
and providers received training on how to deliver PrEP. In January 2020, we conducted a day-long 
stakeholder meeting – including regulators, other government agencies, pharmacy professional 
associations, pharmacy provider representatives, community members, and others – to assess the 
potential for and general framework of a pharmacy-based PrEP delivery model. This protocol reflects 
learning from that formative work and stakeholder meeting. 
We hypothesize that pharmacies may offer a novel access point for PrEP delivery in Kenya, especially 
during the COVID-19 pandemic when individuals may fear visiting health facilities for fear of COVID-19 
infection. With a multidisciplinary team, we propose an evaluation of pharmacy-based PrEP care –a 
stand-alone model with the following aim:   
Aim 1a: We will conduct an initial pilot evaluation of pharmacy-based PrEP initiation and refills.   
Approach: At two pharmacies in Kisumu, we will implement the novel care pathway for PrEP 
initiation developed from formative research and stakeholder engagement and measure PrEP 
initiations, consumer characteristics, retention in care, and adherence (up to n=150 people starting 
PrEP, followed for six months). Hypothesis:  Individuals will successfully initiate PrEP at pharmacies 
and be retained in care.  
Aim 1b: Within the Aim1a pilot pharmacies, we will probe potential weak points for pharmacy-
based PrEP delivery, in domains relating to acceptability, fidelity, and costs.  
Approach: We will conduct in-depth interviews with clients initiating (n=10/pharmacy) and refilling 
(n=10/pharmacy) PrEP, pharmacy providers (n=2/pharmacy), and clinicians providing remote 
oversight (n=1/pharmacy) (n=46 in total) and collect transcripts from consultations between 
pharmacy providers and remote clinicians via WhatsApp to explore experiences accessing or 
delivering pharmacy PrEP. We will use quantitative surveys to measure costs and cost preferences 
(of clients and pharmacy providers) associated with pharmacy-based PrEP initiation and refills. 

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Hypothesis:  Understanding potential weak points for PrEP delivery in pharmacies will permit 
refinement of the delivery algorithm developed from the formative research and tested in Aim 1a. 
Aim 1c: We will modify the care pathway to address weak points identified in Aim 1b and 
conduct an extended pilot evaluation of the refined care pathway. 
Approach: We will implement the refined care pathway at a total of 6 pharmacies in Kisumu (2 from 
the initial pilot evaluation described in Aim 1a plus an additional 4 pharmacies). Clients who have 
been receiving PrEP services at the two Aim 1a pharmacies as part of Aim 1a will be allowed to 
continue their PrEP care under the refined model for the duration of this extended pilot evaluation. 
We will continue to measure the same client outcomes as in the initial pilot: PrEP initiations, 
consumer characteristics, retention in care, and adherence (up to 540 people starting PrEP under 
the refined care pathway, followed for six months). We will also assess the acceptability and 
feasibility of the refined care pathway through quantitative surveys with clients and pharmacy 
providers. Hypothesis: The refined care pathway will result in greater PrEP uptake and improve the 
acceptability and feasibility of the pharmacy PrEP model among clients and providers. 
 
 

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LAY SUMMARY 
Pre-exposure prophylaxis (PrEP) is a powerful HIV prevention tool; PrEP delivery in low resource 
settings will require approaches that are time- and cost-efficient, for patients, care providers, and the 
health care system. In this highly innovative study, we propose a new delivery model for PrEP delivery 
that has never been explored in an African setting: pharmacy-based PrEP delivery (with remote 
physician oversight). Through formative research, we have developed a care pathway for pharmacy-
based PrEP delivery that we plan on pilot testing, initially in two pharmacies in Kisumu (Aim 1a) and, 
later, six pharmacies in Kisumu. We hypothesize that pharmacy-based PrEP delivery will be acceptable 
and feasible in Kenya and that individuals who uptake PrEP in pharmacies will be retained in care.  
 
 
ABSTRACT 
Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as 
recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need 
to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is 
being added to a public health infrastructure which is sometimes burdened by overcrowding and drug 
stock out. The ability of health systems to maximize PrEP access necessitates finding novel delivery 
strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting 
times, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. 
In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important 
gap in the health care system providing first stop access to treatment, monitoring and preventive care 
of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over 
facility-delivered PrEP for reasons including increased convenience, increased privacy and greater 
engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer 
free, subsidized or affordable healthcare services. The core components of PrEP – including HIV 
testing, adherence and risk reduction counselling, assessment of side effects and provision of refills – 
are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. From prior 
formative qualitative research and a stakeholder meeting, we have developed a care pathway for 
pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation 
meeting that included a wide spectrum of regulatory, professional, government, and community 
stakeholders in Kenya. We plan to pilot this care pathway in two retail pharmacies in Kisumu. 
Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in domains 
relating to acceptability, fidelity, and costs. Thereafter, we will refine the care pathway tested in Aim 1a 
to address client- and provider-facing barriers identified in Aim 1b and implement it at 6 pharmacies in 
Kisumu.      

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BACKGROUND 
Importance of the problem   
More than two million persons become newly infected with HIV each year, the majority in Africa.1 In 
Kenya, more than 1.5 million people are living with HIV,2, making it the country with the fourth largest 
epidemic. The past five years have witnessed major strides in the development of highly-effective HIV 
prevention interventions, particularly using antiretroviral medications: antiretroviral therapy (ART) to 
decrease infectiousness and pre-exposure prophylaxis (PrEP) to prevent acquisition. Novel strategies 
to successfully and efficiently deliver these strategies, at scale, are needed to achieve maximum HIV 
prevention impact.  
PrEP is an effective, recommended, and impactful strategy for HIV prevention.  
PrEP has been demonstrated to be efficacious and safe for reducing HIV risk among men who have 
sex with men (MSM)3, heterosexual men and women,4,5 and injection drug users6 in diverse geographic 
settings. In 2012, the US Food and Drug Administration approved combination tenofovir disoproxil 
fumarate/emtricitabine (TDF/FTC) as the first medication with a label indication for HIV prevention in 
adults7 – an action followed by drug regulatory authorities in a number of other countries including 
Kenya (in December 2015). In 2015, the World Health Organization issued guidance recommending 
TDF-containing PrEP as an additional prevention option for all persons at high risk for acquiring HIV.8  
Adherence is essential for PrEP efficacy. PrEP clinical trials had a wide range of results for estimates of 
PrEP’s efficacy for HIV protection – explained by the degree to which the trial populations were 
adherent to PrEP.9 Secondary analyses from clinical trials and demonstration studies have shown that 
PrEP is highly efficacious and safe when taken as prescribed: at the individual level, HIV protection is 
on the order of 90-100% in both MSM and heterosexual populations when PrEP adherence was high, 
as measured by the presence and quantity of PrEP in blood samples.4,10,11 PrEP adherence and HIV 
prevention effectiveness have been higher than in prior clinical trials, in many cases very high, in open-
label demonstration projects among HIV serodiscordant couples, MSM, and young women at risk for 
HIV,12–14 which has been hypothesized to be a result of offering a strategy with demonstrated safety 
and effectiveness and without a placebo. In those PrEP demonstration studies, HIV incidence has been 
very low and visits were generally quarterly and brief, suggesting that many who initiate PrEP in the 
context of known safety and efficacy may not need intensive follow-up to achieve high adherence. In 
some high income settings (e.g., Sydney, San Francisco), delivery of PrEP at scale, layered onto high 
coverage of HIV testing and ART delivery, has resulted in substantial reductions in new HIV infections 
in the past five years.15–17  
Strategies to effectively and efficiently deliver PrEP are needed, for all settings but particularly 
for settings with limited resources. 
PrEP delivery can be expensive, in terms of costs for health systems and opportunity costs for PrEP 
users. For health systems, costs associated with PrEP include medication, staffing time, and laboratory 
testing. In addition, user opportunity costs – e.g., time away from work or childcare to wait, usually for 
many hours, at a public clinic for a PrEP visit – can be substantial. Mathematical modeling analyses 
from high-income settings have argued that, while PrEP is cost-effective when delivered to high-risk 
persons, it is still costly.18–20 For developing country settings, PrEP costs are mitigated by the lower cost 
inputs from generic/non-branded or discounted medication pricing, lower staff salary costs, and more 
limited laboratory testing as recommended by WHO.19,21 Nevertheless, reducing the costs of PrEP 
delivery are necessary to maximize its impact. In costing analyses we have conducted in East Africa, 

PROTOCOL: Pharmacy PrEP Pilot                                                                               January 19, 2022 
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we estimated the cost of adding PrEP to routine public health services using Ministry of Health (MOH) 
personnel, drug, and laboratory costs; the greatest proportion of the total costs was not medication but 
instead personnel (39%).22 That finding emphasizes the need for efficiency in PrEP delivery, particularly 
given that public clinic medical staff in Kenya and similar settings are often highly over-stretched, 
because of competing priorities in overburdened health systems. Our modeling did not take into 
account client costs related to PrEP; however, we have learned through providing PrEP in studies to 
over 5000 individuals over the past 10 years that travel and time away from work and costs for getting 
to PrEP clinic visits can be a substantial challenge.23,24 Efficient strategies to deliver PrEP could reduce 
costs, potentially improving client engagement and allow services to be available to a larger number of 
people as a result – and this kind of approach would be applicable in a variety of settings, in Africa and 
worldwide.  
Diverse models for PrEP delivery are needed  
Barriers to facility-based PrEP delivery include long travel distances, lack of privacy, and lengthy wait 
times 23,24. In low-income countries, long travel distances to dispersed healthcare facilities can result in 
significant costs associated with transportation. Facilities are often overcrowded, which result in long 
wait times, rushed medical care, and a lack of anonymity that may deter individuals from returning to 
the healthcare facility for follow-up care. Time traveling and waiting is time away from work and children 
– resulting in substantial opportunity costs. Importantly, PrEP is an intervention for HIV uninfected 
individuals – in our experience and that of others, healthy persons report that they do not like 
frequenting healthcare facilities for HIV preventive care.24 Recent PrEP demonstration projects from 
Africa have found poor retention in care, for reasons including challenges accessing PrEP at facilities 
for continuation.25–28  
Diverse models have been developed for ART delivery to overcome similar barriers related to facility-
based care.29,30 Models of ART delivery that are not facility-based include home delivery of ART 
medication31 and community-based care, ART adherence groups,32 peer care coordinators,33 and even 
drug-dispensing ATMs.34 One previous study that explored the use of pharmacies to deliver ART 
medications in Nigeria found that this approach was feasible and that retention in care was high.35 PrEP 
delivery is simpler than ART – with less testing, fewer complications, and without comorbidities – and 
thus is primed for simple delivery models.   
Pharmacy-based PrEP delivery is a novel approach that could expand the reach of PrEP, 
respond to the needs of PrEP consumers, and improve PrEP continuation  
Nearly half of all individuals in low-income countries seek healthcare at retail pharmacies.36–38 In 
sub-Saharan Africa, pharmacies and licensed drug shops fill an important gap in the medical system 
and individuals often rely on and prefer the use of pharmacies over healthcare facilities to address their 
medical needs.39 Pharmacies can address both urgent needs (e.g., evaluation and medication for 
sexually transmitted infections) and preventive care (e.g., contraception)40 and have advantages over 
healthcare facilities, including increased convenience and anonymity.41 Going to a pharmacy first to 
address a medical issue (e.g., symptoms of malaria) is common, and individuals often go to a 
healthcare facility only later if the issue is not resolved.  
Advantages of pharmacy-based PrEP delivery may include increased convenience, privacy, and 
quality of care. In any given location, pharmacies often outnumber healthcare facilities and thus might 
be nearer to individuals interested in PrEP, saving both time and money.41–46 Individuals also visit 
pharmacies for both non-medical and medical reasons, potentially enabling individuals who seek PrEP 
to maintain privacy and overcome barriers associated with PrEP stigma.23,24 Pharmacies also have the 
advantage of being self-sustaining by offering subsidized or fee-for-service care, which may make them 
more responsive to client demands47–49 and may result in sustained client engagement if individuals 

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value services purchased 50. Finally, the delivery of PrEP in pharmacies expands choice of locations to 
access PrEP, enabling individuals to select their preferred model. 
Pharmacy-based PrEP delivery is feasible and within the domain of care for Kenyan 
pharmacists.        PrEP delivery has relatively few necessary components – HIV testing, adherence 
and risk reduction counseling, assessment of acute HIV infection and PrEP side effects, PrEP 
prescribing, and the provision of refills51,52 – all can be done by pharmacists/pharmaceutical 
technologists in Kenya.53 Pharmacies in Kenya are dispensing HIV self-tests on the market without a 
prescription,54 and pharmacies are dispensing PrEP now by prescription (brought after a clinic visit). 
Developing a rigorous and evidence-based model for pharmacy-based PrEP now could head off 
unregulated development of private models. In the United States, one model of full-service pharmacy-
based PrEP delivery has been successfully implemented through a collaborative practice agreement 
overseen by a remote clinician (Fig. 1), with standard PrEP services being done by the pharmacy and 
branch points for clients with complex medical or social issues to be sent to the overseeing clinician.55–
60 Pharmacy-based PrEP delivery is a client-centered model that is no less safe or rigorous than a 
clinic-based approach. A similar model could be highly successful for Africa.  
 
 
Fig. 1. Pharmacy-based PrEP care pathway, overseen by a remote physician, from Seattle 
(adapted from (56))   
The ongoing COVID-19 pandemic might affect the delivery and uptake of pharmacy-based PrEP  
We are currently in the midst of a global respiratory pandemic, coronavirus disease 2019 (COVID-19), 
which has dramatically changed the lives of individuals living in Kenya and other settings across the 
globe. Because COVID-19 is a newly emerging pandemic, the science on this new virus – including our 
understanding of transmission dynamics, treatment, and prevention – continues to evolve. What is 

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known, is that it COVID-19 is transmitted via respiratory droplets in the air or on surfaces, and that the 
risk of infection can be reduced with regular hand washing, social distancing, and wearing a face mask 
while in public settings. To help slow the risk of COVID-19 infection, Kenya (like many other countries) 
has implemented a number of measures including national curfews, road blocks, and stay at home 
orders.  
This ongoing epidemic is likely to affect the care seeking and providing behaviors of pharmacy clients 
and providers in ways that might impact the delivery and uptake of pharmacy-based PrEP delivery. For 
example, during COVID-19 pharmacy clients might decrease access of pharmacy care if they fear 
infection in a public setting, or they may increase access of pharmacy care if they fear visiting health 
facilities for regular services. Similarly, pharmacy providers might be restricting pharmacy hours during 
COVID-19 to reduce risk of infection to staff and clients, or they may be increasing pharmacy hours if 
there is an increased demand for pharmacy services during this unique period. The delivery of 
pharmacy-based PrEP delivery during COVID-19 may also have a number of unique challenges, 
including space constraints (e.g., a well-ventilated private room for counseling and HIV testing or 
ensuring enough space for social distancing among clients), limited protective gear for pharmacy 
workers, and limited pharmacy access for clients (due to curfews and fear or using public transport). 
We aim to understand the impact of COVID-19 on the uptake and delivery of pharmacy services, 
including PrEP, during this unique time so that we can understand the generalizability of our pilot 
findings in a post-COVID-19 era or during another future global pandemic.   
The prevalence of sexually transmitted infections (STI) among individuals at HIV risk in sub-
Saharan Africa is very high; there are concerns that expanded PrEP delivery could increase the 
prevalence of STIs. In Africa, there additionally exists an STI and HIV syndemic, with STIs frequently 
foreshadowing HIV infections.61–64 One of the populations most at risk of both HIV and STI infection in 
this region is adolescent girls and young women (AGYW), whose risk of HIV and STIs is roughly double 
or more than that of their male age-mates.65,66 The vast majority of bacterial STIs are asymptomatic and 
thus remain undiagnosed and untreated.67 The consequences of untreated bacterial STIs on sexual 
and reproductive health can be profound (especially among AGYW68) and include pelvic inflammatory 
disease, chronic pelvic pain, tubal infertility, pregnancy complications, fetal and neonatal death, and 
increased susceptibility to HIV.61,64,69–72  In 2017, Kenya launched PrEP scale-up and currently has 
more individuals on PrEP than any other African country.73,74 Evidence from different populations in 
different settings (e.g., men who have sex with men in high-income countries) suggests that the 
expansion of PrEP use may increase population-level STI prevalence if individuals at HIV risk forego 
using condoms for HIV prevention.75–79 The Kenya Ministry of Health recognizes the need for increased 
STI control efforts with PrEP scale-up, but faces challenges including limited access to laboratory 
testing for STI diagnosis.  
Findings from the Partners Scale-Up Project and MPYA Study 
PrEP delivery in HIV clinics is associated with stigma. A main delivery point for PrEP in Kenya 
currently is HIV clinics. We have learned from qualitative work conducted among clients and providers 
in our Partners Scale-up Project that many PrEP users consider HIV clinics as spaces for HIV infected 
people, and thus feel uncomfortable attending these clinics as HIV uninfected persons. Additionally, 
PrEP users face difficulties fitting in when waiting for services at the HIV clinics since most of the health 
discussions focus on illness, not prevention and health (Table 1). 
Table 1. HIV uninfected persons’ concerns with accessing PrEP at HIV Comprehensive Care 
Clinics  (Partners Scale-up Project) 

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Diverse options for PrEP delivery are desired among individuals taking PrEP. Preliminary 
qualitative data from PrEP users and providers in the Partners Scale-up Project and community leaders 
in the MPYA study have demonstrated the desire for locations other than HIV clinics for PrEP 
prescribing and refilling. Table 2 demonstrates how PrEP users would like PrEP delivery to be as easy 
as access to condoms and separate from HIV clinics for increased privacy. Table 2 additionally 
demonstrates community leaders’ interest in pharmacies as a potential location for PrEP delivery and 
refill as a result of their easy accessibility, availability of pharmacists/pharmaceutical technologists for 
PrEP prescribing/refilling, and long open hours. 
 
Pharmacy-based delivery of PrEP is of interest to 
communities. We recently conducted two anonymous, 
telephone-based, community surveys in Western Kenya 
(PrIYA study) with young women and men (<25 years) who 
had a phone and had agreed to be part of mSurvey – a 
national polling organization that connects to mobile phones in 
Kenya and pays a small amount for survey completion. In the 
June 2018 survey 515 individuals participated, and in the 
January 2019 survey 2274 individuals participated. None of 
these individuals were otherwise part of our ongoing research 
studies. In both surveys, PrEP knowledge was high: in the 
June 2018 survey, 83% of individuals had heard of PrEP and 
43% knew someone on PrEP; in the January 2019 survey, 69% of individuals had heard of PrEP. The 
majority (58%) of individuals in the January 2019 survey said they would be willing to pay for PrEP and 
“I told you that experience is difficult, because we normally go to the CCC and the CCC clinic is for HIV+ 
people and therefore there is no difference between that person who is infected and the one who is not” – 
PrEP user: Female. 
“I used to fear because when people see me, they would think I am sick” – PrEP user: Male. 
“There is still stigma with the negative patients coming to the CCC to take PrEP because they are associated 
with HIV+” – Healthcare provider: Nurse. 
“I know there are a lot of people who really wish to take PrEP, but when they learn that it is being given at the 
CCC they just disappear, so having another place to dispense PrEP will help” – Healthcare provider: 
Counselor 
Table 2. PrEP users’, providers’, and counselors’ desires for diverse PrEP delivery options 
(Partners Scale-up Project and MPYA study)  
“PrEP should be made available just like condoms are easily accessible and available in dispensers” –PrEP 
user, Partners Scale-up 
“I feel that PrEP should be delivered separately from the CCC [HIV clinic] … yes it should be delivered at a 
different point because of stigma” –  PrEP user, Partners Scale-up 
“Sometime there are those people who do not want others to know about their thing, so there should be a way 
that one can be treated from wherever they are even without coming to the clinic” – PrEP user, Partners Scale-
up 
“Community pharmacies would work [for PrEP delivery] because they are easily accessible and the pharmacists 
are always available ... some of them work until late hours” – NGO program officer, MPYA 
“For refill maybe we… observe how they are faring with the product [PrEP] then after 3 times … she can pick it 
at any given point like dispensaries and pharmacies around where they live because nowadays there are so 
many all over” – Community-based organization leader, MPYA  
 
Fig. 2. Preferred PrEP locations 
(mSurvey results) 

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35% visited a retail pharmacy (“drug shop”) every 2-3 months. Interestingly, almost half of individuals 
who were familiar with PrEP in the June 2018 survey thought that people would most prefer to get PrEP 
from retail pharmacies compared to other locations (e.g., clinics) (Fig. 2).  
Findings from formative research on pharmacy-based PrEP delivery 
As formative research for this project, in the second half of 2019 we conducted in-depth interviews with 
pharmacy clients (n=40) and pharmacy providers (n=12) to understand their health seeking behaviors 
(clients), interactions with clients and commonly provided services (providers), and attitudes towards 
pharmacy-based PrEP delivery (both). We interviewed client who currently purchase pharmacy 
products and services, self-reported being HIV negative, and were identified as at-risk for HIV using the 
Rapid Assessment and Screening Tool (RAST). We interviewed pharmacy providers who currently 
provide services at retail pharmacies. Study participants were recruited from four different areas of 
Thika and Kisumu: urban informal settlements, urban non-informal settlements, peri-urban areas, and 
rural areas. Exactly half of the pharmacy clients recruited were male, and half were under the age of 
25. Participants were interviewed one-on-one by a trained Kenyan qualitative researcher. All interviews 
took place in a private room, were audio recorded, and subsequently transcribed verbatim. Major 
themes were identified inductively using content analysis. Some of the main findings are summarized 
below.  
Pharmacies are often clients’ first resort for care-seeking; clients’ preference for pharmacy-care 
is multifaceted. The majority (78%, 31/40) of clients reported that when they are ill, they first seek care 
at retail pharmacies and only seek care at healthcare facilities if their symptoms persist and/or worsen. 
Most (75%, 30/40) clients also reported seeking preventive care at retail pharmacies, most commonly 
through purchase of contraceptives. Clients identified six characteristics that underlie their preference 
for pharmacy care over facility-based care: 1) convenience (e.g., more locations, longer opening hours, 
faster service times); 2) privacy (e.g., less crowded, purpose of visit not obvious to on-lookers); 3) 
customer service (e.g., pharmacy providers are “friendly”, “kind”, and “not in a hurry”); 4) rapport (clients 
have ongoing, personal relationships with pharmacy providers who know their medical history); 5) 
flexibility (e.g., pharmacies work to provide services within clients’ budget, some offer credit); and 6) 
autonomy (more client decision-making power in terms of timing and location of care, more negotiation 
power with pharmacy providers when deciding treatment plan, ability to seek care elsewhere if 
dissatisfied with services.)  
Overall, pharmacy clients and providers strongly support the idea of pharmacy-based PrEP 
delivery, especially because the demand for PrEP is already there. Participants felt that the same 
six aforementioned advantages to general pharmacy care would also apply to pharmacy-based PrEP 
delivery, with many heavily emphasizing that pharmacy-based PrEP delivery would help circumvent 
HIV/PrEP stigma currently associated with HIV clinics, where PrEP is currently delivered. Providers 
reported that clients are already requesting PrEP at their pharmacies, and two providers said that they 
sell PrEP on demand. Clients similarly expressed interest in acquiring PrEP at retail pharmacies, with 
one client reporting that she had already purchased PrEP at a pharmacy previously. Overall, 
participants found pharmacy-based PrEP delivery highly acceptable, with 83% (10/12) of providers 
saying they would offer PrEP at their pharmacies and 95% (38/40) clients expressing support for this 
idea. 
Clients’ main recommendation for pharmacy-based PrEP delivery was to ensure client privacy 
and that providers are properly trained to deliver PrEP. When asked about undergoing HIV testing, 
counseling, and adherence and side effect assessments at a pharmacy, most clients reported that they 
would be comfortable so long as these activities occurred in a private consultation room and they felt 
sure that the provider would maintain their confidentiality. Clients also stressed that providers must 

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have the proper training to conduct these activities. Other ideas for increasing client comfort with 
pharmacy-based PrEP included offering HIV self-testing and ensuring consistency of provider at follow-
up visits.  
Providers felt that delivering PrEP in pharmacies would be feasible so long as they have 
sufficient content knowledge of PrEP and staff to handle any additional workload. Providers 
supported the idea of pharmacy-based PrEP delivery being overseen by a remote clinician with 
PrEP expertise. In general, providers reported that they could deliver PrEP using the same practices 
they currently use to deliver other drugs (e.g., pill counts and phone calls to assess adherence, 
referrals of clients experiencing serious side effects). Half of providers also desired additional training 
on HIV testing and counseling to deliver PrEP. All providers (12/12) supported the idea of oversight by 
a remote PrEP clinician, with several calling for resources like a standardized checklist to ensure that 
clients meet eligibility criteria and clinical safety requirements to receive PrEP.     
Findings from stakeholder meeting pharmacy-based PrEP delivery 
In January of 2020, we convened 19 stakeholders from regulatory agencies and suppliers (e.g., 
National AIDS & STI Control Programme, Pharmacy & Poisons Board, Kenya Medical Laboratory 
Technology & Technicians Board, Kenya Medical Practitioners & Dentists Council, Kenya Medical 
Supplies Agency), professional bodies (e.g., Kenya Pharmaceutical Association, Pharmaceutical 
Society of Kenya, Kenya Medical Association), PrEP implementing partners (JHPIEGO, Clinton Health 
Access Initiative), healthcare and pharmacy providers, Civil Society Organizations. The purpose of this 
meeting was to build consensus around a model for pharmacy-based PrEP initiations and pharmacy-
based PrEP refills that could be pilot tested in Kenya. Following presentations on the role of PrEP in 
Kenya’s national plan for HIV prevention, results from the formative research, and a mock care pathway 
for pharmacy-based PrEP delivery, participants were divided into small groups to brainstorm potential 
barriers and solutions—both for pilot testing and, if successful, for eventual scale-up—of pharmacy-
based PrEP delivery. The outcomes from the stakeholder meeting are summarized below. 
Stakeholders were supportive of the idea of pharmacy-based PREP delivery. There was 
overwhelming consensus that pilot work to better understand whether pharmacy-based PrEP initiation 
and refills could be done successfully. Importantly, no meeting attendee objected to trying pharmacy-
based PrEP delivery. Stakeholders were in favor of a pilot test of pharmacy-based PrEP delivery and 
felt it would help identify matters requiring further clarification before further scale up.  
Stakeholders identified potential challenges and solutions to pharmacy-based PrEP delivery for 
both the pilot study and, if successful, for larger scale up (Table 3). Anticipated challenges 
primarily centered on pharmacy provider knowledge and skills to deliver PrEP and lack of guidelines 
specifying, for example, what type of HIV test is permissible for initiation of PrEP at pharmacies, how 
pharmacies would procure and document PrEP, and reporting requirements. Stakeholders suggested 
numerous ways forward that could be incorporated into the pilot study. With respect to scaling up 
pharmacy-based PrEP delivery, stakeholders also suggested potential solutions, many of which would 
require the cooperation of local and national policymakers.  

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Table 3. Potential challenges and solutions to pharmacy-based PrEP delivery, according to stakeholder meeting attendees 
Delivery component 
Potential challenge 
Potential solution: pilot 
Potential solution: scale up 
Promoting 
pharmacy-based 
PrEP 
• Most pharmacies receive their 
promotional materials from suppliers.  
• Existing limitations on how pharmacies 
can advertise products/services. 
• CCCs may be reluctant to inform PrEP 
clients about pharmacy-based PrEP if 
trying to reach PrEP target numbers.  
• Word-of-mouth promotion (e.g., 
PrEP providers at the affiliated 
CCC)  
• Ask customers seeking services 
indicating HIV risk-related sexual 
behaviors (e.g., condoms, 
emergency contraception) if they 
might be interested in PrEP. 
• Display posters within the confines 
of the pharmacy. 
• NASCOP works with pharmacies to 
create PrEP materials for display. 
• NASCOP works with counties so PrEP 
promotional materials can be displayed 
without a county-level license.  
• MOH helps spread knowledge of 
pharmacy-based PrEP delivery through 
national awareness campaigns. 
• PPB revises advertisement restrictions 
for PrEP. 
• Pair pharmacies with CCCs so 
pharmacy-based PrEP users count 
toward CCC targets. 
HIV testing 
• No existing framework for pharmacies to 
do HIV rapid testing (e.g., Determine, 
First Response), although some already 
doing. 
• Only select pharmacies currently 
providing assisted HIV self-testing 
(blood- or oral-based). 
• No guidelines stating that PrEP can be 
initiated based on the results of an HIV 
self-test. 
• Concerns over counterfeit HIV self-tests.   
• Select pilot pharmacies already 
certified to do assisted HIV self-
testing. 
• Could consider a special approval 
from regulatory agencies to offer 
HIV rapid testing at pharmacies for 
the pilot.  
• MOH develops guidelines so that 
pharmacies can conduct HIV rapid 
testing, which currently is provided in 
many pharmacies for ~one-fifth the 
price of HIV self-tests. 
• MOH could limit PrEP delivery to 
pharmacies that are certified to do 
assisted HIV self-testing and obtain 
their HIV self-testing kits through 
KEMSA.  
• PPB could reclassify the HIV self-testing 
so treated like any other HIV test. 
 
Counseling 
• Pharmacy providers not trained on PrEP 
counseling.  
• No privacy at some pharmacies for 
counseling. 
• Pharmacies have a business approach, 
• Train pilot pharmacies on PrEP 
counseling, per NASCOP 
guidelines. 
• Pilot pharmacies should have a 
private counseling space to offer 
• MOH requires pharmacy providers to be 
trained on PrEP delivery in order to 
deliver PrEP. MOH customizes 
NASCOP training to fit the retail 
pharmacy setting. 

