Behind the scenes of the PRIME intervention: designing a complex intervention to improve malaria care at public health centres in Uganda

Background In Uganda, health system challenges limit access to good quality healthcare and contribute to slow progress on malaria control. We developed a complex intervention (PRIME), which was designed to improve quality of care for malaria at public health centres. Objective Responding to calls for increased transparency, we describe the PRIME intervention's design process, rationale, and final content and reflect on the choices and challenges encountered during the design of this complex intervention. Design To develop the intervention, we followed a multistep approach, including the following: 1) formative research to identify intervention target areas and objectives; 2) prioritization of intervention components; 3) review of relevant evidence; 4) development of intervention components; 5) piloting and refinement of workshop modules; and 6) consolidation of the PRIME intervention theories of change to articulate why and how the intervention was hypothesized to produce desired outcomes. We aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for the study context; could be evaluated within a randomized controlled trial; and had the potential to be scaled up sustainably. Results The process of developing the PRIME intervention package was lengthy and dynamic. The final intervention package consisted of four components: 1) training in fever case management and use of rapid diagnostic tests for malaria (mRDTs); 2) workshops in health centre management; 3) workshops in patient-centred services; and 4) provision of mRDTs and antimalarials when stocks ran low. Conclusions The slow and iterative process of intervention design contrasted with the continually shifting study context. We highlight the considerations and choices made at each design stage, discussing elements we included and why, as well as those that were ultimately excluded. Reflection on and reporting of ‘behind the scenes’ accounts of intervention design may improve the design, assessment, and generalizability of complex interventions and their evaluations.

processes combined with respectful interpersonal interactions and adequate resources (5). Benefits of providing good quality care include increased demand for services (6Á8), improved attendance at health centres (9), better relationships between patients and health workers (10), and increased clinic loyalty (11), potentially producing better health outcomes (12). Interventions are urgently needed to improve the quality of care provided at health centres, increase patient attendance, and ultimately improve health outcomes for malaria and other illnesses (13,14). However, the optimal approach to improving quality of care is not clear, particularly in low-resource settings (15). Provision of basic training and health education have been tried, but appear to have limited impact, prompting calls for more complex interventions targeting the multidimensional nature of patient treatment seeking (16) and provider practices (17,18).
For the PRIME trial (19), we developed a complex intervention targeting malaria case management at public health centres in Uganda. Drawing on the available literature (20,21), we aimed to design an intervention that was evidence-based and grounded in theory, was tailored to our study setting, could be evaluated within a randomized controlled trial, and had the potential to be scaled up sustainably by the Ugandan Ministry of Health. The final PRIME intervention consisted of four components: 1) training in fever case management and use of rapid diagnostic tests for malaria (mRDTs); 2) workshops in health centre management (HCM); 3) workshops in patient-centred services (PCS); and 4) ensuring the supply of mRDTs and artemetherÁlumefantrine (AL, the firstline ACT for malaria in Uganda). The primary outcome for the evaluation of the PRIME intervention was the prevalence of anaemia (haemoglobin B11.0 g/dL) in individual children under five measured in annual surveys of communities surrounding health centres enrolled in the PRIME trial (19).
Interventions such as PRIME can be considered complex due to their multiple, interacting components, which address multifaceted problems within dynamic systems (22,23). Responding to calls for more detailed and transparent reporting of intervention components (24Á26) and designs (27,28), here we describe the process of designing the PRIME intervention, including the choices we made and the challenges we faced, and how this shaped the final intervention package.

Study setting
The PRIME intervention was designed for Tororo, Uganda, an area of high malaria transmission (29). In both health centres and communities, infrastructure is limited. Health centres are generally run by nurses or nursing assistants; many lack electricity, running water, functioning laboratories, and adequate staffing. As a result of system-wide reforms in the 1990s and early 2000s, public healthcare was decentralized and, in theory, provided free of charge (30). Due to frequent stock-outs of essential drugs, including antimalarials, patients were often forced to purchase drugs or go without adequate treatment (31).

