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THE SCIENCE OF PREVENTION (JD STEKLER AND J BAETEN, SECTION EDITORS)
Successful Implementation of HIV Preexposure Prophylaxis:
Lessons Learned From Three Clinical Settings
Julia L. Marcus
1
&Jonathan E. Volk
2
&Jess Pinder
3
&Albert Y. Liu
4
&
Oliver Bacon
4
&C. Bradley Hare
2
&Stephanie E. Cohen
4
#Springer Science+Business Media New York 2016
Abstract The past 3 years have marked a transition from
research establishing the safety and efficacy of HIV
preexposure prophylaxis (PrEP) to questions about how
to optimize its implementation. Until recently, PrEP was
primarily offered as part of randomized controlled trials
or open-label studies. These studies highlighted the key
components of PrEP delivery, including regular testing
for HIV and other sexually transmitted infections
(STIs), adherence and risk-reduction support, and moni-
toring for renal toxicity. PrEP is now increasingly pro-
vided in routine clinical settings. This review summarizes
models for PrEP implementation from screening through
initiation and follow-up, focusing on the strengths and
weaknesses of three delivery systems: a health mainte-
nance organization, an STI clinic, and a primary care
practice. These early implementation experiences demon-
strate that PrEP can be successfully delivered across a
variety of settings and highlight strategies to streamline
PrEP delivery in clinical practice.
Keywords Preexposure prophylaxis (PrEP) .PrEP delivery .
PrEP implementation .Human immunodeficiency virus
(HIV) .Implementation .Sexually transmitted infections .
Delivery of health care .Science of prevention .Review
Introduction
In July 2012, the US Food and Drug Administration
(FDA) approved the use of daily oral emtricitabine/
tenofovir (FTC/TDF, Truvada
©
) as preexposure prophy-
laxis (PrEP) for the prevention of sexually acquired
HIV infection. This landmark decision was based on data
from multi-national, placebo-controlled trials demonstrat-
ing the safety and efficacy of FTC/TDF PrEP in men
who have sex with men (MSM) and heterosexual men
and women [1–3], and was followed by a trial demon-
strating the safety and efficacy of PrEP in people who
inject drugs [4]. The Centers for Disease Control and
Prevention (CDC) endorse PrEP as a critical element of
a combination approach to HIV prevention and released
guidelines for its use in adults at risk of HIV acquisition
in 2014 [5].
This article is part of the Topical Collection on The Science of Prevention
*Stephanie E. Cohen
stephanie.cohen@sfdph.org
Julia L. Marcus
julia.l.marcus@kp.org
Jonathan E. Volk
jonathan.e.volk@kp.org
Jess Pinder
jpinder@onemedical.com
Oliver Bacon
oliver.bacon@sfdph.org
C. Bradley Hare
brad.hare@kp.org
1
Division of Research, Kaiser Permanente Northern California, 2000
Broadway, 2nd Floor, Oakland, CA 94612, USA
2
Kaiser Permanente Northern California, San Francisco Medical
Center, 2238 Geary Boulevard, San Francisco, CA 94115, USA
3
One Medical Group, 201 Spear St. Suite 230, San
Francisco, CA 94105, USA
4
San Francisco Department of Public Health, University of California,
356 7th Street, San Francisco, CA 94103, USA
Curr HIV/AIDS Rep
DOI 10.1007/s11904-016-0308-x
The past 3 years have marked a transition from research
establishing the safety and efficacy of PrEP to questions about
how to optimize its implementation and maximize its public
health impact. Until recently, PrEP was primarily delivered in
the USA in settings that offered time-limited access, such as
placebo-controlled trials [3], open-label extension studies [6•],
and demonstration projects [7•,8]. PrEP is now increasingly
being provided in a variety of clinical settings that aim to offer
ongoing access. While early reports suggested that PrEP use
outside of research contexts was low [9], recent surveys sug-
gest that PrEP use is increasing throughout the USA [10–12].
