Introducing Wicked Issues for HIV Pre-Exposure
Prophylaxis Implementation in the U.S.
Dawn K. Smith, MD, MS, MPH, James W. Dearing, PhD,
Travis Sanchez, DVM, MPH, Ronald H. Goldschmidt, MD
laxis (PrEP) use in the U.S., there is urgent need to begin
addressing the complex, multi-stakeholder, and rapidly
evolving (i.e., “wicked”) issues posed for the safe, effec-
tive, and appropriately targeted use of PrEP for preven-
tion of the sexual acquisition of HIV infection. In this
supplement1–18to the American Journal of Preventive
Medicine, a series of articles is presented from diverse
research and implementation disciplines to explore key
issues and identify conceptual frameworks, practice
sion of how best to introduce, disseminate, and evaluate
PrEP as a new component of HIV prevention services in
Recent clinical trials of daily oral antiretroviral PrEP
have offered evidence of safety and the potential for sub-
stantial effıcacy of this clinical approach to HIV preven-
tion. Yet even before trial results were available, impor-
tant questions were being raised about how, if PrEP were
to be made available and implemented domestically19
and globally,20that would best be done. Answers to dis-
semination and implementation questions are increas-
uate the impact of PrEP for individuals and populations
at highest risk of HIV infection in the U.S.
Making PrEP widely available to those who can most
benefıt from it has the features of a “wicked problem,” a
framework that has been used to understand attempts to
health inequity.23Wicked problems are those in which
ollowing U.S. Food and Drug Administration ap-
proval and the issuance of interim guidance docu-
(1) the problem is unique enough that standard practices
and protocols are insuffıcient; (2) the defınition of the
problem is influenced by any solution formulated and
solved; (3) there are no right or wrong solutions, only
invested stakeholders with multiple defınitions of the
problem that change over time; and (5) there is change
over time of the resource and policy constraints to which
the problem is subject and the resources needed to solve
it. Integrating PrEP into a portfolio of existing HIV pre-
vention methods (combination prevention), while offer-
ing more choices and the opportunity for improved tai-
loring of approaches to the needs of patients and the
resources of providers, increases the wickedness of the
less wicked (“tamed”) but never completely resolved. In
this journal supplement, diverse perspectives are pre-
sented on the many critical issues for introducing and
implementing PrEP in the U.S. in an attempt to begin to
tame this wicked issue.
The introduction of PrEP as one component of effec-
tive HIV prevention programs in the U.S. comes as the
science of dissemination and implementation is begin-
ning to yield important information about the factors
that contribute to the successful translation of evidence-
of clinical interventions, important contributions to this
understanding come from multiple applied research
frameworks, including, but not limited to, diffusion and
dissemination science,25,26health services research,27
public health systems research,28systems theory,29,30
health economics,31and translational epidemiology.32
Khoury’s continuum of public health translation re-
the articles in this supplement to AJPM (Figure 1). Our
overarching goals are to provide information that builds
on the clinical trial and observation evidence base (T2);
that considers the resources, skills, and practices needed
ents ways to assess the impact on population health, in-
cluding subpopulations currently experiencing inequita-
ble rates of HIV infection (T4).
From the Division of HIV/AIDS Prevention, National Center for HIV/
AIDS, Viral Hepatitis, STD and TB Prevention (Smith), CDC, Atlanta; the
Department of Epidemiology (Sanchez), Rollins School of Public Health,
Emory University, Atlanta, Georgia; the Center for Health Education Dis-
semination and Implementation Research (Dearing), Kaiser Permanente
Institute for Health Research, Denver, Colorado; and the Department of
Family and Community Medicine (Goldschmidt), National HIV/AIDS
Clinicians’ Consultation Center, San Francisco General Hospital, Univer-
sity of California, San Francisco, California
HIV/AIDS Prevention, CDC, 1600 Clifton Road, MS E-45, Atlanta GA
30333. E-mail: email@example.com.
Published by Elsevier Inc. on behalf of American Journal of Preventive MedicineAm J Prev Med 2013;44(1S2):S59–S62
In this supplement,
Campbell and colleagues1
present the current data
from PrEP effıcacy and
safety trials in men who
(MSM) and for hetero-
sexual men and women.