Intervention development
In developing the intervention, we followed a step-wise approach informed by the literature (22,32,33), including the following: 1) formative research to identify target areas and refine objectives; 2) prioritization of intervention components; 3) review of relevant evidence to support intervention content; 4) development of intervention components; 5) piloting and refinement; and 6) consolidation of the PRIME intervention theories of change.
Step 1. Formative research to identify target areas and refine objectives In 2009Á2010, we conducted mixed methods research to characterize the population and local health services using a household survey, situational analysis of governmentrun health centres, and qualitative assessment of health workers' and community members' experiences at health centres (34). Through an iterative thematic analysis, we identified aspirations for good quality care and malaria case management and suggestions of how these might be achieved. Health workers and community members shared ideals of what constituted good care, suggesting that patients might be attracted to attend health centres if quality of care was improved (Fig. 1). However, multiple challenges were identified, including lack of equipment and basic infrastructure, high patient-to-staff ratios, poor health centre management, and stock-outs of antimalarials and other drugs. Social challenges were also identified, including low health worker motivation and difficult relationships between health workers and community members due to lack of trust, language barriers, discriminatory behaviours, and requests for informal payments for services.
We categorized the challenges identified, including health centre factors, cultural and systemic issues, and wider system factors. The results of our analysis identified eight key components of good quality care and corresponding target areas for potential intervention (Fig. 2). Through this process, we differentiated challenges that were amenable to implementation research from those that were beyond the project's scope, thereby reducing a range of complex challenges into a definable set of factors for action at health centres.
Step 2. Prioritization of intervention components Prioritizing components to include in the PRIME intervention was an iterative process. We conducted a workshop and follow-up meetings with stakeholders involved in malaria control and child health programmes, including researchers and programme officers at the Ministry of Health, the National Malaria Control Programme, Makerere University, and a local malaria-related nongovernmental organization. Together, we reviewed the findings of the formative research and prioritized potential interventions based on stakeholders' guidance.
Overall, stakeholders agreed that we should target malaria case management, patient-centred care, and HCM. However, some of the activities we proposed were deemed beyond the scope of our project. For example, to address staffing shortages and absenteeism, we suggested negotiating with district officials to increase salaries and hire additional staff. We also suggested supplementing the primary healthcare fund Á a small cash fund provided to health centre in-charges (often erratically) to pay for essential activities, including transportation of drugs, cleaning services, and necessary supplies. However, district officials were against these propositions, arguing that they would be difficult to administer and sustain. Through this process of prioritization we arrived at four intervention components ( Table 2, Supplementary file 1), including the following: 1) training in fever case management and use of mRDTs (FCM); 2) workshops in HCM; 3) workshops in PCS; and 4) supporting the supply of mRDTs and AL.  Step 3. Review of relevant evidence to support intervention content We searched for existing training packages in the published and grey literature, both online and in local library collections, prioritizing interventions that had been evaluated and found to be effective in Uganda or similar low-resource contexts.

FCM module
For the FCM module, we identified a training package developed by the Joint Uganda Malaria Training Program (JUMP) team, utilizing mRDT training guidelines and job aids adopted by Uganda's Ministry of Health (35). The training consists of lectures and practical sessions, followed by three rounds of support supervision by the JUMP team on-site at health centres (at 1 week, 6 weeks, and 6 months post-training). The training has been shown to improve fever case management and reduce the number of unnecessary antimalarial treatments when implemented in public health centres in Uganda (Hopkins, unpublished observations) (36).

HCM and PCS modules
For the HCM and PCS modules, we were unable to identify suitable pre-existing interventions. Although interpersonal interactions between health workers and patients are considered to be central to good quality care (5,13,37,38), the philosophy of PCS is not as prominent in African healthcare (39) as it is elsewhere (40,41 (38), by reorienting the care-seeking experience towards patients' aspirations for good quality care (5).

Supply of mRDTs and AL
We aimed to align the PRIME supply component with Uganda's existing supply system and the SURE programme (42). However, while we were developing the intervention, Uganda's National Medical Stores (NMS) distribution system changed from a 'pull' system, in which drugs were ordered by health centres, to a 'push' system, with regular delivery of a pre-determined package of drugs, requiring us to revise the PRIME supply component. We identified an existing health worker to act as a liaison, who was responsible for gathering stock information from health centres and facilitating delivery of mRDTs and AL from PRIME when the NMS supply was inadequate or failed. The SURE programme, introduced in 2009, aimed to gather drug stock information and minimize stock-outs through supervision visits. The PRIME intervention utilized SURE's pharmaceutical management information system forms and procedures.
Step 4. Development of intervention components: HCM and PCS modules To develop the HCM and PCS modules, we reviewed evidence on successful intervention activities; translated evidence into content; incorporated behaviour change theory, adult learning cycles, and learning activities; and created workshop manuals.

