Enhancing Trachoma control in Tanzania, the role of design thinking in Trachoma persistence contexts

¹Department of Community Medicine, Kairuki University, Dar es Salam, Tanzania, ²Trachoma Control Program, Ministry of Health, Dodoma, Tanzania, ³Department of Behavioural Sciences, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, ⁴Department of Behavioural Sciences, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

^&Corresponding author
Innocent Semali, Department of Community Medicine, Kairuki University, Dar es Salam, Tanzania

Introduction    

Trachoma has been a worldwide public health problem since historical times, but with improved personal hygiene and environmental management by the 20^th century, it had been successfully eliminated in most of the developed world; unfortunately, it remains a persistent problem in most developing countries despite existing effective SAFE interventions [1]. Consequently, by the early 2000s it was estimated that 156 million people were at risk of trachoma across nations, mostly in sub-Saharan Africa [1]. Trachoma is caused by Chlamydia trachomatis, an obligate intracellular bacterium that is both directly and indirectly transmitted from one person to another [1,2]. Trachoma spreads directly through contact with discharge from infected eyes, eyelids, nose, or throat of an infected person. The eye infection progresses through two phases in five stages; the first phase is infectious trachoma, which can lead to blindness if left untreated. It's first stage is trachomatous inflammation-follicular (TF), which is most common among children aged 1 to 9 years and can progress to a more severe stage two known as trachomatous inflammation-intense (TI). The non-infectious phase is an outcome of recurrent trachoma infections over years, usually occurring among those 14 years and above, depending on the trachoma endemicity level. It begins with stage three, which is trachomatous scarring (TS), marked by scarring of the tarsal conjunctiva, followed by the fourth stage, trachomatous trichiasis (TT). Trachomatous trichiasis is the result of multiple infections from childhood with chlamydia trachomatis, which causes recurrent chronic inflammation in the tarsal conjunctiva; consequently, affected eyelids turn inward due to scarring rubbing the eyeball. The continued rubbing of the eyeball leads to corneal opacity (CO) at the fifth stage, characterized by distorted vision, including blindness, most commonly affecting individuals over the age of 20 [3].

Current effective trachoma intervention carries the acronym SAFE, meaning S (surgery for trichiasis) for tertiary prevention of eye deformities and A (antibiotic therapy) as primary and secondary prevention; F (facial cleanliness) and E (environmental improvement) collectively are a primary prevention strategy to achieve the elimination of trachoma as a public health problem threshold goal [4]. Correspondingly, S in the SAFE acronym refers to surgical treatment of trachomatous scarring and Trichiasis trachoma. A is Antibiotic administered for treatment of infectious stages of trachomatous follicular (TF) and trachomatous inflammation intense (TI); it is also distributed as prophylaxis given as mass drug administration (MDA) to all at risk. F refers to facial cleanliness (F), and E refers to environmental improvement; both are primary prevention practices to stop transmission of chlamydia trachomatis, the causative agent. Surgery, antibiotics, facial cleanliness, environmental (SAFE) improvement has been field-tested in several countries, revealing significantly high effectiveness in achieving the elimination threshold of trachoma as a public health problem [5,6]. The global effectiveness of the SAFE strategy was further supported by strong evidence from China, where trachoma prevalence that ranged from 50% to 90% before the 1980s, dropped to less than 10% following the rollout of the SAFE strategy in the mid-1980s [7]. Given the further evidence of SAFE effectiveness, in 1996 the WHO, governments and partners, through a global alliance, set a goal to achieve Global Elimination of Trachoma as a public health problem by 2020 (GET 2020).

Tanzania ratified the GET2020, whose goal was to achieve the elimination of trachoma as a public health problem threshold, which was to achieve the decline in prevalence of trachoma to less than 5.0% and Trichiasis <0.1% [8]. Thus, in order to achieve the elimination of trachoma as a public health problem threshold, high emphasis was placed on mass distribution of Azithromycin (MDA) as part of the SAFE trachoma control strategy adopted [8]. Towards the end of 2020, WHO alerted that despite the GET 2020 with SAFE strategy, 44 countries that embarked on the rollout of the SAFE strategy only Morocco, Ghana, and Togo were certified by the WHO to have attained the trachoma elimination threshold as a public health problem by 2020 [2]. Usually, after attaining the respective elimination threshold prevalence, countries embarked on close surveillance to detect recrudescence of the infection and take appropriate action to control chlamydial re-infection [9]. However, by 2020, other countries in Africa were yet to achieve the elimination of trachoma as a public health problem threshold; testimony included the estimation that 138 million people still lived in trachoma endemic communities and 8.2 million required surgery, while 1.3 million were visually impaired [2,10]. Although such countries did not receive the WHO elimination certification, they had achieved success in some clusters while others recorded failure. For example, the trachoma elimination threshold was achieved in some parts of Nigeria, while other parts did not due to implementation challenges of the SAFE strategy, highlighting the need for improved health system measures to support the attainment of the elimination threshold goal [11]. Other challenges to attaining the elimination threshold of Trachoma included difficulty locating and finding trachomatous trichiasis cases in remote villages, insecurity and funding shortfalls in the face of declining funders; and, in some cases, health system failures [2].