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gets in the way of counseling. 
• Existing counseling prompted by clients, 
not pharmacy providers. 
PrEP. 
Prescribing 
• Pharmacy providers are not trained on 
how to prescribe PrEP (and not allowed 
to prescribe). 
• Who will bear the costs of prescription? 
(incentives for pharmacies if get drug for 
free) 
• Train pharmacy providers on how to 
prescribe using a checklist and 
remote clinician oversight. 
• Charge small consulting fee that 
covers counseling and dispensing. 
• Allow pharmacies to charge for HIV 
testing (necessary for prescription). 
• PPB reschedules PrEP so that it can be 
sold without a prescription. 
• Pharmacy providers purchase PrEP 
from a generic manufacturer. 
• Pair pharmacies with CCC clinics for co-
signing and oversight. 
• Remote PrEP clinicians (MOH 
supported?) for remote oversight and 
co-signing. 
Dispensing 
• Retail pharmacies not registered in the 
Master Facility List (MFL) and thus lack 
codes necessary to: (1) acquire PrEP 
through KEMSA, and (2) report 
dispensing.  
• Current retail pharmacy records do not 
tend to track clients over time.  
• Some clients move between pharmacies. 
• Clients might not be able to afford 3-
months PrEP at a time. 
• Link pilot pharmacies with CCCs; 
have pharmacies use CCC MFL 
code to obtain PrEP; then CCC 
reports the drugs dispensed. 
• Set up unique tracking system for 
pilot. 
• Have clients pay only for testing & a 
consulting/dispensing fee; make 
PrEP drug free. 
• Give pharmacies MFL codes. 
• Use system similar to diabetes for 
tracking prescriptions over time (e.g., 
“PrEP card”). 
• MOH provides PrEP to pharmacies for 
free. 
• MOH establishes minimum criteria that 
pharmacy providers must meet in order 
to deliver PrEP (e.g., completion of 
NASCOP PrEP training). 
Oversight/Referrals 
• Many retail pharmacies lack formal 
connections to PrEP facilities.   
• Clinicians busy, hard to reach when 
called. 
• Cost of oversight? Who pays? 
• Ethics – how do you know pharmacies 
will use when needed? 
• Who is the clinician?  
• Link pharmacies with specific CCC. 
• Have study-staff clinician on call.  
• Monitor the frequency of calls and 
record the content. 
• PrEP clinician hotline? 
• WhatsApp group for PrEP clinicians and 
pharmacy providers? 
• Include cost of oversight in the 
consultation/dispensing fee client pays 
to pharmacy. 
Other/over-arching  
• Some pharmacies only have one staff 
member working at a time. 
• Pharmacy providers may lack knowledge 
• Pharmacy providers selected for 
this pilot will be trained on PrEP 
delivery and provided with a 
standardized checklist to walk them 
• MOH establishes minimum criteria (e.g., 
possession of a private consultation 
room, completion of NASCOP training) 
that pharmacy establishments and 

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about PrEP and/or skills to conduct HIV 
testing and counseling. Some pharmacy 
providers may discriminate against 
clients, especially marginalized key 
populations (e.g., MSM, commercial sex 
workers).  
• Currently, there are no regulations for 
pharmacy-based PrEP delivery. 
through each step.  
• Pharmacy providers will also be 
connected to a remote PrEP 
clinician who can answer any 
questions they have and receive 
referrals of complex clients. 
providers must meet to deliver PrEP.  
• MOH requires pharmacy-based PrEP 
providers to undergo a sensitization 
training on PrEP stigma/discrimination.   
• MOH establishes guidelines for 
pharmacy-based PrEP delivery, 
including any price regulation and 
accountability mechanisms (e.g., in 
cases of client mismanagement).  

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Stakeholders helped refine a care pathway to be pilot tested. The care pathway is illustrated in Fig. 
3 with the core components detailed in Table 4. The checklist pharmacy providers will use to assess 
PrEP eligibility (both at initiation and refills) is included in Appendix III. 
  
 
Fig. 3. Care pathway for pharmacy-based PrEP delivery 
 
Preliminary findings from Aims 1a, 1b, and conversations with PrEP policy makers from the 
Kenya MOH, WHO, and PEPFAR. In Aim 1c, we propose refining the care pathway implemented in 
the Aim 1a pilot to address (1) challenges reported by the clients and providers we interviewed and 
surveyed in Aim 1b and (2) evidence gaps identified by representatives from the Kenya Ministry of 
Health (MOH), WHO, and PEPFAR. The identified challenges and proposed refinements to how PrEP 
delivery is implemented (i.e., “implementation strategies”) are summarized in table below: 
 
Table 4. Core components of pharmacy-based PrEP delivery 
Oversight 
With clinician input, we developed a 
checklist tool that walks pharmacy 
providers through each step required to 
initiate a client on PrEP and/or refill an 
existing PrEP prescription. All checklist 
items need to be completed in order for 
the client to receive PrEP. If at any point 
the pharmacy provider has questions, 
s/he can consult with a remote clinician 
and/or refer the client for care. 
Testing 
Assisted self-testing for HIV using rapid blood or 
oral fluid tests (optional STI testing).  
Counseling 
Includes risks and benefits associated with PrEP, 
PrEP adherence, recognizing symptoms of acute 
HIV infection, behavioral risk assessment (using 
Kenya’s PrEP Rapid Screening Tool - RAST80), 
and side effects assessment. 
Prescribing 
Prescribing of PrEP drugs for those initiating PrEP 
for the first time and continuation of prescriptions 
for clients coming in for refills. 
Dispensing/ 
Refilling 
PrEP 
drugs 
dispensed/refilled 
by 
pharmacy 
provider; reliable drug supply required. 

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Challenge Identified 
Proposed Refinement to Model 
Implementation Strategy 
Name1 
Some clients cannot afford the fee study 
pharmacies are charging for PrEP (300 
Kenyan schillings/~$2.75 USD). 
Eliminate the pharmacy fee. 
“Free PrEP” 
Some clients felt uncomfortable completing 
the HIV risk assessment for PrEP (which 
includes highly sensitive questions about 
sexual behaviors) verbally with the pharmacy 
providers. 
Give clients the option to self-
administer 
this 
questionnaire, 
with review by pharmacy provider 
who can ask questions if needed. 
“Optional Self-RAST” 
 (“RAST” stands for “Risk 
Assessment 
Screening 
Tool”) 
Some prospective PrEP clients who do not 
know their HIV status are hesitant to undergo 
HIV testing at a pharmacy for fear for testing 
positive there. 
Give prospective PrEP clients the 
option to complete an initial HIV 
self-test at home, and provide 
those who accept this offer an 
HIV self-test kit free of charge. 
“Optional Initial Self-Test” 
Some client populations with HIV risk—
especially 
adolescent 
girls 
and 
young 
women—are not being reached by this 
model.  
Incentivize PrEP clients to refer 
their peers to study pharmacies 
to learn about PrEP. 
“Peer Referral” 
The oral-fluid HIV self-tests being used in our 
pilots have a lower sensitivity than blood-
based HIV self-tests. 
Switch to using blood-based HIV 
self-tests (and continue to have 
pharmacy providers assist clients 
with conducting these).  
“Assisted Blood-Based HIV 
Self-Testing” 
Some clients who undergo screening for 
PrEP 
are 
found 
to 
be 
post-exposure 
prophylaxis (PEP) candidates and have to be 
referred to public HIV clinics for PEP access 
(because pharmacies do not currently offer 
PEP).  
Add PEP services to study 
pharmacies so that they can keep 
PEP clients engaged in care and 
offer them PrEP upon PEP 
completion. 
“PEP-as-a-Bridge-to-PrEP” 
Pharmacies receive a high volume of clients 
seeking testing and/or treatment for sexually 
transmitted infections (STIs) and currently 
have no way to formally test and diagnosis 
these clients.  
At 
a 
subset 
of 
2 
study 
pharmacies, offer clients seeking 
STI testing and/or treatment free 
STI testing and treatment with 
optional PrEP screening. 
“STI Testing-as-a-Bridge-to-
PrEP” 
1For the extended pilot (Aim 1c), we define each of these implementation strategies prior to asking providers for their 
feedback on them in the baseline and follow-up questionnaires (Appendices XIX and XX). 
 
The refined care pathway we propose implementing in an extended pilot study (Aim 1c) is illustrated in 
Fig. 4 with the new implementation strategies (refinements) highlighted in yellow. 

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Fig. 4. Refined care pathway for pharmacy-based PrEP delivery for extended pilot study (Aim 1c) 
 
 

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METHODS 
Taking PrEP to scale will require simplifying and diversifying models for delivery to achieve options that 
are affordable, accessible, and meet the needs of clients and health systems. We have assembled a 
multidisciplinary team to test pharmacy-based models as alternative strategies for PrEP delivery. We 
hypothesize that pharmacy-based PrEP delivery will be feasible, acceptable, and preferred. 
 
Study Objectives 
1. To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot 
studies (Aim 1a). 
2. To identify weak points for pharmacy-based PrEP delivery, in domains relating to 
acceptability, fidelity, and costs (Aim 1b). 
 
3. To test a refined care pathway for pharmacy-based PrEP initiation and refills through an 
extended pilot study (Aim 1c)   
 
Hypothesis. Individuals will be interested in pharmacy-based PrEP delivery and will successfully initiate 
and refill PrEP at pharmacies and be retained in care. Understanding the potential weak points for 
PrEP delivery in pharmacies will permit refinement of the care pathway, and this refined pathway will 
result in greater PrEP uptake and improve the acceptability and feasibility of the pharmacy PrEP model 
among clients and providers.     
 
Research Questions 
• 
What is the uptake of pharmacy-based PrEP delivery among eligible pharmacy clients? (Aim 1a) Do 
model refinements result in greater uptake? (Aim 1c) 
 
• 
What does PrEP retention and adherence look like among individuals who started PrEP at 
pharmacies? (Aim 1) Do model refinements result in increased PrEP retention and adherence? 
(Aim 1c) 
 
• 
Could pharmacy-based PrEP refills increase PrEP retention and adherence compared to facility-
based PrEP refills? (Aims 1a & 1c) 
 
 
• 
What is the fidelity of pharmacy-based PrEP delivery? (Aim 1b) 
 
• 
What is the acceptability of pharmacy-based PrEP delivery among both pharmacy clients and 
providers? (Aim 1b) Do model refinements result in greater acceptability? (Aim 1c) 
 
• 
What is the cost of pharmacy-based PrEP delivery and how much might pharmacy clients and 
providers be willing to pay for/provide PrEP at pharmacies? (Aim 1b) 
 
Study Design 
This study is a one-arm intervention trial, or pilot study. There is no comparison arm in this pilot 

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study. The intervention we are testing was developed from extensive formative research, including 
analysis of data from in-depth qualitative interviews and a stakeholder meeting. We hope to use the 
information gained from this research to inform development of a larger randomized trial, which will 
include a comparison arm.  
Setting 
We will conduct the research for this study in Kisumu (Fig. 5). Kisumu is 
a major urban center located in Western Kenya, surrounded by a large 
fishing and farming area, thus both an urban and rural population. HIV 
prevalence in Kisumu is among the highest in Kenya, at 21%. In Kisumu 
County, where Kisumu town is located, there are 119 retail community, 
7 wholesale, and 27 hospital pharmacies.  
The site has a  team with extensive experience in the provision of PrEP 
to diverse populations, beginning with the Partners PrEP Study clinical 
trial,4 continuing to the open-label Partners Demonstration Project,81 and 
current leadership of the Partners Scale-Up Project, MPYA study, 
POWER project, and others. The site has technical expertise related to 
PrEP, community engagement with diverse populations (with high 
recruitment and retention >90%), and collaborative experience working 
with health providers outside of its own research clinics – precisely the 
components necessary for this work.  
As described, the location has numerous private, retail 
pharmacies that are high quality, well-stocked, and capable 
of implementing pharmacy-based PrEP delivery (example: 
Fig. 6). Finally, the site has extensive experience with the 
development of PrEP delivery models in Kenya – members 
of study teams have been deeply involved in the Kenya 
PrEP guideline process, including the clinical delivery 
guidelines.52 All work proposed will be done adhering to the 
minimal safety package defined in those guidelines – 
analogous to the pharmacy-based checklist model from the 
US (Fig. 1).55,57  
 
 
Pilot pharmacies 
Pharmacy selection  
For Aim 1a, we will select two retail pharmacies of different sizes in Kisumu to conduct our pilot: (1) one 
medium-sized pharmacy (~100 customers/day), and (2) one large pharmacy (~500 customers/day) (=2 
pharmacies in total). For Aim 1c (extended pilot), we will select four additional pharmacies, for a total of 
six pharmacies: four medium ones (~50 customers/day) and two large ones (~100 customers/day). In 
order for pharmacies to be eligible for study participation, they must: 1) be properly licensed with a 
fulltime licensed pharmacy provider, 2) have a private counseling space where HIV testing and PrEP 
counseling can occur, and 3) must be already certified to provide provider-assisted HIV self-testing. 
The majority of licensed retail pharmacies in Kenya have a private counseling room in the back that is 
regularly used to counsel clients on sensitive topics including, STI treatment, HIV self-testing, and 
family planning, amongst other things. Then, the lead provider at each pharmacy selected must agree 
to: 1) offer PrEP (with relevant providers undergoing project training), 2) allow a trained research 
 
Fig. 6.  Retail pharmacy in Kenya 
Source: www.howwemadeitinafrica.com  
 
 
Fig. 5.  Study setting.  

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assistant to collect client data (e.g., self-reported adherence, dried blood spot samples), and 3) allow 
one or more pharmacy staff members to participate in a confidential and voluntary in-depth interview 
about their experiences delivering PrEP (Aim 1a only), a confidential survey about their experiences 
delivering PrEP (Aim 1c only), and a monitored WhatsApp group with the remote clinician providing 
PrEP oversight (Aim 1a and 1c). Pharmacies that participate in the extended pilot (Aim 1c) must agree 
to offer post-exposure prophylaxis or “PEP” (with relevant providers undergoing project training), and 
two of the four pharmacies that participate in the extended pilot (Aim 1c) must also agree to offer STI 
testing (again, with relevant providers undergoing project training). 
 
 
Pharmacy provider training  
The pharmacy providers who will deliver PrEP and/or PEP (Aim 1c only) in the pilot study will undergo 
a training based on the Kenya MOH PrEP training (which our team helped develop) and Partners 
Scale-Up Project training (used at public clinics).82 All individuals at the pilot pharmacies who plan on 
implementing pharmacy-based PrEP/PEP delivery must complete the training. The training will cover: 
1) a review on how to perform assisted HIV self-testing, 2) how and where to refer individuals for HIV 
care if they test HIV-positive, 3) how to counsel individuals interested in initiating PrEP or PEP (Aim 1c 
only), including screening for PrEP/PEP eligibility using the standardized checklist, 4) how to refer 
individuals with complex medical backgrounds and/or side effects to the remote clinician, how to use 
and access the remote clinician, and 5) how to dispense drugs to individuals starting PrEP or PEP (Aim 
1c only) for the first time (one-month drug supply) and individuals returning for PrEP refills (three-month 
drug supply), and 6) how to maintain proper safety precautions during the COVID-19 outbreak. 
Additionally, pharmacy providers participating in the pilot will complete training by members of the 
Kisumu research team on research ethics and the importance of confidentiality, as well as consistent 
protocols for PrEP/PEP record keeping, including instructions on how to complete and securely store 
the pharmacy-based PrEP/PEP delivery prescribing checklists (Appendix III. Prescribing checklist), 
referral forms (Appendix IV. Referral form), and the remote clinician contact forms (Appendix V. 
Remote clinician form). All other research-related activities at the pharmacy (e.g., completion of 
informed consent documents and the quantitative questionnaires) will be completed by a full-time 
research assistant (trained by the Kisumu team on research methods and ethics) stationed full-time at 
the pilot pharmacies. 
 
 

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Participant eligibility & recruitment -  
For Aim 1a, we aim to enroll up to 150 clients in total across the two Aim 1a pharmacies (Table 5). We 
will stop enrolling participants in the pilot once we achieve the desired sample size Aim 1a sample 
sizes. This sample size is similar to that we have used in other pilot studies to test the feasibility and 
acceptability of new health intervention. For Aim 1c (extended pilot study), we aim to enroll up to 540 
new clients, and to extend to Aim 1a enrollees the option to continue refilling PrEP at pilot pharmacies 
so long as they still meet study and PrEP eligibility criteria and complete the Aim 1c informed consent 
process.  
 
 
Table 5. Number of clients to be enrolled at pilot pharmacies 
 
Enrollment 
location 
Study site 
Pharmacy 
size 
# 
Clients 
Total Clients 
Aim 1a 
Pharmacy A 
Kisumu 
Medium 
~75 
Up to 150 
Pharmacy B 
Kisumu 
Large 
~75 
Aim 1c 
(extended 
pilot) 
Pharmacy A* 
Kisumu 
Medium 
~90 
Up to 540 
Pharmacy B* 
Kisumu 
Large 
~90 
Pharmacy C 
Kisumu 
Medium 
~90 
Pharmacy D 
Kisumu 
Medium 
~90 
Pharmacy E 
Kisumu 
Medium 
~90 
Pharmacy F 
Kisumu 
Large 
~90 
*Will be invited to participate in the extended pilot (Aim 1c) 
 
All participating pharmacies will continue to provide PrEP for 6 months following enrollment of each 
participant (Fig. 7). The eligibility criteria and recruitment plan for the pilot and pilot evaluation activities 
are outlined for clients and providers in Table 6 and Table 7, respectively. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 6. Client eligibility, recruitment, and evaluation 
 
Pilot 
Pilot Evaluation Component 
 
Eligibility 
Recruitment 
Quantitative Survey & DBS 
In-depth Interview (Aim 1b) 
Aim 1a and 
Aim 1c 
(n=2 
pharmacies 
for Aim 1a 
and n=6 
pharmacies 
for Aim 1c) 
• >18 years 
• Interested in initiating 
PrEP at a pilot pharmacy 
(Aim 1a) or interested in 
initiating PrEP or PEP or 
undergoing STI testing at a 
pilot pharmacy (Aim 1c)  
• Meets all criteria (e.g., 
tests HIV-negative) for 
PrEP initiation on the 
checklist (Aim 1a) or for 
PrEP, PEP, and/or STI 
testing (Aim 1c). 
• Able & willing to provide 
written informed consent1 
• 
Display posters that encourage 
customers to ask their 
pharmacy provider about PrEP  
• 
Have pharmacy providers ask 
customers buying HIV self-
tests, emergency contraception, 
or STI treatment if they are 
interested in initiating PrEP at 
the time of check-out  
• 
Peer referral incentives (Aim 1c 
only) 
• 
Offer free STI testing with 
optional PrEP screening to 
clients seeking STI diagnosis or 
treatment services (“STI 
Testing-as-a-Bridge-to-PrEP”, 
Aim 1c only) 
• 
Offer PEP to clients seeking 
PEP and/or reporting a recent 
HIV exposure, encouraging 
those who accept and complete 
the PEP treatment regimen to 
consider taking PrEP (“PEP-as-
a-Bridge-to-PrEP”, Aim 1c only) 
• 
Other strategies developed 
from the formative research and 
stakeholder meeting  
At each study visit, RAs 
stationed at the pharmacy will 
conduct the quantitative 
survey with and collect the 
DBS samples from 
participants.  
 
Up to four surveys and four 
DBS samples will be 
collected from each client 
enrolled in the Aim 1a pilot.  
Up to four surveys and four 
DBS samples will be 
collected from each client 
enrolled in the Aim 1c 
extended pilot.  
Study staff will identify a 
sample of enrollees to invite 
to participate in an in-depth 
interview.2 RAs will approach 
these individuals to see if 
they are interested in 
participating. 
 
At each Aim 1a pharmacy, up 
to 10 clients who initiate PrEP 
and 10 clients who also refill 
PrEP will be interviewed 
during Aim 1a (n=40 client 
interviews total). 
 
1By signing the consent form (Appendices I-II), Aim 1a participants agree to 1) receive PrEP services (e.g., HIV testing); 2) complete a quantitative survey; and 3) 
give a DBS sample. Participants from Aim 1a pharmacies additionally consent to being invited to participate in an in-depth interview about their PrEP care 
experiences. By signing the consent form for the extended pilot (Appendices XII and XIII), Aim 1c participants agree to 1) receive PrEP, PEP, or STI testing services; 
2) complete a quantitative survey; and 3) give a DBS sample. All participants must provide written on electronic consent to participate in study activities.     
2We will purposely sample clients of different ages, sex, and duration of PrEP use to reflect a range of experiences and perspectives on pharmacy-based PrEP 
delivery. 
 
 

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Table 7. Provider eligibility and recruitment plan  
 
 
Pilot Evaluation Component 
 
Eligibility1 
In-depth Interview 
WhatsApp Group 
Pharmacy providers  
from Aim 1a and Aim 1c 
pharmacies 
• >18 years 
• Provides PrEP at a pilot pharmacy 
or provides PrEP, PEP, and/or STI 
testing at a pilot pharmacy (Aim 
1c) 
• Able & willing to provide consent 
Prior to agreeing to be part of the Aim 
1a pilot study, providers will be 
informed that they will be invited at a 
later time to participate in a 
confidential in-depth interview. 
  
Study staff will identify a sample of 
providers to invite to participate in an 
in-depth interview. RAs will approach 
these individuals to see if they are 
interested in participating. 
 
At each Aim 1a pharmacy, we will 
interview 2 pharmacy providers and 1-
2 clinicians providing remote oversight 
during Aim 1a (n=8 provider interviews 
total).  
Prior to agreeing to be part of the Aim 1a pilot 
study and Aim 1c extended pilot study, 
providers will be informed that, if they desire, 
they may contact each other via a WhatsApp 
group created and accessible to study staff 
for the purposes of understanding the kinds of 
support pharmacy providers request in 
initiating clients on PrEP and/or refilling PrEP 
prescriptions. Providers are not obligated to 
use this WhatsApp group but may instead opt 
to contact each other through other means 
(e.g., phone calls), the content of which will 
not be known to study staff during Aim 1a. 
For Aim 1c, providers will consent to having 
study-related phone consultations audio 
recorded for subsequent transcription. 
 
The total number of providers participating in 
the WhatsApp group will depend on the 
number of pharmacy providers who are 
trained at each pilot Aim 1a and Aim 1c pilot 
pharmacy to deliver PrEP (likely 1-2 
individuals) and the number of clinicians 
providing remote oversight to these 
pharmacies (likely 1-2). We therefore 
anticipate that approximately 16 providers will 
participate in the WhatsApp group during Aim 
1a and approximately 48 providers will 
participate in the WhatsApp group during Aim 
1c.  
Remote oversight clinicians 
for Aim 1a and Aim 1c 
pharmacies 
• >18 years 
• PrEP clinician at a project-affiliated 
CCC who provides remote 
oversight to a pilot pharmacy  
• Able & willing to provide consent 
1Eligibilty criteria for participating in an in-depth interview and/or the study WhatsApp Group. All participants must provide written or electronic consent to participate in study 
activities. To continue participating in the extended pilot (Aim 1c), pharmacy providers and clinicians who participated in the Aim 1a pilot will need to be re-consented using the Aim 
1c informed consent form (Appendices     
 
 

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28 
 
Pilot procedures 
We have chosen single-arm trials for this study (i.e., no comparison pharmacies) because this study is 
focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways for this 
delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general comparison in 
terms of demographics, retention, and adherence.   
 
Study visits 
Aim 1a pilot: 
All Aim 1a participants will complete a maximum of four study visits: at months 0, 1, 4, and 7 (Fig. 7). 
Participants from Aim 1a pharmacies will initiate PrEP at a pilot pharmacy and be instructed to return to 
the pharmacy one month later (the Kenya standard); thereafter, they will return quarterly to test for HIV 
and refill their PrEP drugs.  
 
Aim 1c pilot: 
Aim 1c participants include the following two populations:  
• Client Population A - Individuals who did not participate in the Aim 1a pilot: These participants 
will initiate PEP, PrEP, and/or undergo STI testing at a pilot pharmacy and be followed for up to 
6 months. They will complete a maximum of four study visits: an initiation visit and follow-up 
visits at 1, 4, and 7 months post-initiation (Fig. 7). 
• Client Population B – Individuals who participated in the Aim 1a pilot: At their last study visit for 
the Aim 1a pilot, these individuals will be informed that they can opt to continue receiving PrEP 
refills at the pilot pharmacy during the extended pilot study but that, to participate in the 
extended pilot study, they will need to complete a new informed consent form. During the 
extended pilot study, participants will be followed for a maximum of 6 months and complete up 
to 3 study visits (in addition to the ones they had during Aim 1a). Figure 8 illustrates the study 
visit schedule and maximum number of study visits participants will have depending on what 
month they enrolled in the Aim 1a or Aim 1c pilot.  Individuals who, after completing their M7 
visit in Aim 1a pilot, continued taking PrEP at a clinic will be notified by study staff about the 
option to obtain PrEP refills at a pilot pharmacy during the extended study. If any such 
individual stopped taking PrEP since their M7 study visit for Aim 1a, but is interested in re-
initiating PrEP at a pilot pharmacy during the extended pilot, s/he will be invited to return to the 
pharmacy to undergo PrEP screening and, if eligible, will be enrolled in the extended pilot and 
follow the study visit schedule for new initiators (i.e., starting with a M0 visit). 
 
Both pilots (Aim 1a and 1c): 
At all study visits that occur at a pharmacy, the pharmacy provider will use the PrEP prescribing/refilling 
checklist (with remote clinician oversight) when delivering PrEP services (Table 8, Appendix III. 
Prescribing checklist). At their last study visit, participants refill PrEP at the pharmacy (receiving a 3-
month supply or a 1-month supply, depending on whether their last visit is a M1 visit or a quarterly 
follow-up visit), complete endline assessments, and be referred to public CCCs for PrEP continuation. 
Throughout the study, the CCC will be a referral point for the pilot pharmacy providers should they have 
any concerns or questions about PrEP clients. 
 
 
 

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29 
 
 
Fig. 7. Timeline of participant enrollment and follow-up 
 
 
Fig. 8. Participant study visits based on enrollment month 
 
PrEP checklist 
In order for pharmacy providers to prescribe PrEP (both at initiation and follow-up visits), they must 
ensure the individual seeking PrEP meets the criteria on a checklist, summarized in Table 8 (also found 
in Appendix III. Prescribing checklist), which we developed in collaboration with Kenyan 
stakeholders (including clinicians, pharmacy providers, etc.) at the stakeholder meeting and updated for 

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30 
 
the extended pilot (Aim 1c) to reflect the Kenya national guidelines for PrEP, which allow pregnant and 
breastfeeding women to initiate PrEP, and the guidelines for PEP.     
 

PROTOCOL: Pharmacy PrEP Pilot                                                                               January 19, 2022 
31 
 
 
 
Interventions 
During Aim 1c, we will incorporate the following interventions to increase demand for PrEP: 
• Peer Referral (Aim 1c only) – Participants coming for a refill visit will be given the option to 
engage in a peer referral program. Those who choose to participate will receive up to 5 referral 
slips (Appendix XXI) at each follow-up visit to distribute to their peers, along with an Information 
Sheet about the peer referral component of this study (Appendix XXII), and will receive a small 
incentive for each of their peers that presents their referral slip at a pilot pharmacy and enquires 
about PrEP. The incentive will be paid even if the referred peer does not ultimately initiate PrEP. 
• PEP-as-a-Bridge-to-PrEP (Aim 1c only): Pharmacy providers will be trained to deliver post-
exposure prophylaxis (PEP) to individuals seeking PEP and/or reporting a recent HIV exposure 
and encourage such clients to return for PrEP. 
• STI Testing-as-a-Bridge-to-PrEP (Aim 1c only) – We will select a subset of 2 pharmacies at which 
pharmacy customers seeking STI diagnosis or treatment services will be offered free STI testing 
plus PrEP screening. Participants who accept STI testing (for C. trachomatis and N. gonorrhoeae) 
can receive it even if they decline being screened for PrEP. Participants that accept STI testing will 
self-collect a urine sample in a private pharmacy room. All pharmacy providers will be trained on 
how to explain urine sample self-collection and contact courier service for sample delivery. 
Couriers will then deliver samples to the nearby study clinic for STI testing (for both C. trachomatis 
and N. gonorrhoeae). Only participants who test positive for an STI will receive a call from study 
physician, who will confirm their identity, screen for potential drug allergies/interactions, and write a 
STI treatment prescription that will be sent electronically to the participant’s choice pilot pharmacy 
for dispensing of free treatment. 
During the Aim 1a and Aim 1c pilots, at each study visit, participants will receive the core components 
of pharmacy-based PrEP delivery identified in the stakeholder engagement meeting (Table 4) and 
incorporated into the care pathway for pharmacy-based PrEP delivery (Fig. 3 and Fig. 4). 
• Counseling – on PrEP or PEP adherence and HIV risk reduction. Specifically, counseling will 
include PrEP/PEP side effect profiles, how to take PrEP/PEP, what to do if PrEP/PEP side effects 
are experienced, and the importance of not sharing PrEP/PEP to optimize potential efficacy and to 
reduce the chances of developing resistance through suboptimal HIV suppression. Depending on 
the study visit, this will be provided by a pharmacy provider. All individuals who administer this 
counseling will have completed PrEP and PEP training, per NASCOP guidelines.  
 