Reviewing evidence on successful intervention activities
We reviewed the literature to identify activities targeting health worker communication and interpersonal relationships, patient satisfaction, health worker supervision and coaching, and management of health centres. We focused on low-cost and low-resource interventions, prioritizing interventions that had been successfully implemented and evaluated. The review methods are described elsewhere (Chandler, unpublished observations).
Several activities have been shown to improve communication between health workers and community members, producing a positive effect on patient satisfaction and health outcomes. These activities include enabling clinicians to give patients time to talk during a consultation by asking good questions (48) and employing active listening (49,50) to elicit better information from patients (51). Activities to build rapport and support emotional care by reassuring patients (52) have also been shown to facilitate patients' therapeutic reactions (53Á55). Likewise, activities promoting 'positive communication' may improve teamwork by recognizing how personal circumstances and work environment affects emotions and communication (52,56). Activities to improve relationships between health workers include building self-awareness and constructive communication through vignettes, which are used to identify and resolve sources of conflict (57). Notably, of these activities, only 'time to talk' was drawn from a low-income setting.
Activities shown to improve patient satisfaction with experiences at health centres include greeting patients (58) and guiding patients through the health centre (46). Interventions promoting supervision and coaching were also identified, although evidence that these activities change provider performance was weak (59, 60). We also considered health worker performance management programmes, including the SURE programme and the Uganda Malaria Surveillance Programme's (UMSP) Continuous Quality Improvement Project, which demonstrated that providing health status reports and regular supervision with constructive feedback improved health worker performance (Mpimbaza, personal communication, 10 June 2010). However, the UMSP activities had not been systematically evaluated. Thus, we were forced to weigh the available evidence and decide which activities best informed the design of our intervention package. We ultimately chose not to include coaching or supervision due to the concerns about sustainability, both during the trial and if scaled up, and the limited evidence base supporting coaching and supervision in our setting (61,62).

Developing intervention content
For drug supply management, we drew on the literature to develop the ACT Drug Distribution Assessment Tool, a one-page tool to support health workers in resolving everyday distribution bottlenecks that are not tracked in standard monitoring tools, but are often the cause of health centre drug stock-outs (63). For financial management, we developed the Primary Health Care Fund Budgeting and Accounting Tool, a one-page tool to assist health workers with managing the health centre primary healthcare fund.
For the PCS modules, we adapted activities to improve health worker communication developed mainly in highincome settings to our study setting by using local cultural and social references drawn from our formative research. We deconstructed concepts contained in activities such as giving time to talk, building rapport and emotional care, and self-awareness and reconstituted these in forms and definitions meaningful to the study context. Thus, activities maintained their intended purpose but were communicated using scenarios and discussion points relevant to health workers' everyday experiences.

Incorporating behaviour change theory
The HCM and PCS modules are underpinned by behaviour change theory to initiate the intended pathway of effect. Both modules aimed to build a supportive community of practice. The Communities of Practice behaviour change theory posits a cyclical process of change, where individuals' frames of reference are transformed through participation in a community of peers, and their participation in turn transforms the community (64). This process serves to create an 'informal curriculum' for health workers in addition to the existing overarching core curricula (65). Through this process, learners engage with other community members and reflect critically on their practice through a social process of individual and collective learning (66).
The theory of Communities of Practice resonated in our setting where many health workers learn primarily on the job. Likewise, our setting lacks many external motivators that have been shown to promote health worker performance, such as financial incentives, constructive supervision, professional accreditation, and opportunities for promotion (67Á71). Therefore, we sought to balance the limitations of the context with the opportunity to stimulate health workers' internal motivations for providing good quality care (72), which included the desire to be viewed as professional, to be respected by colleagues and community members, and to be valued for providing good healthcare services (34). We theorized that, as health workers built, demonstrated, and received positive feedback on their clinical, interpersonal, and managerial skills, the social processes emerging from participation in the community of practice would help them to develop their professional identity and sustain positive skills and behaviours (73).