Questions have now arisen about optimal settings for PrEP
delivery, such as sexually transmitted infection (STI) clinics,
by HIV specialists, or in primary care.
This review focuses on implementation models that
represent the future of PrEP provision. We discuss three
examples of PrEP delivery systems, summarizing pub-
lished data where available and highlighting the advan-
tages and disadvantages of each setting with respect to
the PrEP continuum of care. Lastly, we discuss what
local health departments can do to support PrEP implementa-
tion in their jurisdiction.
What Is the Continuum of Care for PrEP Delivery?
Here, we define the continuum of care for PrEP delivery as (1)
the identification of individuals at risk for HIV infection; (2)
linkage of individuals at risk for HIV to a site of PrEP delivery
and a PrEP provider; (3) initiation of PrEP, which includes
baseline laboratory tests and identifying a mechanism for pay-
ing for PrEP medication; and (4) engagement in PrEP care
(i.e., clinical monitoring, maintenance of adherence, risk-
reduction counseling, and retention in care) throughout pe-
riods of HIV risk (Fig. 1).
Initial PrEP studies shed light on factors along the PrEP
continuum of care that contribute to effective PrEP delivery.
Demonstration projects have shown that PrEP uptake is high
across a distribution of age, race/ethnicity, and education
levels, but that some subgroups, including MSM of color,
are less likely to seek out PrEP or achieve high levels of
adherence and retention [7•,8,13•]. Trials have illustrated that
adherence drives PrEP efficacy [6•,14–16] yet presents chal-
lenges for measurement [17,18], while demonstration pro-
jects are testing strategies to support adherence among PrEP
users [19–21]. Trial results also demonstrated the importance
of diagnosing HIV, including acute HIV infection, at PrEP
initiation and during PrEP use to reduce the risk of drug resis-
tance [22–24]. Small reductions in creatinine clearance [14,
15] and bone mineral density [25,26] were noted among PrEP
trial participants [27,28], highlighting the need for ongoing
monitoring of renal function during PrEP use and education
regarding bone health at PrEP initiation. Increases in sexual
risk behavior or STI incidence were not observed in placebo-
controlled trials [29–31] or open-label studies [6•,13•,32,33],
despite fears that risk compensation would reduce or negate
the protective benefits of PrEP [34]. However, rates of STIs,
including hepatitis C, have been high among PrEP users in
open-label studies [8,35••] and clinical practice [36•,37].
Risk-reduction counseling is recommended during PrEP use,
along with frequent screening and treatment for STIs to min-
imize the risk of HIVacquisition and other sequelae [5].
While PrEP studies to date have provided guidance on the
clinical components of PrEP delivery, they have been less
informative about operational aspects of implementation, in-
cluding how to identify patients at risk for HIV infection in a
clinical setting; how to increase patient and provider aware-
ness of PrEP; how to identify providers who are knowledge-
able about and able to prescribe PrEP; how to address gaps in
insurance coverage for PrEP and improve affordability;
how to optimize engagement in a PrEP program and
deliver adherence support, risk-reduction counseling,
and laboratory tests in a busy clinical setting; and the
staff capacity required to deliver PrEP, including the
types of staff (e.g., clinicians, nurses, counselors, phar-
macists) who should be involved.
What Are Current Models for Ongoing PrEP
Implementation?
PrEP is currently being delivered across a variety of settings in
the USA [38,39], including community-based HIV/STI test-
ing sites; health maintenance organizations (HMOs); HIV
clinics; lesbian, gay, bisexual, and transgender health clinics;
primary care; and STI clinics, witheach offering strengths and
weaknesses with respect to the PrEP continuum of care
(Table 1). Here, we describe PrEP delivery in three clinical
settings in San Francisco: an HMO, an STI clinic, and a pri-
mary care clinic.
