SUPPLEMENT ARTICLE
The Importance of Context in Implementation Research
Nancy Edwards, RN, PhD* and Pierre M. Barker, MD, MB, ChB†‡
Abstract: This article describes the pertinence of context in HIV/
AIDS implementation research. Without attending to context and
how it interacts with interventions, national protocols for HIV/AIDS
interventions are likely to fail or underperform. With its focus on
what works, for whom, under what contextual circumstances, and
whether interventions are scalable, implementation research yields
context-sensitive designs and enhances the likelihood of scale-up for
equitable outcomes. A framework for implementation science is
presented alongside a review of published HIV/AIDS protocols for
complex interventions. A case study of the South African Prevention
of Mother-to-Child Transmission of HIV program highlights the
application of complex system improvement principles in developing adaptive and context-sensitive scale-up designs. Preliminary
recommendations are provided that can be used to characterize
context when reporting interventions and describing how context can
be accounted for in implementation strategies.
Key Words: implementation science, context-sensitive research,
HIV/AIDS
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INTRODUCTION
Although due attention is given to rigorous cause-andeffect fixed-protocol designs for efficacy and effectiveness
research, the usefulness of these studies to health system
planners and implementers is limited in the more complex
settings and systems that are encountered outside of controlled study environments. Like much of the efficacy and
effectiveness literature, many studies of HIV interventions
have incomplete descriptions of the contextual environment
in which the studies are conducted, in part due to the lack of
a common typology to elucidate its features.1 Consequently,
context is rarely and inconsistently mentioned in systematic
reviews, creating difficulties for decision makers and program
planners who play a key role in contextualizing interventions.2 The purpose of this article is to describe the pertinence
of context in implementation research, propose some preliminary recommendations that can be used to characterize
From the *School of Nursing, University of Ottawa, Ottawa, CA; †Institute for
Health Care Improvement (IHI), Cambridge, MA; and ‡Gillings School of
Global Public Health, University of North Carolina, Chapel Hill, NC.
The authors have no funding or conflicts of interest to disclose.
Correspondence to: Nancy Edwards, RN, PhD, School of Nursing, University
of Ottawa, 1 Stewart Street, Suite 124, Ottawa, ON K1N 6N5, Canada
(e-mail: nedwards@uottawa.ca).
Copyright © 2014 by Lippincott Williams & Wilkins. This is an open access
article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any
medium, provided the original work is properly cited.
context when reporting interventions, and describe how context can be accounted for in implementation strategies.
RATIONALE AND KEY CONSIDERATIONS
Implementation science examines what works, for
whom, under what contextual circumstances, and whether
interventions are scalable in equitable ways.3 The intervention
includes the “what”—typically, a biomedical activity (eg,
a drug given in a specific format to a defined population) or
behavioral activity (eg, counseling using a theory-informed
approach)—as well as the “how”—the implementation activities that are required to achieve full (equitable) coverage of
the biomedical or behavioral intervention. The schemata in
Figure 1 show the progression of knowledge from efficacy to
full-scale implementation on 3 dimensions: determinants and
their pathways, framing the research question, and design of
the intervention. As described below, each of these dimensions is represented by a continuum.
The first axis of implementation has proximal and
sociostructural determinants as its end points. Proximal
determinants are individual characteristics such as socioeconomic status, household income, or education level. Sociostructural determinants reflect embedded social conditions such
as class, stigma, or discrimination, and power relationships.
Even when officially repealed or abolished (eg, Apartheid in
South Africa and residential schools for aboriginal children in
Canada), these determinants may continue to drive inequities.
The second axis concerns the framing of research
questions, with causal questions at 1 end of the continuum
(eg, Does a particular intervention produce a specific outcome
in heterogeneous implementation contexts?), and adaptation
questions at the other (eg, What adaptations and improvements to the intervention are required so that the intended
outcomes are achieved in heterogeneous implementation
contexts?). These adaptation processes may produce new
emergent properties of the intervention, as well as the system
and related subsystems into which they are introduced.4
The third axis focuses on the intervention, contrasting
contextualized versus standardized interventions. Efficacy
studies are typically conducted with fixed protocols applied
in controlled environments; fidelity to the protocol is key.