• Assisted HIV self-testing – will be provided at each study visit to clients wishing to initiate PrEP or 
PEP and/or refill PrEP by a pharmacy provider trained on HIV self-testing. During the Aim 1a pilot, 
clients will receive either assisted blood-based or assisted oral-fluid HIV self-testing. During Aim 
Table 8. Checklist for pharmacy PrEP prescribing and refilling. Month (M) 
• 
HIV risk: at risk (determined using the Kenya Rapid Assessment and Screening Tool, RAST) 
• 
Recent HIV exposure: if yes, screen for PEP instead 
• 
Counseling: completed (e.g., risk reduction, PrEP adherence, etc.) 
 
 
 
 
• 
HIV status: negative (confirmed with assisted HIV self-testing at pharmacy) 
 
 
 
 
• 
HIV symptoms: none 
 
 
 
 
• 
Clinical safety & side effect assessment: confirmed (e.g., no known kidney disease) 
• 
Records: completed (for prescribing and dispensing) 
 
 
 
 

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1c, only assisted blood-based HIV self-testing will be used. With assisted HIV self-testing, 
pharmacy clients (including study participants) test for HIV in the presence of and with the support 
of a pharmacy provider using a self-testing kit purchased at the pharmacy (during Aim 1a) or 
provided free of cost at the pharmacy (during Aim 1c). Provider-assisted HIV self-testing (using 
both blood-based and oral-fluid kits) is already ongoing in Kenya, and thus pharmacies included in 
the pilot must already be certified to conduct this assisted self-testing. We are using assisted HIV 
self-testing in these pilots because technically only laboratory technologists are allowed to conduct 
rapid HIV testing in Kenya according to national guidelines (as determined at our stakeholder 
meeting). In Aim 1c, we are switching to blood-based HIV self-testing to assuage ongoing 
concerns about the sensitivity of oral fluid-based HIV self-testing among key decision-makers, 
such as the Kenya MOH and WHO. 
 
• Optional initial at-home HIV self-testing (Aim 1c only) – Clients interested in initiating PrEP at a 
pilot pharmacy during Aim 1c will have the option to take home an HIV self-testing kit (blood-based 
or oral-fluid) and complete the self-test at home before undergoing assisted HIV self-testing with a 
pharmacy provider as required for PrEP initiation. Findings from several PrEP implementation 
studies in Kenya, including the formative research conducted for this study and preliminary findings 
from Aim 1b, suggest that some clients are uncomfortable testing for HIV at a pharmacy without 
knowing their HIV status. Giving clients the option to learn of their HIV status in the privacy of their 
homes may help lower this barrier to PrEP initiation. Clients who opt to complete an initial HIV self-
test at home will receive the kit free of charge. 
 
• PrEP/PEP prescribing – including determination of clinical safety and screening for potential 
PrEP/PEP side effects. To prescribe PrEP /PEP at initiation and follow-up visits, pharmacy 
providers must complete the checklist for PrEP/PEP prescribing (Table 9, Appendix III. 
Prescribing checklist) and keep record of the prescription.  
 
• PrEP/PEP dispensing – once the checklist for PrEP/PEP prescribing (Table 9) has been 
completed, pharmacy providers can dispense PrEP or PEP. At PrEP initiation visits, pharmacy 
providers  will only dispense a 1-month supply of PrEP, per Kenya MOH guidelines. At all follow-up 
visits, pharmacy providers will dispense a 3-month supply of PrEP. At PEP initiation visits, 
pharmacy providers (in Aim 1c) will dispense a 1-month supply of PEP, per Kenya MOH 
guidelines. 
 
• Oversight/referral – A Kenyan study clinician with experience in PrEP and PEP prescribing will be 
available 24/7 for consultation throughout the pharmacy PrEP delivery pilots. Pharmacy providers 
with any questions about PrEP or PEP eligibility or side effects can call the remote clinician for free 
using a number provided, or can consult with the PrEP clinician via a study-created WhatsApp 
group. All pharmacy providers will be trained on when consultation with the remote clinician is 
appropriate and how to share questions or concerns via the WhatsApp group without identifying 
patient information. Pharmacy providers will be trained to record the content of their discussions 
with the remote clinician using a specific study form (Appendix V. Remote clinician form).  
Pharmacy providers will also be given referral forms for nearby CCCs, which they can use to refer 
participants should they test HIV-positive or should they experience any PrEP side effects.  Again, 
pharmacy providers will be trained to record any referrals to CCC using specific study forms 
(Appendix VI. Referral form).    
 
• DBS samples – Trained research assistants will collect dried blood spot (DBS) samples to 
measure blood-level of PrEP adherence. 
To remind participants to refill their PrEP drugs at pharmacies or to return for follow-up after being 
dispensed PEP, we will use retention methods used in Kenyan PrEP clinics (e.g., telephone reminders 

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33 
 
for missed appointments). At the final follow-up visit before the end of the extended pilot study, we will 
do active tracing to have final data on all participants. Participants that are contacted via active tracing 
will still complete quantitative questionnaires (including DBS sample collection) so that we can 
understand the reasons why they might not have returned to the pharmacy for PrEP refills or following 
PEP dispensing; these participants that we actively trace, however, will not count towards our PrEP 
retention measurement. 
Individuals interested in initiating PrEP or PEP and/or refilling PrEP at pharmacies, but not interested in 
participating in study-related activities (including quantitative surveys or DBS collection) will be referred 
to a nearby CCC for free PrEP or PEP care. The total number of such individuals will be tracked over 
time, but no other information will be collected from them.  
Although the PrEP and PEP medications and potentially HIV self-tests for this pilot study will be 
provided by NASCOP via the Kenya Medical Supplies Agency (KEMSA), a consulting fee will be 
associated with pharmacy-based PrEP delivery in our initial pilot study (Aim 1a, as is the case with 
other pharmacy-based services) to reflect the real-world sustainability of the delivery model. This fee 
will be agreed upon in a meeting with participating pharmacy providers and may vary by pharmacy 
depending on the clientele of that pharmacy (i.e., urban, high-income pharmacies may charge more for 
pharmacies in informal settlements). From preliminary conversations with pharmacy providers, we 
estimate that this fee may be between 200-500 KSH, however, if HIV self-tests are not provided for by 
NASCOP via KEMSA, then this fee may be between 300-700 KSH.  During Aim 1c, to assess the 
impact of removing client fees on PrEP initiation and continuation, the study will cover this consulting 
fee and participants will not pay any out-of-pocket expenses to receive PrEP, PEP, or STI testing and 
treatment.   
Condoms will be available for purchase at all participating pilot pharmacies, but not included in the 
package of PrEP services provided in this study.  
The interventions that participants receive at each study visit are summarized in Table 9:.  
Table 9. Interventions received at each study visit. Month (M) 
Study intervention 
Study visit* 
M0 
M1 
M4 
M7 
Counseling: on PrEP use and side effects, PrEP adherence, HIV risk reduction 
X 
X 
X 
X 
Testing: for HIV, STIs (if available), and hepatitis B (if available) 
X 
X 
X 
X 
Safety oversight: ensuring that PrEP is not contraindicated (e.g., history of renal disease, 
diabetes)  
X 
X 
X 
X 
PrEP/PEP prescribing: if all checklist items completed.  
X 
 
 
 
PrEP dispensing: 30-day supply at initiation; 90-day supply at follow-up visits 
X 
X 
X 
PEP dispensing: 30-day supply 
X 
 
 
 
STI testing (optional): if client arrives seeking STI diagnosis and/or treatment services 
X 
 
 
 
Consultation with remote clinician and/or referral to CCC: for complex PrEP cases 
X 
X 
X 
X 
Dried blood spot sampling: for measurement of PrEP adherence 
X 
X 
X 
X 
Social harm: reports of physical, sexual, or verbal violence 
X 
X 
X 
X 
*Aim 1a participants who opt to participate in the extended pilot (Aim 1c) will continue to receive the M7 study 
interventions on a quarterly basis until the study’s end 
 
 
PrEP medication 
Tenofovir disoproxil fumarate (or TDF, 9-[(R)-2-[[bis [[(isopropoxycarbonyl) oxy] methoxy] phosphinyl] 

PROTOCOL: Pharmacy PrEP Pilot                                                                               January 19, 2022 
34 
 
methoxy] propyl] adenine fumarate), emtricitabine (or FTC, 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-
oxatholan-5-yl]cytosine), and lamivudine (or 3TC, 2',3'-dideoxy-3'-thiacytidine 4-Amino- 1-[(2R,5S)- 2-
(hydroxymethyl)- 1,3-oxathiolan-5-yl]- 1,2-dihydropyrimidin- 2-one) are reverse transcriptase inhibitors 
that have been approved for the treatment of HIV infection in humans in Kenya and the United States. 
A fixed-dose, oral co-formulation of FTC/TDF (Truvada®) has also been approved for HIV prevention 
in Kenya and the United States. The World Health Organization recommends TDF-containing 
medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and 
TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing 
medications that align with WHO and Kenya national guidelines for PrEP will be used in this study. 
PrEP will be prescribed for once-daily use.  Study medication will be provided by the Kenya Ministry of 
Health and stored in accordance with the drug manufacturer’s recommendations. 
 
PrEP discontinuation 
PrEP continuation will be according to Kenya PrEP guidelines. Use of PrEP may be interrupted by the 
site investigators, trained pharmacy providers, or remote clinician due to safety concerns for the 
participant or use of concomitant medications that could interfere with PrEP or present a safety 
concern. For female participants that report pregnancy during the pilot studies, PrEP care will be 
discontinued at the participating pilot pharmacy and the pharmacy provider will refer these women to 
the nearest antenatal care clinic for care (including PrEP care). All treatment interruptions will be 
documented.   
 
Referral to continued PrEP care 
For participants that continue to return to the pilot pharmacies for PrEP refills, at their final pharmacy 
PrEP refill visit before the study’s end, pharmacy providers will dispense another 3-month PrEP supply 
(assuming the individual meets the criteria on the prescribing checklist, Appendix III. Prescribing 
checklist) and then will refer participants to a nearby public CCC for free continued PrEP care 
(Appendix IV. Referral form).  
PEP medication 
Tenofovir disoproxil fumarate (or TDF, 9-[(R)-2-[[bis [[(isopropoxycarbonyl) oxy] methoxy] phosphinyl] 
methoxy] propyl] adenine fumarate) and dolutegravir (or DTG, 1,2-bis(2-methylphenyl)guanidine) are 
reverse transcriptase inhibitators that, in combination with lamivudine (or 3TC, 2',3'-dideoxy-3'-
thiacytidine 4-Amino- 1-[(2R,5S)- 2-(hydroxymethyl)- 1,3-oxathiolan-5-yl]- 1,2-dihydropyrimidin- 2-
one)—an integrase strand transfer inhibitor—have been approved for use as HIV post-exposure 
prophylaxis in Kenya among individuals age 15 or older or weighing 35 kg or more. For women and 
adolescent girls of childbearing potential, the Kenyan guidelines recommend a regimen that substitutes 
3TC 
for 
atazanavir/ritonavir 
(or 
ATV/r, 
3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-
(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl 
ester). PEP will be prescribed for once-daily use, and participants found eligible for PEP will be 
dispensed a one-month supply, as per Kenya national guidelines. Study medication will be provided by 
the Kenya Ministry of Health and stored in accordance with the drug manufacturer’s recommendations.       
Referral for continued PEP care 
During the extended pilot (Aim 1c), any individual who is found eligible for PEP but who declines to 
initiate PEP at a pilot pharmacy will be referred to an HIV comprehensive care clinic. Any participant 
who is dispensed PEP at less than 1 month before study endline will be instructed to go to an HIV 
comprehensive care clinic for PEP follow-up care and given a referral form (Appendix VII. Referral 
form). 

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Data Collection 
Quantitative client surveys & DBS (Aims 1a and 1c) 
Trained research assistants (RAs) stationed at pilot pharmacies will approach eligible individuals and 
invite them to participate in the study. They will review the informed consent form (Appendix I for Aim 
1a and Appendices XII and XIII for Aim 1c) with these individuals and answer any questions they 
may have regarding participation. Once written informed consent is obtained, RAs will conduct a 
structured quantitative survey with the participant (Appendix VI. Questionnaire: Baseline for Aim 1a 
and Appendix XVII for Aim 1c). (The timing of the survey for each pilot is outlined above in Fig. 7.) 
Table 10 outlines the information we will collect in these surveys, including information to be collected 
in the follow-up questionnaire (Appendix VII. Questionnaire: Follow-up for Aim 1a and Appendix 
XVIII for Aim 1a). All quantitative data will be collected on a tablet using CommCare (Dimagi, 
Cambridge, USA), an electronic data collection platform. At each study visit, RAs will also collect a DBS 
sample from participants. PrEP adherence will be assessed using self-reported drug adherence in 
quantitative surveys and batched drug levels in DBS samples at PrEP initiation and follow-up visits. 
Dried blood spots and plasma from batched drug levels will be  processed and analyzed for tenofovir 
drug levels. 
 
 
Costs (Aim 1a and 1c) 
To measure costs and cost preferences associated with pharmacy-based PrEP deliver, we have 
included questions related to participants’ expenditures on health goods/services (at clinics or 
pharmacies) and their willingness to pay for pharmacy-based PrEP delivery in the quantitative surveys 
(Table 10, Appendix VI. Questionnaire: Baseline, Appendix VII. Questionnaire: Follow-up; 
Appendix XVII: Baseline questionnaire for Aim 1c participants, Appendix XVIII: Follow-up 
questionnaire for Aim 1c participants). Additionally, we will conduct two quantitative surveys with the 
lead staff member of each Aim 1a pilot pharmacy (n=4): 1) shortly after the pharmacy training on pilot 
procedures and before the first participant is enrolled, and 2) at study completion, seven months after 
Table 10. Information collected in the quantitative surveys. Month (M) 
 
Study visit 
Information collected 
M0 
M1 
M4 
M7 
Socio-demographic: gender, age, education, employment 
X 
 
 
 
Alcohol use: # days in past week, alc. problem screen (RAPS4-Q4) 
X 
X 
X 
X 
Depression: PHQ-9 depression screening tool, often used in SSA 
X 
X 
X 
X 
Relationship: partner status, social support, partner violence  
X 
X 
X 
X 
Sexual behaviors: sex frequency, condom use, sexual power, STI history 
X 
X 
X 
X 
Fertility intentions: # children (& goal #), pregnancy history, current contraception 
X 
X 
X 
X 
HIV stigma: scale + disclosure to fam./friends & adverse effects 
X 
X 
X 
X 
COVID-19 assessment: prevention measures, risk, impact on health seeking 
X 
X 
X 
X 
PrEP adherence: pills missed (past week) 
 
X 
X 
X 
Clinical safety: pregnancy, history of kidney disease, etc.  
X 
X 
X 
X 
Potential drug side effects: nausea, vomit, dizziness, headache 
 
X 
X 
X 
Social harm: reports of physical, sexual, or verbal violence 
 
X 
X 
X 
Costs: $ spent at last pharmacy/clinic visit, willingness to pay (see Table 10) 
X 
X 
X 
X 
Implementation strategies: acceptability and feasibility (Aim 1c only) 
X 
X 
X 
X 
*For Aim1a participants who opt to participate in the extended pilot (Aim 1c), we will continue to collect the 
same information as shown for M7 above on a quarterly basis until the study’s end. 

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36 
 
the last participant has been enrolled. Table 11 details the costs we will measure in surveys for 
providers and clients. All surveys will be conducted by trained research assistants on tablets using 
CommCare, an electronic data collection platform. 
  
Standardized patient actors (Aim 1a only) 
To measure fidelity of the Aim 1a pharmacy-based PrEP delivery intervention (i.e., counseling, HIV 
testing, safety assessment), we will use unannounced standardized patient actors. Standardized 
patient actors have been shown to accurately measure care and assess provider performance in a 
variety of settings, including PrEP research in Kenya.84–90 The use of standardized patient actors is 
advantageous in this study because it enables us to identify weak points in our pharmacy-based PrEP 
delivery care pathway for individuals and scenarios that are of particular interest (e.g., pregnant 
women, or individuals who test HIV positive). While pharmacy providers will not know that the 
standardized patient actor is an actor at the time of that individual’s study visit, providers will be 
informed of and agree to this study procedure when they agree to participate in the pilot study.  
 
Case scripts 
In consultation with Kenyan medical PrEP providers, we have developed case scripts informed by 
previously conducted formative research. We developed scripts for four distinct participant populations 
hypothesized to benefit most from pharmacy-based services:  
 
(1) Young woman, seeking emergency contraception 
(2) Man who has sex with other men, presenting for STI treatment 
(3) Young man, seeking sexual performance enhancing drugs (e.g., Viagra)  
(4) Young woman, has trouble doing HIV test  
 
Actors 
We will train 4-6 study staff (not participating in research related to this project) as standardized patient 
actors. These staff will participate in a standardized patient actor training (conducted by a trainer with 
years of experience) on case scripts that detail key elements of pharmacy-based PrEP delivery, 
including general PrEP inquires, eligibility requirements, symptoms of PrEP side effects, and PrEP non-
adherence. The study staff that volunteer to be standardized actors have to not be living with HIV and 
must agree to HIV testing at the pilot pharmacies; we will take every precaution to ensure their HIV 
status remains confidential should one of these individuals test HIV positive at a pilot pharmacies. The 
number of actors (N=4) and visits (2 visits/actor, =8 visits in total) we are proposing for this assessment 
is consistent with similar evaluations conducted in other settings.84 
 
Table 11. Pharmacy-based PrEP delivery costs measured 
Client costs 
Provider costs 
●  Service(s)/item(s) purchased at most recent 
pharmacy visit, & amount spent on each 
●  Service(s)/item(s) provided by the pharmacy, & the cost of 
these services 
●  Travel time, time away from work, child care, & 
other costs associated with pharmacy PrEP visit 
●  Overhead costs (including salaries and space) of running a 
pharmacy 
●  Perceptions on price at which pharmacy-based 
PrEP was provided in the pilot  
●  Perceptions on price at which pharmacy-based PrEP was 
provided in the pilot 
●  Price willing to pay for pharmacy-based PrEP  
●  Price willing to provide pharmacy-based PrEP  
 
●  Time spent recruiting PrEP clients and with each PrEP 
client for  PrEP initiation (including counseling) and refills 

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37 
 
Unannounced visits 
The patient actors will visit the Aim 1a pilot pharmacies two times: 1) once to initiate PrEP, and 2) a 
second time to refill their PrEP drug supply. The patient actors will complete all steps in the pharmacy-
based PrEP delivery care pathway that would be completed by any other PrEP client. 
 
Standardized patient checklist 
At the end of each unannounced visit, standardized patients will complete a debriefing visit with a 
research assistant collecting data for the pilot study. This debriefing visit will occur on the same day of 
the actor’s unannounced visit, in a private setting outside the pilot pharmacy. At this debriefing visit 
(which will be audio recorded), the standardized patient actor will complete two checklists with the 
research assistant: 1) a technical checklist that identifies what services they were offered and how 
much they paid, and 2) a checklist that assess the quality of care, including duration of the visit and the 
actors’ perceptions of how they were treated by the pharmacy PrEP provider (summarized in Table 12, 
Appendix XIV. Standardized Patient Actor Checklist). The technical checklists will vary slightly for 
PrEP initiation (enrollment) and PrEP refill (follow-up) to account for the different services associated 
with these visits. All checklist data will be collected electronically on a tablet or phone using 
CommCare, an electronic data platform. The audio recordings from the debriefing visit with be 
transcribed so that can be later used to supplement the checklist data. 
 
 
In-depth interviews (Aim 1b)  
We will conduct in-depth qualitative interviews with clients and providers (both pharmacy providers and 
clinicians providing remote oversight) who participated in the Aim 1a pilot to explore their experiences 
with this new PrEP delivery model and understand the acceptability of pharmacy-based PrEP. In client 
interviews (Appendix VIII. In-Depth Interview Guide: Clients), we will assess perceptions of quality of 
care, attitudes towards paying for pharmacy-based PrEP delivery, and their interest in continuing to 
receive PrEP at pharmacies. In provider interviews (Appendix IX. In-Depth Interview Guide: 
Providers, Appendix X. In-Depth Interview Guide: Clinicians), we will assess pharmacy providers’ 
attitudes toward providing PrEP and interest in continuing to provide PrEP at pharmacies or remote 
oversight. The topics to be discussed during these interviews are summarized in Table 13. All 
pharmacy providers that participate in these in-depth interviews will sign documents of informed 
consent (Appendix II); consent for the in-depth qualitative interviews was included in the consent for 
participation in the pilot study for pharmacy clients (Appendix I). 
 
All qualitative interviews will be conducted in the participant’s preferred language (English, Dholuo or 
Kiswahili) by trained research assistants using pre-piloted, semi-structured guides. Each interview will 
be audio recorded, transcribed, and translated into English by study team members who will also 
Table 12. Standardized fidelity checklists items (PrEP initiation) 
Technical assessment 
Quality of care assessment  
●  Asked if they were interested in initiating PrEP  
●  Greeted when entered pharmacy 
●  Tested for HIV 
●  Pharmacist made eye contact and smiled 
●  Counseled on importance of PrEP adherence 
●  Pharmacist explained why providing services 
●  Counseled on potential side effects of PrEP 
●  Pharmacist did not use judging or stigmatizing language 
●  Screening for pre-existing health conditions, 
including COVID-19 symptoms 
●  Patient felt that privacy was maintained throughout their 
visit 
●  Received 1-month (initiation) or 3-month (refill) 
PrEP supply 
●  Interactions with the pharmacists were not rushed 
 
• 
Measures were in place for COVD-19 protection. 

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38 
 
routinely complete debriefing reports83 to accelerate real-time learning. Dr. Ngure, an experienced 
behavioral scientist who has led our qualitative research in Thika for the past decade, will supervise 
these interviews in collaboration with Dr. Kwena, a social scientist based in Kisumu.  
 
 
WhatsApp Group (Aim 1a and 1c) 
 
Prior to agreeing to be part of this pilot study, providers will be informed that, if they desire, they may 
contact each other via a WhatsApp group created and accessible to study staff for the purposes of 
understanding the kinds of support pharmacy providers request in initiating clients on PrEP and/or 
refilling PrEP prescriptions. Providers are not obligated to use this WhatsApp group but may instead opt 
to contact each other through other means (e.g., phone calls). By signing the consent form for Aim 1c, 
pharmacy providers and remote study clinicians consent to having any study-related phone 
consultation recorded and subsequently transcribed for analysis. Study staff will export any 
conversation threads (hereafter, “transcripts”) from the study-created WhatsApp group for analysis. All 
pharmacy provider and remote clinicians that participate in this WhatsApp Group will sign documents of 
informed consent (Appendix II). 
 
Quantitative provider surveys (Aim 1c only) 
 
For Aim 1c, we will conduct baseline and monthly follow-up surveys (Appendices XIX and XX) with 
pharmacy providers who are involved in the delivery of PrEP, PEP, and/or STI testing at a pilot 
pharmacy (n=up to 2 providers surveyed per pilot pharmacy, or 12 survey participants total). These 
surveys will collect basic demographic information about the providers, their assessments of 
acceptability and feasibility of the care pathway refinements (peer referral, PEP-as-a-bridge-to-PrEP, 
STI testing-as-a-bridge-to-PrEP, optional client self-administration of the HIV risk assessment tool, 
optional initial HIV self-test at home, provider assisted blood-based HIV self-testing), and their 
willingness to charge for pharmacy-based PrEP services. All surveys will be conducted by trained 
research assistants on tablets using CommCare, an electronic data collection platform. For the handful 
of survey questions that are open-ended, the research assistant will audio record the participant’s 
response. These audio recordings will be subsequently transcribed, translated to English (if necessary), 
and stored securely.    
 
Table 13. Topics to be discussed during qualitative interviews 
Services received 
• 
Description of client services received at pharmacy (e.g., greeting, counseling, 
screening, dispensing, etc.) 
Likes/dislikes of 
pharmacy-based 
PrEP delivery 
• 
Discussion of client and provider preferences related to pharmacy-based PrEP 
delivery – what worked, what did not work, elements of services that were or were 
not appreciated or convenient.  
Quality of services  
• 
Discussion of how clients were treated by pharmacists, including participants’ 
attitudes on how comfortable and confident pharmacists seemed providing PrEP 
services.  
Cost of pharmacy-
based PrEP  
• 
Discussion of the costs associated with pharmacy-based PrEP delivery – did clients 
find them reasonable? Would provider be willing to continue to provide PrEP at 
these costs? How might the costs be adjusted?   
Future interest in 
pharmacy-based 
PrEP 
• 
Discussion of where clients might want to access PrEP in the future: standard of 
care clinic-based delivery or preference for the new model of pharmacy-based PrEP 
delivery? 
COVID-19 impact 
• 
Discussion of how the COVID-19 outbreak affected healthcare seeking behaviors, 
including participants’ ability to access PrEP at pilot pharmacies.  

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39 
 
Data Analysis & Outcomes 
Quantitative client surveys & DBS (Aims 1a and 1c) 
Table 14 shows the study outcomes that will be obtained from the quantitative surveys  (Appendix VI. 
Questionnaire: Baseline, Appendix VII. Questionnaire: Follow-up for Aim 1a and Appendices 
XVII and XVIII for Aim 1c) and DBS data. For Aims 1a and 1c, we will calculate the number of 
participants who initiated PrEP at pilot pharmacies, and the proportion of these who: returned for PrEP 
refills, were adherent to PrEP, and experienced any PrEP side effects or study-related social harms. 
Additionally, we will measure the percentage of participants that elected to complete STI testing, the 
percentage of these that tested positive for an STI (either C. trachomatis or N. gonorrhoeae), and the 
percentage of these who linked to a pilot pharmacy for free STI treatment.  
• PrEP initiation. We will report the socio-demographic characteristics of participants who initiate 
PrEP at pharmacies (Aim 1a) and compare those with the sociodemographic characteristics of 
participants from our other studies who have initiated PrEP at healthcare facilities. 
 
• PrEP refills. We will report the socio-demographic characteristics of participants who refilled PrEP 
at a pharmacy and compare those with the sociodemographic characteristics of participants from 
our other studies who have refilled PrEP at healthcare. 
 
• PrEP discontinuation. For individuals who are in known HIV serodiscordant relationships, if a 
participant discontinues PrEP use because their HIV infected partner has initiated and sustained 
ART for >6 months (the Kenya standard for discontinuing PrEP), this participant will be considered 
PrEP-adherent. Similarly, if PrEP is discontinued for safety reasons (but not adherence reasons) 
as determined by the pharmacy providers and confirmed by the remote clinician, follow-up 
thereafter will be censored, since the subject will not be able to be assessed for adherence to 
PrEP.  
 
Adjusted analyses will be done as needed, controlling for potential confounders based on our prior work 
assessing correlates of PrEP use: demographics (e.g., age, educational level), sexual behaviors (e.g., 
condom use, MSM, number of partners), medical status (e.g., depression), and beliefs (e.g., risk 
perception, PrEP efficacy). We will assess specifically for gender as a key variable. Stata or R will be 
used for all analyses.   
 
We will take a random sample of 10% of the DBS samples and measure concentrations of tenofovir 
diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) using validated liquid chromatography 
tandem mass spectrometry (LC-MS/MS), which has become the gold standard for research evaluations 
of PrEP adherence.10,11  Any concentrations of TFV-DP in a DBS punch >700 fmol will be considered 
PrEP adherent.10 All DBS samples that we collect from study participants will initially be stored in a 
secure freezer at the Kisumu study site. However, the DBS samples that are randomly selected for 
TFV-DP and FTC-TP drug concentration testing will be shipped to a laboratory for analysis. 
 
Table 14. Outcomes from quantitative survey and DBS samples (Aim 1a and 1c) 
 
Aim(s) 
Definition 
Data Source(s) 
Timing 
PrEP initiation 
Aim 1a 
# of participants that initiated PrEP at pilot 
pharmacies 
• Quant survey 
• Pharm records 
M0 
PrEP retention 
Aim 1a 
% of participants who return to the pilot 
pharmacies for PrEP refills 
• Quant survey 
• Pharm records 
 
M1, M4, M7 
PrEP 
Aim 1a  • % of participants that missed no pills in 
• Quant survey 
M1, M4, M7 

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adherence 
previous week 
• % of participants that refill drugs at pharmacy 
• % of DBS samples with drug concentrations 
indicating adherence 
• Pharm records 
• DBS 
 
 
Selection of 
STI testing 
Aim 1a  • % of participants that selected to test for STIs 
at their pharmacy PrEP visit 
o 
% of STIs among participants who tested  
• % of participants who tested positive to 
received free STI treatment from the pilot 
pharmacy 
• Quant survey 
• Pharm records 
N/A 
PEP initiation 
Aim 1c 
# of participants that initiated PEP at enrollment 
at a pilot pharmacy 
• Quant survey 
M0 
PrEP initiation 
following PEP 
Aim 1c 
# of participants that initiated PrEP at a pilot 
pharmacy and, at a later study visit, initiated 
PrEP 
• Quant survey 
M0, M1, M4, 
M7 
STI testing 
Aim 1c 
# of participants that underwent STI testing at 
enrollment at a pilot pharmacy 
• Quant survey 
M0 
Concurrent STI 
testing and 
PrEP initiation 
Aim 1c 
# of participants that underwent STI testing at 
enrollment at a pilot pharmacy and initiated 
PrEP at that same visit 
• Quant survey 
M0 
PrEP initiation 
following STI 
testing 
Aim 1c 
# of participants that underwent STI testing at a 
pilot pharmacy and, at a later study visit, 
initiated PrEP 
• Quant survey 
M0, M1, M4, 
M7 
Acceptability & 
feasibility of 
implementation 
strategies used 
in the refined 
care pathway 
Aim 1c 
Median rating of each implementation strategy 
(i.e., care pathway refinement shown in Figure 
4) 
• Quant survey 
M0, M1, M4, 
M7 
*Aim 1a participants who opt to participate in the extended pilot (Aim 1c) will continue to contribute data at 
quarterly follow-up visits until the study’s end. 
 