Fig. 1 Continuum of care for PrEP delivery. PrEP preexposure prophylaxis, STI sexually transmitted infection
Curr HIV/AIDS Rep
PrEP Implementation in an HMO Setting
Kaiser Permanente’s San Francisco Medical Center (KPSF) is
an HMO serving more than 170,000 adult members. A recent
report from KPSF described a large and rapidly growing spe-
cialized PrEP program [36•]; nearly 1000 patients have initiat-
ed PrEP at KPSF as of July 2015. Notably, there have been no
HIV seroconversions in this population [36•]. The program is
staffed by three infectious disease (ID) physicians, each with
up to 6 hours per week of clinical time dedicated to PrEP, as
well as part-time support from a nurse, two pharmacists, a
health educator, and a program assistant. PrEP visits are coded
as “prophylaxis”(International Classification of Disease,
Version 9 [ICD-9] code: V07.8; ICD-10 code: Z41.8).
Steps 1 and 2: Identification and Linkage The majority of
referrals to the PrEP program are initiated by patients during
in-person or telephone visits with a provider or through secure
email messages sent by patients to primary care providers
(PCPs). A minority of referrals are initiated by clinicians
based on a sexual risk assessment, STI diagnosis, or use of
non-occupational post-exposure prophylaxis (nPEP). To edu-
cate PCPs at KPSF about PrEP and the availability of the
program, an ID physician has given grand rounds and
reminded PCPs through emails and department meetings to
consider PrEP for HIV-uninfected individuals with rectal STI
or syphilis diagnoses.
Step 3: Initiation After being referred to the KPSF PrEP pro-
gram, patients are seen by an ID physician or an ID-trained
pharmacist who conducts an in-person intake visit, with a re-
view of the patient’s medical history, a risk assessment, and
education about PrEP, including side effects, required monitor-
ing, and adherence. Clinical follow-up is done by the ID
Tabl e 1 Strengths and weaknesses of models for ongoing PrEP implementation
Delivery setting Strengths Weaknesses
Community-based HIV/STI
testing sites
•Serve a population at risk for HIV
•Providers are aware of PrEP
•Staff are accustomed to assessing HIV risk and
providing risk-reduction counseling
•Lack infrastructure for continuity of care and creatinine testing
•May need to rely on copayment assistance program to cover
PrEP
•May not be prepared to provide adherence support
•May lack a prescribing provider and/or medical liability
insurance to cover the prescribing
Health maintenance
organizations
•Infrastructure for continuity of care and STI, HIV,
and creatinine testing
•Most patients’plans cover a portion of the cost of
PrEP
•Capacity to conduct panel management activities
•HIV risk assessments may not be routinely conducted
•Providers may lack awareness of PrEP or be unwilling to
prescribe it
•May not be prepared to provide risk-reduction or adherence
support
•Benefits navigation may be needed to avoid high copayments
HIV clinics •Serve a population at risk for transmitting or
acquiring HIV
•Providers are aware of PrEP
•Staff are accustomed to providing risk-reduction
counseling
•May be accustomed to providing adherence
support
•May need to rely on copayment assistance program to cover
PrEP cost for uninsured patients
•May not have HIV-uninfected clients or funding to provide
care to HIV-uninfected clients
•Possible stigma associated with attending an HIV clinic
LGBT clinics •Serve a population at risk for HIV
•Providers are aware of PrEP
•Staff are accustomed to assessing HIV risk,
screening/treating STIs, and providing risk-
reduction counseling
•May not be prepared to provide risk-reduction and adherence
counseling
•May need to rely on copayment assistance program to cover
PrEP cost for uninsured patients
•Lack infrastructure for continuity of care and creatinine
testing
Primary care (private practice
or publicly funded)
•Infrastructure for continuity of care and STI, HIV,
and creatinine testing
•Most insurance plans cover a portion of the cost of
PrEP
•HIV risk assessments may not be routinely conducted
•Providers may lack awareness of PrEP or be unwilling to
prescribe it
•May not be prepared to provide risk-reduction or adherence
support
•Benefits navigation may be needed to avoid high copayments
STI clinics •Serve a population at risk for HIV
•Providers are aware of PrEP
•Staff are accustomed to assessing HIV risk and
providing risk-reduction counseling
•May need to rely on copayment assistance program to cover
PrEP
•Lack infrastructure for continuity of care and creatinine
testing
•May not be prepared to provide adherence support
LGBT lesbian gay bisexual transgender, PrEP preexposure prophylaxis, STI sexually transmitted infection, PCP primary care provider
Curr HIV/AIDS Rep
physician or pharmacist who conducted the intake visit, with
physician support for the pharmacist for symptomatic STIs or
abnormal laboratory tests. Some patients (18 %) have elected
to not start PrEP after this intake visit, citing a variety of rea-
sons, including low risk for HIV, concern about cost, and not
wanting to adhere to the required follow-up [36•].
