P2D phase methods

A key aspect of the approach adopted is the initial, P2D phase, which offered a diagnosis of the challenges and opportunities for strengthening in the district. The methods of this particular phase has been described elsewhere,27 but are summarised here for context. Three data sources were used to develop an initial snapshot of TB care in the district. First, semistructured interviews were conducted with healthcare managers; clinical staff; private for-profit health service providers; and TB service users (the term ‘service user’ has its roots in South Africa’s National Health Act No 61 of 2003, which cemented a shift in legislation and policy from the passive, dependant term ‘patient’ to terminology that reflects someone who is entitled of basic human rights) in three PHC clinics and a regional hospital outpatient department. Second, direct, non-participant, semistructured observations were conducted within non-clinical areas of the four facilities. Researchers spent 2–3 hours in outside waiting areas, inside triage areas and waiting areas outside consultation rooms, filling out observation sheets—these were later used to draw process maps of service provider flow. Third, a document review was carried out. Policy and guidelines were reviewed to identify and highlight best practices for TB screening, testing, diagnosis, treatment and follow-up, and infection control. TB morbidity and mortality data were retrieved from the District Health Information System (DHIS) and reviewed for the reporting year of 2018–2019, which aided in highlighting facilities with higher burdens. This was further supported by a review of an internal TB mortality report of Amajuba. Facility-level routine TB data elements and indicators (monthly and quarterly breakdown of data elements according to the TB programme cascade, from screening, testing, to treatment, both total numbers and rates: people screened for TB symptoms; TB symptomatic clients testing positive; TB symptomatic clients with sputum sent; and TB clients started on treatment) from four preceding reporting quarters were extracted from the DHIS to further help identify possible health system bottlenecks.27

ToC as planning tool

An LHS lens is applied to describe health system planning and implementation activities using ToC as a tool. ToC is an interactive, collaborative process that draws from a range of methods and data sources, describing how a programme intends to reach specific outcomes through a logical sequence of short-term and medium-term steps.32 An essentially pragmatic approach, it is not a once-off exercise but rather represents and steers a strategic process of engagement between stakeholders, open to regular modification as new data becomes available.33 Though there are many different ways in which ToC processes are approached, it usually results in the generation of graphic maps that illustrate how causal chains are expected to work, along with underlying assumptions that could influence succession towards overall outcomes.32 In this study, we drew from a range of quantitative and qualitative data sources, analysed and interpreted collectively in face to face and virtual workshops. The programme timeline, from conception to present, is presented in online supplemental file 1. A key output of this process is a package of codeveloped intervention strategies, designed to target key bottlenecks and piloted in a limited number of facilities before larger scaling up. The process leading to the development of this package is detailed here, drawing from the cyclical steps of an LHS approach.

Patient and public involvement

Due to the focus of the study falling on collaborative working between a research team and healthcare management towards systems strengthening, service users and the public were not involved in the design, conduct or reporting of this study.

Establishing a learning community

Building on existing relationships with the district management through integrated mental healthcare initiatives, the research team met with key members of Amajuba District in 2018, after which initial data were collected on TB care bottlenecks. During August 2019, a 1-day workshop was held in a regional hospital in the district, where the key challenges and possible solutions to TB care in Amajuba District were discussed and interpreted among the research team and senior healthcare managers. Here, two important developments occurred: (1) An initial ToC map was developed on which to build going forward and (2) a collaborative coordinating structure was formalised where DoH stakeholders and the research team together formed a learning community. This Learning Community was engaged in the refinement of the proposed challenges, identifying poor TB outcomes and discussing possible causes, as well as possible solutions to these problematic causal processes. Prior to piloting of proposed interventions, the ToC and associated objectives were revised to assist in supporting efforts to fighting COVID-19. This was especially pressing, after initial reports surfaced about the programmatic effects that the pandemic had on other priority programmes such as TB and the psychosocial well-being of HCWs. Little to no intervention work could be conducted during the first wave of COVID-19 infections, though the Learning Community team continued to communicate virtually. During standing weekly meetings, the Learning Community adapted the original, TB-focused ToC to focus on newly identified challenges, namely the integration of COVID-19 responses with TB, and addressing the psychosocial burden of the pandemic on HCWs.