Incorporating an adult learning cycle and learning activities
The HCM and PCS modules were designed as interactive weekly 3-hour workshops to promote group learning, contributing to the development of a community of practice. The structure was designed to allow time to reflect and practice skills in between workshops and to get feedback at subsequent workshops. Small groups of health workers were selected to enhance participation and encourage peer support in the future. The workshops were led by three members of the PRIME research team, who had medical backgrounds but little experience in interactive training methods, as is the norm in Uganda (74).
The workshops were framed as continuing professional development with interactive learning activities which have been shown to improve health worker knowledge, skills, attitudes, and behaviours leading to improved patient outcomes (75Á77). The workshops were structured as a six-step adult learning cycle drawn from Kolb's (78) experiential learning theory, which includes four stages: experience, reflection, conceptualization, and planning; and from Knowles' (79) theory of adult learning, which asserts that adults must first establish why they should learn something before proceeding to acquiring new knowledge. The six steps involve developing a 'need to know', individual reflection, conceptualization, experimentation, group reflection, and planning. To activate this learning cycle, the workshops employ a variety of participatory learning methods drawn from training modules in similar contexts (Supplementary file 2) (Haaland, personal communication, 15 May 2010) (37,48).
The PCS module also included weekly self-observation activities (SOA) that aimed to stimulate learners' purposeful critical analysis of their knowledge and experience (80), enabling them to engage and deal with their emotions (81) and develop appreciation and respect for others (82). Semi-structured SOAs followed by feedback in groups provided opportunities for both individual learning and change as a community (66). The SOAs were adapted from tasks designed and tested in a number of other healthcare settings (Haaland,personal communication,15 May 2010) (48).

Creation of Workshop Manuals
For each HCM and PCS workshop, we created corresponding trainer and learner manuals Á 18 in total (Supplementary file 2). We contracted with an experienced public health consulting firm (83) to fine-tune the learning activities and typeset the manuals. This was a collaborative effort, requiring significant input on a new layer of design considerations, including the colours and fonts that would best communicate the ethos of the workshops and how pictures and layout of activities could support learning retention. We also considered how the trainer instructions would encourage active facilitation but also support trainers in drawing out learners' reflections and experiences.
Step 5. Piloting and refinement: HCM and PCS modules We conducted two rounds of piloting the HCM and PCS modules with 10 health workers from outside of the study area. We administered questionnaires to learners and trainers, gathered daily feedback from trainers and the piloting team, and conducted focus group discussions with participants at the end of the modules. The piloting evaluated the relevance and applicability of the learning objectives and content, as well as the delivery of the training (84). The piloting proved to be an invaluable exercise, unexpectedly revealing that the learning capacity of our intended learners was not in line with our expectations. Whereas the six-step learning process and interactive activities appeared to support learning, some of the module concepts and language were too advanced, requiring us to readjust our expectations of how these concepts could be feasibly introduced. The trainers, who had more experience with didactic approaches, also reported challenges with the interactive format of the manuals. Thus, we revised the modules, aiming to 'hit the mark' with our intended learners by simplifying the language, reducing the number of new concepts and learning objectives per module, including more interactive activities, and revising the prompts and instructions throughout the trainers' manuals. See Table 3 for examples of revisions made. The second round of piloting indicated that the revised modules did meet our intended Table 3. Example of revisions made to the PCS and HCM modules as a result of piloting Revised learning objective for drug supply management to 'Accurately complete the forms required in the drug distribution system'.
Calculations for the forms were completed as group work, and more information was provided in the learners' manual for later reference when completing forms at the health centre. Step 6. Consolidation of the PRIME intervention theories of change Drawing on complex intervention design and evaluation guidance (22, 86Á88), we articulated two complementary intervention theories Á a programme theory and an implementation theory. These theories make explicit how and why we hypothesized the PRIME intervention components would combine to produce desired outcomes (89). The programme theory, represented in a logic model (Fig. 3), describes why the four intervention components are anticipated to produce specific outcomes. It hypothesizes that an intervention addressing the barriers to providing good quality care for malaria and febrile illnesses will improve appropriate malaria case management and patient satisfaction, leading to repeat attendance at health centres, and ultimately, improved health outcomes in community children. The implementation theory (Fig. 4) articulates how the intervention will stimulate behaviour change. It hypothesizes that a learning process stimulating health workers' cognitive, emotional, and social learning processes through interactive workshops reinforced within a community of practice will lead to immediate and sustained change in health worker motivation, behaviour, and practice for providing good quality care.