Prior to initiating PrEP, KPSF patients have blood drawn
for HIV antibody and viral load, syphilis, and creatinine test-
ing at the onsite laboratory. A baseline urinalysis is done, and
patients are provided swabs and a urine kit for self-collection
of specimens to screen for pharyngeal, rectal, and urethral
gonorrhea and chlamydia [40,41]. Patients are also tested
for hepatitis A, B, and C, and vaccination for hepatitis A and
B is offered if indicated based on laboratory results. Alanine
aminotransferase is tested at baseline and quarterly thereafter
to monitor for incident hepatitis C infections. Most laboratory
tests, with the exception of the HIV viral load, are completed
before the intake visit. After the viral load and any outstanding
tests are done, the patient goes to the onsite pharmacy to
receive a 30-day supply of FTC/TDF, with 90 days of medi-
cation provided with subsequent refills.
KPSF is a combined insurance plan and healthcare organi-
zation; the patient’s share of cost for PrEP at KPSF depends on
the specifics of the patient’s plan. While copayments for PrEP
are less than $50 per month for the majority of KPSF members,
some plans have high deductibles or require substantial
copayments for laboratory tests or clinic visits. Patients are in-
formed of the copayment assistance program offered by Gilead
Sciences, the company that produces Truvada, which provides
FTC/TDF for PrEP at no cost to US residents who earn <500 %
of the federal poverty level [42]. However, because the
copayment card cannot be used at KPSF pharmacies, patients
must purchase the medication and then seek reimbursement. In
addition, not all KPSF members, such as those with Medicare
Part D, are eligible for the copayment assistance program. Thus,
while the majority of KPSF patients can access PrEP at an
affordable cost, barriers remain even in this HMO context.
Step 4: Engagement Although the intake visit is conducted in
person to create a comfortable environment for discussing sex-
ual risk, most follow-up visits are over the telephone or
through secure email messages. Patients request refills online,
and the medication is picked up in the pharmacy or mailed to
the patient. Patients are advised to complete their quarterly
follow-up laboratory testing (i.e., HIVantibody, STIs, and cre-
atinine) at the same time the medication is refilled. More fre-
quent STI and HIV testing is available if desired by patients,
who are advised to visit the laboratory without an appointment,
including on evenings and weekends, for these tests as often as
monthly. Patients are informed that they will be contacted if an
HIV test is positive; all other test results are viewable online.
While treatment of STIs is part of the PrEP program, patients
receive other primary care services from their PCP.
Strengths and Weaknesses HMO settings such as KPSF
have the infrastructure to provide continuity of care to PrEP
patients. KPSF leverages its robust electronic health record
(EHR) to conduct panel management activities to facilitate
engagement in PrEP care. For example, PrEP program staff
receive a biweekly list with the names of patients who have
not refilled their prescription, or had HIVor creatinine testing,
in more than 100 days. These patients are contacted by a
member of the PrEP delivery team, who provides brief adher-
ence counseling, a reassessment of HIV risk, and a reminder
of the importance of regular laboratory testing. Self-collection
of specimens for STI testing—available at most Kaiser
Permanente Northern California laboratories, including
KPSF—facilitates this telemedicine approach to PrEP fol-
low-up, which decreases programmatic costs and provides
flexibility to patients.