Practice-to-data

From 2018 to 2019, prior to the COVID-pandemic, a diagnostic work package was carried out that formed the P2D phase. The focus in the diagnostic phase was to collect data that would allow us to generate theoretical understanding of the contextual determinants of TB care. This required building relationships and trust with staff over time, and sensitively negotiating the use of formal research methods of interviews and observations within everyday clinic settings. These interactions provided critical insights in themselves. Requests to interview or observe practice, or informal discussions with staff revealed concerns over individual accountability and anonymity which located these encounters within the wider political, institutional and sociocultural context of TB. We then reflected on these experiences in research team meetings, deepening our understanding and allowing us to formulate a preliminary hypothesis: TB treatment outcomes can be improved in the district by improving (1) service users’ experiences of care, (2) the clinical management of TB and comorbid TB and depression, and (3) facility-level TB infection control. This improvement can be achieved through a codeveloped intervention package that leverages clinical training and mentorship, clinical communication skills training, and stigma reduction and self-care strategies for service users.

Data to knowledge

Following the diagnostic phase of the project, data were assembled, thematically analysed and interpreted using the Context and Implementation of Complex Interventions framework.34 Accordingly, several contextual factors were identified that influence TB care in The District. For example, as illustrated in figure 2, factors that delay TB diagnosis included macrolevel cultural stigma against TB, verticalisation of programmes and fragmentation between public and private spheres; mesolevel inadequate community screening and poor referral pathways and microlevel poor sputum collection practices.

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Figure 2

Findings on delayed diagnosis at community/clinic level. TB, tuberculosis.

As mentioned earlier, these findings were presented and cointerpreted at the 1-day workshop in August 2019, which resulted in the development of a first draft ToC map. In this configuration, the findings were assembled into the main levels of the TB care cascade, namely, Early Identification, Diagnosis, Early Treatment Initiation and Treatment Adherence and Support. Furthermore, key problems and possible solutions were stratified according to community and PHC facility level. Importantly, a key guidance during this early period of ToC development focused on the urgency of reducing substantial TB mortality rates in the District. Subsequently, the main, long-term outcome that was decided among the group was to reduce deaths in the District from drug-sensitive TB. Four factors were identified that could help to achieve this goal, namely to improve TB case finding; to improve early diagnosis; to improve treatment monitoring; and to improve education and psychosocial support among service user.

The internal logic of this initial draft map assumed that if people with TB symptoms are identified earlier and referred for diagnosis; if people who have been referred for diagnosis and were found to be positive for TB are earlier initiated on treatment; and if people on treatment receive adequate psychosocial and treatment adherence support; then, people’s TB disease severity would be curtailed and their clinical prognosis would improve, leading to a reduction in mortality rates.

During refinement of the ToC draft, the Learning Community collectively decided that more exploratory data was required to better understand the causal linkages described in the ToC. This led to a second round of data gathering, where additional facilities were included to conduct interviews with people presumptive with TB. At a 1-day workshop in December 2019, these additional insights were assembled and interpreted within the Learning Community to further revise the ToC map, which, following several iterations, ultimately focused on the following priority objectives: (1) poor literacy among service users; (2) inaccurate TB screening in PHC facilities; (3) poor sputum sample quality and (4) poor data quality. A key consideration in this amendment was time and resources available to reach appropriate targets for the ASSET programme. At this stage, towards the end of 2019, an intervention package was designed to address these identified challenges. The intervention package included a three-pronged approach:

1. A training package for HCWs, focusing on TB screening and diagnosis (target beneficiaries: PHC HCWs).

2. Educational posters and leaflets that provide targeted information in local languages about TB prevention, identification and management (target beneficiaries: Service users visiting PHC clinics; PHC HCWs).

3. Mentoring support in implementing changes and sustaining new and adapted practices in screening, sputum sample collection and data management (target beneficiaries: PHC HCWs and management).