Additionally, a recent literature review suggested that enhancing multi-sectoral collaboration would lead to canvassing for more participation and resources, facilitating successful implementation of SAFE [12]. It was further concluded that to improve SAFE implementation, there was a need to address the existing dearth of information through more research on the organizational, health systems, community, and implementation process-related factors to identify strategies that will enable achieving the Trachoma elimination threshold. Similarly, Tanzania experienced SAFE implementation challenges despite successful piloting of mass administration of azithromycin (MDA) in 1999 in a few districts and subsequent rollout to all 71 trachoma endemic districts in the country[13,14]. Fortunately, towards the end of 2018, 60 districts had reached the elimination of trachoma as a public health problem threshold, which is a prevalence <5.0% and also a criterion for stopping MDA in those districts. Unfortunately, eleven districts did not achieve the elimination threshold and thus had to continue with MDA, which failed despite additional concerted efforts[15,16]. The persistent districts included Kiteto, Simanjiro, Monduli, Longido and Ngorongoro, which could then benefit from innovative novel strategies focused on solving the SAFE implementation challenges [17]. Hence, there is a need for an in-depth understanding of the SAFE implementation challenges to enable the creation of novel strategies to facilitate meeting the goal of eliminating trachoma as a public health problem in Tanzania as outlined in the current roadmap for 2021-2030 [18]. This is further supported by recent observations that, in order to achieve GET2020 within the 2030 timeframe, it will require a strong focus and in-depth knowledge in addressing the needs and rights of marginalized populations in low-income countries [19]. Consequently, this study will adopt a design thinking approach to develop innovative solutions that will be desirable, feasible, and viable among the communities in the trachoma persistent areas, contributing towards the efforts to achieve the elimination of trachoma as a public health problem threshold in Tanzania.

Problem statement: Tanzania ratified the WHO Alliance for GET2020, followed by the implementation of the SAFE strategy among the 71 trachoma-endemic districts since 2006 [20]. However, an impact survey in 2018 showed that only 63 out of the 71 endemic districts had attained the trachoma elimination threshold, a prevalence of TF < 5%, while trachoma remained persistent by 2020 [15]. Thus, despite regular implementation of SAFE strategy interventions, including MDA, trachoma remained persistent in five clusters, namely, Kiteto, Simanjiro, Monduli, Longido, and Ngorongoro [21]. The situation did not improve despite additional implementation efforts; hence, the need for design thinking (DT) to facilitate human-centered innovation to address the SAFE implementation challenges [22-24]. Thus, the DT approach uses in-depth studies to gain a deeper understanding of the determinants and other contexts of the implementation challenges [24,25]. Design thinking will enable developing and testing novel strategies to address the SAFE implementation challenges and achieve elimination of trachoma as a public health problem by 2030 [26]. This protocol outlines a research approach employing DT to address trachoma persistence, funded by the Bill and Melinda Gates Foundation under grant agreement investment reference ID INV-046340. The project will be jointly implemented by Kairuki KU; the Neglected Tropical Diseases Program (NTDs) under the Ministry of Health in Dodoma, Tanzania; and other partners.

Justifications for the study: the Tanzania Ministry of Health is seeking solutions to the SAFE implementation challenges in those trachoma-persistent districts to facilitate achieving the goal of eliminating trachoma as a public health problem by 2030. Trachoma-persistent districts are where infectious trachoma prevalence remains above 5%, and most are home to vulnerable and marginalized communities, especially nomadic populations. Thus, to address these challenges, the study will employ DK, which is a human-centered approach to identify an innovative novel strategy that will facilitate implementation of the SAFE strategy for trachoma among this nomadic population and hence achieve the trachoma control goal by 2030. DK is thus human-centered, iterative, and flexible compared to the traditional approach methods, which are linear approaches to problem-solving relying on a pre-established outcome, a structured process of analysis, and decision-making in order to deliver a viable solution and hence limited to incremental achievements [27]. Consequently, the study will revisit current implementation strategies, engaging communities, stakeholders, and related contexts to gain a deeper, empathic understanding of their needs and environments to design a novel strategy that will address the implementation challenges.