The KPSF experience also reveals some of the challenges
of PrEP implementation in an HMO setting. Most of the PrEP
referrals have been initiated by patients rather than providers.
Furthermore, most patients receiving PrEP at KPSF are white,
and 99 % are MSM. To identify potential PrEP candidates
who do not recognize their risk for HIV infection, do not know
about PrEP, or do not have the agency to seek out PrEP, PCPs
must routinely ask patients about their sexual orientation, gen-
der identity, sexual history, and drug use, a practice that is
underperformed in many clinical practice settings [43–45].
Despite training non-physician staff to assist in many aspects
of PrEP delivery, including adherence and risk-reduction
counseling, the KPSF PrEP program was initially strained
by the demand for PrEP, and additional provider staffing
was needed to minimize wait time for appointments and man-
age the growing cohort of patients on PrEP. Finally, at KPSF,
stopping and restarting PrEP is common as a result of chang-
ing risk or gapsin insurance coverage, and resources are need-
ed to assist patients and providers in navigating these
transitions.
PrEP Implementation in an STI Clinic Setting
STI clinics in San Francisco (i.e., San Francisco City Clinic
[SFCC]) and Miami (i.e., Miami-Dade County Downtown
STD Clinic) have provided PrEP as part of time-limited dem-
onstration projects [46]. Baseline data from the open-label US
PrEP Demonstration Project (The Demo Project) indicated
that interest in PrEP was high in a diverse population of eligi-
ble MSM attending STI clinics [7•]. Adherence was excellent
in The Demo Project, with 80–86 % of participants tested
having drug levels consistent with taking at least four doses
of FTC/TDF per week across study visits [13•]; such drug
levels have been estimated to reduce HIV risk by over 96 %
[16]. Similar to the KPSF PrEP program, demand for PrEP as
part of The Demo Project at SFCC exceeded clinic capacity,
resulting in a waitlist for interested individuals [47]—and, like
Curr HIV/AIDS Rep
KPSF, The Demo Project found that a commonly reported
reason for declining PrEP was not having enough time for
participation [7•].
Based on the feasibility demonstrated by The Demo Project
and ongoing demand from patients, SFCC initiated its “PrEP
navigation program”in May 2014. SFCC is the only munic-
ipal STI clinic in San Francisco and conducts approximately
19,000 visits per year, with 48 % of the patients being MSM
[48]. Clinical care is provided primarily by nurse practitioners
(NPs). Funding has been provided to SFCC by the San
Francisco Department of Public Health for additional staff
(one coordinator, a counselor, and a half-time NP) and to
pay for creatinine testing and hepatitis B screening, two ser-
vices that were not previously offered at the clinic. As of
July 2015, over 500 patients have received PrEP counseling
and navigation, and 185 have initiated PrEP. Of those initiat-
ing PrEP, 48 % were uninsured; of the uninsured patients
initiating PrEP, 38 % have subsequently enrolled in compre-
hensive health insurance coverage. Compared with the
cohort who enrolled in The Demo Project at SFCC,
PrEP navigation program clients are younger (median
age 30 vs. 35 years) and more likely to be non-white
(63 vs. 38 %). While STI rates have been high, there have
been no seroconversions among clients who are regularly re-
ceiving PrEP.