Costs (Aim 1a and 1c) 
We will use descriptive statistics to summarize the various aspects of pharmacy-based PrEP delivery 
costs (Table 11). We will use multivariable regression models to determine the socio-demographic 
characteristics of PrEP clients (collected in the baseline quantitative survey) that might be associated 
with cost-related outcomes (e.g., willingness to pay). 
 
Standardized patient actors (Aim 1a only) 
For each pharmacy, we will calculate the percentage of actors who received the items on the technical 
and quality-of-care checklists (Appendix XI. Standardized Patient Actor Checklist). We will pre-
determine what items on the checklist are essential for pharmacy-based PrEP delivery and calculate 
the percentage of actors who received all of these services. We will also supplement the findings from 
the checklist with insights (i.e., quotes) shared during the debriefing meeting and captured in the audio 
recordings/transcripts of these meetings. Additionally, we will identify key areas of our care pathway 
that will require additional training, modification, or reinforcement during implementation.  
 
In-depth interviews (Aim 1b), WhatsApp group (Aim 1a and 1c), and phone consultation 
transcripts (Aim 1c only) 
Interview transcripts, WhatsApp transcripts, and phone consultation transcripts will be reviewed 
separately by two qualitative researchers, who will ensure completeness. These researchers will 

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41 
 
immerse themselves in the data through repeated readings of the transcripts and create a preliminary 
codebook of inductive84,85 and deductive86–88 codes to capture client and provider experiences of 
pharmacy-based PrEP delivery, including barriers and facilitators. A sample of transcripts will be 
double-coded independently by two or more researchers, with coding discrepancies identified and 
resolved via consensus. During this process, the codebook will be refined, with existing codes 
combined, separated, or eliminated and new codes added as needed to capture emerging themes.89,90 
Thereafter, remaining transcripts will be coded in Dedoose (Los Angeles, California, USA) and Atlas.ti 
(Berlin, Germany).  Study team have extensive experience analyzing qualitative data to inform 
intervention development.24,91–112 
 
Quantitative provider surveys (Aim 1c only) 
We will calculate median provider ratings for each survey item assessing acceptability and/or feasibility 
of the model refinements. We will also assess change in providers’ ratings over time, and we will 
calculate median willingness to charge for pharmacy-based PrEP services. Excel, Stata, or R will be 
used for all quantitative analyses. We will qualitatively analyze the transcriptions of provider responses 
to open-ended questions using content analysis. 
 
Participant retention and withdrawal 
The Kisumu site will develop retention methods tailored to and most efficient for the local study setting. 
Retention activities may include explanation of the study visit schedule and procedural requirements 
during the informed consent process and re-emphasis at each study visit, collection and updating of 
locator information, and use of appropriate and timely visit reminder mechanisms (including phone calls 
and text messages). To provide complete information at the end of the study, efforts will be made to 
have a final follow-up visit for each participant.  
 
Participants may voluntarily withdraw from the study for any reason at any time. The site Investigators 
also may withdraw participants from the study in order to protect their safety and/or if they are unwilling 
or unable to comply with required study procedures.  Reasons for withdrawal will be recorded.  
 
Limitations 
These pilot studies have some potential limitations that are important to note. First, the pharmacies and 
pharmacy providers selected to participate in these pilot studies will be selected on specific criteria and 
may not be generalizable to all private pharmacies and pharmacy providers throughout Kenya. For 
example, all pharmacies participating in these pilots must be registered with the different Kenyan 
pharmaceutical boards, thus the findings from this study cannot extend to non-registered pharmacies or 
drug kiosks – which will unlikely to be able to legally deliver PrEP in a real-world setting without 
registration anyways.  
 
Additionally, the remote PrEP clinicians that will oversee any questions pharmacy providers may have 
about pharmacy-based PrEP delivery will be PrEP experts within the Kenya PrEP delivery setting and 
might not be representative of all remote clinicians available for consultation if pharmacy-based PrEP 
delivery is to be scaled throughout Kenya. However, since these PrEP clinicians just have to be 
available remotely and not in person, it should be feasible to have a rotation of PrEP experts available 
for consultation if this model is to be scaled-up in Kenya. 
 
Finally, in these pilot studies, the PrEP drugs and HIV self-tests are being provided by the Kenya 
Ministry of Health, and thus the price pilot participants pay for pharmacy-based PrEP delivery in Aim 1a 

PROTOCOL: Pharmacy PrEP Pilot                                                                               January 19, 2022 
42 
 
is just a mark-up that covers the overhead of pharmacy PrEP storage and providers’ time. This model, 
where the Ministry of Health provides PrEP and HIV self-test kits to private pharmacies for distribution, 
might not be feasible if pharmacy-based PrEP delivery is to be scaled nationally in Kenya. Thus, the 
future price of pharmacy-based PrEP may differ from that in this pilot study (i.e., it will likely increase), 
which may influence (i.e., decrease) PrEP uptake and retention among individuals who access PrEP at 
pharmacies.  
 

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SAFETY 
PrEP  
Multinational studies demonstrated that PrEP (including FTC/TDF) was safe for use in heterosexual 
men and women from Kenya and Uganda. There were no statistically significant differences in the 
frequency of deaths, serious adverse events, adverse events overall, or key laboratory adverse events 
(specifically, creatinine elevation and phosphorus decrease) for those receiving PrEP compared to 
those receiving placebo in the Partners PrEP study.   
 
For the purposes of this study, only serious adverse events (SAEs) will be documented. SAEs felt to be 
related to PrEP will result in temporary hold of PrEP. In the case of temporary holds, the hold will 
continue until the event is stabilized or resolved. If the event resolves, PrEP may be reinitiated at the 
discretion of the Data Monitoring Committee (see “Study oversight” below), resuming safety monitoring. 
The severity of clinical symptoms will be scored using the DAIDS Table (July 2017 Version) for Grading 
the Severity of Adult and Pediatric AEs. Reporting on adverse events to relevant IRBs will be according 
to relevant regulations.   
 
Pregnancy 
Animal and human data, including from the Partners PrEP Study and Partners Demonstration Project, 
suggest safety of FTC/TDF when used by HIV infected women during pregnancy and breastfeeding.  
Other studies are exploring detailed safety of PrEP use in pregnancy. In the pilot evaluations described 
in Aims 1a, we excluded pregnant and breastfeeding women because it was felt, at the time, that 
assessing the PrEP eligibility of pregnant women was outside of the scope of care of pharmacy 
providers in Kenya. However, through consultation with members of the Kenya Ministry of Health and 
other PrEP stakeholders, we have come to the realization excluding pregnant women from those pilot 
studies was unnecessary for two reasons. First, Kenya’s current national PrEP guidelines allow 
pregnant women to be initiated on PrEP, in line with WHO recommendations. In fact, the guidelines 
explicitly state, “Pregnancy and breastfeeding are not contraindications to provision of PrEP. Pregnant 
or breastfeeding women whose sexual partners are HIV positive or are at high risk of HIV infection may 
benefit from PrEP as part of combination prevention of HIV infection”, and throughout Kenya, PrEP is 
regularly prescribed to pregnant and breastfeeding women, for example, at family planning and 
antenatal care clinics. Second, within the Kenya national PrEP guidelines, the criteria that individuals 
must meet to qualify for PrEP do not vary based on the prospective client’s pregnancy status. As such, 
pharmacy providers in this pilot study would not need any additional training beyond that which we 
provided in Aim 1a in order to safely initiate pregnant and breastfeeding women on PrEP. Lastly, 
excluding pregnant and breastfeeding women from our extended pilot study (Aim 1c) who otherwise 
meet both study and PrEP eligibility criteria (i.e., who test negative for HIV, are determined to be at high 
risk of HIV using the Kenya Risk Assessment Screening Tool, and who have no other PrEP 
contraindications) may represent a greater risk to them than including them in the study would, as it 
would constitute denying them access to PrEP—a drug that has been found to reduce the risk of 
getting HIV by sex by about 99% (CDC, 2021). For these reasons, we propose allowing pregnant and 
breastfeeding women to participate in our extended pilot study (Aim 1c).  
 
Social harm considerations 
We have extensively considered the risk of social harm related to both PrEP use and the delivery and 
prescribing of PrEP at pharmacies, including risks of depression/anxiety and disclosure and stigma.  
Our extensive experience with longitudinal follow-up of heterosexual HIV serodiscordant couples and 
women at risk mitigates some of this risk, and we found very little risk of social harms or anxiety related 

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44 
 
to HIV self-testing in our pilot evaluation, among couples. Analyses of social harm related to pharmacy-
based PrEP delivery will be done overall, by sex and by relationship status, given the potential for 
differential gendered and relationship risks.  In the event of a clinical need (e.g., side effects, symptoms 
of a sexually transmitted infection), participants will be referred to nearby HIV clinics for care. 
 

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HUMAN SUBJECTS CONSIDERATIONS 
The protocol, informed consent forms (for pilot participation and for interviews of participants and 
providers), and patient education and recruitment materials will be reviewed and approved by the 
institutional review boards at the University of Washington and at KEMRI. All participants will provide 
written informed consent before participation in the pilot and quantitative/qualitative interviews. 
Participants will be informed the purpose of the study, the procedures to be followed and the risks and 
benefits of participation. The consents forms will be translated into Kiswahili. Specifically, the 
participants will be informed that this novel study will answer critical questions on acceptability, 
feasibility, and costs of pharmacy-based PrEP delivery in Kenya.   
 
Study oversight 
This study will be subject to oversight by an independent data monitoring committee that will 
periodically review data from the study, including study execution, adherence, HIV incidence, 
PrEP/PEP side effects, serious adverse events and social harms by study arm. We have had a Data 
Monitoring Committee for many of our other ongoing studies. The independent data monitoring 
committee will provide recommendations to the study team as part of periodic reviews. Reports from all 
reviews will be provided for submission to overseeing IRBs/ECs. 
 
Risks 
Participants may become embarrassed, worried, or anxious when completing their HIV risk assessment 
and/or receiving HIV counseling at pharmacies. They also may become worried or anxious while 
waiting for their HIV test results at the pharmacy. Individual counseling and discussions of study 
participation may raise issues in individuals. Participants who learn that they have HIV may experience 
anxiety or depression related to their test results. At all study sites, individual and couples-based HIV 
counseling will be provided by pharmacists who have been trained in specific issues related to HIV risk, 
HIV acquisition, and care of HIV serodiscordant couples, including stigma, blame, methods to avoid 
transmission, and available support services. 
 
Although study sites will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others, particularly as this project will 
be conducted at community-based settings. There is a possibility that social harms may result (i.e., 
because participants could become known as participating in a pilot involving HIV prevention).  For 
example, participants could be treated unfairly or discriminated against, or could have problems being 
accepted by their families and/or communities.  Understanding the risk/benefit balance for confidential 
delivery of PrEP services in community settings is an explicit goal of this project. Moreover, we have 
extensive experience with the strategies to minimize the potential for social harms in populations 
participating in HIV prevention studies.  
 
Risks and side effects related to PrEP include gastrointestinal intolerance and rarely more serious side 
effects; these are detailed on the package insert and this project is not testing PrEP itself but its 
delivery.  The medical risks of HIV testing using blood collection are small.  
 
Protection against risk 
The study team has extensive experience with counseling about HIV risk, PrEP, and strategies for HIV 
prevention in general. Study procedures will include qualitative interviews and prospective follow-up, 

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46 
 
HIV testing, blood collection, assessment of uptake and adherence to PrEP for HIV prevention. PrEP 
will be provided by the study site and will follow Kenya clinical guidelines. Counseling about 
antiretroviral-based HIV prevention will include messaging describing the benefits of all strategies, 
based on evolving available data and national policies / national roll-out of antiretrovirals (including 
earlier treatment and PrEP) for HIV prevention.  
 
For data collection, standardized questionnaires will be used that will include questions on sensitive 
topics, including sexual behavior, depression, alcohol use, and stigma. We have extensive experience 
with these questionnaires from our prior studies and the expertise and counseling resources required to 
attend to study participants (e.g., those with depression). We have published on very low rates of social 
harm and intimate partner violence in our prospective studies of HIV serodiscordant couples, which 
likely reflects the counseling available to couples; for women at risk, we have extensive experience with 
management of potential social harms, through our prevention studies (detailed in Preliminary Results 
and also experience in clinical trials such as ASPIRE, the MTN study of the dapivirine vaginal ring for 
HIV prevention).  
  
The risks from the anticipated activities will be no greater than in our previous studies; in fact, given the 
proven prevention benefits of PrEP and now national roll-out in Kenya, risks are anticipated to be less 
than in some of our prior studies. We feel the risks associated with the study are small. The benefits are 
consistent with clinical care benefits and cultural expectations and they follow the established standard 
with IRB approval in our other studies. We therefore believe the balance of benefit and risk is 
appropriate. 
 
Benefits 
All pilot participants will benefit by having novel access to PrEP during the study period. HIV prevention 
practices, according to national guidelines, will be provided to all participants enrolled in this study.  
This will include risk reduction counseling, addressing sexually transmitted infections (STIs), and 
access to condoms. There are also possible benefits from ongoing access to HIV risk reduction 
counseling and other prevention services at the pilot pharmacies. In addition, participants and others 
also may benefit in the future from information learned from this study. There may be no other direct 
benefits to participants in this study.   
 
Care for persons identified as HIV infected 
This study will identify persons who are infected with HIV, either as part of the study screening process 
or during follow-up of enrolled participants. Study staff will provide participants with their HIV test results 
in the context of post-test counseling. Persons identified as HIV infected during the study screening 
process, but who do not meet eligibility criteria or who do not wish to enroll in the study, will be referred 
to nearby clinics where they can receive free HIV care and treatment services. For participants who are 
HIV infected and who also become pregnant during follow-up, every effort will be made to facilitate 
access to programs for preventing mother-to-child HIV transmission for appropriate antiretroviral 
treatment to reduce the probability of HIV transmission from mother to child.   
 
Benefits to the community 
An important goal of this study is to achieve the study objectives in a way that provides benefits to the 
community that endure beyond the proposed study lifetime regardless of the specific outcome of the 
study. Some of these community benefits include development of optimized approaches to HIV 
prevention care and community awareness of comprehensive HIV prevention.  
 

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Importance of the knowledge to be gained 
Knowledge gained from the studies proposed in this application will include information about optimal 
delivery of PrEP for HIV prevention, which may have substantial impact on the global burden of HIV. 
 
Treatment for injury 
Participants will be asked to inform the clinic staff if they feel they have been injured because of taking 
part in the study. Injuries may also be identified during laboratory testing, medical histories, and 
physical examinations. Treatment for adverse events related to study participation will be provided by 
the treatment clinic. If treatment is required that is beyond the capacity of the clinic, the clinic staff will 
refer the participant to appropriate services or organizations that can provide care for the injury.  
 
Study records 
Implementation investigators will maintain, and store in a secure manner, complete, accurate, and 
current study records throughout the study.  Study records include administrative documentation and 
regulatory documentation as well as documentation related to each participant enrolled in the cohort, 
including informed consent forms, data forms, notations of all contacts with the participant, and all other 
source documents.   
 
Confidentiality 
Every effort will be made to protect participant privacy and confidentiality to the extent possible. 
Personal identifying information will be retained at the local study site and not forwarded to the 
University of Washington Coordinating Center. The site will use its standard operating procedure for 
confidentiality protection that reflects the input of study staff and community representatives to identify 
potential confidentiality issues and strategies to address them. 
   
All study-related information will be stored securely at the study sites. All participant information will be 
stored in areas with limited access. Data collection, administrative forms, laboratory specimens, and 
other reports will be identified only by a coded number to maintain participant confidentiality. All records 
that contain names or other personal identifiers, such as locator forms and informed consent forms, will 
be stored separately from study records identified by code number. All local databases will be secured 
with password-protected access systems. Forms, lists, logbooks, appointment books, and any other 
listings that link participant ID numbers to other identifying information will be stored in a separate, 
locked file in an area with limited access. 
 
Dissemination Plan 
The study team for this award is committed to public dissemination of results of pilot studies, to 
participants, local stakeholders in Kenya, the global scientific community, and US, Kenyan, and global 
policymakers. Dissemination of pilot results will follow principles of good participatory practice. Results 
will be published in conference abstracts and peer-reviewed journals. Study results will be 
disseminated through presentations to local stakeholders and policymakers in Kenya, including the 
Ministry of Health.   
 
 

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TIMELINE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BUDGET 
Table 17. Pilot budget 
 
 
Item 
Year 1 
Year 2 
Year 3 
Total 
Salaries 
$27,642 
$29,801 
$175026 
$232451 
Travel 
$4,135 
$4,135 
$5368 
$13638 
Supplies 
$9,502 
$10,749 
$15842 
$36093 
Pharmacy support 
$2,000 
$2,000 
$4000 
$8,000 
Participant reimbursement 
$1,000 
$1,000 
$5179 
$7,179 
Other expenses 
$12,949 
$9,902 
$32485 
$55336 
TOTAL 
$64,508 
$65,338 
$236899 
$366745 
 
 
BUDGET    JUSTIFICATION 
 
 
            
PERSONNEL COSTS 
 
PERSONNEL 
 
Table 16. Timeline of activities 
Year 1 
(2021) 
Year 2 
(2022) 
Data collection activity  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
AIM 1a: Pilot 
Train pharmacists on pharmacy-based PrEP delivery  
 
 
 
 
 
 
 
 
Pilot of pharmacy-based PrEP delivery  
 
 
 
 
 
 
 
 
AIM 1b: Identify pilot weak points 
Acceptability: Qualitative interviews with consumer  
 
 
 
 
 
 
 
 
Costs: Use of quantitative surveys at baseline and follow-up 
 
 
 
 
 
 
 
 
Model Refinement  
 
 
 
 
 
 
 
 
Aim 1c: Extended pilot 
Train pharmacists on pharmacy-based PrEP/PEP delivery 
 
 
 
 
 
 
 
 
Pilot of refined pharmacy-based PrEP delivery model 
 
 
 
 
 
 
 
 

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Prof. Elizabeth Bukusi, Principal Investigator 
She is the KEMRI PI and will work in association with the Co-investigators in the overall implementation 
of the Project. She is responsible for overseeing the progress of the study and the chief liaison with the 
local government and other regulatory bodies. 
 
Study Coordinator 
 
The Study Coordinator is responsible for the smooth functioning of the project, coordinating 
communications with regulatory boards, staff, and investigators, assisting investigators with 
implementation, planning and problem-solving on behalf of the PI to ensure project goals are met. 
Providing protocol guidance to staff, supervising and monitoring staff performance general day-to-day 
study administration.  
 
Vincent Momanyi & Peris Otieno, Field Research Assistants 
 
The field research assistants will be responsible for recruiting of the participants to the study by using 
known working strategies. They will also be responsible for conducting the scheduled qualitative 
interviews for the participants.  
 
Alfred Obiero, Administrator 
 
This administrator will be responsible for assisting in overall planning for the project in liaison with the 
Project coordinator, budget preparation, maintaining of proper audit trail for study funds and 
expenditures, generate monthly invoices, and other financial reports as required in the subcontract. He 
will also be responsible for the handling and accounting for the field imprest given to the project. 
 
Denis Ochola, HRM  
 
The Human Resource Manager is responsible for the recruitment of personnel and all staff related 
issues such as disciplinary, medical insurance, salaries, and remuneration among others.  
 
Grace Waititu, Chief Admin Officer -Nairobi 
 
The Finance & Admin Manager is based in Nairobi and is instrumental in terms of procurement of 
equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters 
and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, subcontracts, 
and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely 
sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to 
budgets.  
 
Dr. Zachary Kwena, Social Scientist 
 
The Social Scientist will support all the qualitative aspects of the study. This is in line with the 
requirement of the KEMRI IRB to ensure that any qualitative study engages a social scientist. 
 
Fringe Benefit Rate 
 
KEMRI contract employees receive a 20% gratuity at the end of their contract. The employees also get 
part of the National Social Security Fund payment which is a mandatory statutory deduction. The 
employees will also get a medical cover to cater for their medical needs while under the contract. 
 

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50 
 
Workers Injury Benefit Insurance                                                                        
 
According to the Workers Injury Benefit Act of Kenya, it is a legal requirement for every employer to get 
a workers’ injury benefit insurance cover for all their employees. The insurance cover is based on the 
total salaries payable per year.    
 
Medical Insurance                                                                                               
 
The staff requires medical insurance cover. The cover will be necessary to take care of the staff in case 
they are taken ill and need medical attention. It will also make the staff to be healthier and more 
productive in the Study and hence a motivation for high performance. 
 
 
Cell phone airtime 
 
 
 
 
 
                                  
 
Communication costs includes cost of making calls to the stakeholders involved in the Study and giving 
as well as receiving the necessary feedback for the Study. It involves making calls using mobile phones 
to mobilize potential participants.  
 
Internet Costs    
 
 
 
 
 
 
                        
 
The internet costs will be about $ 2,526 to facilitate internet communication through emails and skype 
calls. This will ensure all correspondence of the study are done in a timely manner.  
 
Training Costs    
 
 
 
 
 
 
                        
 
The study will incur about $ 4,526 on the training costs which will include training of the staff on the 
protocol, SOPSs and other relevant issues related to the study. The cost will cater for venue and 
training materials required.  
 
Stakeholders Meeting   
 
 
 
 
 
                        
 
The study will incur about $ 4,526 on stakeholders meeting to discuss PrEP implementation at the 
pharmacy and get feedback on areas requiring improvements and necessary changes. The cost will 
cater for venue and meeting materials required.  
 
Archival Costs   
 
 
 
 
 
 
 
The study will incur about $ 669 on preparation for archival of study materials as required by the local 
IRBs.  
 
Translation and Transcription Costs        
 
 
 
        
 
 
The study will incur about $ 1,895 for the translation and transcription of the study work. Translation 
costs include the translation of participant consent forms from English language to Dholuo and Kiswahili 
languages. These are the common languages spoken by participants in Kisumu region. It also includes 
the translation of the recorded in-depth interviews into English language. The transcription costs will 
include costs of transcribing the recorded interviews to written versions. 
 
Utilities       
 
 
 
 
 
 
                                  
 
The study will incur approximately $ 2,000 for the utilities. This will include space use of the facility, 

PROTOCOL: Pharmacy PrEP Pilot                                                                               January 19, 2022 
51 
 
electricity, water, and refreshments needed for the smooth functioning of the study. 
 
Local Travel                                                                                                            
 
The principal investigator resides in Nairobi but makes regular trips to Kisumu. The cost caters for 
travelling and per diems paid to her to facilitate her movements. It also helps in facilitating other study 
travel arrangements such as visiting different pharmacies and attending relevant project trainings and 
meetings such as presentation of the study at the IRB level, among others.  
 
IDI Materials     
 
 
 
 
 
 
                       
 
In depth Interviews will require materials such as headphones, voice recorders and batteries for 
efficiency. These are estimated to cost approximately $ 1,579. 
 
Printing & Stationery     
 
 
 
 
 
 
             
 
Printing and stationery costs includes cost for reams of paper and cartridge for initially printing of the 
consent forms, it also involves photocopying of the consent forms to be administered to the Study 
participants.  
 
Participants Reimbursements 
 
 
 
 
 
              
 
The participant reimbursements will include cost of transport and time for the scheduled in-depth 
interviews planned. 
 
Laptops                                  
 
 
 
 
                        
The study will require laptops for writing reports and transcription and transcribing of the in-depth 
interviews. 
 
8% Administrative Cost  
 
 
 
 
 
 
 
 
 
This budget line will help the host institution KEMRI to meet part of the costs associated with providing 
support to this project, it will help in meeting costs such fixed line telephone bills, payments processing, 
utility bills, security, necessary reviews, bank charges, payroll processing costs etc.  
 
BUDGET JUSTIFICATION FOR THIS AMENDMENT 
 
The increased number of pharmacies and sample size will have implications on the budget in terms of 
pharmacy support, participant reimbursement and supplies. We expect the cost to increase as 
indicated in the budget. The additional cost is being funded by the Bill & Melinda Gates Foundation. 
 

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52 
 
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perceptions among HIV-serodiscordant couples experiencing pregnancy in Kenya. AIDS Care 26, 

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1283–1287 (2014). 
98. Ngure, K. et al. A qualitative study of barriers to consistent condom use among HIV-1 
serodiscordant couples in Kenya. AIDS Care 24, 509–516 (2012). 
99. Ngure, K. et al. I Knew I Would Be Safer. Experiences of Kenyan HIV Serodiscordant Couples 
Soon After Pre-Exposure Prophylaxis (PrEP) Initiation. AIDS Patient Care STDs 30, 78–83 (2016). 
100. 
Pintye, J. et al. Fertility Decision-Making Among Kenyan HIV-Serodiscordant Couples Who 
Recently Conceived: Implications for Safer Conception Planning. AIDS Patient Care STDs 29, 510–
516 (2015). 
101. 
Patel, R. C. et al. What motivates serodiscordant couples to prevent HIV transmission within 
their relationships: findings from a PrEP implementation study in Kenya. Cult. Health Sex. 20, 625–
639 (2018). 
102. 
Patel, R. C. et al. Facilitators and Barriers of Antiretroviral Therapy Initiation among HIV 
Discordant Couples in Kenya: Qualitative Insights from a Pre-Exposure Prophylaxis Implementation 
Study. PloS One 11, e0168057 (2016). 
103. 
Patel, R. et al. HIV-positive men’s experiences with integrated family planning and HIV services 
in western Kenya: integration fosters male involvement. AIDS Patient Care STDs 28, 418–424 
(2014). 
104. 
Izugbara, C. O. et al. ‘It takes more than a fellowship program’: reflections on capacity 
strengthening for health systems research in sub-Saharan Africa. BMC Health Serv. Res. 17, 696 
(2017). 
105. 
Curran, K. et al. ‘If I am given antiretrovirals I will think I am nearing the grave’: Kenyan HIV 
serodiscordant couples’ attitudes regarding early initiation of antiretroviral therapy. AIDS Lond. 
Engl. 28, 227–233 (2014). 
106. 
Musoke, P. et al. Men’s hopes, fears and challenges in engagement in perinatal health and the 
prevention of mother-to-child transmission of HIV in rural Kenya. Cult. Health Sex. 1–14 (2018) 
doi:10.1080/13691058.2018.1426785. 
107. 
Kwena, Z. A. et al. Jaboya (‘Sex for Fish’): A Qualitative Analysis of Contextual Risk Factors for 
Extramarital Partnerships in the Fishing Communities in Western Kenya. Arch. Sex. Behav. 46, 
1877–1890 (2017). 
108. 
Rogers, A. J. et al. Implementation of repeat HIV testing during pregnancy in Kenya: a 
qualitative study. BMC Pregnancy Childbirth 16, 151 (2016). 
109. 
Hilliard, S. et al. Perceived Impact of a Land and Property Rights Program on Violence Against 
Women 
in 
Rural 
Kenya: 
A 
Qualitative 
Investigation. 
Violence 
Women 
(2016) 
doi:10.1177/1077801216632613. 
110. 
Onono, M. et al. ‘You Know You Are Sick, Why Do You Carry A Pregnancy Again?’ Applying the 
Socio-Ecological Model to Understand Barriers to PMTCT Service Utilization in Western Kenya. J. 
AIDS Clin. Res. 6, (2015). 

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111. 
Camlin, C. S., Kwena, Z. A., Dworkin, S. L., Cohen, C. R. & Bukusi, E. A. ‘She mixes her 
business’: HIV transmission and acquisition risks among female migrants in western Kenya. Soc. 
Sci. Med. 1982 102, 146–156 (2014). 
112. 
Walcott, M. M., Hatcher, A. M., Kwena, Z. & Turan, J. M. Facilitating HIV status disclosure for 
pregnant women and partners in rural Kenya: a qualitative study. BMC Public Health 13, 1115 
(2013). 