Study hypothesis: after more than 20 years of implementing the SAFE strategy in Tanzania, five districts (clusters) failed to achieve the goal of the elimination of trachoma as a public problem. It is hypothesized that employing a design thinking approach will enable designing a novel solution strategy that will address the SAFE implementation challenges in the trachoma-persistent districts.

Goal: the goal is to create a novel strategy that will contribute to solving the SAFE implementation challenges in the trachoma-persistent clusters, which is desirable, feasible, and viable among the SAFE target population in Tanzania. Specific objectives will be aligned to each of the phases of design thinking, namely empathy, definition, ideation, prototyping, and testing.

Literature review: recent estimates reveal that 125 million people remained at risk of trachoma-related blindness, while 1.9 million were blind or visually impaired due to the disease [28]. That notwithstanding, these figures reflect substantial gains from the various global and national efforts to achieve trachoma elimination as a public health problem compared to 1995, when 48 countries were affected by trachoma and 6 million were blind [5,29]. Additionally, despite the remaining burden, it reflects GET2020 achievements, which included a 90% decline in populations requiring intense SAFE interventions and an 80% reduction in cases of trachomatous trichiasis. Consequently, to address the remaining trachoma burden, the elimination timeframe was reset to 2030 when solutions for the SAFE implementation challenges in trachoma-persistent clusters would have been successfully created and practiced. Strategies proposed to enable achieving the 2021-2030 goal to eliminate trachoma as a public health problem, among others, included fighting poverty and enhancing socioeconomic status of the people, improved sanitation, and special efforts targeting the vulnerable and hard-to-reach populations. It was also advised to facilitate an in-depth understanding of the SAFE implementation challenges to facilitate actions that will enhance access to the SAFE strategy among the target population [5,25]. Consequently, this study will employ the DT approach, which is human-centered, to develop innovative solutions that align with community experiences, desire and needs to enhance achieving the new 2021-2030 elimination of Trachoma as a public health problem [30]. The approach is also supported by the SDG framework, which calls for increased research, extending partnerships, increased service coverage, and addressing the needs and rights of the marginalized to reduce trachoma transmission [19,31].

Thus, existing discussions support the need to create novel solutions to address the complex SAFE implementation challenges in such broader contexts. Consequently, employing a design thinking approach will enable creating novel interventions focusing on the needs, hard-to-reach areas, and those vulnerable, including children and women who carry the highest burden of trachoma [32,33]. This further strengthens the observation that deploying novel solutions would address the SAFE implementation challenges in order to achieve the 201-2030 trachoma control roadmap. The novel solution has to consider the mixed nature of SAFE intervention components and assume an efficient strategy that will facilitate optimal positive interaction effects of the SAFE components, thus expediting progress toward the goal of eliminating trachoma as a public health problem by 2030. The novel innovation could also be complemented by current multisectoral efforts to increase access to water and enhance environmental hygiene [7,34,35]. Eventually, the final assessment to decide that a solution is innovative and novel will be when it perfectly meets the criteria of desirability, viability, and feasibility or the sweet spot among the SAFE solution testing community [26,27]. Ultimately, the successful novel strategy will be systematically rolled out among the clusters experiencing persistent trachoma while being closely monitored. In addition, monitoring of the novel strategy rollout will be guided by the WHO's SAFE ultimate intervention goals (UIG) for each SAFE component [36]. That notwithstanding, this study will use design thinking methodology to identify a novel innovation that will be human-centered to address the SAFE implementation challenges, thus contributing to the elimination of trachoma as a public health problem in Tanzania.

Methods     

Methodology

Study setting and population: this will be an 18-month prospective study beginning January 2023 that will employ a design thinking approach to be conducted in a sample of two villages experiencing trachoma persistence despite regular implementation of SAFE interventions since 1996. These study villages are located in a trachoma-endemic district within the Manyara region and were selected by the National Trachoma Control Program in the Neglected Tropical Disease (NTD) program in the Ministry of Health, Tanzania. The study population will be all communities in the two selected villages, who are also collectively referred to as the SAFE target population. Additionally, the study population will also include NTD program staff at all levels, Council health management teams, health facility leaders, and community leaders. The research team will be composed of experts from diverse fields, including ethnographers, social scientists, public health specialists, and epidemiologists.