Adherence to the underlying theory (eg, behavior change
theory) underpinning the intervention is considered essential,
but that adherence is challenged the moment the intervention
strays into environments that are different from those of the
original studies.5 Various approaches (eg, protocols, manuals)
are used by researchers and implementers to try to ensure
interventions are delivered as planned. Effectiveness studies often examine the causes of deviation from fidelity to
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FIGURE 1. Progression of knowledge from efficacy to full-scale implementation.
the protocol (eg, provider/patient adherence). In contrast,
adaptive interventions adjust, purposefully or otherwise,
through contextual interactions with interventions and
systems feedback processes to replicate the desired outcomes
of the intervention in a more heterogeneous set of external influences.4 Contextualized interventions are guided by a theory of
change, with an emphasis on understanding how the intervention
and context interact as interventions are implemented and scaled
up, aiming to achieve high degrees of effectiveness in heterogeneous complex environments.
These 3 axes highlight the pertinence of context to
implementation science and the different ways in which context
is understood, examined, and addressed across efficacy, effectiveness, and adaptive implementation studies. With respect to
efficacy and effectiveness studies, context is considered a nuisance factor, a cointervention or confounder that must be
controlled or adjusted.6 In contrast, implementation science questions can only be answered when the intervention is tested in
a heterogeneous mix of contextual settings, since the adaptability
of the intervention to different settings will test the limits of its
scalability. Both proximal and more distal elements of context
are considered relevant. Furthermore, what is relevant is determined by what contextual elements (both static and dynamic)
interact with the intervention, shaping and modifying it, rather
than how context is defined a priori by the research team.
Although efficacy studies aim to reduce the signal-tonoise ratio by controlling for context, implementation science
seeks to understand and examine context, how it shapes and
interacts with interventions, and how interventions are modified/adapted by patients, providers, organizations, and communities in response to shifting contextual circumstances.
It follows that key features of implementation science
are the purposeful selection of heterogeneous contexts
(systems, organizations, and populations), understanding the
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interaction between interventions and context through an
adaptation lens, and the transposition of findings7 to other
contexts and systems.
SCALABILITY AND REPLICABILITY
OF INTERVENTIONS
Although this review focuses on the importance of
context in the scalability of an intervention, we must
differentiate between scalability and replicability. Scalability
concerns the equitable reach of the intervention. The rate,
pace, and reach of scalability is determined by many political,
infrastructural, and personnel factors as well as the characteristics of the populations themselves.8,9
The field of HIV implementation is notable for the
profusion of effectiveness studies. Many are not scalable,
however, either because they require a level of resources and
infrastructural elements that do not currently exist in the
broader health system, or they lack the methods and capability
to adapt the intervention into complex environments that may
be very different from the original study environments.
It is problematic to simply replicate most efficacy and
effectiveness studies. Replicability implies disseminating the
intervention without further adaptation and is unlikely to
succeed unless the new environment is very similar to the test
environment. Thus, rapid spread can only occur once testing
and adaptation of the delivery process has occurred in
multiple contexts likely to be encountered in a complex
scale-up environment. Only when adapted to work across
multiple contexts can an intervention be replicated with little
further adaptation. This approach was used during the latter
stages of the scale-up of the South African Prevention of
Mother-to-Child Transmission (PMTCT) program.10–12 At the
same time, key attributes of the intervention itself (eg, relative
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advantage, compatibility, simplicity) can increase the likelihood of dissemination.13
Similarly, strategies for preparing an environment for
change and advice on promoting rapid spread of a new
intervention (eg, leadership roles for change, packaging the
new ideas, communication strategies, strengthening the social
system of the adopter community, measurement and feedback, and knowledge management) have been well
described.14 However, much less attention has been given
to describing context and the accommodation of context in
implementation research designs.