Knowledge to practice

Once the intervention package was agreed among the Learning Community, materials were developed and planning was initiated to conduct pilot training in selected facilities towards the start of 2020. These activities—which initiated the K2P phase—started in one pilot facility, just before the first COVID-19 lockdown period. By February 2020, the pandemic spread in South Africa to such an extent to raise serious concern, and by March the first of several national lockdowns was put in place, thereby freezing all research and development activities.

Given the new contexts and new set of challenges, it was necessary to first return briefly to the P2D phase. A site visit of two PHC clinics was undertaken by members of the ASSET team, which included observations of patient pathways in terms of TB and COVID-19, as well as interviews with facility and district staff. The data were rapidly transcribed and analysed thematically, and included in learning community discussions on an adapted intervention package. Accordingly, key areas of concern were identified, including poor literacy among service users on TB and COVID-19; suboptimal screening for TB and COVID-19 in facilities; suboptimal diagnostic processes for TB and COVID-19 in facilities; poor TB and COVID-19 data quality; substantial strain on the mental well-being of staff; poor infection control practices; and suboptimal mentorship in dealing with a rapidly changing emerging disease. The Learning Community team subsequently revised the ToC (figure 3) and agreed that the project fixed its focus on the following objectives:

• Strengthen TB, mental health and COVID-19 literacy.

• Strengthen sputum collection and swab taking processes.

• Strengthen TB and COVID-19 screening.

• Strengthen managers’ capacity to contain anxieties of staff in the context of the additional stressors imposed on them by the COVID-19 pandemic.

• Strengthen data quality for follow-up of presumptive TB and COVID-19.

• Support the psychological well-being of health workers through the COVID-19 crisis.

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Figure 3

ToC map for the integration and strengthening of COVID-19 and TB programmes on PHC level. HCWs, healthcare workers; PHC, primary healthcare; TB, tuberculosis; ToC, theory of change.

As depicted in figure 4, five intervention packages were developed to address the objectives generated in the ToC process. Health education materials that included pamphlets and posters (digital and hard copy) were developed to increase service user and HCW literacy in TB, COVID-19, and mental health, as well as to promote safe practices in facilities.35 Online videos were developed to support psychosocial coping among managers, HCWs and services users, as well as to develop capacitate managers with skills to contain staff anxieties.36 This was generated in partnership with a sister programme—the Southern African Consortium for Mental Health Integration (S-MhINT).37 Updated Adult Primary Care (APC) clinical guidelines—nationally endorsed PHC guidelines—were provided to facilities, as well as APC COVID-19 guidelines.38 The distribution of these materials was supported by various online training initiatives, including courses for non-clinical staff on safe work practices; accompanying training on APC guidelines for clinical staff; a course on psychosocial well-being and orientation on psychoeducational materials; and training on the clinical integration of TB, COVID-19 and mental health on PHC level. In addition to training HCWs, an additional step focuses on the development of facility-based trainers, who can decentralise training facilitation from Cape Town-based facilitators to include staff members who can help support and drive online training participation. Details of the intervention are provided in online supplemental file 2, presented in terms of the Template for Intervention Description and Replication checklist.39

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Figure 4

Relation between codeveloped interventions and objectives. CQI, continuous quality improvement; HCWs, healthcare workers; TB, tuberculosis.

These educational and training resources were further supported by the adoption of a continuous quality improvement (CQI) approach. In partnership with S-MhINT and the DoH, a CQI mentor was recruited, trained and positioned in the District. The CQI coordinator has a dedicated office space in the district DoH offices, thereby creating a more direct line of support. Furthermore, the CQI mentor works closely with PHC facilities, to work with staff to, by using tools such as Plan–Do–Study–Act, identify bottlenecks and challenges related to data management, diagnostic sample collection, screening and infection control for TB and COVID-19, and codeveloping solutions tailored to each facility. A good example of an unforeseen challenge emerged in terms of technical capability and resources among some staff to be able to connect to online training platforms. In order to bridge this gap, a technical assistant was employed to provide hands-on support to staff members during online training sessions. A related challenge was the cost of data, which was bridged by enlisting the services of a third-party business to render all online training and educational content data-free, thereby removing a significant barrier in accessing resources. Finally, the distribution of health education resources and the supporting of online training was facilitated by an online webinar for managers and facility trainers, as well as through the establishment of a training support WhatsApp group.

