Reducing the equity gap in under-5 mortality through an innovative community health program in Ethiopia: an implementation research study.

BACKGROUND: The Ethiopian government implemented a national community health program, the Health Extension Program (HEP), to provide community-based health services to address persisting access-related barriers to care using health extension workers (HEWs). We used implementation research to understand how Ethiopia leveraged the HEP to widely implement evidence-based interventions (EBIs) known to reduce under-5 mortality (U5M) and address health inequities. METHODS: This study was part of a six-country case study series using implementation research to understand how countries implemented EBIs between 2000-2015. Our mixed-methods research was informed by a hybrid implementation science framework using desk review of published and gray literature, analysis of existing data sources, and 11 key informant interviews. We used implementation of pneumococcal conjugate vaccine (PCV-10) and integrated community case management (iCCM) to illustrate Ethiopia's ability to rapidly integrate interventions into existing systems at a national level through leveraging the HEP and other implementation strategies and contextual factors which influenced implementation outcomes. RESULTS: Ethiopia implemented numerous EBIs known to address leading causes of U5M, leveraging the HEP as a platform for delivery to successfully introduce and scale new EBIs nationally. By 2014/15, estimated coverage of three doses of PCV-10 was at 76%, with high acceptability (nearly 100%) of vaccines in the community. Between 2000 and 2015, we found evidence of improved care-seeking; coverage of oral rehydration solution for treatment of diarrhea, a service included in iCCM, doubled over this period. HEWs made health services more accessible to rural and pastoralist communities, which account for over 80% of the population, with previously low access, a contextual factor that had been a barrier to high coverage of interventions. CONCLUSIONS: Leveraging the HEP as a platform for service delivery allowed Ethiopia to successfully introduce and scale existing and new EBIs nationally, improving feasibility and reach of introduction and scale-up of interventions. Additional efforts are required to reduce the equity gap in coverage of EBIs including PCV-10 and iCCM among pastoralist and rural communities. As other countries continue to work towards reducing U5M, Ethiopia's experience provides important lessons in effectively delivering key EBIs in the presence of challenging contextual factors.

Crohn's Disease Among the Poorest Billion: Burden of Crohn's Disease in Low- and Lower-Middle-Income Countries.

BACKGROUND: To establish the epidemiology and patterns of care of Crohn's Disease in low- and lower-middle-income countries. METHODS: A cross-sectional survey of gastroenterology providers in countries where the world's poorest billion live was conducted to learn more about the state of diagnostic and treatment capacity for Crohn's. Quantitative data were analyzed in R and Excel. RESULTS: A total of 46 survey responses from 15 countries were received, giving a response rate of 54.8%. All responses collected were from providers practicing in Africa and South Asia. The mean number of patients with Crohn's cared for in the last year was 89.5 overall but ranged from 0 reported at one facility in Rwanda to 1000 reported at two different facilities in India. Overall, Crohn's disease made up 20.6% of the inflammatory bowel disease diagnoses reported by survey respondents, with Africa exhibiting a larger proportion of Crohn's compared to ulcerative colitis than Asia. Most providers reported that patients with Crohn's have symptoms for 6-24 months prior to diagnosis and that 26-50% of their patients live in rural areas. The most reported diagnostic challenges are differentiating between Crohn's and intestinal tuberculosis, poor disease awareness, and lack of trained pathologists. The most widely reported challenge in managing Crohn's disease is patients' inability to afford biologics, reported by 65% of providers. CONCLUSION: Our study suggests there may be a greater burden of Crohn's disease in low- and lower-middle-income countries than is indicated in prior literature. Respondents reported many challenges in diagnosing and treating Crohn's disease.

Understanding integrated service delivery: a scoping review of models for noncommunicable disease and mental health interventions in low-and-middle income countries.

BACKGROUND: Noncommunicable diseases (NCDs) and mental health conditions represent a growing proportion of disease burden in low- and middle-income countries (LMICs). While past efforts have identified interventions to be delivered across health system levels to address this burden, the challenge remains of how to deliver heterogenous interventions in resource-constrained settings. One possible solution is the Integration of interventions within existing care delivery models. This study reviews and summarizes published literature on models of integrated NCD and mental health care in LMICs. METHODS: We searched Pubmed, African Index Medicus and reference lists to conduct a scoping review of studies describing an integrated model of NCD or neuropsychiatric conditions (NPs) implemented in a LMIC. Conditions of interest were grouped into common and severe NCDs and NPs. We identified domains of interest and types of service integration, conducting a narrative synthesis of study types. Studies were screened and characteristics were extracted for all relevant studies. Results are reported using PRISMA-ScR. RESULTS: Our search yielded 5004 studies, we included 219 models of integration from 188 studies. Most studies were conducted in middle-income countries, with the majority in sub-Saharan Africa. Health services were offered across all health system levels, with most models implemented at health centers. Common NCDs (including type 2 diabetes and hypertension) were most frequently addressed by these models, followed by common NPs (including depression and anxiety). Conditions and/or services were often integrated into existing primary healthcare, HIV, maternal and child health programs. Services provided for conditions of interest varied and frequency of these services differed across health system levels. Many models demonstrated decentralization of services to lower health system levels, and task shifting to lower cadre providers. CONCLUSIONS: While integrated service design is a promising method to achieve ambitious global goals, little is known about what works, when, and why. This review characterizing care integration programs is an initial step toward developing a structured study of care integration.