In addition, they review
the acceptability, cost ef-
fectiveness, and impact
of modeling studies for
PrEP use in the U.S.,
which can inform imple-
mentation efforts in the
near term. Two articles—
by Dearing et al.2and
Norton and colleagues3—
propose frameworks from
diffusion and implemen-
tation science and sug-
duction and initial diffu-
sion of PrEP services,
which will support its fu-
munity partnerships necessary for the safe and effective
use of PrEP.
The integrated delivery of clinical, behavioral, and
structural interventions presents a wicked set of issues
mitigating many of the key threats to the nation’s public
prevention of chronic disease (e.g., tobacco cessation,
improving childhood nutrition) and infectious diseases
(e.g., tuberculosis, HIV infection).
understanding of many standard clinical and behavioral
care methodologies as well as those unique to HIV preven-
cation (buprenorphine) for management of opiate addic-
tion into nonspecialist clinical care practices may be useful
for anticipating issues with integrating PrEP into primary
care settings.5Lessons learned from a decade of experience
in attempting modest program coverage of non-occupational
post-exposure prophylaxis (nPEP) for sexual and injec-
tion HIV exposures can be useful in considering imple-
mentation and scale-up of antiretroviral-based HIV pre-
vention that is the core of PrEP services.4
In addition to fındings from the PrEP trials, there are
important lessons to be learned from experiences with
medication-adherence support, and behavioral risk-
reduction counseling. Koenig et al.18discuss what has
been learned about medication adherence and counsel-
treatment programs for HIV infection. However, medi-
cation adherence during treatment of those with HIV
with daily medication for uninfected people. Medication
adherence can be considered one key element of “self-
management” practices for an individual’s health, along
with management of sexual and other HIV risk behav-
iors, compliance with regular medical care visits, and
HIV testing. ElZarrad and colleagues6discuss what we
know from extensive experience with interventions in
clinical care practices designed to promote medication
self-management (adherence) for other clinical preven-
tive and treatment purposes, particularly with asymp-
tomatic patients, to reduce the risk of future health
threats. Similarly, for sexual risk-reduction counseling,
Thrun7and Malotte8discuss experiences gained from
sexually transmitted disease (STD) clinic and PrEP trial
Five articles9,13–16address some key policy issues that
sustainable and effective PrEP services, including poten-
tial payment mechanisms for PrEP in clinical settings,14
Figure 1. Phases of translational research in clinical public health
Note: Adapted from Khoury.33All the references listed above appear in this supplement to the American
Journal of Preventive Medicine.
Smith et al / Am J Prev Med 2013;44(1S2):S59–S62
minors without parental notifıcation and consent,13en-
mation about PrEP by sociodemographic groups at very
high risk of HIV acquisition,15and planning dissemina-
tion and implementation for equitable access.16
To begin the discussion about developing practice-
three topics: (1) assessing the use and impacts of PrEP
including a potential monitoring and evaluation frame-
work11; (2) a discussion of the potential uses of clinical
registries10; and (3) lessons learned from the Health Re-
tation research efforts.12A fınal article suggests ap-
proaches to the design of demonstration projects and
implementation pilot studies.17The generation of early
practice-based evidence can inform the next stages of
PrEP dissemination, implementation, and scale-up.
By highlighting and exploring the clinical, behavioral,
health systems, and public health issues that need to be
addressed in introducing, disseminating, and evaluating
U.S., we hope to tame some of the wicked problems and
Publication of this article was supported by the CDC through
the Association for Prevention Teaching and Research (CDC–
APTR) Cooperative Agreement number 11-NCHHSTP-01.
the authors and do not necessarily represent the views of the
No fınancial disclosures were reported by the authors of this
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