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STUDY PROTOCOL: THIKA 
 
 
 
Pharmacy delivery to expand the reach of PrEP in Kenya:  
 
Pilot study 
 
 
 
NCT04558554 
 
January 19, 2022 
 
 
 
 
 
 
 
 
Funding: 
 
United States National Institute of Mental Health (NIMH) and Bill and Melinda Gates Foundation 
(BMGF) 

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PROTOCOL TEAM 
 
University of Washington, Seattle, USA 
 
Jared Baeten, MD, PhD (Co-investigator) 
 
Katrina Ortblad, ScD, MPH (PI) 
Renee Heffron, PhD, MPH (Co-investigator) 
Andy Stergachis, PhD, MS, BPharm (Co-investigator) 
Pamela Kohloer, PhD, MPH, BSN (Co-investigator) 
Stephanie Roche, MPH (Co-investigator) 
 
 
Jomo Kenyatta University of Agriculture and Technology Nairobi, Kenya 
 
Kenneth Ngure, PhD, MPH, MSc (Site PI) 
 
 
Kenya Medical Research Institute, Nairobi, Kenya 
 
Elizabeth Bukusi, MBChB, MMed, PhD (Co-investigator) 
Nelly R. Mugo, MBChB, MMed, MPH (Co-investigator) 
Peter Mugo, PhD, MSc, BPharm (Consultant) 
 
 
National AIDS & STI Control Programme, Nairobi, Kenya 
 
Mary Mugambi, BA (Consultant) 
 
 
University of Colorado School of Pharmacy 
 
Peter Anderson, PharmD (Co-investigator) 
 
 
 
 
Kelly-Ross Pharmacy 
 
Elyse Tung, PharmD (Consultant)  
 
Partners in Health and Research Development, Thika, Kenya  
Peter Mogere, Dip. Pharmacy, B.Sc. (Project Coordinator) 
Catherine Kiptinness BPharm, MPH (Site Coordinator) 

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TABLE OF CONTENTS 
 
ABREVIATIONS ......................................................................................................................................................... 64 
PROTOCOL SUMMARY ............................................................................................................................................. 65 
LAY SUMMARY .............................................................................................................................. 67 
ABSTRACT ..................................................................................................................................... 67 
BACKGROUND ............................................................................................................................... 68 
METHODS ....................................................................................................................................... 81 
Study Objectives .............................................................................................................................................. 81 
Research Questions ......................................................................................................................................... 81 
Study Design .................................................................................................................................................... 82 
Setting .............................................................................................................................................................. 82 
Pilot pharmacies .............................................................................................................................................. 83 
Participant eligibility & recruitment ................................................................................................................ 84 
Pilot procedures .............................................................................................................................................. 88 
Data Analysis & Outcomes .............................................................................................................................. 98 
Participant retention and withdrawal ........................................................................................................... 101 
Limitations ..................................................................................................................................................... 102 
SAFETY ......................................................................................................................................... 103 
PrEP ................................................................................................................................................................ 103 
Pregnancy ...................................................................................................................................................... 103 
Social harm considerations............................................................................................................................ 103 
HUMAN SUBJECTS CONSIDERATIONS ..................................................................................... 105 
Study oversight .............................................................................................................................................. 105 
Risks ............................................................................................................................................................... 105 
Protection against risk ................................................................................................................................... 105 
Benefits .......................................................................................................................................................... 106 
Care for persons identified as HIV infected ................................................................................................... 106 
Benefits to the community ............................................................................................................................ 106 
Importance of the knowledge to be gained .................................................................................................. 107 
Treatment for injury ...................................................................................................................................... 107 
Study records ................................................................................................................................................. 107 
Confidentiality ............................................................................................................................................... 107 
Dissemination Plan ........................................................................................................................................ 107 

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TIMELINE ...................................................................................................................................... 108 
REFERENCES .......................................................................................................................................................... 109 
 
ABREVIATIONS 
 
3TC 
 
Lamivudine 
AIDS  
Acquired Immunodeficiency Virus 
AE 
 
Adverse Event 
ART 
 
Antiretroviral Therapy 
ARC 
 
AIDS Related Complex 
CCC 
 
Comprehensive Care Clinic 
CDC 
 
Centers for Disease Control and Prevention (US) 
CHCT  
Couples HIV testing and Counseling 
DAIDS  
Division of AIDS (NIH) 
DALY  
Disability-Adjusted Life Year  
DBS 
 
Dried Blood Spots 
EC 
 
Ethics Committee 
FDA 
 
Food and Drug Administration (US) 
FTC 
 
Emtricitabine 
FTC-TP 
Emtricitabine-triphosphate  
HIV 
 
Human Immunodeficiency Virus 
GEE 
 
Generalized Estimating Equations  
HTTP    
Hypertext Transfer Protocol (presentation of web data) 
ICER  
Incremental Cost-Effectiveness Ratios  
IRB 
 
Institutional Review Board 
KEMRI  
Kenya Medical Research Institute 
NACOSTI  
National Commission of Science, Technology and Innovation  
NIH 
 
National Institutes of Health (US) 
PEP 
 
Post-exposure prophylaxis 
PrEP  
Pre-exposure prophylaxis 
SAS 
 
Statistical Analysis Software 
STI 
 
Sexually transmitted infection 
TDF 
 
Tenofovir 
TFV-DP 
Tenofovir diphosphate 
UNAIDS 
Joint United Nations Program on HIV/AIDS 
US 
 
United States 
UW 
 
University of Washington 
VCT 
 
Voluntary counseling and testing 
WHO  
World Health Organization 

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PROTOCOL SUMMARY 
Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for 
optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, 
PrEP is being added to an already-burdened public health infrastructure and the ability of the health 
systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility 
evaluations of PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, 
the costs of staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions. 
In Kenya, retail pharmacies fill an important gap in the health care system, providing access to 
treatment of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid 
prescription), monitoring of chronic conditions (e.g., blood pressure testing), and preventative care 
(e.g., contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV 
self-tests or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes 
that may be desirable for potential PrEP users, including convenience (as pharmacies outnumber 
clinics and have shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), 
and engagement (which may be greater for a preventative service at a pharmacy than at a clinic that 
prioritizes treating ill individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, 
and paying for a service could result in greater sustained consumer engagement. The core components 
of PrEP – including HIV testing, adherence and risk reduction counseling, assessment of side effects, 
and provision of refills – are within the scope of practice for pharmacists (including pharmaceutical 
technologists, common in sub-Saharan Africa), and one US model has demonstrated that PrEP can be 
provided by pharmacists, facilitated by oversight by a remote clinician.  
In the second half of 2019, we conducted formative work among pharmacy providers and clients in 
Kenya to assess the feasibility and acceptability of pharmacy-based initiation and continuation of PrEP. 
Overall, the pharmacy providers and clients in our formative study strongly supported the idea of 
pharmacy-based PrEP delivery and felt it would be feasible so long as client privacy could be ensured 
and providers received training on how to deliver PrEP. In January 2020, we conducted a day-long 
stakeholder meeting – including regulators, other government agencies, pharmacy professional 
associations, pharmacy provider representatives, community members, and others – to assess the 
potential for and general framework of a pharmacy-based PrEP delivery model. This protocol reflects 
learning from that formative work and stakeholder meeting. 
We hypothesize that pharmacies may offer a novel access point for PrEP delivery in Kenya, especially 
during the COVID-19 pandemic when individuals may fear visiting health facilities for fear of COVID-19 
infection. With a multidisciplinary team, we propose two parallel evaluations of pharmacy-based PrEP 
care – one as a stand-alone model and one as a refill-only model – with the following aims:   
Aim 1a: We will conduct an initial pilot evaluation of pharmacy-based PrEP initiation and refills.   
Approach: At two pharmacies in Kiambu County, Kenya we will implement the novel care pathway 
for PrEP initiation developed from formative research and stakeholder engagement and measure 
PrEP initiations, consumer characteristics, retention in care, and adherence (up to n=150 people 
starting PrEP, followed for six months). Hypothesis:  Individuals will successfully initiate PrEP at 
pharmacies and be retained in care.  
Aim 1b: Within the Aim1a pilot pharmacies, we will probe potential weak points for pharmacy-
based PrEP delivery, in domains relating to acceptability, fidelity, and costs.  
Approach: We will conduct in-depth interviews with clients initiating (n=10/pharmacy) and refilling 
(n=10/pharmacy) PrEP, pharmacy providers (n=2/pharmacy), and clinicians providing remote 
oversight (n=1/pharmacy) (n=46 in total) and collect transcripts from consultations between 
pharmacy providers and remote clinicians via WhatsApp to explore experiences accessing or 

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delivering pharmacy PrEP. We will use unannounced standardized patient actors to explore fidelity 
(of counseling, HIV testing, safety assessment), and use quantitative surveys to measure costs and 
cost preferences (of clients and pharmacy providers) associated with pharmacy-based PrEP 
initiation and refills. Hypothesis:  Understanding potential weak points for PrEP delivery in 
pharmacies will permit refinement of the delivery algorithm developed from the formative research 
and tested in Aim 1a. 
Aim 1c: We will modify the care pathway to address weak points identified in Aim 1b and 
conduct an extended pilot evaluation of the refined care pathway. 
Approach: We will implement the refined care pathway at a total of 6 pharmacies in Kiambu County 
(2 from the initial pilot evaluation described in Aim 1a plus an additional 4 pharmacies). Clients who 
have been receiving PrEP services at the two Aim 1a pharmacies as part of Aim 1a or Aim 2a will 
be allowed to continue their PrEP care under the refined model for the duration of this extended 
pilot evaluation. We will continue to measure the same client outcomes as in the initial pilot: PrEP 
initiations, consumer characteristics, retention in care, and adherence (up to 540 people starting 
PrEP under the refined care pathway, followed for six months). We will also assess the acceptability 
and feasibility of the refined care pathway through quantitative surveys with clients and pharmacy 
providers. Hypothesis: The refined care pathway will result in greater PrEP uptake and improve the 
acceptability and feasibility of the pharmacy PrEP model among clients and providers. 
Aim 2a: We will conduct a pilot evaluation of pharmacy-based PrEP refills only. 
Approach: At the same time, we conduct Aim 1a, we will implement the care pathway for PrEP 
refills at two public healthcare facilities in Kiambu County. This pathway was developed from 
formative research and stakeholder engagement. In this pathway, PrEP users who initiate or refill 
PrEP at two public HIV clinics (up to n=200) will have the option of pharmacy-based PrEP refills (3-
month supply); we will measure selection of pharmacy refills and follow participants for 6 months, 
comparing PrEP retention, adherence, and safety between those who chose clinic and pharmacy 
refills. Hypothesis: Many PrEP users will select pharmacy-based PrEP refills, which will result in 
equivalent PrEP retention, adherence and safety as clinic-based refills. 
Aim 2b: We will conduct interviews with Aim 2a participants who did not opt to use pharmacy-
based PrEP refills to understand factors that influenced their decision (e.g., barriers) and their 
perceived acceptability of this refills-only model. 
Approach: At study endline, we will conduct in-depth interviews with 30 clients who enrolled into the 
study at an Aim 2a public healthcare facility and who returned for at least one PrEP refill but did not 
opt to get that refill at a pilot pharmacy. We will use semi-structured interview guides to solicit 
details about clients’ decision-making process, acceptability and feasibility of obtaining/delivering 
PrEP via this care pathway, and suggested improvements. Hypothesis: Understanding clients’ 
reasons for not refilling PrEP at retail pharmacies will permit insight into the potential reach of this 
care pathway and help inform future iterations of this model.  
 
We will collate information from these two approaches in a final stakeholder meeting to assess the 
potential ways forward with pharmacy-based PrEP delivery in Kenya 
 
 

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LAY SUMMARY  
Pre-exposure prophylaxis (PrEP) is a powerful HIV prevention tool; PrEP delivery in low resource 
settings will require approaches that are time- and cost-efficient, for patients, care providers, and the 
health care system. In this highly innovative study, we propose a new delivery model for PrEP delivery 
that has never been explored in an African setting: pharmacy-based PrEP delivery (with remote 
clinician oversight). Through formative research, we have developed a care pathway for pharmacy-
based PrEP delivery that we plan on pilot testing initially in four Kenyan pharmacies (2 in Thika and 2 in 
Kisumu) and later refining and pilot testing at 12 Kenyan pharmacies (6 in Thika and 6 in Kisumu). We 
hypothesize that pharmacy-based PrEP delivery will be acceptable and feasible in Kenya and that 
individuals who uptake PrEP in pharmacies will be retained in care.  
 
 
ABSTRACT 
Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as 
recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need 
to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is 
being added to a public health infrastructure which is sometimes burdened by overcrowding and drug 
stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery 
strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting 
times, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. 
In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important 
gap in the health care system providing first stop access to treatment, monitoring and preventive care 
of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over 
facility-delivered PrEP for reasons including increased convenience, increased privacy and greater 
engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer 
free, subsidized or affordable healthcare services. The core components of PrEP – including HIV 
testing, adherence and risk reduction counselling, assessment of side effects and provision of refills – 
are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. From prior 
formative qualitative research and a stakeholder meeting, we have developed a care pathway for 
pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultative 
meeting that included a wide spectrum of regulatory, professional, government, and community 
stakeholders in Kenya. We plan to pilot this care pathway in four retail pharmacies in Kiambu County, 
Kenya. Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in 
domains relating to acceptability, fidelity, and costs. Thereafter, we will refine the pharmacy-based 
PrEP initiations-plus-refills model (the one tested in Aim 1a) to address client- and provider-facing 
barriers identified in Aim 1b and implement it in 6 pharmacies in Kiambu County.      

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BACKGROUND 
Importance of the problem   
More than two million persons become newly infected with HIV each year, the majority in Africa.1 In 
Kenya, more than 1.5 million people are living with HIV,2 making it the country with the fourth largest 
epidemic. The past five years have witnessed major strides in the development of highly-effective HIV 
prevention interventions, particularly using antiretroviral medications: antiretroviral therapy (ART) to 
decrease infectiousness and pre-exposure prophylaxis (PrEP) to prevent acquisition. Novel strategies 
to successfully and efficiently deliver these strategies, at scale, are needed to achieve maximum HIV 
prevention impact.  
PrEP is an effective, recommended, and impactful strategy for HIV prevention  
PrEP has been demonstrated to be efficacious and safe for reducing HIV risk among men who have 
sex with men (MSM)3, heterosexual men and women,4,5 and injection drug users6 in diverse geographic 
settings. In 2012, the US Food and Drug Administration approved combination tenofovir disoproxil 
fumarate/emtricitabine (TDF/FTC) as the first medication with a label indication for HIV prevention in 
adults7 – an action followed by drug regulatory authorities in a number of other countries including 
Kenya (in December 2015). In 2015, the World Health Organization issued guidance recommending 
TDF-containing PrEP as an additional prevention option for all persons at high risk for acquiring HIV.8  
Adherence is essential for PrEP efficacy. PrEP clinical trials had a wide range of results for estimates of 
PrEP’s efficacy for HIV protection – explained by the degree to which the trial populations were 
adherent to PrEP.9 Secondary analyses from clinical trials and demonstration studies have shown that 
PrEP is highly efficacious and safe when taken as prescribed: at the individual level, HIV protection is 
on the order of 90-100% in both MSM and heterosexual populations when PrEP adherence was high, 
as measured by the presence and quantity of PrEP in blood samples.4,10,11 PrEP adherence and HIV 
prevention effectiveness have been higher than in prior clinical trials, in many cases very high, in open-
label demonstration projects among HIV serodiscordant couples, MSM, and young women at risk for 
HIV,12–14 which has been hypothesized to be a result of offering a strategy with demonstrated safety 
and effectiveness and without a placebo. In those PrEP demonstration studies, HIV incidence has been 
very low and visits were generally quarterly and brief, suggesting that many who initiate PrEP in the 
context of known safety and efficacy may not need intensive follow-up to achieve high adherence. In 
some high income settings (e.g., Sydney, San Francisco), delivery of PrEP at scale, layered onto high 
coverage of HIV testing and ART delivery, has resulted in substantial reductions in new HIV infections 
in the past five years.15–17  
Strategies to effectively and efficiently deliver PrEP are needed, for all settings but particularly 
for settings with limited resources 
PrEP delivery can be expensive, in terms of costs for health systems and opportunity costs for PrEP 
users. For health systems, costs associated with PrEP include medication, staffing time, and laboratory 
testing. In addition, user opportunity costs – e.g., time away from work or childcare to wait, usually for 
many hours, at a public clinic for a PrEP visit – can be substantial. Mathematical modeling analyses 
from high-income settings have argued that, while PrEP is cost-effective when delivered to high-risk 
persons, it is still costly.18–20 For developing country settings, PrEP costs are mitigated by the lower cost 
inputs from generic/non-branded or discounted medication pricing, lower staff salary costs, and more 
limited laboratory testing as recommended by WHO.19,21 Nevertheless, reducing the costs of PrEP 
delivery are necessary to maximize its impact. In costing analyses we have conducted in East Africa, 

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we estimated the cost of adding PrEP to routine public health services using Ministry of Health (MOH) 
personnel, drug, and laboratory costs; the greatest proportion of the total costs was not medication but 
instead personnel (39%).22 That finding emphasizes the need for efficiency in PrEP delivery, particularly 
given that public clinic medical staff in Kenya and similar settings are often highly over-stretched, 
because of competing priorities in overburdened health systems. Our modeling did not take into 
account client costs related to PrEP; however, we have learned through providing PrEP in studies to 
over 5000 individuals over the past 10 years that travel and time away from work and costs for getting 
to PrEP clinic visits can be a substantial challenge.23,24 Efficient strategies to deliver PrEP could reduce 
costs, potentially improving client engagement and allow services to be available to a larger number of 
people as a result – and this kind of approach would be applicable in a variety of settings, in Africa and 
worldwide.  
Diverse models for PrEP delivery are needed  
Barriers to facility-based PrEP delivery include long travel distances, lack of privacy, and lengthy wait 
times 23,24. In low-income countries, long travel distances to dispersed healthcare facilities can result in 
significant costs associated with transportation. Facilities are often overcrowded, which result in long 
wait times, rushed medical care, and a lack of anonymity that may deter individuals from returning to 
the healthcare facility for follow-up care. Time traveling and waiting is time away from work and children 
– resulting in substantial opportunity costs. Importantly, PrEP is an intervention for HIV uninfected 
individuals – in our experience and that of others, healthy persons report that they do not like 
frequenting healthcare facilities for HIV preventive care.24 Recent PrEP demonstration projects from 
Africa have found poor retention in care, for reasons including challenges accessing PrEP at facilities 
for continuation.25–28  
Diverse models have been developed for ART delivery to overcome similar barriers related to facility-
based care.29,30 Models of ART delivery that are not facility-based include home delivery of ART 
medication31 and community-based care, ART adherence groups,32 peer care coordinators,33 and even 
drug-dispensing ATMs.34 One previous study that explored the use of pharmacies to deliver ART 
medications in Nigeria found that this approach was feasible and that retention in care was high.35 PrEP 
delivery is simpler than ART – with less testing, fewer complications, and without comorbidities – and 
thus is primed for simple delivery models.   
Pharmacy-based PrEP delivery is a novel approach that could expand the reach of PrEP, 
respond to the needs of PrEP consumers, and improve PrEP continuation  
Nearly half of all individuals in low-income countries seek healthcare at retail pharmacies.36–38 In 
sub-Saharan Africa, pharmacies and licensed drug shops fill an important gap in the medical system 
and individuals often rely on and prefer the use of pharmacies over healthcare facilities to address their 
medical needs.39 Pharmacies can address both urgent needs (e.g., evaluation and medication for 
sexually transmitted infections) and preventive care (e.g., contraception)40 and have advantages over 
healthcare facilities, including increased convenience and anonymity.41 Going to a pharmacy first to 
address a medical issue (e.g., symptoms of malaria) is common, and individuals often go to a 
healthcare facility only later if the issue is not resolved.  
Advantages of pharmacy-based PrEP delivery may include increased convenience, privacy, and 
quality of care. In any given location, pharmacies often outnumber healthcare facilities and thus might 
be nearer to individuals interested in PrEP, saving both time and money.41–46 Individuals also visit 
pharmacies for both non-medical and medical reasons, potentially enabling individuals who seek PrEP 
to maintain privacy and overcome barriers associated with PrEP stigma.23,24 Pharmacies also have the 
advantage of being self-sustaining by offering subsidized or fee-for-service care, which may make them 
more responsive to client demands47–49 and may result in sustained client engagement if individuals 

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value services purchased 50. Finally, the delivery of PrEP in pharmacies expands choice of locations to 
access PrEP, enabling individuals to select their preferred model. 
Pharmacy-based PrEP delivery is feasible and within the domain of care for Kenyan 
pharmacists.        PrEP delivery has relatively few necessary components – HIV testing, adherence 
and risk reduction counseling, assessment of acute HIV infection and PrEP side effects, PrEP 
prescribing, and the provision of refills51,52 – all can be done by pharmacists/pharmaceutical 
technologists in Kenya.53 Pharmacies in Kenya are dispensing HIV self-tests on the market without a 
prescription,54 and pharmacies are dispensing PrEP now by prescription (brought after a clinic visit). 
Developing a rigorous and evidence-based model for pharmacy-based PrEP now could head off 
unregulated development of private models. In the United States, one model of full-service pharmacy-
based PrEP delivery has been successfully implemented through a collaborative practice agreement 
overseen by a remote clinician (Fig. 1), with standard PrEP services being done by the pharmacy and 
branch points for clients with complex medical or social issues to be sent to the overseeing clinician.55–
60 Pharmacy-based PrEP delivery is a client-centered model that is no less safe or rigorous than a 
clinic-based approach. A similar model could be highly successful for Africa.  
 
 
Fig. 1. Pharmacy-based PrEP care pathway, overseen by a remote physician, from Seattle 
(adapted from (56))   
The ongoing COVID-19 pandemic might affect the delivery and uptake of pharmacy-based PrEP  
We are currently in the midst of a global respiratory pandemic, coronavirus disease 2019 (COVID-19), 
which has dramatically changed the lives of individuals living in Kenya and other settings across the 
globe. Because COVID-19 is a newly emerging pandemic, the science on this new virus – including our 
understanding of transmission dynamics, treatment, and prevention – continues to evolve. What is 

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known, is that it COVID-19 is transmitted via respiratory droplets in the air or on surfaces, and that the 
risk of infection can be reduced with regular hand washing, social distancing, and wearing a face mask 
while in public settings. To help slow the risk of COVID-19 infection, Kenya (like many other countries) 
has implemented a number of measures including national curfews, road blocks, and stay at home 
orders.  
This ongoing epidemic is likely to affect the care seeking and delivery behaviors of pharmacy clients 
and providers in ways that might impact the uptake of pharmacy-based PrEP delivery. For example, 
during COVID-19 pharmacy clients might decrease access of pharmacy care if they fear infection in a 
public setting, or they may increase access of pharmacy care if they fear visiting health facilities for 
regular services. Similarly, pharmacy providers might restrict pharmacy hours during COVID-19 to 
reduce risk of infection to staff and clients, or they may be increase pharmacy hours if there is greater 
demand for pharmacy services during this unique period (i.e., because individuals no longer feel 
comfortable visiting health facilities). The delivery of pharmacy-based PrEP delivery during COVID-19 
may also have a number of unique challenges, including space constraints (e.g., availability of a well-
ventilated private room for counseling and HIV testing or ensuring the appropriate space for social 
distancing among clients), limited protective gear for pharmacy workers, and limited pharmacy access 
for clients (due to curfews and fear or using public transport). We aim to understand the impact of 
COVID-19 on the delivery and uptake of pharmacy services, including PrEP, during this unique time so 
that we can understand the generalizability of our pilot findings in a post-COVID-19 era or during 
another future global pandemic.   
Findings from the Partners Scale-Up Project and MPYA Study 
PrEP delivery in HIV clinics is associated with stigma. A main delivery point for PrEP in Kenya 
currently is HIV clinics. We have learned from qualitative work conducted among clients and providers 
in our Partners Scale-up Project that many PrEP users consider HIV clinics as spaces for HIV infected 
people, and thus feel uncomfortable attending these clinics as HIV uninfected persons. Additionally, 
PrEP users face difficulties fitting in when waiting for services at the HIV clinics since most of the health 
discussions focus on illness, not prevention and health (Table 1). 
 
Diverse options for PrEP delivery are desired among individuals taking PrEP. Preliminary 
qualitative data from PrEP users and providers in the Partners Scale-up Project and community leaders 
in the MPYA study have demonstrated the desire for locations other than HIV clinics for PrEP 
prescribing and refilling. Table 2 demonstrates how PrEP users would like PrEP delivery to be as easy 
as access to condoms and separate from HIV clinics for increased privacy. Table 2 additionally 
demonstrates community leaders’ interest in pharmacies as a potential location for PrEP delivery and 
refill as a result of their easy accessibility, availability of pharmacists/pharmaceutical technologists for 
PrEP prescribing/refilling, and long open hours. 
Table 1. HIV uninfected persons’ concerns with accessing PrEP at HIV Comprehensive Care Clinics  (Partners 
Scale-up Project) 
“I told you that experience is difficult, because we normally go to the CCC and the CCC clinic is for HIV+ people and 
therefore there is no difference between that person who is infected and the one who is not” – PrEP user: Female 
“I used to fear because when people see me they would think I am sick” – PrEP user: Male 
“There is still stigma with the negative patients coming to the CCC to take PrEP because they are associated with HIV+” – 
Healthcare provider: Nurse 
“I know there are a lot of people who really wish to take PrEP, but when they learn that it is being given at the CCC they 
just disappear, so having another place to dispense PrEP will help” – Healthcare provider: Counselor 

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Pharmacy-based delivery of PrEP is of interest to communities. We recently conducted two 
anonymous, telephone-based, community surveys in Western Kenya (PrIYA study) with young women 
and men (<25 years) who had a phone and had agreed to be part of mSurvey – a national polling 
organization that connects to mobile phones in Kenya and pays a small amount for survey completion. 
In the June 2018 survey 515 individuals participated, and in the January 2019 survey 2274 individuals 
participated. None of these individuals were otherwise part of our ongoing research studies. In both 
surveys, PrEP knowledge was high: in the June 2018 survey, 83% of individuals had heard of PrEP 
and 43% knew someone on PrEP; in the January 2019 survey, 69% of individuals had heard of PrEP. 
The majority (58%) of individuals in the January 2019 survey said they would be willing to pay for PrEP 
and 35% visited a retail pharmacy (“drug shop”) every 2-3 months. Interestingly, almost half of 
individuals who were familiar with PrEP in the June 2018 survey thought that people would most prefer 
to get PrEP from retail pharmacies compared to other locations (e.g., clinics) (Fig. 2).  
Findings from formative research on pharmacy-based 
PrEP delivery 
As formative research for this project, in the second half of 
2019 we conducted in-depth interviews with pharmacy clients 
(n=40) and pharmacy providers (n=12) to understand their 
health seeking behaviors (clients), interactions with clients and 
commonly provided services (providers), and attitudes towards 
pharmacy-based PrEP delivery (both). We interviewed client 
who currently purchase pharmacy products and services, self-
reported being HIV negative, and were identified as at-risk for 
HIV using the Rapid Assessment and Screening Tool (RAST). 
We interviewed pharmacy providers who currently provide 
services at retail pharmacies. Study participants were recruited 
from four different areas of Thika and Kisumu: urban informal 
settlements, urban non-informal settlements, peri-urban areas, and rural areas. Exactly half of the 
pharmacy clients recruited were male, and half were under the age of 25. Participants were interviewed 
one-on-one by a trained Kenyan qualitative researcher. All interviews took place in a private room, were 
audio recorded, and subsequently transcribed verbatim. Major themes were identified inductively using 
Table 2. PrEP users’, providers’, and counselors’ desires for diverse PrEP delivery options (Partners Scale-up 
Project and MPYA study)  
“PrEP should be made available just like condoms are easily accessible and available in dispensers” –PrEP user, Partners 
Scale-up 
“I feel that PrEP should be delivered separately from the CCC [HIV clinic] … yes it should be delivered at a different point 
because of stigma” –  PrEP user, Partners Scale-up 
“Sometime there are those people who do not want others to know about their thing, so there should be a way that one 
can be treated from wherever they are even without coming to the clinic” – PrEP user, Partners Scale-up 
“Community pharmacies would work [for PrEP delivery] because they are easily accessible and the pharmacists are always 
available ... some of them work until late hours” – NGO program officer, MPYA 
“For refill maybe we… observe how they are faring with the product [PrEP] then after 3 times … she can pick it at any 
given point like dispensaries and pharmacies around where they live because nowadays there are so many all over” – 
Community-based organization leader, MPYA  
 
Fig. 2. Preferred PrEP locations 
(mSurvey results) 

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content analysis. Some of the main findings are summarized below.  
Pharmacies are often clients’ first resort for care-seeking; clients’ preference for pharmacy-care 
is multifaceted. The majority (78%, 31/40) of clients reported that when they are ill, they first seek care 
at retail pharmacies and only seek care at healthcare facilities if their symptoms persist and/or worsen. 
Most (75%, 30/40) clients also reported seeking preventive care at retail pharmacies, most commonly 
through purchase of contraceptives. Clients identified six characteristics that underlie their preference 
for pharmacy care over facility-based care: 1) convenience (e.g., more locations, longer opening hours, 
faster service times); 2) privacy (e.g., less crowded, purpose of visit not obvious to on-lookers); 3) 
customer service (e.g., pharmacy providers are “friendly”, “kind”, and “not in a hurry”); 4) rapport (clients 
have ongoing, personal relationships with pharmacy providers who know their medical history); 5) 
flexibility (e.g., pharmacies work to provide services within clients’ budget, some offer credit); and 6) 
autonomy (more client decision-making power in terms of timing and location of care, more negotiation 
power with pharmacy providers when deciding treatment plan, ability to seek care elsewhere if 
dissatisfied with services.)  
Overall, pharmacy clients and providers strongly support the idea of pharmacy-based PrEP 
delivery, especially because the demand for PrEP is already there. Participants felt that the same 
six aforementioned advantages to general pharmacy care would also apply to pharmacy-based PrEP 
delivery, with many heavily emphasizing that pharmacy-based PrEP delivery would help circumvent 
HIV/PrEP stigma currently associated with HIV clinics, where PrEP is currently delivered. Providers 
reported that clients are already requesting PrEP at their pharmacies, and two providers said that they 
sell PrEP on demand. Clients similarly expressed interest in acquiring PrEP at retail pharmacies, with 
one client reporting that she had already purchased PrEP at a pharmacy previously. Overall, 
participants found pharmacy-based PrEP delivery highly acceptable, with 83% (10/12) of providers 
saying they would offer PrEP at their pharmacies and 95% (38/40) clients expressing support for this 
idea. 
Clients’ main recommendation for pharmacy-based PrEP delivery was to ensure client privacy 
and that providers are properly trained to deliver PrEP. When asked about undergoing HIV testing, 
counseling, and adherence and side effect assessments at a pharmacy, most clients reported that they 
would be comfortable so long as these activities occurred in a private consultation room and they felt 
sure that the provider would maintain their confidentiality. Clients also stressed that providers must 
have the proper training to conduct these activities. Other ideas for increasing client comfort with 
pharmacy-based PrEP included offering HIV self-testing and ensuring consistency of provider at follow-
up visits.  
Providers felt that delivering PrEP in pharmacies would be feasible so long as they have 
sufficient content knowledge of PrEP and staff to handle any additional workload. Providers 
supported the idea of pharmacy-based PrEP delivery being overseen by a remote clinician with 
PrEP expertise. In general, providers reported that they could deliver PrEP using the same practices 
they currently use to deliver other drugs (e.g., pill counts and phone calls to assess adherence, 
referrals of clients experiencing serious side effects). Half of providers also desired additional training 
on HIV testing and counseling to deliver PrEP. All providers (12/12) supported the idea of oversight by 
a remote PrEP clinician, with several calling for resources like a standardized checklist to ensure that 
clients meet eligibility criteria and clinical safety requirements to receive PrEP.     
Findings from stakeholder meeting pharmacy-based PrEP delivery 
In January of 2020, we convened 19 stakeholders from regulatory agencies and suppliers (e.g., 
National AIDS & STI Control Programme, Pharmacy & Poisons Board, Kenya Medical Laboratory 
Technology & Technicians Board, Kenya Medical Practitioners & Dentists Council, Kenya Medical 

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Supplies Agency), professional bodies (e.g., Kenya Pharmaceutical Association, Pharmaceutical 
Society of Kenya, Kenya Medical Association), PrEP implementing partners (JHPIEGO, Clinton Health 
Access Initiative), healthcare and pharmacy providers, Civil Society Organizations. The purpose of this 
meeting was to build consensus around a model for pharmacy-based PrEP initiations and pharmacy-
based PrEP refills that could be pilot tested in Kenya. Following presentations on the role of PrEP in 
Kenya’s national plan for HIV prevention, results from the formative research, and a mock care pathway 
for pharmacy-based PrEP delivery, participants were divided into small groups to brainstorm potential 
barriers and solutions—both for pilot testing and, if successful, for eventual scale-up—of pharmacy-
based PrEP delivery. The outcomes from the stakeholder meeting are summarized below. 
Stakeholders were supportive of the idea of pharmacy-based PREP delivery. There was 
overwhelming consensus that pilot work to better understand whether pharmacy-based PrEP initiation 
and refills could be done successfully. Importantly, no meeting attendee objected to trying pharmacy-
based PrEP delivery. Stakeholders were in favor of a pilot test of pharmacy-based PrEP delivery and 
felt it would help identify matters requiring further clarification before further scale up.  
Stakeholders identified potential challenges and solutions to pharmacy-based PrEP delivery for 
both the pilot study and, if successful, for larger scale up (Table 3). Anticipated challenges 
primarily centered on pharmacy provider knowledge and skills to deliver PrEP and lack of guidelines 
specifying, for example, what type of HIV test is permissible for initiation of PrEP at pharmacies, how 
pharmacies would procure and document PrEP, and reporting requirements. Stakeholders suggested 
numerous ways forward that could be incorporated into the pilot study. With respect to scaling up 
pharmacy-based PrEP delivery, stakeholders also suggested potential solutions, many of which would 
require the cooperation of local and national policymakers.  