Living with type 1 diabetes in Neno, Malawi: a qualitative study of self-management and experiences in care.

BACKGROUND: The prevalence of type 1 diabetes (T1D) is increasing in low-income countries including Malawi. In this setting, care is frequently impacted by challenges in diagnosis and management. Access to high-quality T1D care remains limited in Malawi, with fairly low availability and high cost of insulin and other supplies and diagnostics, lack of T1D knowledge, and absence of readily accessible guidelines. In the Neno district, Partners In Health established advanced care clinics at district hospitals to provide comprehensive, free care for T1D and other noncommunicable diseases. Prior to this study, experiences in care for people living with T1D (PLWT1D) at these clinics remained unexplored. Here we examine the impact of living with T1D, knowledge and self-management of, and facilitators and barriers to T1D care in Neno District, Malawi. METHODS: We conducted a qualitative study utilizing behavior change theory that consisted of twenty-three semi-structured interviews conducted in Neno, Malawi in January 2021 with PLWT1D, their families, providers, and civil society members to explore the psychosocial and economic impact of living with T1D, T1D knowledge and self-management, and facilitators and barriers to accessing care. Interviews were analyzed thematically using a deductive approach. RESULTS: We found that PLWT1D had good knowledge and practice of self-management activities for T1D. Key facilitators to care identified by informants included extensive patient education and availability and provision of free insulin and supplies. Significant barriers included distance from health facilities, food insecurity, and low literacy/numeracy. Informants described T1D as having a notable psychosocial and economic impact on PWLT1D and their families, notably worrying about having a lifelong condition, high transportation costs, and reduced working ability. While home visits and transport refunds helped facilitate access to the clinic, informants reported the refunds as inadequate given high transport costs faced by patients. CONCLUSIONS: T1D was found to have a significant impact on PLWT1D and their families. Our findings represent important areas of consideration in design and implementation of effective programs for treating PLWT1D in resource-limited settings. Facilitators to care identified by informants may be applicable and beneficial in similar settings, while persisting barriers represent areas for continued improvement in Neno.

Implementing surgical mentorship in a resource-constrained context: a mixed methods assessment of the experiences of mentees, mentors, and leaders, and lessons learned.

BACKGROUND: A well-qualified workforce is critical to effective functioning of health systems and populations; however, skill gaps present a challenge in low-resource settings. While an emerging body of evidence suggests that mentorship can improve quality, access, and systems in African health settings by building the capacity of health providers, less is known about its implementation in surgery. We studied a novel surgical mentorship intervention as part of a safe surgery intervention (Safe Surgery 2020) in five rural Ethiopian facilities to understand factors affecting implementation of surgical mentorship in resource-constrained settings. METHODS: We designed a convergent mixed-methods study to understand the experiences of mentees, mentors, hospital leaders, and external stakeholders with the mentorship intervention. Quantitative data was collected through a survey (n = 25) and qualitative data through in-depth interviews (n = 26) in 2018 to gather information on (1) intervention characteristics including areas of mentorship, mentee-mentor relationships, and mentor characteristics, (2) organizational context including facilitators and barriers to implementation, (3) perceived impact, and (4) respondent characteristics. We analyzed the quantitative and qualitative data using frequency analysis and the constant comparison method, respectively; we integrated findings to identify themes. RESULTS: All mentees (100%) experienced the intervention as positive. Participants perceived impact as: safer and more frequent surgical procedures, collegial bonds between mentees and mentors, empowerment among mentees, and a culture of continuous learning. Over 70% of all mentees reported their confidence and job satisfaction increased. Supportive intervention characteristics included a systems focus, psychologically safe mentee-mentor relationships, and mentor characteristics including generosity with time and knowledge, understanding of local context, and interpersonal skills. Supportive organizational context included a receptive implementation climate. Intervention challenges included insufficient clinical training, inadequate mentor support, and inadequate dose. Organizational context challenges included resource constraints and a lack of common understanding of the intervention. CONCLUSION: We offer lessons for intervention designers, policy makers, and practitioners about optimizing surgical mentorship interventions in resource-constrained settings. We attribute the intervention's success to its holistic approach, a receptive climate, and effective mentee-mentor relationships. These qualities, along with policy support and adapting the intervention through user feedback are important for successful implementation.