Next steps

Following the development of the revised intervention package in the K2P phase, piloting was initiated in a limited number of facilities. As illustrated in figure 5, this is followed by wider implementation, which is monitored in weekly learning community team meetings. In addition, process evaluation data, collected at different time points, are analysed along with pre–post survey data and routine indicators, will form the basis of evaluation of the effectiveness of the intervention package on key outcome measures.

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Figure 5

Programme timeline as interpreted through an LHS approach. LHS, learning health systems; ToCs, theory of changes.

The importance of building and sustaining relationships

Our first lesson, and certainly the most obvious and well known, is the importance of building and sustaining relationships of collaboration, trust and mutual support, between researchers, policy makers, managers and front-line workers—not only in the beginning phases of a programme, but throughout its trajectory. Established relationships and collaborative structures are vital starting points for LHS cycles to be initiated and sustained over time.40 In this vein, our programme’s sustainability was significantly elevated by a pre-established relationship between the research team and district stakeholders, which facilitated more resilience in responding to emerging challenges. In the emergency contexts of COVID-19, resources needed to be maximised more than ever. A participatory, flexible approach was therefore especially useful in bringing together and sharing resources across government and academic sectors, as well as across different programmes with different funders. The value of collaboration was key in helping the ASSET programme to adapt to rapidly changing contexts. In this vein, a case is to be made—based on our experiences relayed here—that more investment is required into building relationships, in addition to developing programme content. Investing in the medium-to-long term nature of building and sustaining trust and cooperation between researcher and local partners, rather than a myopic focus on project lifecycles, has important consequences for how health system strengthening initiatives are funded and supported in global health.41

The utility of colearning, coproduction and adaptive capacity

The second lesson that emerged from our experience relates to the importance of colearning. It has become increasingly critical for health systems—especially ones in LMICs—to embrace collaborative and dynamic forms of learning.22 As mentioned earlier, a key strategy in LHS is to speed up knowledge translation through colearning and coproduction. More traditional, static methods of knowledge dissemination with limited uptake, for instance, policy briefs, are simply not effective in response to a complex and rapidly changing environment.42 The creation of a space where mutual learning can occur, and then result in the coproduction of potential solutions, was a valuable tool in adapting to the uncertainties raised by COVID-19. There is a growing body of work describing the benefits of collaboration, partnership and coproduction in health systems, particularly in LMIC settings, where local ownership is a critical factor in determining successful outcomes.43 A central expectation of coproduction—the explicit inclusion of stakeholders in the development of the agenda, design, implementation, interpretation and dissemination of research—is to generate findings that are relevant, useable, useful and used.44 45 Sustained coproduction and learning are further intertwined with trust, accountability and mutual benefit, particularly in fragmented health systems.23 While the ideal of coproduction has received increasing attention during the past decade, the urgency to adopt the approach in real-life settings have been propelled forward substantially by COVID-19. While some coproduction cases are embedded in large, macro structures, for instance, Thailand’s ‘triangle that moves the mountain’ initiative (a framework relying on three power poles of collaboration, between a government sector, a knowledge sector and a people’s sector),46 others are on a much smaller scale—our work falls in the latter.