Steps 1 and 2: Identification and Linkage Clients are iden-
tified as PrEP candidates during the STI visit by the clinician,
who conducts a standardized risk assessment prompted by
questions in the EHR, or come into the clinic specifically to
request PrEP. They are provided brief PrEP education by the
clinician and referred to the PrEP program coordinator or
counselor. Patients who are insured and have a PCP are pro-
vided information about how to talk to their provider about
PrEP, how to determine what their out-of-pocket costs for
PrEP would be, and how to access the copayment assistance
program. Uninsured patients or those who have difficulty
accessing PrEP in primary care are offered PrEP at the STI
clinic.
Step 3: Initiation Prior to PrEP initiation, an NP takes a
medical history, assesses for signs or symptoms of acute
HIV infection, reviews concurrent medications and allergies,
discusses potential side effects and toxicities of FTC/TDF, and
provides patient educational materials on PrEP (see supple-
mentary material in [47]). Patients are tested for HIV (rapid
HIV antibody and pooled RNA [49]) and STIs, and blood is
drawn for creatinine, hepatitis B surface antigen, and a hepa-
titis C antibody test. Insured patients are given a prescription
for 30 days of FTC/TDF with no refills. While patients are not
responsible for the cost of laboratory tests and clinic visits
associated with PrEP, program staff assist uninsured patients
with applying for the medication assistance program to cover
the cost of the medication. In addition, uninsured patients are
counseled regarding eligibility for health insurance and are
encouraged to enroll in a health insurance plan that covers
PrEP. Insured patients who have faced barriers in accessing
PrEP (e.g., report feeling uncomfortable speaking to their pro-
vider about sexual health or being denied PrEP by their pro-
vider) are provided a list of local PrEP-knowledgeable pro-
viders [38].
Step 4: Engagement Patients are seen 1 month after PrEP
initiation for a brief in-person visit to discuss side effects
and adherence, be tested for HIV, and receive their next
PrEP prescription. After the 1-month follow-up visit, patients
are seen quarterly. At each quarterly visit, an NP performs an
STI evaluation, assesses for signs or symptoms of acute HIV
infection, orders a creatinine test for kidney function monitor-
ing, and writes a prescription for FTC/TDF. Non-clinician
PrEP program staff disclose the rapid HIV-antibody result,
provide brief adherence and risk-reduction counseling, pro-
vide the prescription for FTC/TDF, schedule the follow-up
visit, and reassess the patient’s insurance status. Non-
clinician PrEP staff conduct reminder calls prior to appoint-
ments and for missed appointments, manage communication
with the medication assistance program (which includes or-
dering refills on a monthly basis and submitting appeals for
patients who are denied access), flag abnormal creatinine re-
sults for clinician review, and provide referrals to psychosocial
services. At each follow-up visit, non-clinician staff reassess
the patient’s access to care, as the ultimate goal is to bridge
clients to a primary care setting where they can receive PrEP.
Strengths and Weaknesses STI clinics serve a population
that is at higher risk for HIV infection than individuals
accessing care in primary care settings, making these clinics
ideal for reaching a PrEP-eligible population. As safety net
providers, STI clinics typically serve underserved populations
that may not have access to primary care. In addition, STI
clinic staff are well-prepared to provide HIV risk assessment
and ongoing risk-reduction counseling to potential and active
PrEP users, as well as linkage to care for clients who are
diagnosed with HIV. As demonstrated by the SFCC PrEP
navigation program, PrEP can serve as an incentive for sexual
health services and a bridge to primary care. STI clinics
that offer nPEP have experience with prescribing antire-
troviral therapy for HIV prevention and may be particu-
larly well-suited to offer PrEP. However, few STI clinics
offer nPEP [50], and unlike primary care settings, STI
clinics do not have systems for providing continuity of
care, with patients typically visiting the clinic on a drop-in or
episodic basis. Thus, STI clinics may need to modify their
practices to allow for the longitudinal care that is required for
PrEP delivery.