ASSESSMENT OF CONTEXT IN HIV/AIDS
STUDY PROTOCOLS
A number of authors have identified limitations in how
context is reported within studies,15 leading to subsequent difficulties in operationalizing the interventions. To survey how
much attention is directed toward context as a factor in evaluation of HIV implementation studies in complex environments,
we reviewed articles describing study protocols related to HIV/
AIDS, identified through a search of the BioMed Central database of study protocols. We identified any articles with the key
words “HIV” or “AIDS.” Nineteen articles were found. These
were then screened using the following inclusion criteria: (1)
protocol is for an intervention (17 articles), (2) study was to be
undertaken in at least 1 low- or middle-income country (15
articles), and (3) the intervention described was deemed complex, defined as multistrategy and/or multilevel, resulting in 6
articles that were used for the final review.
We (N.E. and C.A.) read each article in its entirety and
extracted any text that described context (Table 1). The pertinent text was then grouped into 2 categories: contextual elements and the ways in which these contextual elements had
been used or would be used in relation to the study protocol.
The first author also reviewed the articles for any explicit reference of a guiding framework used to identify contextual
parameters for study. With the exception of gender analysis16–18 and domains of care provision,19 none of the protocols
referred to a framework that had been explicitly used or would
be used to guide the identification of contextual characteristics.
The types of contextual characteristics described varied considerably and tended to focus on the study settings (ie, communities or facilities where study would be undertaken rather
than the health system as a whole). Thus, descriptions of health
system features such as financing, governance, leadership,
human resource capacity, health information systems, and universal access to health services were largely absent.
A CASE STUDY OF THE SOUTH AFRICAN
PMTCT PROGRAM
The South African health system has started more
patients on antiretroviral treatment than any other nation and
has successfully scaled up its PMTCT.11 The South African
PMTCT program is a leading model where a complex intervention was implemented at full national scale across a large
number of different geographic and sociocultural contexts. By
2012, the nationally reported transmission rate for Mother-to 2014 Lippincott Williams & Wilkins
Context-Sensitive Designs for Health Programs
Child Transmission (MTCT) was less than 3%,12 close to the
reported transmission rates under clinical trial conditions.22 But
the South African rollout of the PMTCT program underwent
significant evolution, from a typical largely ineffective, contextinsensitive, cascaded-training approach to a sophisticated health
systems intervention that used modern adaptive designs.
Major social and political drama preceded the launch of
the South African PMTCT program in 2002. The program was
initiated when the epidemic had been underway for at least 10
years, by a reluctant administration that had been forced to do so
by public action and court order.23 The reasons for the delay,
which occurred in the early postapartheid era, were complex,
and undoubtedly the government’s antipathy toward PMTCT
reflected the slow start and initial poor performance of the program. Although efficacy studies showed single-dose nevirapine
decreased MTCT of HIV by more than half, more than 2 years
after full deployment of the PMTCT program (training of nursing staff at all clinical sites across the country, and universal
availability of the nevirapine), an impact study in KwaZulu-Natal
province showed the program was minimally effective.24 This
prompted several demonstration projects that used more adaptive
designs to improve the performance of the PMTCT program.10,25
These designs, increasingly being promoted for improving performance of health systems at a large scale, followed
principles of complex system improvement adapted from
manufacturing processes.26 The approach, known collectively
as Quality Improvement (QI), seeks to improve performance by developing a common simplified view of the
components and linkages of the system, real-time data feedback to track system performance, understanding the psychology of system change, and crucially, the testing and
incorporation of ideas for performance improvement from
the front-line practitioners, managers, and customers in
a broader range of contexts.
After successful demonstration of the effectiveness of
this approach, the South African government adopted the
method and tested its wider application11 before rapidly scaling up key elements of the approach across the country. This
scale-up was promoted by significant political shifts resulting
in crucial senior governmental leadership support for urgent
solutions to the HIV epidemic for the first time. Other key
determinants were more efficacious drug regimes, deployment of mobile treatment teams, and policy changes that
allowed nurses to initiate antiretroviral therapy.11 As a result,
within a few years, the MTCT rate across the South African
public health delivery system fell to levels that were unprecedented in a public system of this size.12
There were additional lessons in the effect of context on
the rate and success of efforts to implement and scale the
program. One of the demonstration projects was designed as
a cluster randomized trial (CRT) of 2 levels of health systems
support27—a QI intervention with and without the use of
a face-to-face collaborative learning system28 to promote
context-sensitive improvement ideas. The project was implemented simultaneously in 3 districts, using a step wedge
design, with clusters of clinics and their supervisors. The
clusters included clinics from the same district but ignored
natural and well-established referral and administrative linkages outside the boundaries of the cluster.