Design thinking approach: design thinking has gained recognition across multiple disciplines as an innovative method for solving complex implementation challenges, which is also supported by recent systematic literature reviews [37,38]. Our study will employ a design thinking approach, which is prospective, iterative, and open-minded; it will allow our research team to get a deep understanding of the SAFE strategy implementation challenges from the perspectives of the community, question their assumptions, redefine problems, and develop human-centered, innovative, novel SAFE implementation solutions. The design thinking process is in five successive phases: empathy, define, ideation, prototype, and testing. The methodology will proceed iteratively through the five phases, each successive phase building on the preceding phase. This iterative process will ensure that the final innovative novel intervention is not only innovative but also closely aligned with the community's needs and contributes to solving the SAFE implementation challenges to enable achieving trachoma control. The product will be declared successful as being novel and innovative using the sweet spot concept, referring to the zone or point at which desirability, feasibility, and viability are optimally aligned. Hence, a proposed solution would be successful if it achieves the alignment, reflecting that SAFE communities simultaneously accept that it is desirable, feasible, and viable within their community. Thus, the sweet spot concept will enable judging the novelty of the agreed novel innovative SAFE implementation strategy at the final stage of the design thinking process, which would start with empathy phases followed by define to the final testing phase as follows.

Phase 1: empathy: this phase will employ a focused ethnography approach to gain an empathic understanding of the SAFE target population in relation to SAFE implementation challenges [39]. It will be an opportunity to understand how they think, how they do things, and why they do so in relation to trachoma infection and implementation of SAFE implementation. It will also enable understanding of their emotional and physical needs, feelings, desires, and contexts concerning the trachoma SAFE interventions and their implementation. This phase will employ multiple data collection methods, namely: observation, ethnographic engagements, key informant interviews, and focus group discussions, which will be processed in empathy mapping.

Empathy mapping: empathy mapping will be created from the empathy data, consisting of four quadrants visually reflecting the four characteristics of the empathy data, namely, what the SAFE community said, did, thought, and felt in relation to trachoma and SAFE implementation. Consequently, the data will be sorted into what the SAFE community said, what they did, what they thought, and what they felt and will be written in each relevant quadrant in the visual empathy map. Empathy mapping will facilitate researchers getting a deeper understanding of the thoughts, pain points, and experiences with the implementation challenges and gain useful insights about the needs of the SAFE target communities regarding the implementation of SAFE strategies. Consequently, the information will enable the team to devise possible solutions that are human-centered with a high likelihood of effectively addressing the SAFE implementation challenges.

Phase 2: define: the define phase involves a workshop of researchers and stakeholders, including program staff and community representatives, who will analyze the observations from the empathy mapping and synthesize them to define the core problems. Problem definition will focus on identification of SAFE target populations' needs, pain points, and motivations. Then, in consensus, the workshop will identify priority problems and frame them as human-centered, priority actionable SAFE implementation problem statements, which will be submitted to the ideation phase.

Phase 3: ideation: the ideation phase workshop will succeed the definition workshop; it will also process the priority actionable problem statements presented from the definition phase. The ideation workshop will employ the "how might we" methodology to break priority SAFE implementation actionable problem statements down into actionable statements, framed as an opportunity rather than an obstacle. Ideation techniques that will be employed will include analogy, brainstorming, and reverse thinking. Then, using the how might we methodology, the brainstorming team will produce a variety of ideas on what the possible solutions are to the SAFE implementation challenges. The possible solutions to the SAFE implementation challenges will be prioritized, and the best will be passed to the prototype phase.

Phase 4: prototyping: research team jointly will process the priority actionable problem statements from the ideation phase to identify the best possible solution for each of the problems identified during the first three phases. Further brainstorming will focus on identifying possible strategies that could solve the SAFE implementation challenges, of which the best will be tested as prototypes. Selected prototypes will be practically shared with some stakeholders, and few community members will be followed to gather their experiences while observing their behaviors towards the prototype. The feedback from the participants will enable refining and improvements of the best-performing strategy as a possible solution, which will proceed to the testing phase.

Phase 5: testing: this phase will involve systematically introducing and implementing the solution to the SAFE target community to test whether it is the right solution capable of successfully addressing the SAFE implementation challenges. Consequently, the research team will closely follow and assess the community members, trachoma program staff, community leaders, health staff, and other opinion leaders to obtain regular data on how the community interacts with the novel innovation. The regular assessment data collection will use FGDs and key informant interviews. In-depth interviews with the SAFE target population, leaders, and document reviews. Data will be synthesized in a workshop setting to get their feedback on the fidelity and the extent its, desirability, feasibility, and viability are aligned among the SAFE target community. Thus, from the perspectives of the SAFE target community and stakeholders, a workshop successful solution that appeals to the needs, emotions, and behaviors of the SAFE target population; thus, it is feasible and desirable. It is also technically viable and self-sustaining; then it will be submitted for further rollout with regular monitoring and refinement. However, if during testing, the solution does not meet the sweet point requirements of viability, feasibility, and desirability, the process will restart at the prototype phase, focusing on the next actionable problem statement or solution ideas in the prototype priority list. In the extreme situation, our research team will go back and repeat the define phase or even empathy as needed until a desirable and acceptable version is obtained.