Curr HIV/AIDS Rep
PrEP Implementation in a Primary Care Setting
One Medical Group (OM) is a multi-site primary care practice
with offices across the USA, including 14 offices serving
71,948 adult members in San Francisco. OM accepts a wide
range of private insurance plans, including some plans offered
under the Affordable Care Act, and Medicare, but does not
accept Medicaid. An estimated 791 patients are currently on
PrEP at OM in San Francisco. Initially, PrEP was primarily
provided by PCPs who provide HIV care. PCPs with
less experience with FTC/TDF and sexual health re-
ceived additional training about PrEP through case-
based conferences and peer-to-peer communication, and
most PCPs at OM now prescribe PrEP as part of their
practices. Providers code PrEP visits in a standardized
fashion [ICD-9 code: V01.79; ICD-10 code: Z20.6],
such that the medical leadership can identify PrEP users
for quality assurance.
Steps 1 and 2: Identification and Linkage PrEP is offered
to patients who specifically request it from their PCPs
and those who are identified as having elevated risk for
HIV infection during a sexual risk assessment. PCPs
have been encouraged to consider PrEP for patients diag-
nosed with an STI, those who have used nPEP (particularly
those who have used it multiple times), and those with an
HIV-infected partner.
Step 3: Initiation The PCP provides basic PrEP education,
screens for symptoms of acute HIVinfection, and orders base-
line laboratory tests, including a fourth-generation HIV
antibody/antigen assay, creatinine, hepatitis B surface antigen,
and STI screen. Phlebotomy is available onsite; a medical
assistant collects a pharyngeal swab and the patient self-
collects a rectal swab for gonorrhea and chlamydia. An HIV
RNA test is ordered for patients with recent exposures
or symptoms of acute infection. The PCP receives test
results through the EHR, communicates with the patient
by secure email or phone, and sends a 90-day prescrip-
tion of FTC/TDF with no refills to the patient’s preferred
pharmacy. Administrative staff assist with prior authoriza-
tions, which can be routed back to the PCP for review and
signature through the EHR. Providers or administrative staff
also assist patients with enrolling in the copayment assistance
program.
Step 4: Engagement After initiating a patient on PrEP, the
PCP uses the EHR toprepare an email to be delivered 1 month
after PrEP initiation to inquire about how the patient is doing
on PrEP, side effects, and adherence. The patient is typically
seen in person 3 and 6 months after PrEP initiation; after this,
in-person visits may occur less frequently, depending on the
patient’s medical conditions or psychosocial needs. However,
all patients are required to be seen in the office at least annu-
ally for continued refills of their medication. Patients are
instructed to come in for an evaluation if they have symptoms
of acute HIVor have been off FTC/TDF for more than 7 days.
To decrease the administrative burden on PCPs, refill requests
for all medications are reviewed by a “virtual medical team,”
consisting of physicians, NPs, physician assistants, and
registered nurses. Refills are only provided if the re-
quired quarterly laboratory testing (i.e., HIV, STIs, and
creatinine) has been completed and the results are within
the acceptable range.
Strengths and Weaknesses The OM model demonstrates that
PrEP can be successfully delivered as part of routine primary
care services by non-HIV specialists. Administrative support
from the virtual medical team increases the efficiency of PrEP
delivery at OM, and as at KPSF, self-collection of rectal swabs
for STI screening facilitates a telemedicine approach to PrEP
follow-up. While some PCPs at OM were initially reluctant to
prescribe PrEP, demand from patients and training by col-
leagues has spurred many to become comfortable with PrEP
delivery, and those who remain uncomfortable with PrEP de-
livery can internally refer patients to a PrEP provider. This
integration of PrEP into primary care settings may facilitate
the normalization of PrEP and provision of sexual health ser-
vices in routine primary care.
The OM experience also demonstrates some of the
challenges of delivering PrEP in a primary care practice.