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Edwards and Barker
TABLE 1. Contextual Elements and Their Application in Selected HIV/AIDS Complex Intervention Protocols
Articles Where Contextual Elements and Their
Application Were Explicit
16
17
Warren et al ; Abramsky et al ;
Andersson et al18
Harding et al19; Abramsky et al17;
Hayes et al20; Andersson et al18
Harding et al19; Warren et al16;
Tomlinson et al21
Warren et al16; Abramsky et al17;
Tomlinson et al21; Hayes et al20;
Andersson et al18
Harding et al19; Tomlinson et al21
Warren et al16; Abramsky et al17
Contextual Elements and Examples
Cultural practices and gender norms
Examples: gender violence, gender inequality,
and related social norms, HIV stigma, sexual
entitlement, and sexual coercion
Characteristics of the study population and/or
communities where the study was going
to be undertaken
Examples: prevalence of HIV and male
circumcision; HIV-related morbidity and
mortality rates; patterns of poverty,
employment, and housing; population size
and mobility; mobile phone ownership;
patterns of alcohol use and social
support structures
Characteristics of health facilities where
research was to be implemented
Examples: level of health care facility; urban,
rural, or remote access to health facility;
administrative and service delivery structures
such as referral systems
Characteristics of formal and informal health
workers including traditional healers
Examples: a strong or exclusive orientation to
those health workers who would be engaged
in the delivery of the intervention
Sources of funding for the intervention
Examples: how PEPFAR program funds were
distributed across types of activities
(eg, treatment versus prevention)
Sociopolitical influences expected to impact on
intervention delivery
Application of Contextual Elements
Shaped intervention design (eg, gender-focused
intervention)
Informed data collection approaches,
selection of outcomes, and proposed
intention to treat analyses
Shaped intervention design
Informed eligibility of study participants
or study settings and/or plans for stratified
sampling or analysis
Informed eligibility criteria for health facilities,
choice of comparative facilities, plans for
stratified analysis, and estimates of health
facility retention rates
Description of who would undertake the
intervention with discussion of its
relevance and feasibility
Accessibility and affordability of
intervention and who was eligible to
receive intervention
Anticipated problems with adherence
and/or discontinuities in offering
intervention and related health services
Examples: political violence and unrest, poor
transportation, and temporary closure of some
services, dynamic government policies
related to integrated care
Leadership attributes and management functionality had
a major impact on the ability to effect change. One district was
led by a highly functional, energized district manager who was
already using systems thinking to organize health program
activities in his district, whereas the second district had weak
leadership and was driven by a power struggle for control of
clinic activities between municipal and district management
structures. The third district had moderate strength of leadership, but a shortage of personnel led to the disbanding of the
cadre of nurse supervisors that formed the basis of the cluster
randomization. Within the districts, there was some urban/rural
variation in sociocultural and economic characteristics,
but there was ethnic and racial homogeneity and uniformly
high clinic attendance (.90%).
The CRT design was abandoned after 12 months
because of a failure of this design to accommodate key
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context-driven issues that were essential to the integrity of
the study:
• The randomization forced a sequence of scale-up that did
not use the interest and good will of an early adopter
community that could have supported the innovation
phases of the scale-up; instead, we were forced to start
the implementation with a spectrum of willing and unwilling participants.
• The randomization unit in 1 district was destroyed when an
administrative decision removed the key nurse–supervisor
role around which the randomization was constructed.
• The support of the participants for the project was severely
tested when the study design prevented the spread of the
intervention along natural lines of clinic aggregation and
patient referral.
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Context-Sensitive Designs for Health Programs
Equally important, the CRT, through its inherent design
characteristics, assumes a homogeneity (or control) of the
external environment and resists any change of the intervention design. As such, the CRT design is destined for failure
when attempting to evaluate complex interventions being
applied in ever-changing, heterogeneous environments. Like
any large complex administrative unit, a health district
includes multiple shifting and interlinked human networks.