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Table 3. Potential challenges and solutions to pharmacy-based PrEP delivery, according to stakeholder meeting attendees 
Delivery component 
Potential challenge 
Potential solution: pilot 
Potential solution: scale up 
Promoting pharmacy-
based PrEP 
• Most pharmacies receive their promotional 
materials from suppliers.  
• Existing limitations on how pharmacies can 
advertise products/services. 
• CCCs may be reluctant to inform PrEP clients 
about pharmacy-based PrEP if trying to 
reach PrEP target numbers.  
• Word-of-mouth promotion (e.g., PrEP 
providers at the affiliated CCC)  
• Ask customers seeking services 
indicating HIV risk-related sexual 
behaviors (e.g., condoms, emergency 
contraception) if they might be 
interested in PrEP. 
• Display posters within the confines of 
the pharmacy. 
• NASCOP works with pharmacies to create 
PrEP materials for display. 
• NASCOP works with counties so PrEP 
promotional materials can be displayed 
without a county-level license.  
• MOH helps spread knowledge of pharmacy-
based PrEP delivery through national 
awareness campaigns. 
• PPB revises advertisement restrictions for 
PrEP. 
• Pair pharmacies with CCCs so pharmacy-
based PrEP users count toward CCC targets. 
HIV testing 
• No existing framework for pharmacies to do 
HIV rapid testing (e.g., Determine, First 
Response), although some already doing. 
• Only select pharmacies currently providing 
assisted HIV self-testing (blood- or oral-
based). 
• No guidelines stating that PrEP can be 
initiated based on the results of an HIV self-
test. 
• Concerns over counterfeit HIV self-tests.   
• Select pilot pharmacies already 
certified to do assisted HIV self-testing. 
• Could consider a special approval from 
regulatory agencies to offer HIV rapid 
testing at pharmacies for the pilot.  
• MOH develops guidelines so that 
pharmacies can conduct HIV rapid testing, 
which currently is provided in many 
pharmacies for ~one-fifth the price of HIV 
self-tests. 
• MOH could limit PrEP delivery to 
pharmacies that are certified to do assisted 
HIV self-testing and obtain their HIV self-
testing kits through KEMSA.  
• PPB could reclassify the HIV self-testing so 
treated like any other HIV test. 
 
Counseling 
• Pharmacy providers not trained on PrEP 
counseling.  
• No privacy at some pharmacies for 
counseling. 
• Pharmacies have a business approach, gets 
• Train pilot pharmacies on PrEP 
counseling, per NASCOP guidelines. 
• Pilot pharmacies should have a private 
counseling space to offer PrEP. 
• MOH requires pharmacy providers to be 
trained on PrEP delivery in order to deliver 
PrEP. MOH customizes NASCOP training to 
fit the retail pharmacy setting. 

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in the way of counseling. 
• Existing counseling prompted by clients, not 
pharmacy providers. 
Prescribing 
• Pharmacy providers are not trained on how 
to prescribe PrEP (and not allowed to 
prescribe). 
• Who will bear the costs of prescription? 
(incentives for pharmacies if get drug for 
free) 
• Train pharmacy providers on how to 
prescribe using a checklist and remote 
clinician oversight. 
• Charge small consulting fee that covers 
counseling and dispensing. 
• Allow pharmacies to charge for HIV 
testing (necessary for prescription). 
• PPB reschedules PrEP so that it can be sold 
without a prescription. 
• Pharmacy providers purchase PrEP from a 
generic manufacturer. 
• Pair pharmacies with CCC clinics for co-
signing and oversight. 
• Remote PrEP clinicians (MOH supported?) 
for remote oversight and co-signing. 
Dispensing 
• Retail pharmacies not registered in the 
Master Facility List (MFL) and thus lack codes 
necessary to: (1) acquire PrEP through 
KEMSA, and (2) report dispensing.  
• Current retail pharmacy records do not tend 
to track clients over time.  
• Some clients move between pharmacies. 
• Clients might not be able to afford 3-months 
PrEP at a time. 
• Link pilot pharmacies with CCCs; have 
pharmacies use CCC MFL code to 
obtain PrEP; then CCC reports the 
drugs dispensed. 
• Set up unique tracking system for pilot. 
• Have clients pay only for testing & a 
consulting/dispensing fee; make PrEP 
drug free. 
• Give pharmacies MFL codes. 
• Use system similar to diabetes for tracking 
prescriptions over time (e.g., “PrEP card”). 
• MOH provides PrEP to pharmacies for free. 
• MOH establishes minimum criteria that 
pharmacy providers must meet in order to 
deliver PrEP (e.g., completion of NASCOP 
PrEP training). 
Oversight/Referrals 
• Many retail pharmacies lack formal 
connections to PrEP facilities.   
• Clinicians busy, hard to reach when called. 
• Cost of oversight? Who pays? 
• Ethics – how do you know pharmacies will 
use when needed? 
• Who is the clinician?  
• Link pharmacies with specific CCC. 
• Have study-staff clinician on call.  
• Monitor the frequency of calls and 
record the content. 
• PrEP clinician hotline? 
• WhatsApp group for PrEP clinicians and 
pharmacy providers? 
• Include cost of oversight in the 
consultation/dispensing fee client pays to 
pharmacy. 
Other/over-arching  
• Some pharmacies only have one staff 
member working at a time. 
• Pharmacy providers may lack knowledge 
about PrEP and/or skills to conduct HIV 
• Pharmacy providers selected for this 
pilot will be trained on PrEP delivery 
and provided with a standardized 
checklist to walk them through each 
• MOH establishes minimum criteria (e.g., 
possession of a private consultation room, 
completion of NASCOP training) that 
pharmacy establishments and providers 

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testing and counseling. Some pharmacy 
providers may discriminate against clients, 
especially marginalized key populations (e.g., 
MSM, commercial sex workers).  
• Currently, there are no regulations for 
pharmacy-based PrEP delivery. 
step.  
• Pharmacy providers will also be 
connected to a remote PrEP clinician 
who can answer any questions they 
have and receive referrals of complex 
clients. 
must meet to deliver PrEP.  
• MOH requires pharmacy-based PrEP 
providers to undergo a sensitization 
training on PrEP stigma/discrimination.   
• MOH establishes guidelines for pharmacy-
based PrEP delivery, including any price 
regulation and accountability mechanisms 
(e.g., in cases of client mismanagement).  

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Stakeholders helped refine a care pathway to be pilot tested in Aim 1a and Aim 2a. The care 
pathway is illustrated in Fig. 3 with the core components detailed in Table 4. The checklist pharmacy 
providers will use to assess PrEP eligibility (both at initiation and refills) is included in Appendix V. 
  
 
Fig. 3. Care pathway for pharmacy-based PrEP delivery 
 
Preliminary findings from Aims 1a, 1b, and 2a and conversations with PrEP policy makers from 
the Kenya MOH, WHO, and PEPFAR. In Aim 1c, we propose refining the care pathway implemented 
in the Aim 1a and Aim 2a pilots to address (1) challenges reported by the clients and providers we 
interviewed and surveyed in Aim 1b and (2) evidence gaps identified by representatives from the Kenya 
Ministry of Health (MOH), WHO, and PEPFAR. The identified challenges and proposed refinements to 
how PrEP delivery is implemented (i.e., “implementation strategies”) are summarized in table below: 
Table 4. Core components of pharmacy-based PrEP delivery 
Oversight 
With clinician input, we developed a 
checklist 
tool 
that 
walks 
pharmacy 
providers through each step required to 
initiate a client on PrEP and/or refill an 
existing PrEP prescription. All checklist 
items need to be completed in order for 
the client to receive PrEP. If at any point 
the pharmacy provider has questions, s/he 
can consult with a remote clinician and/or 
refer the client for care. 
Testing 
Assisted self-testing for HIV using rapid blood or oral 
fluid tests.  
Counseling 
Includes risks and benefits associated with PrEP, PrEP 
adherence, recognizing symptoms of acute HIV 
infection, behavioral risk assessment (using Kenya’s 
PrEP Rapid Screening Tool - RAST62), and side effects 
assessment. 
Prescribing 
Prescribing of PrEP drugs for those initiating PrEP for 
the first time and continuation of prescriptions for 
clients coming in for refills. 
Dispensing/ 
Refilling 
PrEP drugs dispensed/refilled by pharmacy provider; 
reliable drug supply required. 

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Challenge Identified 
Proposed Refinement to Model 
Implementation Strategy 
Name1 
Some clients cannot afford the fee study 
pharmacies are charging for PrEP (300 Kenyan 
schillings/~$2.75 USD per visit). 
Eliminate the pharmacy fee. 
“Free PrEP service” 
Some clients felt uncomfortable completing the 
HIV risk assessment for PrEP (which includes 
highly sensitive questions about sexual behaviors) 
verbally with the pharmacy providers. 
Give clients the option to self-
administer this questionnaire, with 
review by pharmacy provider who 
can ask questions if needed. 
“Optional Self-RAST” 
 (“RAST” 
stands 
for 
“Risk 
Assessment Screening Tool”) 
Some prospective PrEP clients who do not know 
their HIV status are hesitant to undergo HIV 
testing at a pharmacy for fear for testing positive 
there. 
Give prospective PrEP clients the 
option to complete an initial HIV 
self-test at home, and provide those 
who accept this offer an HIV self-
test kit free of charge. 
“Optional Initial Self-Test” 
Some client populations with HIV risk—especially 
adolescent girls and young women—are not 
being reached by this model.  
Incentivize PrEP clients to refer their 
peers to study pharmacies to learn 
about PrEP. 
“Peer Referral” 
The oral-fluid HIV self-tests being used in our 
pilots have a lower sensitivity than blood-based 
HIV self-tests. 
Switch to using blood-based HIV 
self-tests (and continue to have 
pharmacy providers assist clients 
with conducting the test).  
“Assisted 
Blood-Based 
HIV 
Self-Testing” 
Some clients who undergo screening for PrEP are 
found to be post-exposure prophylaxis (PEP) 
candidates and have to be referred to public HIV 
clinics for PEP access (because pharmacies do not 
currently offer PEP).  
Add 
PEP 
services 
to 
study 
pharmacies so that they can keep 
PEP clients engaged in care and 
offer 
them 
PrEP 
upon 
PEP 
completion. 
“PEP-as-a-Bridge-to-PrEP” 
Pharmacies receive a high volume of clients 
seeking testing and/or treatment for sexually 
transmitted infections (STIs) and currently have 
no way to formally test and diagnose these 
clients.  
At a subset of 4 study pharmacies, 
offer clients seeking STI testing 
and/or treatment free STI testing 
and treatment with optional PrEP 
screening. 
“STI 
Testing-as-a-Bridge-to-
PrEP” 
1For the extended pilot (Aim 1c), we define each of these implementation strategies prior to asking providers for their feedback on 
them in the baseline and follow-up questionnaires (Appendices XXII and XXIII). 
 
The refined care pathway we propose implementing in an extended pilot study (Aim 1c) is illustrated in 
Fig. 4 with the new implementation strategies (refinements) highlighted in yellow. 
 

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Fig. 4. Refined care pathway for pharmacy-based PrEP delivery for extended pilot study (Aim 1c) 

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METHODS 
Taking PrEP to scale will require simplifying and diversifying models for delivery to achieve options that 
are affordable, accessible, and meet the needs of clients and health systems. We have assembled a 
multidisciplinary team to test pharmacy-based models as alternative strategies for PrEP delivery. We 
hypothesize that pharmacy-based PrEP delivery will be feasible, acceptable, and preferred. 
 
Study Objectives 
4. To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot 
studies (Aims 1a and 2a). 
5. To identify weak points for pharmacy-based PrEP delivery, in domains relating to 
acceptability, fidelity, and costs (Aims 1b and 2b).   
 
6. To understand the potential impact of the COVID-19 pandemic on the uptake and 
continuation of pharmacy-based PrEP delivery (Aim 1b only). 
 
7. To test a refined pathway for pharmacy-based PrEP initiation and refills through an 
extended pilot study (Aim 1c) 
 
Hypothesis. Individuals will be interested in pharmacy-based PrEP delivery and will successfully initiate 
and refill PrEP at pharmacies and be retained in care. Understanding the potential weak points for 
PrEP delivery in pharmacies will permit refinement of the care pathway, and this refined pathway will 
result in greater PrEP uptake and improve the acceptability and feasibility of the pharmacy-based PrEP 
delivery model among clients and providers. COVID-19 will impact how pharmacy clients and providers 
access and deliver care, including the provision of PrEP for HIV prevention.     
 
Research Questions 
• 
What is the uptake of pharmacy-based PrEP delivery among eligible pharmacy clients? (Aim 1a) Do 
model refinements result in greater uptake? (Aim 1c) 
 
• 
What does PrEP retention and adherence look like among individuals who started PrEP at 
pharmacies? (Aim 1) Do model refinements result in increased PrEP retention and adherence? 
(Aim 1c) 
 
• 
Could pharmacy-based PrEP refills increase PrEP retention and adherence compared to facility-
based PrEP refills? (Aims 1a, 1c, & 2a) 
 
• 
What is the preference for pharmacy-based versus facility-based PrEP refills among PrEP users? 
(Aim 2a and 2b) 
 
• 
For clients who decide against obtaining PrEP refills at a pilot pharmacy, what factors influenced 
their decision-making? (Aim 2b) 
 
• 
What is the fidelity of pharmacy-based PrEP delivery? (Aim 1b) 

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• 
What is the acceptability of pharmacy-based PrEP delivery among both pharmacy clients and 
providers? (Aim 1b) Do model refinements result in greater acceptability? (Aim 1c) 
 
• 
What is the cost of pharmacy-based PrEP delivery and how much might pharmacy clients and 
providers be willing to pay for/provide PrEP at pharmacies? (Aim 1b) 
 
• 
How has the COVID-19 pandemic affected the provision and uptake of pharmacy services in 
Kenya, including PrEP? (Aims 1 & 2) 
 
Study Design 
This study is a one-arm intervention trial, or pilot study. There is no comparison arm in this pilot study. 
The intervention we are testing was developed from extensive formative research, including analysis of 
data from in-depth qualitative interviews and a stakeholder meeting. We hope to use the information 
gained from this research to inform development of a larger randomized trial, which will include a 
comparison arm.  
 
Setting 
We will conduct the research for this study in Kiambu County led 
by a team of investigators based in Thika, Kenya (Fig. 5). Thika is 
an urban center, ~40 km outside of Nairobi in Central Kenya, 
which has a large peri-urban and rural surrounding population. HIV 
prevalence in Thika is 6%.63 In Kiambu County, where Thika is 
located, there are 517 retail community, 15 wholesale, and 47 
hospital pharmacies (all legal and registered).  
 
We selected Thika, Kenya to conduct this research because the 
research team implementing the project here has extensive 
experience with the provision of PrEP to diverse populations. They 
were involved in the Partners PrEP Study clinical trial,4 then the 
open-label Partners Demonstration Project,61 and are currently 
leading the Partners Scale-Up Project, MPYA study, POWER 
project, and other studies. The site has technical expertise related 
to PrEP, community engagement with diverse populations (with 
high 
recruitment 
and 
retention 
>90%), 
and 
collaborative 
experience working with health providers outside of their own 
research clinics – precisely the components necessary for this work.  
Thika is an appropriate place to conduct this research 
because in Thika there are numerous private, retail 
pharmacies that are high quality, well-stocked, and capable of 
implementing pharmacy-based PrEP delivery (example: Fig. 
6). The Thika research team also has extensive experience 
with the development of PrEP delivery models in Kenya – 
members of our study teams were deeply involved in the 
Kenya PrEP guideline process, including guidelines for 
clinical delivery.52 All work proposed will be done adhering to 
the minimal safety package defined in those guidelines – 
analogous to the pharmacy-based checklist model from the 
 
 
Fig. 6.  Retail pharmacy in Kenya 
Source: www.howwemadeitinafrica.com  
 
 
 
Fig. 5.  Study setting.  

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US (Fig. 1).55,57 
Pilot pharmacies 
Pharmacy selection  
For Aim 1a/2b, we will select two retail pharmacies of different sizes to conduct our pilot: 1) one 
medium-sized pharmacies (~100 customers/day), and 2) one large pharmacies (~500 customers/day). 
For Aim 1c (extended pilot), we will select four additional pharmacies, for a total of six pharmacies: four 
medium ones (~50 customers/day) and two large ones (~100 customers/day). The medium- and large-
sized pharmacies will be equally distributed across aims and locations. In order for pharmacies to be 
eligible for study participation, they must: 1) be properly licensed with a fulltime licensed pharmacy 
provider, 2) have a private counseling space where HIV testing and PrEP counseling can occur, and 3) 
must be already certified to provide provider-assisted HIV self-testing. The majority of licensed retail 
pharmacies in Kenya have a private counseling room in the back that is regularly used to counsel 
clients on sensitive topics including, STI treatment, HIV self-testing, and family planning, amongst other 
things. Then, the lead provider at each pharmacy selected must agree to: 1) offer PrEP (with relevant 
providers undergoing project training), 2) allow a trained research assistant to collect client data (e.g., 
self-reported adherence, dried blood spot samples), and 3) allow one or more pharmacy staff members 
to participate in a confidential and voluntary in-depth interview about their experiences delivering PrEP 
(Aim 1a/2a only), a confidential survey about their experiences delivering PrEP (Aim 1c only), and a 
monitored WhatsApp group with the remote clinician providing PrEP oversight (Aim 1a/2a and Aim 1c). 
Pharmacies that participate in the extended pilot (Aim 1c) must agree to offer post-exposure 
prophylaxis or “PEP” (with relevant providers undergoing project training), and two of the four 
pharmacies that participate in the extended pilot (Aim 1c) must also agree to offer STI testing (again, 
with relevant providers undergoing project training). 
 
Pharmacy provider training  
The pharmacy providers who will deliver PrEP and/or PEP (Aim 1c only) in the pilot studies will undergo 
a training based on the Kenya MOH PrEP training (which our team helped develop) and Partners 
Scale-Up Project training (used at public clinics).64 All individuals at the pilot pharmacies who plan on 
implementing pharmacy-based PrEP/PEP delivery must complete the training. The training will cover: 
1) a review on how to perform assisted HIV self-testing, 2) how and where to refer individuals for HIV 
care if they test HIV-positive, 3) how to counsel individuals interested in initiating PrEP or PEP (Aim 1c 
only), including screening for PrEP/PEP eligibility using the standardized checklist, 4) how to refer 
individuals with complex medical backgrounds and/or side effects to the remote clinician, how to use 
and access the remote clinician, and 5) how to dispense drugs to individuals starting PrEP or PEP (Aim 
1c only) for the first time (one-month drug supply) and individuals returning for PrEP refills (three-month 
drug supply), and 6) how to maintain proper safety precautions during the COVID-19 outbreak. 
Additionally, pharmacy providers participating in the pilot will complete training by members of the Thika 
research team on research ethics and the importance of confidentiality, as well as consistent protocols 
for PrEP/PEP record keeping, including instructions on how to complete and securely store the 
pharmacy-based PrEP/PEP delivery prescribing checklists (Appendix IV. Prescribing checklist), 
referral forms (Appendix V. Referral form), and the remote clinician contact forms (Appendix VI. 
Remote clinician form). All other research-related activities at the pharmacy (e.g., completion of 
informed consent documents and the quantitative questionnaires) will be completed by a full-time 
research assistant (trained by the Thika team on research methods and ethics) stationed full-time at the 
pilot pharmacies.  
 

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Participant eligibility & recruitment  
For Aim 1a/2a, we aim to enroll up to 150 clients in total across the two Aim 1a pharmacies and up to 
200 clients in total initiating PrEP at two public HIV clinic participating in our pilot (Table 5). We will stop 
enrolling participants in the pilots once we achieve the desired Aim 1a and Aim 2a sample sizes. For 
Aim 1c (extended pilot study), we aim to enroll up to 540 new clients, and to extend to Aim 1a/2a 
enrollees the option to continue refilling PrEP at pilot pharmacies so long as they still meet study and 
PrEP eligibility criteria and complete the Aim 1c informed consent process.  
 
Table 5. Number of clients to be enrolled at pilot pharmacies 
 
Enrollment 
location 
Study 
site 
Pharmacy 
size 
# Clients 
Total Clients 
Aim 1a 
Pilot Pharmacies 
Thika 
N/A 
N/A 
Up to 150 
 
 
Aim 2a 
HIV CCC A 
Thika 
N/A 
~100 
Up to 200 
HIV CCC B 
Thika 
~100 
Aim 1c 
Pilot Pharmacies 
Thika 
N/A 
N/A 
Up to 540 
 
Our sample size calculation for Aim 1a/2a is detailed in Table 6. If we assume that 50% of Aim 2a 
participants will select pharmacy-based PrEP refills (at either of the 2 participating pilot pharmacies) 
over CCC-based PrEP refills, then this should give us sufficient power to measure a difference of 10% 
or more in retention between participants selecting pharmacy-based PrEP refills and participants 
selecting facility-based PrEP refills. For Aim 1a/2a, all participating pharmacies will provide PrEP to 
enrolled participants on a quarterly basis until December 2021 (Figure 7). The eligibility criteria and 
recruitment plan for the pilot and pilot evaluation activities are outlined for clients and providers in Table 
7 and Table 8, respectively.  
 
 
  
For Aim 1c (extended pilot), our primary focus is on evaluating the model refinements (Fig. 4) and 
whether clients and providers find these refinements acceptable and feasible to use/implement. As 
such, there is not a minimum size per group required for the Aim 1c primary analysis. Participating 
pharmacies will provide PrEP to enrolled participants through July 2022. 
Table 6. Sample size calculation for Aim 1a/2a. 
Assume: 50% pharmacy refill \ selection, 10% non-inferiority limit, 80% power, 5% alpha, 1-sided CI.  
Calculate: Minimum size per group:  
% retention: pharm         
clinic 
65% 
70% 
75% 
80% 
60%  129 
70 
43 
28 
70%  n/a 
n/a 
110 
58 

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Table 7. Client eligibility, recruitment, and evaluation 
 
Pilot 
Pilot Evaluation Component 
 
Eligibility 
Recruitment 
Quantitative Survey & DBS 
In-depth Interviews 
Aim 1a and 
Aim 1c 
(n=2 
pharmacies for 
Aim 1c and 
n=6 
pharmacies for 
Aim 1c) 
• >18 years 
• Interested in initiating PrEP 
at a pilot pharmacy (Aim 1a) 
or interested in initiating 
PrEP or PEP or undergoing 
STI testing at a pilot 
pharmacy (Aim 1c) 
• Meets all criteria (e.g., tests 
HIV-negative) for PrEP 
initiation on the checklist 
(Aim 1a) or for PrEP, PEP 
and/or STI testing (Aim 1c)  
• Able & willing to provide 
written informed consent1 
• 
Display posters that encourage 
customers to ask their pharmacy 
provider about PrEP  
• 
Have pharmacy providers ask 
customers buying HIV self-tests, 
emergency contraception, or STI 
treatment if they are interested in 
initiating PrEP at the time of 
check-out  
• 
Other strategies developed from 
the formative research and 
stakeholder meeting  
At each study visit, research 
assistants (RAs) stationed at the 
pharmacy will conduct the 
quantitative survey with and 
collect the DBS samples from 
participants.  
 
 
Aim 1b: Study staff will identify 
a sample of enrollees to invite 
to participate in an in-depth 
interview.3 RAs will approach 
these individuals to see if they 
are interested in participating. 
 
At each pharmacy that 
participated in Aim 1a (n=2), up 
to 10 clients who initiate PrEP 
and 10 clients who also refill 
PrEP will be interviewed (n=40 
client interviews total). 
 
Aim 2a 
(n=2  
HIV CCC) 
• >18 years 
• Initiated or refilled PrEP at  
project-affiliated CCCs 
• Meets all criteria (e.g., tests 
HIV-negative) for PrEP refill 
on the checklist 
• Able & willing to provide 
written informed consent2 
• 
PrEP providers at affiliated CCCs 
will inform clients newly initiating 
PrEP and those refilling PrEP of the 
option to refill their PrEP at pilot 
pharmacies for a consulting fee.  
• 
We will also hang posters about 
PrEP’s availability at pilot 
pharmacies and in affiliated CCCs. 
 
Up to 200 clients from the Aim 2a HIV 
CCC will be enrolled in total. 
At all study visits that occur at 
an HIV CCC, RAs stationed at the 
participating HIV CCCs will 
conduct the quantitative survey 
with and collect the DBS 
samples from participants. For 
all study visits that occur at a 
study pharmacy, RAs stationed 
at the pharmacy will conduct 
the aforementioned activities. 
 
Aim 2b: Study staff will identify 
a sample of participants (n=30) 
who were referred from CCCs 
for PrEP refills in the pharmacies 
and who refilled PrEP at least 
once during the study but did 
not refill at a pilot pharmacy to 
invite to participate in an in-
depth interview. 3RAs will 
approach these individuals to 
see if they are interested in 
participating. 
 
1By signing the consent form (Appendices I-III), Aim 1a participants agree to 1) receive PrEP services (e.g., HIV testing); 2) complete a quantitative survey; and 3) give a DBS sample. 
Participants from Aim 1a pharmacies and Aim 2b (CCCs) additionally consent to being invited to participate in an in-depth interview about their PrEP care experiences. By signing 
the consent form for the extended pilot (Appendices XIII and XIV), Aim 1c participants agree to 1) receive PrEP, PEP, or STI testing services; 2) complete a quantitative survey; and 3) 
give a DBS sample. All participants must provide written or electronic consent to participate in study activities. 2Because the original consent form for Aim 2a client participants did 
not cover voluntary participation in an in-depth interview, we have created an additional consent form that select Aim 2b participants will complete prior to participating in an 
interview. 3We will purposely sample clients of different ages, sex, and duration of PrEP use to reflect a range of experiences and perspectives on pharmacy-based PrEP delivery. 
 

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Table 8. Provider eligibility and recruitment plan  
 
 
Pilot Evaluation Component 
 
Eligibility 
In-depth Interview 
WhatsApp Group 
Pharmacy providers  
from Aim 1a, Aim 1c, & Aim 2a 
pharmacies 
• >18 years 
• Provides PrEP at a pilot pharmacy 
(Aim 1a/2a) or provides PrEP, PEP, 
and/or STI testing at a pilot pharmacy 
(Aim 1c) 
• Able & willing to provide consent1 
Prior to agreeing to be part of the 
Aim 1a/2a pilot study, Aim 1a 
providers will be informed that they 
will be invited at a later time to 
participate in a confidential in-depth 
interview. 
 