Models of care for sickle cell disease in low-income and lower-middle-income countries: a scoping review.

Sickle cell disease has a growing global burden falling primarily on low-income countries (LICs) and lower-middle-income countries (LMICs) where comprehensive care is often insufficient, particularly in rural areas. Integrated care models might be beneficial for improving access to care in areas with human resource and infrastructure constraints. As part of the Centre for Integration Science's ongoing efforts to define, systematise, and implement integrated care delivery models for non-communicable diseases (NCDs), this Review explores models of care for sickle cell disease in LICs and LMICs. We identified 99 models from 136 studies, primarily done in tertiary, urban facilities in LMICs. Except for two models of integrated care for concurrent treatment of other conditions, sickle cell disease care was mostly provided in specialised clinics, which are low in number and accessibility. The scarcity of published evidence of models of care for sickle cell disease and integrated care in rural settings of LICs and LMICs shows a need to implement more integrated models to improve access, particularly in rural areas. PEN-Plus, a model of decentralised, integrated care for severe chronic non-communicable diseases, provides an approach to service integration that could fill gaps in access to comprehensive sickle cell disease care in LICs and LMICs.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study.

OBJECTIVES: The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi. DESIGN: We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach. SETTING: First-level hospitals in Neno district, Malawi. PARTICIPANTS: Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers. RESULTS: Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management. CONCLUSIONS: Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings. TRIAL REGISTRATION NUMBER: PACTR202102832069874; Post-results.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

OBJECTIVES: To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes. DESIGN: A 2:1 open randomised controlled feasibility trial. SETTING: Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi. PARTICIPANTS: 45 people living with type 1 diabetes (PLWT1D). INTERVENTIONS: Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education. OUTCOMES: Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life. RESULTS: Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention. CONCLUSIONS: This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Protocol for an evaluation of the initiation of an integrated longitudinal outpatient care model for severe chronic non-communicable diseases (PEN-Plus) at secondary care facilities (district hospitals) in 10 lower-income countries.

INTRODUCTION: The Package of Essential Noncommunicable Disease Interventions-Plus (PEN-Plus) is a strategy decentralising care for severe non-communicable diseases (NCDs) including type 1 diabetes, rheumatic heart disease and sickle cell disease, to increase access to care. In the PEN-Plus model, mid-level clinicians in intermediary facilities in low and lower middle income countries are trained to provide integrated care for conditions where services traditionally were only available at tertiary referral facilities. For the upcoming phase of activities, 18 first-level hospitals in 9 countries and 1 state in India were selected for PEN-Plus expansion and will treat a variety of severe NCDs. Over 3 years, the countries and state are expected to: (1) establish PEN-Plus clinics in one or two district hospitals, (2) support these clinics to mature into training sites in preparation for national or state-level scale-up, and (3) work with the national or state-level stakeholders to describe, measure and advocate for PEN-Plus to support development of a national operational plan for scale-up. METHODS AND ANALYSIS: Guided by Proctor outcomes for implementation research, we are conducting a mixed-method evaluation consisting of 10 components to understand outcomes in clinical implementation, training and policy development. Data will be collected through a mix of quantitative surveys, routine reporting, routine clinical data and qualitative interviews. ETHICS AND DISSEMINATION: This protocol has been considered exempt or covered by central and local institutional review boards. Findings will be disseminated throughout the project's course, including through quarterly M&E discussions, semiannual formative assessments, dashboard mapping of progress, quarterly newsletters, regular feedback loops with national stakeholders and publication in peer-reviewed journals.

Protocol for a feasibility randomised control trial for continuous glucose monitoring in patients with type 1 diabetes at first-level hospitals in rural Malawi.

INTRODUCTION: The majority of people living with type 1 diabetes (PLWT1D) struggle to access high-quality care in low-income countries (LICs), and lack access to technologies, including continuous glucose monitoring (CGM), that are considered standard of care in high resource settings. To our knowledge, there are no studies in the literature describing the feasibility or effectiveness of CGM at rural first-level hospitals in LICs. METHODS AND ANALYSIS: This is a 3-month, 2:1 open-randomised trial to assess the feasibility and clinical outcomes of introducing CGM to the entire population of 50 PLWT1D in two hospitals in rural Neno, Malawi. Participants in both arms will receive 2 days of training on diabetes management. One day of training will be the same for both arms, and one will be specific to the diabetes technology. Participants in the intervention arm will receive Dexcom G6 CGM devices with sensors and solar chargers, and patients in the control arm will receive Safe-Accu home glucose metres and logbooks. All patients will have their haemoglobin A1c (HbA1c) measured and take WHO Quality of Life assessments at study baseline and endline. We will conduct qualitative interviews with a selection of participants from both arms at the beginning and end of study and will interview providers at the end of the study. Our primary outcomes of interest are fidelity to protocols, appropriateness of technology, HbA1c and severe adverse events. ETHICS AND DISSEMINATION: This study is approved by National Health Sciences Research Committee of Malawi (IRB Number IR800003905) and the Mass General Brigham (IRB number 2019P003554). Findings will be disseminated to PLWT1D through health education sessions. We will disseminate any relevant findings to clinicians and leadership within our study catchment area and networks. We will publish our findings in an open-access peer-reviewed journal. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Experience of living with type 1 diabetes in a low-income country: a qualitative study from Liberia.