All adherence and risk-reduction counseling is delivered
by the PCP. Patients who initiate PrEP but miss a
follow-up appointment may not come to the attention
of the PCP and thus may be lost to follow-up without
an opportunity to assess barriers or support engagement
in PrEP care. Lastly, in this private practice setting,
financial sustainability requires delivering billable ser-
vices; conducting PrEP follow-up by email and phone is ef-
ficient for the patient but not reimbursable for the provider,
and some PCPs may thus not have the time or administrative
support to deliver PrEP in this manner, especially as uptake
increases.
Conclusions
These early implementation experiences demonstrate that
PrEP can be successfully delivered in a diverse array of clin-
ical settings, including primary care. However, the need to
streamline delivery is clear. Although PrEP appears to be
reaching a population at high risk for HIV acquisition, MSM
of color, adolescent MSM, people who inject drugs, and trans-
gender women and men are underrepresented among PrEP
users and may benefit from additional outreach. PrEP is being
successfully delivered by some PCPs, but most PrEP users in
Curr HIV/AIDS Rep
primary care settings are self-referred; building capacity
among PCPs to take a sexual history and identify potential
PrEP candidates is important for reaching patients who do
not know about PrEP or are not comfortable with initi-
ating a conversation about sexual health with their pro-
vider. The burden of PrEP on the healthcare system
may be reduced by leveraging existing EHRs; providing
a self-collection option for STI testing; and training
nurses, health educators, and pharmacists to administer
aspects of PrEP care. Finally, although most private in-
surance companies cover PrEP, cost continues to present
a barrier to access for some individuals.
In some cases, PrEP programs are implementing
more frequent laboratory testing compared with what
is recommended in the CDC guidelines [5]. The high
ratesofSTIs[8,36•] among PrEP users suggest that
quarterly rather than semiannual or annual screening for
these infections may be appropriate. Furthermore, quar-
terly laboratory testing allows patients to obtain 90-day
medication refills at the same time as laboratory testing
in some settings, thus streamlining PrEP follow-up.
Which HIV diagnostic tests to use at PrEP initiation
and follow-up (e.g., HIV antibody and/or RNA tests),
whether and how to screen for HCV infection, and
how best to monitor for renal toxicity are unclear.
Determining the frequency and components of laborato-
ry testing to maximize safety and optimize cost-
effectiveness should be an ongoing focus of PrEP im-
plementation research.
Local health departments could support PrEP imple-
mentation and address these systemic gaps in several
ways. First, health departments may consider offering
PrEP in municipal STI clinics, which already reach a
population at risk for HIV. Second, health department
staff could train community-based organizations that
currently provide HIV counseling and testing to provide
PrEP education, navigation services, and ongoing risk
reduction and adherence counseling to PrEP users.
Third, health education campaigns could be used to in-
crease awareness of PrEP in the community, with a
focus on vulnerable populations with lower PrEP aware-
ness, and among healthcare providers, particularly in
primary care settings. Fourth, health departments can partner
with AIDS education and HIV/STD-prevention training cen-
ters to generate lists of PrEP-knowledgeable providers and
offer trainings to providers across a range of disciplines to
increase the number of PrEP providers in the jurisdiction.
Fifth, gaps in PrEP access can be filled by programs modeled
after the AIDS Drug Assistance Program, an approach that has
been adopted by state health departments in Washington and
New York [51,52]. Finally, health departments may play a
role in establishing a surveillance system to monitor PrEP use
and its population-level impact.
Acknowledgments This work was supported by a Kaiser Permanente
Northern California Community Benefit research grant to Dr. Julia L.
Marcus.
Compliance with Ethical Standards
Conflict of Interest Julia L. Marcus reports grants from Merck.
Albert Y. Liu reports non-financial support from Gilead and personal
fees from IAS-USA.
Stephanie E. Cohen reports non-financial support from Gilead.
Jonathan E. Volk, Jess Pinder, C. Bradley Hare, and Oliver Bacon
declare they have no conflict of interest.
Human and Animal Rights and Informed Consent This article does
not contain any studies with human or animal subjects performed by any
of the authors.
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