Prior to agreeing to be part of the 
extended pilot (Aim 1c), providers 
will be informed that they will be 
invited to participate in monthly 
confidential surveys. 
  
Aim 1b only: Study staff will identify 
a sample of providers to invite to 
participate in an in-depth interview. 
RAs will approach these individuals 
to see if they are interested in 
participating. 
 
At each Aim 1a pharmacy, we will 
interview 2 pharmacy providers and 
1-2 clinicians providing remote 
oversight (n=8 provider interviews 
total).  
Prior to agreeing to be part of the Aim 
1a/2a and Aim 1c pilot studies, providers 
will be informed that, if they desire, they 
may contact each other via a WhatsApp 
group created and accessible to study 
staff for the purposes of understanding 
the kinds of support pharmacy providers 
request in initiating clients on PrEP 
and/or refilling PrEP prescriptions. 
Providers are not obligated to use this 
WhatsApp group but may instead opt to 
contact each other through other means 
(e.g., phone calls), the content of which 
will not be known to study staff during 
Aim 1a/2a. For Aim 1c, providers will 
consent to having study-related phone 
consultations audio recorded for 
subsequent transcription. 
 
The total number of providers 
participating in the WhatsApp group will 
depend on the number of pharmacy 
providers who are trained at each pilot 
Aim 1a pilot pharmacy to deliver PrEP 
(likely 1-2 individuals) and the number of 
clinicians providing remote oversight to 
these pharmacies (likely 1-2). We 
therefore anticipate that approximately 8 
providers will participate in the WhatsApp 
group.  
Remote oversight clinicians 
for Aim 1a, Aim 1c, & Aim 2a 
pharmacies 
• >18 years 
• PrEP clinician at a project-affiliated 
CCC who provides remote oversight 
to  pilot pharmacies  
• Able & willing to provide consent1 

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1Eligibilty criteria for participating in an in-depth interview and/or the study WhatsApp Group. All participants must provide written electronic consent (Appendix II) to participate in 
study activities. To participate in the extended pilot (Aim 1c), all pharmacy providers and remote clinicians, including those who previously participated in Aim 1a/2a, must provide 
written electronic or physical consent (Appendices XV and XVI).  
 
 
 
 
 

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Pilot procedures 
We have chosen single-arm trials for this study (i.e., no comparison pharmacies or CCCs) because this 
study is focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways 
for this delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general 
comparison in terms of demographics, retention, and adherence.   
 
Study visits 
Aim 1a pilot: 
All Aim 1a pilot participants will be followed for 6 months and complete a maximum of four study visits: 
at months 0, 1, 4, and 7 (Fig. 7). All Aim 1a participants will initiate PrEP at a pilot pharmacy and be 
instructed to return to the pharmacy one month later (the Kenya standard); thereafter, they will return 
quarterly to test for HIV and refill their PrEP drugs.  
 
Aim 1a pilot: 
All Aim 2a participants will initiate PrEP at a project-affiliated public CCC and enroll in the study either 
at the time of PrEP initiation or during a scheduled clinic-based PrEP refill appointment. Then, these 
participants will have the option to refill PrEP at one of two participating pilot pharmacies or at the CCC 
over the next 6 months (at months 1, 4, and 7 for participants initiating PrEP at the clinic and at months 
3 and 6 for participants refilling PrEP at the clinic).  
 
Aim 1c pilot: 
Aim 1c participants include the following two populations:  
• 
Client Population A - Individuals who did not participate in the Aim 1a or Aim 2a pilot: These 
participants will initiate PEP, PrEP, and/or undergo STI testing at a pilot pharmacy and be 
followed for up to 6 months. They will complete a maximum of four study visits: an initiation visit 
and follow-up visits at 1, 4, and 7 months post-initiation (Fig. 5). 
• 
Client Population B – Individuals who participated in the Aim 1a or Aim 2a pilots: At their last 
study visit for the Aim 1a or Aim 2a pilot, these individuals will be informed that they can opt to 
continue receiving PrEP refills at the pilot pharmacy during the extended pilot study but that, to 
participate in the extended pilot study, they will need to complete a new informed consent form. 
During the extended pilot study, participants will be followed for a maximum of 6 months and 
complete up to 2 study visits (in addition to the ones they had during Aim 1a or Aim 2a). Figure 
8 illustrates the study visit schedule and maximum number of study visits participants will have 
depending on what month they enrolled in the Aim 1a, Aim 2a, or Aim 1c pilot.  Individuals who, 
after completing their M7 visit in Aim 1a or Aim 2a pilot, continued taking PrEP at a clinic will be 
notified by study staff about the option to obtain PrEP refills at a pilot pharmacy during the 
extended study. If any such individual stopped taking PrEP since their M7 study visit for Aim 1a 
or Aim 2a pilot, but is interested in re-initiating PrEP at a pilot pharmacy during the extended 
pilot, s/he will be invited to return to the pharmacy to undergo PrEP screening and, if eligible, 
will be enrolled in the extended pilot and follow the study visit schedule for new initiators (i.e., 
starting with a M0 visit).  
  
All pilots (Aims 1a, 1c, and 2a): 
At all study visits that occur at a pharmacy, the pharmacy provider will use the PrEP prescribing/refilling 
checklist (with remote clinician oversight) when delivering PrEP services (Table 9, Appendix IV. 
Prescribing checklist). At their last study visit, participants will refill PrEP at the pharmacy (receiving a 
3-month supply or a 1-month supply, depending on whether their last visit is a M1 visit or a quarterly 
follow-up visit), complete endline assessments, and be referred to public CCCs for PrEP continuation. 
Throughout the study, the CCC will be a referral point for the pilot pharmacy providers should they have 

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any concerns or questions about PrEP clients. 
 
 
 
Fig. 7. Timeline of participant enrollment and follow-up for Aims 1a and 2b 
Note: For Aim 2a participants that enroll in the pilot during a clinic-based PrEP refill visit, they will be eligible for 6 
months of pharmacy PrEP refills (i.e., at months 3 and 6) 
 
 
Figure 8. Participant study visits based on enrollment month  
 

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PrEP checklist 
In order for pharmacy providers to prescribe PrEP (both at initiation and follow-up visits), they must 
ensure the individual seeking PrEP meets the criteria on a checklist, summarized in Table 9 (also found 
in Appendix III. Prescribing checklist), which we developed in collaboration with Kenyan 
stakeholders (including clinicians, pharmacy providers, etc.) at the stakeholder meeting and updated for 
the extended pilot (Aim 1c) to reflect the Kenya national guidelines for PrEP, which allow pregnant and 
breastfeeding women to initiate PrEP, and the guidelines for PEP.   
 
Interventions 
During Aim 1c, we will incorporate the following interventions to increase demand for PrEP: 
• Peer Referral (Aim 1c only) – Participants coming for a refill visit will be given the option to 
engage in a peer referral program. Those who choose to participate will receive up to 5 referral 
slips (Appendix XXIV) at each follow-up visit to distribute to their peers and receive a small 
incentive for each of their peers that presents their referral slip at a pilot pharmacy and inquires 
about PrEP. The incentive will be paid even if the referred peer does not ultimately initiate PrEP. 
• PEP (Aim 1c only): Pharmacy providers will be trained to deliver post-exposure prophylaxis (PEP) 
to individuals seeking PEP and/or reporting a recent HIV exposure and encourage such clients to 
return for PrEP. 
• STI Testing (Aim 1c only) – We will select a subset of 4 pharmacies (2 in Kisumu and 2 in Thika) 
at which pharmacy customers seeking STI diagnosis or treatment services will be offered free STI 
testing plus PrEP screening. Participants will have the option to complete STI testing (for C. 
trachomatis and N. gonorrhoeae). Participants that accept STI testing with PrEP delivery will self-
collect a urine sample in a private pharmacy room. All pharmacy providers will be trained on how 
to explain urine sample self-collection and contact courier service for sample delivery. Couriers will 
then deliver samples to the PHRD Thika study clinic for STI testing (both C. trachomatis and N. 
gonorrhoeae). Only participants who test positive for an STI will receive a call from study clinician, 
who will confirm their identity, screen for potential drug allergies/interactions, and write a STI 
treatment prescription that will be sent electronically to the participant’s choice pilot pharmacy for 
dispensing of free treatment. 
 
During Aim 1a, Aim 2a, and Aim 1c, at each study visit, participants will receive the core components of 
pharmacy-based PrEP delivery identified in the stakeholder engagement meeting (Table 4) and 
incorporated into the care pathway for pharmacy-based PrEP delivery (Fig. 3 and Fig. 4). 
• Counseling – on PrEP or PEP adherence and HIV risk reduction. Specifically, counseling will 
Table 9. Checklist for pharmacy PrEP and PEP prescribing and refilling. Month (M) 
• 
HIV risk: at risk (determined using the Kenya Rapid Assessment and Screening Tool, RAST) 
• 
Recent HIV exposure: if yes, screen for PEP instead 
 
 
 
 
• 
Counseling: completed (e.g., risk reduction, PrEP/PEP adherence, etc.) 
 
 
 
 
• 
HIV status: negative (confirmed with assisted HIV self-testing at pharmacy) 
 
 
 
 
• 
HIV symptoms: none 
 
 
 
 
• 
Clinical safety & side effect assessment: confirmed (e.g., no known kidney disease) 
• 
Records: completed (for prescribing and dispensing) 
 
 
 
 

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include PrEP/PEP side effect profiles, how to take PrEP/PEP, what to do if PrEP/PEP side effects 
are experienced, and the importance of not sharing PrEP/PEP to optimize potential efficacy and to 
reduce the chances of developing resistance through suboptimal HIV suppression. Depending on 
the study visit, this will be provided by a pharmacy provider or a clinician at the CCC. All individuals 
who administer this counseling will have completed PrEP and PEP training, per NASCOP 
guidelines.  
 
• Assisted HIV self-testing – will be provided at each study visit to clients wishing to initiate PrEP or 
PEP and/or refill PrEP by a pharmacy provider trained on HIV self-testing. During the Aim 1a and 
Aim 2a pilots, clients will receive either assisted blood-based or assisted oral-fluid HIV self-testing. 
During Aim 1c, only assisted blood-based HIV self-testing will be used. With assisted HIV self-
testing, pharmacy clients (including study participants) test for HIV in the presence of and with the 
support of a pharmacy provider using a self-testing kit purchased at the pharmacy (during Aim 1a) 
or provided free of cost at the pharmacy (during Aim 1c). Provider-assisted HIV self-testing (using 
both blood-based and oral-fluid kits) is already ongoing in Kenya, and thus pharmacies included in 
the pilot must already be certified to conduct this assisted self-testing. We are using assisted HIV 
self-testing in these pilots because technically only laboratory technologists are allowed to conduct 
rapid HIV testing in Kenya according to national guidelines (as determined at our stakeholder 
meeting). In Aim 1c, we are switching to blood-based HIV self-testing to assuage ongoing 
concerns about the sensitivity of oral fluid-based HIV self-testing among key decision-makers, 
such as the Kenya MOH and WHO. 
 
• Optional initial at-home HIV self-testing (Aim 1c only) – Clients interested in initiating PrEP at a 
pilot pharmacy during Aim 1c will have the option to take home an HIV self-testing kit (blood-based 
or oral-fluid) and complete the self-test at home before undergoing assisted HIV self-testing with a 
pharmacy provider as required for PrEP initiation. Findings from several PrEP implementation 
studies in Kenya, including the formative research conducted for this study and preliminary findings 
from Aim 1b, suggest that some clients are uncomfortable testing for HIV at a pharmacy without 
knowing their HIV status. Giving clients the option to learn of their HIV status in the privacy of their 
homes may help lower this barrier to PrEP initiation. Clients who opt to complete an initial HIV self-
test at home will receive the kit free of charge. 
 
• PrEP/PEP prescribing – including determination of clinical safety (for PrEP initiation in Aim 1a and 
for PrEP and/or PEP initiation in Aim 1c) and screening for potential PrEP/PEP side effects (for 
PrEP refills in Aims 1a, 1c & 2a or PEP follow-up visits in Aim 1c). To prescribe PrEP/PEP at 
initiation and follow-up visits, pharmacy providers must complete the checklist for PrEP/PEP 
prescribing (Table 9, Appendix IV. Prescribing checklist) and keep record of the prescription.  
 
• PrEP/PEP dispensing – once the checklist for PrEP/PEP prescribing (Table 9, Appendix IV. 
Prescribing checklist) has been completed, pharmacy providers can dispense PrEP or PEP. At 
PrEP initiation visits, pharmacy providers (in Aims 1a and 1c) and CCC clinicians (in Aim 2a) will 
only dispense a 1-month supply of PrEP, per Kenya MOH guidelines. At all follow-up visits, 
pharmacy providers will dispense a 3-month supply of PrEP. At PEP initiation visits, pharmacy 
providers (in Aim 1c) will dispense a 1-month supply of PEP, per Kenya MOH guidelines. 
 
• Oversight/referral – A Kenyan study clinician with experience in PrEP and PEP prescribing will be 
available 24/7 for consultation throughout the pharmacy PrEP delivery pilot (Aim 1a, Aim 2a, and 
Aim 1c). Pharmacy providers with any questions about PrEP or PEP eligibility or side effects can 
call the remote clinician for free using a number provided, or can consult with the PrEP clinician via 
a study-created WhatsApp group. All pharmacy providers will be trained on when consultation with 
the remote clinician is appropriate and how to share questions or concerns via the WhatsApp 
group without identifying patient information. Pharmacy providers will be trained to record the 

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content of their discussions with the remote clinician using a specific study form (Appendix VI. 
Remote clinician form). Pharmacy providers will also be given referral forms for nearby CCCs, 
which they can use to refer participants should they test HIV-positive or should they experience 
any PrEP/PEP side effects. Again, pharmacy providers will be trained to record any referrals to 
CCC using specific study forms (Appendix V. Referral form).    
 
• DBS samples – Trained research assistants will collect dried blood spot (DBS) samples.  
To remind participants to refill their PrEP drugs at pharmacies or the CCC (Aim 2a) or to return for 
follow-up after being dispensed PEP, we will use retention methods used in Kenyan PrEP clinics (e.g., 
telephone reminders for missed appointments). At the final follow-up visit before the end of the 
extended pilot study, we will do active tracing to have final data on all participants. Participants that are 
contacted via active tracing will still complete quantitative questionnaires (including DBS sample 
collection) so that we can understand the reasons why they might not have returned to the pharmacy 
for PrEP refills or following PEP dispensing; these participants that we actively trace, however, will not 
count towards our PrEP retention measurement. 
Individuals interested in initiating PrEP or PEP and/or refilling PrEP at pharmacies, but not interested in 
participating in study-related activities (including quantitative surveys or DBS collection) will be referred 
to a nearby CCC for free PrEP or PEP care. The total number of such individuals will be tracked over 
time, but no other information will be collected from them.  
Although the PrEP and PEP medications and potentially HIV self-tests for this pilot study will be 
provided by NASCOP via the Kenya Medical Supplies Agency (KEMSA), a consulting fee will be 
associated with pharmacy-based PrEP delivery in our initial pilot study (Aim 1a and Aim 2a, as is the 
case with other pharmacy-based services) to reflect the real-world sustainability of the delivery model. 
This fee will be agreed upon in a meeting with participating pharmacy providers and may vary by 
pharmacy depending on the clientele of that pharmacy (i.e., urban, high-income pharmacies may 
charge more for pharmacies in informal settlements). During Aim 1c, to assess the impact of removing 
client fees on PrEP initiation and continuation, the study will cover this consulting fee and participants 
will not pay any out-of-pocket expenses to receive PrEP, PEP, or STI testing and treatment.   
If this pilot study is ongoing during the COVID-19 pandemic, participants may be screened at the 
pharmacy entrance for symptoms of COVID-19 (including temperature) and may be asked to wear a 
face mask to reduce the risk of COVID-19 infection to pharmacy providers and other pharmacy clients.  
Condoms will be available for purchase at all participating pilot pharmacies, but not included in the 
package of PrEP services provided in this study.  
The interventions that participants receive at each study visit are summarized in Table 10 below.  
Table 10. Interventions received at each study visit. Month (M) 
Study intervention 
Study visit* 
M0 
M1 
M4 
M7 
Counseling: on PrEP use and side effects, PrEP adherence, HIV risk reduction 
X 
X 
X 
X 
Testing: for HIV, STIs (if available), and hepatitis B (if available) 
X 
X 
X 
X 
Safety oversight: ensuring that PrEP is not contraindicated (e.g., history of renal disease, diabetes)  
X 
X 
X 
X 
PrEP prescribing: if all checklist items completed.  
X 
 
 
 
PrEP dispensing: 30-day supply at initiation; 90-day supply at follow-up visits 
X 
X 
X 
X 
Consultation with remote clinician and/or referral to CCC: for complex PrEP cases 
X 
X 
X 
X 
Dried blood spot sampling: for measurement of PrEP adherence 
X 
X* 
X* 
X 

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Social harm: reports of physical, sexual, or verbal violence 
X 
X 
X 
X 
 
*All Aim 2 participants will initiate PrEP at a clinic and will only complete two follow-up visits at 3 and 6 months. Aim 1a and Aim 2a 
participants who opt to participate in the extended pilot (Aim 1c) will continue to receive the M7 study interventions on a quarterly basis 
until the study’s end.   
PrEP medication 
 
Tenofovir disoproxil fumarate (or TDF, 9-[(R)-2-[[bis [[(isopropoxycarbonyl) oxy] methoxy] phosphinyl] 
methoxy] propyl] adenine fumarate), emtricitabine (or FTC, 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-
oxatholan-5-yl]cytosine), and lamivudine (or 3TC, 2',3'-dideoxy-3'-thiacytidine 4-Amino- 1-[(2R,5S)- 2-
(hydroxymethyl)- 1,3-oxathiolan-5-yl]- 1,2-dihydropyrimidin- 2-one) are reverse transcriptase inhibitors 
that have been approved for the treatment of HIV infection in humans in Kenya and the United States. 
A fixed-dose, oral co-formulation of FTC/TDF (Truvada®) has also been approved for HIV prevention 
in Kenya and the United States. The World Health Organization recommends TDF-containing 
medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and 
TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing 
medications that align with WHO and Kenya national guidelines for PrEP will be used in this study. 
PrEP will be prescribed for once-daily use.  Study medication will be provided by the Kenya Ministry of 
Health and stored in accordance with the drug manufacturer’s recommendations. 
 
PrEP discontinuation 
 
PrEP continuation will be according to Kenya PrEP guidelines. Use of PrEP may be interrupted by the 
site investigators, trained pharmacy providers, or remote clinician due to safety concerns for the 
participant or use of concomitant medications that could interfere with PrEP or present a safety 
concern. All treatment interruptions will be documented.   
 
Referral to continued PrEP care 
 
For participants that continue to return to the pilot pharmacies for PrEP refills, at their final pharmacy 
PrEP refill visit before the study’s end, pharmacy providers will dispense another 3-month PrEP supply 
(assuming the individual meets the criteria on the prescribing checklist, Appendix IV. Prescribing 
checklist) and then will refer participants to a nearby public CCC for free continued PrEP care 
(Appendix V. Referral form). This procedure will apply to all enrolled participants, regardless of 
whether they initiated PrEP at the pilot pharmacy or clinic.  
PEP medication 
Tenofovir disoproxil fumarate (or TDF, 9-[(R)-2-[[bis [[(isopropoxycarbonyl) oxy] methoxy] phosphinyl] 
methoxy] propyl] adenine fumarate) and dolutegravir (or DTG, 1,2-bis(2-methylphenyl)guanidine) are 
reverse transcriptase inhibitors that, in combination with lamivudine (or 3TC, 2',3'-dideoxy-3'-
thiacytidine 4-Amino- 1-[(2R,5S)- 2-(hydroxymethyl)- 1,3-oxathiolan-5-yl]- 1,2-dihydropyrimidin- 2-
one)—an integrase strand transfer inhibitor—have been approved for use as HIV post-exposure 
prophylaxis in Kenya among individuals age 15 or older or weighing 35 kg or more. For women and 
adolescent girls of childbearing potential, the Kenyan guidelines recommend a regimen that substitutes 
3TC 
for 
atazanavir/ritonavir 
(or 
ATV/r, 
3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-
(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl 
ester). PEP will be prescribed for once-daily use, and participants found eligible for PEP will be 
dispensed a one-month supply, as per Kenya national guidelines. Study medication will be provided by 
the Kenya Ministry of Health and stored in accordance with the drug manufacturer’s recommendations.       

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Referral for continued PEP care 
During the extended pilot (Aim 1c), any individual who is found eligible for PEP but who declines to 
initiate PEP at a pilot pharmacy will be referred to an HIV comprehensive care clinic. Any participant 
who is dispensed PEP at less than 1 month before study endline will be instructed to go to an HIV 
comprehensive care clinic for PEP follow-up care and given a referral form (Appendix VII. Referral 
form). 
Data Collection Quantitative client surveys & DBS (Aims 1a, 1c, and 2a) 
Trained research assistants (RAs) stationed at pilot pharmacies and project-affiliated CCCs will 
approach eligible individuals and invite them to participate in the study. They will review the informed 
consent form (Appendix I & Appendix III for Aim 1a and Aim 2a, and Appendices XIII and XIV for 
Aim 1c) with these individuals and answer any questions they may have regarding participation. Once 
written informed consent is obtained, RAs will conduct a structured quantitative survey with the 
participant (Appendix VII. Questionnaire: Baseline for Aim 1a and Aim 2a, and Appendix XX for 
Aim 1c). (The timing of the survey for each pilot is outlined above in Fig. 7.) Table 11 outlines the 
information we will collect in these surveys, including information to be collected in the follow-up 
questionnaire (Appendix VIII. Questionnaire: Follow-up). All quantitative data will be collected on a 
tablet using CommCare (Dimagi, Cambridge, USA), an electronic data collection platform.  
At each study visit, RAs will also collect a DBS sample from participants. PrEP adherence will be 
assessed using self-reported drug adherence in quantitative surveys and batched drug levels at PrEP 
initiation and follow-up visits. Dried blood spots from batched drug levels will be shipped to the 
University of Washington (USA) for processing and analysis for tenofovir drug levels because currently 
the only laboratories that have the capacity to do that testing are located there. 
 
 
 
Table 11. Information collected in the quantitative surveys. Month (M) 
 
Study visit* 
Information collected 
M0 
M1 
M4 
M7 
Socio-demographic: gender, age, education, employment 
X 
 
 
 
Alcohol use: # days in past week, alc. problem screen (RAPS4-Q4) 
X 
X 
X 
X 
Depression: PHQ-9 depression screening tool, often used in SSA 
X 
X 
X 
X 
Relationship: partner status, social support, partner violence  
X 
X 
X 
X 
Sexual behaviors: sex frequency, condom use, sexual power 
X 
X 
X 
X 
Fertility intentions: # children (& goal #), pregnancy history, current contraception 
X 
X 
X 
X 
HIV stigma: scale + disclosure to fam./friends & adverse effects 
X 
X 
X 
X 
COVID-19 assessment: prevention measures, risk, impact on health seeking 
X 
X 
X 
X 
PrEP adherence: pills missed (past week) 
 
X 
X 
X 
Clinical safety: pregnancy, history of kidney disease, etc.  
X 
X 
X 
X 
Potential drug side effects: nausea, vomit, dizziness, headache 
 
X 
X 
X 
Social harm: reports of physical, sexual, or verbal violence 
 
X 
X 
X 
Costs: $ spent at last pharmacy/clinic visit, willingness to pay (see Table 10) 
X 
X 
X 
X 
Implementation strategies: acceptability and feasibility (Aim 1c only)  
X 
X 
X 
X 
*Aim 2a participants who enrolled at a CCC during a PrEP refill visit will only complete two follow-up visits at 3 and 6 months.  For Aim 
1a and Aim 2a participants who opt to participate in the extended pilot (Aim 1c), we will continue to collect the same information as 
shown for M7 above on a quarterly basis until the study’s end.   
 

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Costs (Aims 1a, 1c, and 2a) 
To measure costs and cost preferences associated with pharmacy-based PrEP deliver, we have 
included questions related to participants’ expenditures on health goods/services (at clinics or 
pharmacies) and their willingness to pay for pharmacy-based PrEP delivery in the quantitative surveys 
(Table 11, Appendix VII. Questionnaire: Baseline, Appendix VIII. Questionnaire: Follow-up; 
Appendix XX: Baseline questionnaire for Aim 1c participants, Appendix XXI: Follow-up 
questionnaire for Aim 1c participants). Additionally, we will conduct two quantitative surveys with the 
lead staff member of each Aim 1a pilot pharmacy (n=4): 1) shortly after the pharmacy training on pilot 
procedures and before the first participant is enrolled, and 2) at study completion, seven months after 
the last participant has been enrolled. Table 12 details the costs we will measure in surveys for 
providers and clients. All surveys will be conducted by trained research assistants on tablets using 
CommCare, an electronic data collection platform. 
Standardized patient actors (Aim 1a only) 
To measure fidelity of the Aim 1a pharmacy-based PrEP delivery intervention (i.e., counseling, HIV 
testing, safety assessment), we will use unannounced standardized patient actors. Standardized 
patient actors have been shown to accurately measure care and assess provider performance in a 
variety of settings, including PrEP research in Kenya.65–71 The use of standardized patient actors is 
advantageous in this study because it enables us to identify weak points in our pharmacy-based PrEP 
delivery care pathway for individuals and scenarios that are of particular interest (e.g., pregnant 
women, or individuals who test HIV positive). While pharmacy providers will not know that the 
standardized patient actor is an actor at the time of that individual’s study visit, providers will be 
informed of and agree to this study procedure when they agree to participate in the pilot study.  
 
Case scripts 
In consultation with Kenyan medical PrEP providers, we have developed case scripts informed by 
previously conducted formative research. We developed scripts for four distinct participant populations 
hypothesized to benefit most from pharmacy-based services:  
 
(5) Young woman, seeking emergency contraception 
(6) Man who has sex with other men, presenting for STI treatment 
(7) Young man, seeking sexual performance enhancing drugs (e.g., Viagra)  
(8) Young woman, has trouble doing HIV test  
 
We have developed unique scripts for each actor and each pharmacy visit (i.e., the first visit for PrEP 
initiation, and the second visit for PrEP refills). The scripts include pseudo names for the actors to use, 
Table 12. Pharmacy-based PrEP delivery costs measured 
Client costs 
Provider costs 
●  Service(s)/item(s) purchased at most recent 
pharmacy (clinic) visit, & amount spent on each 
●  Service(s)/item(s) provided by the pharmacy, & the cost of these 
services 
●  Travel time, time away from work, child care, & 
other costs associated with pharmacy PrEP visit  
●  Overhead costs (including salaries and space) of running a 
pharmacy 
●  Perceptions on price at which pharmacy-based PrEP 
was provided in the pilot  
●  Perceptions on price at which pharmacy-based PrEP was 
provided in the pilot 
●  Price willing to pay for pharmacy-based PrEP  
●  Price willing to provide pharmacy-based PrEP  
●  Time spent recruiting PrEP clients and with each PrEP client for  
PrEP initiation (including counseling) and refills 

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as well as detailed personal information about these fictional individuals – including date of birth, 
relationship status, medical and sexual history, tobacco and alcohol use, occupation and education, 
and current living arrangement.  
 
Actors 
We will train 4-6 study staff (not participating in research related to this project) as standardized patient 
actors. These staff will participate in a standardized patient actor training (conducted by a trainer with 
years of experience) on case scripts that detail key elements of pharmacy-based PrEP delivery, 
including general PrEP inquires, eligibility requirements, symptoms of PrEP side effects, and PrEP non-
adherence. The study staff that volunteer to be standardized actors have to not be living with HIV and 
must agree to HIV testing at the pilot pharmacies; we will take every precaution to ensure their HIV 
status remains confidential should one of these individuals test HIV positive at a pilot pharmacies. The 
number of actors (N=4) and visits (2 visits/actor, =8 visits in total) we are proposing for this assessment 
visits is consistent with similar evaluations conducted in other settings.65  
 
Unannounced visits 
The patient actors will visit the Aim 1a pilot pharmacies in Thika two times: 1) once to initiate PrEP, and 
2) a second time to refill their PrEP drug supply. The patient actors will complete all steps in the 
pharmacy-based PrEP delivery care pathway that would be completed by any other PrEP client. They 
will not reveal to the pharmacy provider that they are a patient actor.  
Right after completion of the unannounced visits, the patient actor will meet with a staff researcher to 
complete the standardized patient checklist, where we measure the fidelity of their pharmacy-based 
PrEP delivery visit (see details below). When the patient actor meets with the research staff, they will 
hand over any PrEP drugs they received at their pharmacy visit. When the patient actor returns for their 
follow-up visit, they will not bring any partially completed PrEP bottles with them and, if asked, tell the 
pharmacy provider that they left their remaining PrEP drugs at home. 
 