INTRODUCTION: While epidemiological data for type 1 diabetes (T1D) in low/middle-income countries, and particularly low-income countries (LICs) including Liberia is lacking, prevalence in LICs is thought to be increasing. T1D care in LICs is often impacted by challenges in diagnosis and management. These challenges, including misdiagnosis and access to insulin, can affect T1D outcomes and frequency of severe complications. Despite the severe nature of T1D and growing burden in sub-Saharan Africa, little is currently known about the impact of T1D on patients and caregivers in the region. METHODS: We conducted a qualitative study consisting of interviews with patients with T1D, caregivers, providers, civil society members and a policy-maker in Liberia to better understand the psychosocial and economic impact of living with T1D, knowledge of T1D and self-management, and barriers and facilitators for accessing T1D care. RESULTS: This study found T1D to have a major psychosocial and economic impact on patients and caregivers, who reported stigma, diabetes distress and food insecurity. Patients, caregivers and providers possessed the knowledge necessary to effectively manage T1D but insufficient community awareness leads to delayed diagnosis, often in an emergency department. Most patients reported receiving free services and materials, though the cost of transportation to clinic visits and recommended foods is a barrier to disease management. Many providers noted the lack of national T1D-specific guidelines and registries. Policy-makers reported a lack of prioritisation of and resources for T1D. These barriers, combined with scarcity and expense of appropriate foods, pose severe barriers for self-management of T1D. CONCLUSION: T1D was found to have a significant impact on patients and caregivers, and informants identified several key individual and systems-level barriers to effective T1D care in Liberia. Addressing these concerns is vital for designing sustainable and effective programmes for treating patients living with T1D.

Surgical data strengthening in Ethiopia: results of a Kirkpatrick framework evaluation of a data quality intervention.

Background: One key challenge in improving surgical care in resource-limited settings is the lack of high-quality and informative data. In Ethiopia, the Safe Surgery 2020 (SS2020) project developed surgical key performance indicators (KPIs) to evaluate surgical care within the country. New data collection methods were developed and piloted in 10 SS2020 intervention hospitals in the Amhara and Tigray regions of Ethiopia. Objective: To assess the feasibility of collecting and reporting new surgical indicators and measure the impact of a surgical Data Quality Intervention (DQI) in rural Ethiopian hospitals. Methods: An 8-week DQI was implemented to roll-out new data collection tools in SS2020 hospitals. The Kirkpatrick Method, a widely used mixed-method evaluation framework for training programs, was used to assess the impact of the DQI. Feedback surveys and focus groups at various timepoints evaluated the impact of the intervention on surgical data quality, the feasibility of a new data collection system, and the potential for national scale-up. Results: Results of the evaluation are largely positive and promising. DQI participants reported knowledge gain, behavior change, and improved surgical data quality, as well as greater teamwork, communication, leadership, and accountability among surgical staff. Barriers remained in collection of high-quality data, such as lack of adequate human resources and electronic data reporting infrastructure. Conclusions: Study results are largely positive and make evident that surgical data capture is feasible in low-resource settings and warrants more investment in global surgery efforts. This type of training and mentorship model can be successful in changing individual behavior and institutional culture regarding surgical data collection and reporting. Use of the Kirkpatrick Framework for evaluation of a surgical DQI is an innovative contribution to literature and can be easily adapted and expanded for use within global surgery.

Implementation Research: An Efficient and Effective Tool to Accelerate Universal Health Coverage.

Success in the implementation of evidence-based interventions (EBIs) in different settings has had variable success. Implementation research offers the approach needed to understand the variability of health outcomes from implementation strategies in different settings and why interventions were successful in some countries and failed in others. When mastered and embedded into a policy and implementation framework, the application of implementation research by countries can provide policy-makers and implementers with the knowledge necessary to work towards universal health coverage (UHC) with the effectiveness, efficiency, sustainability, and fidelity needed to achieve sustainable positive health outcomes for all. To achieve this goal however, work is needed by the communities of research producers and consumers to create more clarity on implementation research methodologies and to build capacity to apply them as a critical tool for countries on their path to achieving UHC.