Our experience highlights the need for a fair degree of adaptive capacity—not only in the health system, but also in terms of research programmes. Adaptive capacity, meaning ‘the capacity to make intentional incremental adjustments in anticipation of or in response to change, in ways that create more flexibility in the future’47 is a key dimension of resilience in the face of external shocks such as COVID-19. Lessons from the 2014–2016 Ebola outbreaks underlined the necessity of resilience and the capacity to effectively anticipate and deal with uncertainties.48 Specifically, stakeholders in health systems strengthening need to anticipate disruptions and opportunities, be able to monitor system processes, respond to immediate demands, and learn from experience.49 The regular engagement in our collaborative learning community team facilitated a sharing of valuable front-line knowledge as the impacts of COVID-19 emerged, and allowed for a more rapid and effective response to identified gaps. Adaptations to TB educational materials to also include COVID-19, and the development of platforms to address psychosocial wellness among overburdened staff are examples of this. The latter was particularly critical, given our findings that suggest high levels of COVID-19-related mental strain among HCWs, and a substantial proportion of managers being in known high-risk groups to contract the disease.50 Managing emergent anxieties associated with healthcare work remains a central concern. Accordingly, the programme was able to draw from ‘situated resilience’, adaptations to front-line facing and operational elements of care.51 Another major advantage in this experience was the ability of our programme to shift and change its objectives from the original proposal to adapt to emergency circumstances. Our ASSET work package also benefited from substantial responsiveness from the S-MhINT programme, by partnering in supporting a CQI mentor and to develop psychosocial wellness materials towards achieving common goals. The ability of a programme to adapt to emerging challenges and to draw from additional resources are essential considerations in health systems strengthening. Nonetheless, purposeful and sustained investment in developing LHS are rare, and health systems strengthening unfortunately occurs inconsistently and often in response to crisis. As concluded in a recent paper, ‘learning investments are not ‘quick fixes’. They do not guarantee rapid or predictable returns. They require the patience and perseverance to nurture human capital for learning, and to conceive and grow learning institutions’.22

The centrality of theory-driven systems strengthening

Our third lesson relates to the need for health system strengthening activities to be theory-driven. While an LHS approach offers flexibility and adaptive capacity, there is an inherent danger of the work becoming problem-driven and reactionary, undermining strategic operationalisation of lessons and rigorous scientific process. By keeping the programme theory at the heart of the enterprise, its lessons become transferable and our understanding on how to strengthen systems improves.52–54 Theory in this sense does not mean fixed and unchanging, but rather a roadmap that constantly requires updating and refinement. As previous similar initiatives have shown, coproduction processes within an LHS frame are very much built on key questions about collective sense-making, the nature of evidence and evidence generation, and analysing and theorising such evidence.55 In this paper, we have demonstrated how the application of ToC can help facilitate LHS cycles by offering guidance on how the programme theory evolves over time. Beyond ToC’s apparent linear logic, examples from Bangladesh, Uganda and India illustrate how ToC can be used as a valuable strategising tool to achieve consensus in a cyclical way.52 In addition to its traditional application as a monitoring and evaluation tool, the ToC double-loop process is designed to facilitate organisational learning, through critical, collective reflection.56 This was particularly an important communication and strategising platform within our learning community engagement. Moreover, ToC is particularly suited to a systems approach, rather than vertical, disease-focused, project-oriented approaches57—this was vital in adapting our ASSET programme to the pandemic and integrating COVID-19 with TB care to promote more person-centredness.

Reflections on LHS as a framework

A final, brief point to be made relates to comments on the LHS as a framework. The approach has fairly recently been formalised, and, to our knowledge, is yet to be rigorously assessed as a pragmatic tool. Nonetheless, our experience suggests that the LHS as a framework offers enough flexibility in its three broad phases to incorporate localised adaptations to the guidelines as originally proposed. A potential area in the framework that could be expanded on is the role of power, given the central concept of coworking and collaboration. Highlighting power more explicitly, with potential strategies to manage different structures, networks and relations of power, might provide helpful guidance for people working in pluralistic health systems such as South Africa’s, often fraught by politics and competing priorities. Further, as noted in the previous paragraph, there might be space for a more central inclusion of theory as an anchoring mechanism of the highly dynamic LHS process. In ASSET, we adopted ToC to help mapping out the programme theory as well as to monitoring changes made in response to new data and needs that might emerge during health systems strengthening. However, integrating a ToC approach within the LHS cycles might help strengthen the framework and allow for a more systematic generation of intervention options and enhance the transferability of lessons to other regions.