Discussion
We designed a complex intervention targeting delivery of care for malaria at public health centres in Uganda (19,90). Informed by best practice, we aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for our study setting using a systematic approach. In the process, we learned several important lessons related to the scope of the intervention and necessary compromises, the tension between static interventions and dynamic contexts, and the challenges of rigorously designing a behaviour change intervention for low-resource settings. By transparently reporting our 'behind the scenes' accounts, we hope to inform the design and content of future complex interventions. Our formative research identified several challenges to providing good quality care at different levels of the health system. Many of these challenges were interpreted to be rooted in wider health system norms that prioritize technical skills and technologies over a patient-centred approach to care. Likewise, our context is characterized by ineffective political systems and a deeply embedded hierarchical structure that perpetuates power imbalances throughout the health system (5). In an attempt to define factors for action at the health centre level, we found it necessary to bracket out much of the complexity and the politicalÁeconomic reality underlying health service provision in Uganda. As a result, we focused on intervention components that had the highest likelihood of success and buy-in from stakeholders within the constraints of a focused project, which others have noted as a critical factor for success when designing health service interventions (91). However, this choice meant that the deeper social, political, and economic challenges that underlie poor healthcare quality and lack of progress on malaria remained unaddressed by our intervention (92). Rather than ignore these challenges as being out of the scope of the intervention design process, engaging with them was required to situate the intervention within the wider health system context and to provide deeper insight into how the intervention components might operate within this system. Recognizing that interventions are a part of complex health systems (23), we urge intervention designers to consider and report on the process of negotiating wider social, political, and economic realities and how this influenced intervention content and design.
The slow and iterative process of intervention design contrasted with the continually shifting study context. During the intervention design process, which took almost 1 year, several changes occurred in the study context that had significant impacts on the intervention. The integration of the SURE programme and implementation of NMS's push delivery system required a reconceptualization of the HCM modules and the supply component. A policy introduced by the District Health Office to remove untrained volunteers from health centres required an adaptation of the PCS module to suit other authorized support staff. This ever-changing context created a 'moving target' with which to align the intervention and contrasted with the need to develop standardized content suitable for evaluation in a cluster-randomized trial. To accommodate this situation, the modules were designed as a structured framework complemented by reflective learning activities to engage with learners' everyday experiences. In this way, the structure of the modules was standardized and reproducible, but the learning points could be adapted to the local context (93). While the challenge of implementing and evaluating static interventions in dynamic contexts has been considered (94Á97), we encountered similar tensions during intervention design. To resolve these issues, flexibility and responsiveness were needed. Although this required additional investments of time and resources, we found this was essential to designing an intervention appropriate for our study setting.
Developing the PRIME intervention required a diversity of expertise, including clinicians, social scientists, epidemiologists, health workers, project managers, and training consultants. Team members approached the design of the intervention from different epistemological and disciplinary backgrounds. Developing the logic model suited the positivist perspective favouring a representation of the intervention as discrete components leading to predefined measurable outcomes. The process of developing the logic model provided an opportunity for the team to share and consolidate ideas and emerged as a convenient communication tool. However, the static nature of the model did not adequately capture the way we expected change to occur, recognizing that change processes would be dynamic, emergent, and contingent on links between the intervention, individuals, and society (98). By utilizing both text and visual models as part of our intervention theories, we endeavoured to articulate a specific intervention theory while acknowledging that the intervention would be enacted in a dynamic context, which would create many unique change processes, both intended and unintended. Our different disciplinary perspectives also led us to engage with questions of what the intervention 'is' Á for example, rather than simply a composition of training materials and events, we began to conceive it as a series of interactions embedded in social relationships through which its meaning would emerge. This raised the possibility that the meaning of the intervention could be constructed differently by different actors, which was important to capture in our evaluation activities. Our experience concurs that an interdisciplinary approach appears to be essential for making meaningful progress towards improving population health (99); however, it should be recognized that this approach is time-and resource-intensive (91,100,101), requiring concerted effort to align perspectives into a shared understanding of the intervention (102).
Our experience designing the PRIME intervention reflected a process that is more interactive and demanding than the available evidence and theory suggest (20). While the literature guiding intervention design is expanding (91,103), few authors discuss the construction process we found necessary to reach the final intervention package. The importance of reporting 'insider accounts' of intervention implementation and evaluation activities to better interpret trial outcomes has been noted (104,105). We argue that this same reflective and transparent reporting practice should apply to intervention design. Guidelines for reporting complex intervention content ask authors to describe the reasons for selecting intervention components, which may include 'experience of or evidence on the suitability of the component to achieve the intended change process' (4: 106). Our experiences revealed manifold reasons influencing the processes through which intervention content was considered, shaped, and integrated (or discarded), in light of research aims, available evidence, and resource constraints. Sharing accounts of activities that were considered but omitted, and why these decisions were made, may be as informative as descriptions of final intervention packages. Thus, we argue that describing these behind-the-scenes accounts of the intervention design process should be considered a key 'experience' included in guidelines for reporting intervention content and their evaluations. A reflective and transparent reporting of the design process may promote assessments of the intervention's internal validity, facilitate interpretation and generalizability of results, and inform future interventions. As complex interventions gain momentum in healthcare, guidelines for developing interventions and reporting on the design process will need to evolve, consistent with current debates of how complex interventions should be conceptualized and evaluated (23,98,107).