Standardized patient checklist 
At the end of each unannounced visit, the standardized patient actors will complete debriefing visits 
with a research assistant collecting data for the pilot study. These debriefing visit will occur on the same 
day of the actors’ unannounced visits, in a private setting outside the pilot pharmacy. At this debriefing 
visit (which will be audio recorded), the standardized patient actor will complete two checklists with the 
research assistant: 1) a technical checklist that identifies what services they were offered and how 
much they paid, and 2) a checklist that assess the quality of care, including duration of the visit and the 
actors’ perceptions of how they were treated by the pharmacy PrEP provider (summarized in Table 13, 
Appendix XII. Standardized Patient Actor Checklist). The technical checklists will vary slightly for 
PrEP initiation (enrollment) and PrEP refill (follow-up) to account for the different services associated 
with these visits. All checklist data will be collected electronically on a tablet or phone using 
CommCare, an electronic data platform. The audio recordings from the debriefing visit with be 
transcribed so that can be later used to supplement the checklist data. 
 
Table 13. Standardized fidelity checklists items (PrEP initiation, Aim 1a only) 
Technical assessment 
Quality of care assessment  
●  Asked if they were interested in initiating PrEP  
●  Greeted when entered pharmacy 
●  Tested for HIV 
●  Pharmacist made eye contact and smiled 
●  Counseled on importance of PrEP adherence 
●  Pharmacist explained why providing services 
●  Counseled on potential side effects of PrEP 
●  Pharmacist did not use judging or stigmatizing language 

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In-depth Interviews (Aims 1b and 2b) 
We will conduct in-depth qualitative interviews with clients and providers (both pharmacy providers and 
clinicians providing remote oversight) who participated in the Aim 1a pilot to explore their experiences 
with this new PrEP delivery model and understand the acceptability of pharmacy-based PrEP. In client 
interviews (Appendix IX. In-Depth Interview Guide: Clients), we will assess perceptions of quality of 
care, attitudes towards paying for pharmacy-based PrEP delivery, and their interest in continuing to 
receive PrEP at pharmacies. In provider interviews (Appendix X. In-Depth Interview Guide: 
Providers, Appendix XI. In-Depth Interview Guide: Clinicians), we will assess pharmacy providers’ 
attitudes toward providing PrEP and interest in continuing to provide PrEP at pharmacies or remote 
oversight. The topics to be discussed during these interviews are summarized in Table 14. All 
pharmacy providers that participate in these in-depth interviews will sign documents of informed 
consent (Appendix II); consent for the in-depth qualitative interviews was included in the consent for 
participation in the pilot study for pharmacy clients (Appendix I). For Aim 2b, we will conduct in-depth 
qualitative interviews with Aim 2a participants (n=30) who refilled PrEP at least once during the Aim 2a 
pilot study but did not ever refill PrEP at a pilot pharmacy. The purpose of these interviews is to 
understand why these participants decided against refilling PrEP at a pharmacy and to identify potential 
ways to improve this model’s acceptability. The interview guide is available in Appendix XVIII. All client 
participants that participate in these in-depth interviews will sign a document of informed consent 
(Appendix XVII). 
 
All qualitative interviews will be conducted in the participant’s preferred language (English, Kikuyu, or 
Kiswahili) by trained research assistants using pre-piloted, semi-structured guides. Each interview will 
be audio recorded, transcribed, and translated into English by study team members who will also 
routinely complete debriefing reports72 to accelerate real-time learning. Dr. Ngure, an experienced 
behavioral scientist who has led our qualitative research in Thika for the past decade, will supervise 
these interviews.  
 
 
●  Screening for pre-existing health conditions, 
including COVID-19 symptoms 
●  Patient felt that privacy was maintained throughout their visit 
●  Received 1-month (initiation) or 3-month (refill) 
PrEP supply 
●  Interactions with the pharmacists were not rushed 
 
●  Measures were in place for COVID-19 protection 
Table 14. Topics to be discussed during qualitative interviews (Aim 1b) 
Services received 
• 
Description of client services received at pharmacy (e.g., greeting, counseling, screening, 
dispensing, etc.) 
Likes/dislikes of 
pharmacy-based PrEP 
delivery 
• 
Discussion of client and provider preferences related to pharmacy-based PrEP delivery – 
what worked, what did not work, elements of services that were or were not appreciated 
or convenient.  
Quality of services  
• 
Discussion of how clients were treated by pharmacists, including participants’ attitudes on 
how comfortable and confident pharmacists seemed providing PrEP services.  
Cost of pharmacy-
based PrEP  
• 
Discussion of the costs associated with pharmacy-based PrEP delivery – did clients find 
them reasonable? Would provider be willing to continue to provide PrEP at these costs? 
How might the costs be adjusted?   
Future interest in 
pharmacy-based PrEP 
• 
Discussion of where clients might want to access PrEP in the future: standard of care clinic-
based delivery or preference for the new model of pharmacy-based PrEP delivery? 
COVID-19 impact 
• 
Discussion of how the COVID-19 outbreak affected healthcare seeking behaviors, including 
participants’ ability to access PrEP at pilot pharmacies.  

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WhatsApp Group (Aims 1a, 1c, and 2a) & phone consultation transcripts (Aim 1c only) 
 
Prior to agreeing to be part of this pilot study, providers will be informed that, if they desire, they may 
contact each other via a WhatsApp group created and accessible to study staff for the purposes of 
understanding the kinds of support pharmacy providers request in initiating clients on PrEP and/or 
refilling PrEP prescriptions. Providers are not obligated to use this WhatsApp group but may instead opt 
to contact each other through other means (e.g., phone calls). By signing the consent form for Aim 1c, 
pharmacy providers and remote study clinicians consent to having any study-related phone 
consultation recorded and subsequently transcribed for analysis. Study staff will export any 
conversation threads (hereafter, “transcripts”) from the study-created WhatsApp group for analysis. All 
pharmacy provider and remote clinicians that participate in this WhatsApp Group will sign documents of 
informed consent (Appendix II).  
 
Quantitative provider surveys (Aim 1c only) 
 
For Aim 1c, we will conduct baseline and monthly follow-up surveys (Appendices XXVII and XXVIII) 
with pharmacy providers who are involved in the delivery of PrEP, PEP, and/or STI testing at a pilot 
pharmacy (n=up to 2 providers surveyed per pilot pharmacy, or 24 survey participants total). These 
surveys will collect basic demographic information about the providers, their assessments of 
acceptability and feasibility of the care pathway refinements (peer referral, PEP-as-a-bridge-to-PrEP, 
STI testing-as-a-bridge-to-PrEP, optional client self-administration of the HIV risk assessment tool, 
optional initial HIV self-test at home, provider assisted blood-based HIV self-testing), and their 
willingness to charge for pharmacy-based PrEP services. All surveys will be conducted by trained 
research assistants on tablets using CommCare, an electronic data collection platform. For the handful 
of survey questions that are open-ended, the research assistant will audio record the participant’s 
response. These audio recordings will be subsequently transcribed, translated to English (if necessary), 
and stored securely.    
 
Data Analysis & Outcomes 
Quantitative client surveys & DBS (Aims 1a, 1c, and 2a) 
Table 15 shows the study outcomes that will be obtained from the quantitative surveys (Appendix VII. 
Questionnaire: Baseline, Appendix VIII. Questionnaire: Follow-up for Aim 1a/2a and Appendices 
XX and XXI for Aim 1c) and DBS data. For Aims 1a and 1c, we will calculate the number of 
participants who initiated PrEP at pilot pharmacies, and the proportion of these who: returned for PrEP 
refills, were adherent to PrEP, and experienced any PrEP side effects or study-related social harms.  
For Aim 2a, we will also calculate the number of participants who initiated or refilled PrEP at a CCC but 
choose to refill PrEP at a pilot pharmacy, and the proportion of these who: returned for PrEP refills, 
were adherent to PrEP, and experienced any PrEP side effects or study-related social harms 
(comparing outcomes with those who remained in PrEP care at the CCC). 
• PrEP initiation. We will report the socio-demographic characteristics of participants who initiate 
PrEP at pharmacies (Aim 1a) and compare those with the sociodemographic characteristics of 
participants from our other studies who have initiated PrEP at healthcare facilities. 
 
• PrEP refills. We will report the socio-demographic characteristics of participants who refilled PrEP 
at a pharmacy and compare those with the sociodemographic characteristics of participants from 
our other studies who have refilled PrEP at healthcare facilities (and the sociodemographic 
characteristics of participants who do not choose to refill PrEP at pharmacies in Aim 2a).  

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• PrEP discontinuation. For individuals who are in known HIV serodiscordant relationships, if a 
participant discontinues PrEP use because their HIV infected partner has initiated and sustained 
ART for >6 months (the Kenya standard for discontinuing PrEP), this participant will be considered 
PrEP-adherent. Similarly, if PrEP is discontinued for safety reasons (but not adherence reasons) 
as determined by the pharmacy providers and confirmed by the remote clinician, follow-up 
thereafter will be censored, since the subject will not be able to be assessed for adherence to 
PrEP.  
 
Adjusted analyses will be done as needed, controlling for potential confounders based on our prior work 
assessing correlates of PrEP use: demographics (e.g., age, educational level), sexual behaviors (e.g., 
condom use, MSM, number of partners), medical status (e.g., depression), and beliefs (e.g., risk 
perception, PrEP efficacy). We will assess specifically for gender as a key variable. Stata or R will be 
used for all analyses.   
 
DBS samples will be measured from all participants in at each PrEP pharmacy or clinic (Aim 2a) visit. 
We will take a random sample of 10% of the DBS samples and measure concentrations of tenofovir 
diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) using validated liquid chromatography 
tandem mass spectrometry (LC-MS/MS), which has become the gold standard for research evaluations 
of PrEP adherence.10,11  Any concentrations of TFV-DP in a DBS punch >700 fmol will be considered 
PrEP adherent.10 All DBS samples that we collect from study participants will initially be stored in a 
secure freezer at the Thika study site. However, the DBS samples that are randomly selected for TFV-
DP and FTC-TP drug concentration testing will be shipped to the USA because currently the only 
laboratories that have the capacity to do this testing are located there.  
 
Table 15. Outcomes from quantitative survey and DBS samples (Aims 1a, 1c, and 2a) 
 
Aim(s) 
Definition 
Data Source(s) 
Timing 
PrEP initiation 
Aim 1a 
& 1c 
# of participants that initiated PrEP at pilot 
pharmacies 
• Quant survey 
• Pharm records 
M0 
PrEP retention 
Aims 
1a, 1c, 
& 2 
% of participants who return to the pilot pharmacies 
(or CCC) for PrEP refills 
• Quant survey 
• Pharm records 
 
M1, M4*, 
M7* 
PrEP adherence 
Aims 
1a, 1c, 
& 2  
• % of participants that missed no pills in previous 
week 
• % of participants that refill drugs at pharmacy 
• % of DBS samples with drug concentrations 
indicating adherence 
• Quant survey 
• Pharm records 
• DBS 
M1, M4*, 
M7* 
 
 
Selection of 
pharmacy-
based PrEP  
Aim 2a 
• % of participants who initiated or refilled PrEP at 
CCC and selected pharmacy-based PrEP refills 
• Quant survey 
• Pharm records 
M0 
PEP initiation 
Aim 1c 
# of participants that initiated PEP at enrollment at a 
pilot pharmacy 
• Quant survey 
M0 
PrEP initiation 
following PEP 
Aim 1c 
# of participants that initiated PrEP at a pilot 
pharmacy and, at a later study visit, initiated PrEP 
• Quant survey 
M0, M1, M4, 
M7 
STI testing 
Aim 1c 
# of participants that underwent STI testing at 
enrollment at a pilot pharmacy 
• Quant survey 
M0 
Concurrent STI 
testing and 
PrEP initiation 
Aim 1c 
# of participants that underwent STI testing at 
enrollment at a pilot pharmacy and initiated PrEP at 
that same visit 
• Quant survey 
M0 

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PrEP initiation 
following STI 
testing 
Aim 1c 
# of participants that underwent STI testing at a pilot 
pharmacy and, at a later study visit, initiated PrEP 
• Quant survey 
M0, M1, M4, 
M7 
Acceptability & 
feasibility of 
implementation 
strategies used 
in the refined 
care pathway 
Aim 1c 
Median rating of each implementation strategy (i.e., 
care pathway refinement shown in Figure 4) 
• Quant survey 
M0, M1, M4, 
M7 
* All Aim 2a participants will initiate PrEP at a clinic and will only complete two follow-up visits at 3 and 6 months. Aim 1a 
and Aim 2a participants who opt to participate in the extended pilot (Aim 1c) will continue to contribute data at quarterly 
follow-up visits until the study’s end. 
 
Costs (Aims 1a, 1c, and 2a) 
We will use descriptive statistics to summarize the various aspects of pharmacy-based PrEP delivery 
costs (Table 12). We will use multivariable regression models to determine the socio-demographic 
characteristics of PrEP clients (collected in the baseline quantitative survey) that might be associated 
with cost-related outcomes (e.g., willingness to pay). 
 
Standardized patient actors (Aim 1a only) 
For each pharmacy, we will calculate the percentage of actors who received the items on the technical 
and quality-of-care checklists (Appendix XII. Standardized Patient Actor Checklist). We will pre-
determine what items on the checklist are essential for pharmacy-based PrEP delivery and calculate 
the percentage of actors who received all of these services. We will also supplement the findings from 
the checklist with insights (i.e., quotes) shared during the debriefing meeting and captured in the audio 
recordings/transcripts of these meetings.  Additionally, we will identify key areas of our care pathway 
that will require additional training, modification, or reinforcement during implementation. 
 
In-depth interviews (Aims 1b and 2b), WhatsApp group (Aims 1a, 1c, and 2a), and phone 
consultation transcripts (Aim 1c only) 
Interview transcripts, WhatsApp transcripts, and phone consultation transcripts will be reviewed 
separately by two qualitative researchers, who will ensure completeness. These researchers will 
immerse themselves in the data through repeated readings of the transcripts and create a preliminary 
codebook of inductive73,74 and deductive75–77 codes to capture client and provider experiences of 
pharmacy-based PrEP delivery, including barriers and facilitators. A sample of transcripts will be 
double-coded independently by two or more researchers, with coding discrepancies identified and 
resolved via consensus. During this process, the codebook will be refined, with existing codes 
combined, separated, or eliminated and new codes added as needed to capture emerging themes.78,79 
Thereafter, remaining transcripts will be coded in Dedoose (Los Angeles, California, USA) and Atlas.ti 
(Berlin, Germany).  We have extensive experience analyzing qualitative data to inform intervention 
development.24,80–101 
 
Quantitative provider surveys (Aim 1c only) 
We will calculate median provider ratings for each survey item assessing acceptability and/or feasibility 
of the model refinements. We will also assess change in providers’ ratings over time, and we will 
calculate median willingness to charge for pharmacy-based PrEP services. Excel, Stata, or R will be 
used for all quantitative analyses. We will qualitatively analyze the transcriptions of provider responses 
to open-ended questions using content analysis. 

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Participant retention and withdrawal 
The Thika site will develop retention methods tailored to and most efficient for the local study settings. 
Retention activities may include explanation of the study visit schedule and procedural requirements 
during the informed consent process and re-emphasis at each study visit, collection and updating of 
locator information, and use of appropriate and timely visit reminder mechanisms (including phone calls 
and text messages). To provide complete information at the end of the study, efforts will be made to 
have a final follow-up visit for each participant.  
 
Participants may voluntarily withdraw from the study for any reason at any time. The site Investigators 
also may withdraw participants from the study in order to protect their safety and/or if they are unwilling 
or unable to comply with required study procedures.  Reasons for withdrawal will be recorded.  
 

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Limitations 
These pilot studies have some potential limitations that are important to note. First, the pharmacies and 
pharmacy providers selected to participate in these pilot studies will be selected on specific criteria and 
may not be generalizable to all private pharmacies and pharmacy providers throughout Kenya. For 
example, all pharmacies participating in these pilots must be registered with the different Kenyan 
pharmaceutical boards, thus the findings from this study cannot extend to non-registered pharmacies or 
drug kiosks – which will unlikely to be able to legally deliver PrEP in a real-world setting without 
registration anyways.  
 
Additionally, the remote PrEP clinicians that will oversee any questions pharmacy providers may have 
about pharmacy-based PrEP delivery will be PrEP experts within the Kenya PrEP delivery setting and 
might not be representative of all remote clinicians available for consultation if pharmacy-based PrEP 
delivery is to be scaled throughout Kenya. However, since these PrEP clinicians just have to be 
available remotely and not in person, it should be feasible to have a rotation of PrEP experts available 
for consultation if this model is to be scaled-up in Kenya. 
 
Finally, in these pilot studies, the PrEP drugs and HIV self-tests are being provided by the Kenya 
Ministry of Health, and thus the price pilot participants pay for pharmacy-based PrEP delivery in Aim 
1a/2a is just a mark-up that covers the overhead of pharmacy PrEP storage and providers’ time. This 
model, where the Ministry of Health provides PrEP and HIV self-test kits to private pharmacies for 
distribution, might not be feasible if pharmacy-based PrEP delivery is to be scaled nationally in Kenya. 
Thus, the future price of pharmacy-based PrEP may differ from that in this pilot study (i.e., it will likely 
increase), which may influence (i.e., decrease) PrEP uptake and retention among individuals who 
access PrEP at pharmacies.  
 

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SAFETY 
PrEP  
Multinational studies demonstrated that PrEP (including FTC/TDF) was safe for use in heterosexual 
men and women from Kenya and Uganda. There were no statistically significant differences in the 
frequency of deaths, serious adverse events, adverse events overall, or key laboratory adverse events 
(specifically, creatinine elevation and phosphorus decrease) for those receiving PrEP compared to 
those receiving placebo in the Partners PrEP study.   
 
For the purposes of this study, only serious adverse events (SAEs) will be documented. SAEs felt to be 
related to PrEP will result in temporary hold of PrEP. In the case of temporary holds, the hold will 
continue until the event is stabilized or resolved. If the event resolves, PrEP may be reinitiated at the 
discretion of the Data Monitoring Committee (see “Study oversight” below), resuming safety monitoring. 
The severity of clinical symptoms will be scored using the DAIDS Table (July 2017 Version) for Grading 
the Severity of Adult and Pediatric AEs. Reporting on adverse events to relevant IRBs will be according 
to relevant regulations.   
 
Pregnancy 
Animal and human data, including from the Partners PrEP Study and Partners Demonstration Project, 
suggest safety of FTC/TDF when used by HIV infected women during pregnancy and breastfeeding.  
Other studies are exploring detailed safety of PrEP use in pregnancy.   In the pilot evaluations 
described in Aims 1a (pharmacy-based PrEP initiations and refills) and Aim 2a (pharmacy-based PrEP 
refills only), we excluded pregnant and breastfeeding women because it was felt, at the time, that 
assessing the PrEP eligibility of pregnant women was outside of the scope of care of pharmacy 
providers in Kenya. However, through consultation with members of the Kenya Ministry of Health and 
other PrEP stakeholders, we have come to the realization that excluding pregnant women from those 
pilot studies was unnecessary for two reasons. First, Kenya’s current national PrEP guidelines allow 
pregnant women to be initiated on PrEP, in line with WHO recommendations. In fact, the guidelines 
explicitly state, “Pregnancy and breastfeeding are not contraindications to provision of PrEP. Pregnant 
or breastfeeding women whose sexual partners are HIV positive or are at high risk of HIV infection may 
benefit from PrEP as part of combination prevention of HIV infection”, and throughout Kenya, PrEP is 
regularly prescribed to pregnant and breastfeeding women, for example, at family planning and 
antenatal care clinics. Second, within the Kenya national PrEP guidelines, the criteria that individuals 
must meet to qualify for PrEP do not vary based on the prospective client’s pregnancy status. As such, 
pharmacy providers in this pilot study would not need any additional training beyond that which we 
provided in Aim 1a in order to safely initiate pregnant and breastfeeding women on PrEP. Lastly, 
excluding pregnant and breastfeeding women from our extended pilot study (Aim 1c) who otherwise 
meet both study and PrEP eligibility criteria (i.e., who test negative for HIV, are determined to be at high 
risk of HIV using the Kenya Risk Assessment Screening Tool, and who have no other PrEP 
contraindications) may represent a greater risk to them than including them in the study would, as it 
would constitute denying them access to PrEP—a drug that has been found to reduce the risk of 
getting HIV by sex by about 99% (CDC, 2021). For these reasons, we propose allowing pregnant and 
breastfeeding women to participate in our extended pilot study (Aim 1c). 
 
Social harm considerations 
We have extensively considered the risk of social harm related to both PrEP use and the delivery and 
prescribing of PrEP at pharmacies, including risks of depression/anxiety and disclosure and stigma.  

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Our extensive experience with longitudinal follow-up of heterosexual HIV serodiscordant couples and 
women at risk mitigates some of this risk, and we found very little risk of social harms or anxiety related 
to HIV self-testing in our pilot evaluation, among couples. Analyses of social harm related to pharmacy-
based PrEP delivery will be done overall, by sex and by relationship status, given the potential for 
differential gendered and relationship risks.  In the event of a clinical need (e.g., side effects, symptoms 
of a sexually transmitted infection), participants will be referred to nearby HIV clinics for care. 
 

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HUMAN SUBJECTS CONSIDERATIONS 
The protocol, informed consent forms (for pilot participation and for interviews of participants and 
providers), and patient education and recruitment materials will be reviewed and approved by the 
institutional review boards at the University of Washington and at KEMRI. All participants will provide 
written informed consent before participation in the pilot and quantitative/qualitative interviews. 
Participants will be informed the purpose of the study, the procedures to be followed and the risks and 
benefits of participation. The consents forms will be translated into Kiswahili. Specifically, the 
participants will be informed that this novel study will answer critical questions on acceptability, 
feasibility, and costs of pharmacy-based PrEP delivery in Kenya.   
 
Study oversight 
This study will be subject to oversight by an independent data monitoring committee that will 
periodically review data from the study, including study execution, adherence, HIV incidence, 
PrEP/PEP side effects, serious adverse events and social harms by study arm. We have had a Data 
Monitoring Committee for many of our other ongoing studies. The independent data monitoring 
committee will provide recommendations to the study team as part of periodic reviews. Reports from all 
reviews will be provided for submission to overseeing IRBs/ECs. 
 
Risks 
Participants may become embarrassed, worried, or anxious when completing their HIV risk assessment 
and/or receiving HIV counseling at pharmacies. They also may become worried or anxious while 
waiting for their HIV test results at the pharmacy. Individual counseling and discussions of study 
participation may raise issues in individuals. Participants who learn that they have HIV may experience 
anxiety or depression related to their test results. At all study sites, individual and couples-based HIV 
counseling will be provided by pharmacists who have been trained in specific issues related to HIV risk, 
HIV acquisition, and care of HIV serodiscordant couples, including stigma, blame, methods to avoid 
transmission, and available support services. 
 
Although study sites will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others, particularly as this project will 
be conducted at community-based settings. There is a possibility that social harms may result (i.e., 
because participants could become known as participating in a pilot involving HIV prevention).  For 
example, participants could be treated unfairly or discriminated against, or could have problems being 
accepted by their families and/or communities. Understanding the risk/benefit balance for confidential 
delivery of PrEP services in community settings is an explicit goal of this project. Moreover, we have 
extensive experience with the strategies to minimize the potential for social harms in populations 
participating in HIV prevention studies.  
 
Risks and side effects related to PrEP include gastrointestinal intolerance and rarely more serious side 
effects; these are detailed on the package insert and this project is not testing PrEP itself but its 
delivery.  The medical risks of HIV testing using blood collection are small.  
 
Protection against risk 
The study team has extensive experience with counseling about HIV risk, PrEP, and strategies for HIV 
prevention in general. Study procedures will include qualitative interviews and prospective follow-up, 

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HIV testing, blood collection, assessment of uptake and adherence to PrEP for HIV prevention. PrEP 
will be provided by the study site and will follow Kenya clinical guidelines. Counseling about 
antiretroviral-based HIV prevention will include messaging describing the benefits of all strategies, 
based on evolving available data and national policies / national roll-out of antiretrovirals (including 
earlier treatment and PrEP) for HIV prevention.  
 
For data collection, standardized questionnaires will be used that will include questions on sensitive 
topics, including sexual behavior, depression, alcohol use, and stigma. We have extensive experience 
with these questionnaires from our prior studies and the expertise and counseling resources required to 
attend to study participants (e.g., those with depression). We have published on very low rates of social 
harm and intimate partner violence in our prospective studies of HIV serodiscordant couples, which 
likely reflects the counseling available to couples; for women at risk, we have extensive experience with 
management of potential social harms, through our prevention studies (detailed in Preliminary Results 
and also experience in clinical trials such as ASPIRE, the MTN study of the dapivirine vaginal ring for 
HIV prevention).  
  
The risks from the anticipated activities will be no greater than in our previous studies; in fact, given the 
proven prevention benefits of PrEP and now national roll-out in Kenya, risks are anticipated to be less 
than in some of our prior studies. We feel the risks associated with the study are small. The benefits are 
consistent with clinical care benefits and cultural expectations and they follow the established standard 
with IRB approval in our other studies. We therefore believe the balance of benefit and risk is 
appropriate. 
 
Benefits 
All pilot participants will benefit by having novel access to PrEP during the study period. HIV prevention 
practices, according to national guidelines, will be provided to all participants enrolled in this study.  
This will include risk reduction counseling, addressing sexually transmitted infections (STIs), and 
access to condoms. There are also possible benefits from ongoing access to HIV risk reduction 
counseling and other prevention services at the pilot pharmacies. In addition, participants and others 
also may benefit in the future from information learned from this study. There may be no other direct 
benefits to participants in this study.   
 
Care for persons identified as HIV infected 
This study will identify persons who are infected with HIV, either as part of the study screening process 
or during follow-up of enrolled participants. Study staff will provide participants with their HIV test results 
in the context of post-test counseling. Persons identified as HIV infected during the study screening 
process, but who do not meet eligibility criteria or who do not wish to enroll in the study, will be referred 
to nearby clinics where they can receive free HIV care and treatment services. For participants who are 
HIV infected and who also become pregnant during follow-up, every effort will be made to facilitate 
access to programs for preventing mother-to-child HIV transmission for appropriate antiretroviral 
treatment to reduce the probability of HIV transmission from mother to child.   
 
Benefits to the community 
An important goal of this study is to achieve the study objectives in a way that provides benefits to the 
community that endure beyond the proposed study lifetime regardless of the specific outcome of the 
study. Some of these community benefits include development of optimized approaches to HIV 
prevention care and community awareness of comprehensive HIV prevention.  
 

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Importance of the knowledge to be gained 
Knowledge gained from the studies proposed in this application will include information about optimal 
delivery of PrEP for HIV prevention, which may have substantial impact on the global burden of HIV. 
 
Treatment for injury 
Participants will be asked to inform the clinic staff if they feel they have been injured because of taking 
part in the study. Injuries may also be identified during laboratory testing, medical histories, and 
physical examinations. Treatment for adverse events related to study participation will be provided by 
the treatment clinic. If treatment is required that is beyond the capacity of the clinic, the clinic staff will 
refer the participant to appropriate services or organizations that can provide care for the injury.  
 
Study records 
Implementation investigators will maintain, and store in a secure manner, complete, accurate, and 
current study records throughout the study. Study records include administrative documentation and 
regulatory documentation as well as documentation related to each participant enrolled in the cohort, 
including informed consent forms, data forms, notations of all contacts with the participant, and all other 
source documents.   
 
Confidentiality 
Every effort will be made to protect participant privacy and confidentiality to the extent possible. 
Personal identifying information will be retained at the local study sites and not forwarded to the 
University of Washington Coordinating Center. The sites will use their standard operating procedure for 
confidentiality protection that reflects the input of study staff and community representatives to identify 
potential confidentiality issues and strategies to address them. 
   
All study-related information will be stored securely at the study sites. All participant information will be 
stored in areas with limited access. Data collection, administrative forms, laboratory specimens, and 
other reports will be identified only by a coded number to maintain participant confidentiality. All records 
that contain names or other personal identifiers, such as locator forms and informed consent forms, will 
be stored separately from study records identified by code number. All local databases will be secured 
with password-protected access systems. Forms, lists, logbooks, appointment books, and any other 
listings that link participant ID numbers to other identifying information will be stored in a separate, 
locked file in an area with limited access. 
 
Dissemination Plan 
The study team for this award is committed to public dissemination of results of pilot studies, to 
participants, local stakeholders in Kenya, the global scientific community, and US, Kenyan, and global 
policymakers. Dissemination of pilot results will follow principles of good participatory practice. Results 
will be published in conference abstracts and peer-reviewed journals. Study results will be 
disseminated through presentations to local stakeholders and policymakers in Kenya, including the 
Ministry of Health.   
 
 

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TIMELINE 
 
Table 16. Timeline of activities 
Year 1 
(2021) 
Year 2 
(2022) 
Data collection activity  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
AIMS 1a & 2a: Pilots 
 
Train pharmacists on pharmacy-based PrEP delivery  
 
 
 
 
 
 
 
 
Pilot of pharmacy-based PrEP delivery  
 
 
 
 
 
 
 
 
AIM 1b: Identify pilot weak points 
 
Acceptability: Qualitative interviews with consumer  
 
 
 
 
 
 
 
 
Fidelity: Use of standardized patient actors and 
checklists 
 
 
 
 
 
 
 
 
Costs: Use of quantitative surveys at baseline and 
follow-up 
 
 
 
 
 
 
 
 
Model Refinement  
 
 
 
 
 
 
 
 
Aim 2b: Identify weak points of pharmacy-based  
refills-only model 
Acceptability: Qualitative interviews with consumer 
 
 
 
 
 
 
 
 
Aim 1c: Extended pilot 
Train pharmacists on pharmacy-based PrEP/PEP 
delivery 
 
 
 
 
 
 
 
 
Pilot of refined pharmacy-based PrEP delivery model 
 
 
 
 
 
 
 
 

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