Any implementation study has to account for these deep
linkages, the tendency for the linkages and resources that
nourish them to change repeatedly over time, and the wide
variation in competencies of leaders, managers, and front-line
workers. This mismatch between CRT design and the
contextual properties of the health systems in which interventions are being implemented and scaled up is particularly
acute at the start of a scale-up process, when new contexts are
being encountered and the theory of change and the
intervention itself are evolving in response to these new
contexts.29 Some argue CRTs can be used to evaluate the
replication phase of scale-up.30
By contrast, adaptive designs are better suited to
generate and study novel strategies that are required to
implement and scale-up interventions in complex environments. The 3-district PMTCT project in KwaZulu Natal
thrived when the randomization was abandoned and a more
context-sensitive scale-up design was adopted. Each district
pursued the same common objective (decrease MTCT to
,5%) but used a different implementation and scale-up strategy.27 The project resulted in numerous innovations for
PMTCT that were collated and rapidly scaled across the province.31 The QI approach provided a template for a rapid
national scale-up that required minimal further modification
since it had already been tested in multiple contexts.10 This
experience provoked questions on whether cluster randomized designs are appropriate if they disrupt naturally occurring
networks or disregard the system properties of administrative
structures (eg, districts) and whether they are appropriate for
testing scale-up of complex health system interventions.30
There is growing consensus that adaptive designs are required
so that the interventions can remain highly effective across
large-scale heterogeneous implementation contexts.4–6
Rapid implementation and scale-up of complex interventions into heterogeneous environments requires a clear
aim (outcome); a core set of measures that track key processes
and progress toward that outcome; and a theory of change that
incorporates anticipating, learning from, and adapting to local
context. For PMTCT in South Africa, the aim was to reduce
MTCT to less than 5% by 2013. A core set of 7 indicators
tracked the continuum of care from early antenatal care
through to early testing of the infant for HIV and became the
basis of a quarterly report.12 The theory of change was that
success would require a combination of motivated leadership,
data feedback systems, and rapid-cycle testing of local ideas
applied to a simplified care pathway for PMTCT that was
clearly understood from leadership to the front line. After
successful demonstrations, the tested change package was
modified in a range of different contexts, and the national
Department of Health was then able to move quickly to
implement well-tested, context-sensitive changes at scale.
RECOMMENDATIONS
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A framework for understanding and describing context,
as well as an adaptive approach for implementing and scaling
up interventions in a context-sensitive way, are essential to
advance the field of implementation science in HIV/AIDS.
Addressing context involves the development of well-informed
assumptions regarding the context for delivery, not just in the
setting where the study will take place but also in the wider
health system that is the target for scale-up. Contextual
parameters must include what health personnel (formal and
informal) are in place, whether health services are accessible
and affordable for those in need, how the health system is
financed and governed, and how health information systems
are operating. Implementation science protocols and articles
describing study results should make explicit reference to the
contextual framework being used. Effort is needed to identify
common typologies, but in the meantime, frameworks such as
the WHO health systems framework9 or the Greenhalgh framework for organizational change32 offer good starting points.
Learning from the South African experience, a framework for context-sensitive implementation and scale-up should
attend to the sequencing of scale-up components. These
include the following: (1) provide a deep understanding of
the dimensions of context to plan scale-up, develop a theory of
change, and design a feedback measurement system and an
adaptive strategy for implementation; (2) undertake prototype
testing of the theory of change and early development of
implementation ideas; (3) implement early scale-up testing in
various complex environments reflecting anticipated variations
in the scale-up area; and (4) follow-up with rapid scale-up,
ensuring full (equitable) coverage with replication and minor
further adaptation of implementation strategies that have been
well tested across multiple contexts.
Finally, a receptive environment to facilitate scale-up is
also needed. This involves building support for change with
leadership, managers, front-line practitioners, and the target
population. It also includes ensuring that the environment is
prepared with data systems, commodities such as supplies and
essential drugs, clinical knowledge.
ACKNOWLEDGMENTS
The authors thank Cody Anderson for assistance with
the literature review and formatting the article.
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