Ethical considerations: the study will not involve any intrusive procedures, for example, blood collection or collection of laboratory specimens; hence, no pain or injury will be inflicted on the study population. The study will use empathy methods to generate multi-dimensional data but with very low possibility of accessing or infringing on the privacy of individuals and/or families. Data collectors will be trained and re-trained regularly to make sure they observe and respect the privacy of the study subjects. The primary data will be kept strictly confidential and delinked from the data sources. Since the information will be used in each subsequent phase of the study, the data will be analyzed and synthesized before submission to the next phase in the process.This protocol was submitted to the KU Institutional Research Ethics Committee (IREC), and research ethical clearance was granted with reference No. HKMU/IREC/27.10/190 of 2023. A copy of the clearance will be presented to the regional and district authorities in which the study sites are located. The authorities will also be requested to give the team permission to undertake the study in those sites and also provide letters of introduction to study site leaders, including the health and governance officials. Participants will be requested to give written, signed consent using a standard format for obtaining consent.

Discussion     

Lessons that will emerge from this study will strengthen the justification of employing a design thinking approach to solve the SAFE implementation challenges experienced in Tanzania, which is also supported by its success elsewhere [40]. Thus, it will provide solutions that will contribute to the elimination of trachoma as a public health problem by 2030, thus meeting the newly established elimination timeframe [8,25]. It will also provide lessons on strategies to address existing inequity in access to care and well-being, especially among women, children, and vulnerable communities. Thus, the proposal will further highlight the significance of the design thinking approach, which is human-centered and focused on empathetic understanding to enable innovation of novel solutions to the SAFE implementation challenges [41]. This is indeed also the first time in Tanzania that the design thinking approach is being employed to contribute to the solution of SAFE implementation challenges; it will also justify its application to solve other complex health problems. In addition, the results will raise awareness among researchers, policy makers as well as other practitioners and managers in Tanzania on the roles and utility of design thinking to manage and address complex problems. By engaging with the populations to identify challenges and co-designing solutions, such an approach will eventually make valid knowledge and skills, contributing to essential contents of training and practices in the field of implementation research. Furthermore, the innovative solution that successfully passes the test will be rolled out on a bigger scale within the district and region and could be adapted to solve other complex health problems.

Conclusion     

While the SAFE strategy has significantly reduced the global burden of trachoma, persistent challenges remain in certain regions, particularly in Manyara, Tanzania. The proposed design thinking approach increases the likelihood of a novel solution that will enhance the universal elimination of trachoma as a public health problem. The outcomes will also contribute additional information to support the benefits of design thinking in various sectors in Tanzania and to justify its use elsewhere. It will ultimately contribute valuable knowledge and practical insights to the field of implementation research. This initiative will not only enhance understanding but also provide critical lessons on effectively applying design thinking in the Tanzanian context. These lessons will focus on how design thinking can be tailored and implemented in similar or different settings to achieve reliable and valid results, especially to address complex implementation challenges.

Competing interests     

The authors declare no competing interests.

Authors' contributions     

Innocent Semali the principal investigator and developed the original concept of the study, and together with Adellah Sariah, Yohana Mashalla, George Kabona and Columba Mbekenga developed this full proposal. Also, together with Adellah Sariah, George Kabona, Yohana Mashalla, Columba Mbekenga and Deodatus Kakok, Innocent Semali designed the study and wrote the study protocol. Deodatus Kakok, George Kabona, Moshi Ntabaye, Adellah Sariah, and Alex Mwijage, conceptualized the fieldwork and, together with Godwin Ndosi and Anitha Kemi made significant contributions to the study protocol. Innocent Semali was also responsible for the conception of all methodological-related study components. Columba Mbekenga, Yohana Mashalla, Moshi Ntabaye, George Kabona and Deodatus Kakok coordinated the field management. Adellah Sariah, Godwin Ndosi, Alex Mwijage, Mhiche Ambakisye and Anitha Kemi contributed to study design and tools development. At the same time, Adellah Sariah, Godwin Ndosi, Columba Mbekenga, Deodatus Kakok, together with Innocent Semali, significantly contributed to logistic management, data handling, and the analysis plan. All authors have read and agreed to the final version of this manuscript.

Acknowledgments     

We would like to sincerely acknowledge and express our gratitude to the Bill & Melinda Gates Foundation for agreeing to fund this protocol.

References