Protocol: identifying policy, system, and environment change interventions to enhance availability of blood for transfusion in Kenya, a mixed-methods study.

BACKGROUND: Safe blood is essential for the care of patients with life-threatening anemia and hemorrhage. Low blood donation rates, inefficient testing procedures, and other supply chain disruptions in blood administration affect patients in low-resource settings across Sub-Saharan countries, including Kenya. Most efforts to improve access to transfusion have been unidimensional, usually focusing on only point along the blood system continuum, and have excluded community stakeholders from early stages of intervention development. Context-appropriate interventions to improve the availability of safe blood at the point of use in low-resource settings are of paramount importance. Thus, this protocol proposes a multifaceted approach to characterize the Kenyan blood supply chain through quantitative and qualitative analyses as well as an industrial engineering approach. METHODS: This study will use a mixed-methods approach in addition to engineering process mapping, modeling and simulation of blood availability in Kenya. It will be guided by a multidimensional three-by-three-by-three matrix: three socioeconomic settings, three components of the blood system continuum, and three levels of urgency of blood transfusion. Qualitative data collection includes one-on-one interviews and focus group discussions with stakeholders across the continuum to characterize ground-level deficits and potential policy, systems, and environment (PSE) interventions. Prospectively-collected quantitative data will be used to estimate blood collection and transfusion of blood. We will create a process map of the blood system continuum to model the response to PSE changes proposed by stakeholders. Lastly, we will identify those PSE changes that may have the greatest impact on blood transfusion availability, accounting for differences across socioeconomic settings and levels of urgency. DISCUSSION: Identifying and prioritizing community-driven interventions to improve blood supply in low-resource settings are of utmost importance. Varied constraints in blood collection, processing, delivery, and use make each socioeconomic setting unique. Using a multifaceted approach to understand the Kenyan blood supply and model the response to stakeholder-proposed PSE changes may lead to identification of contextually appropriate intervention targets to meet the transfusion needs of the population.

Feasibility, performance and acceptability of an innovative vital signs monitor for sick newborns in Western Kenya: A mixed-methods study.

Introduction: Low- and middle-income countries (LMICs) account for 99% of the global neonatal mortality. Limited access to advanced technology, such as bedside patient monitors contributes to disproportionately poor outcomes for critically ill newborns in LMICs. We designed a study to assess the feasibility, performance, and acceptability of a low-cost wireless wearable technology for continuous monitoring of sick newborns in resource-limited settings. Methods: This was a mixed-methods implementation study conducted between March and April 2021 at two health facilities in Western Kenya. Inclusion criteria for newborns monitored included: age 0 to 28 days, birthweight ≥2.0 kg, low-to-moderate severity of illness at admission and the guardian's willingness to provide informed consent. Medical staff who participated in monitoring the newborns were surveyed about their experience with the technology. We used descriptive statistics to summarize our quantitative findings and qualitative data was coded and analyzed as an iterative process to summarize quotes on user acceptability. Results: The results of the study demonstrated that adoption of neoGuard was feasible and acceptable in this setting. Medical staff described the technology as safe, user-friendly and efficient, after successfully monitoring 134 newborns. Despite the positive user experience, we did observe some notable technology performance issues such as a high percentage of missing vital signs data. Conclusion: The results of this study were critical in informing the iterative process of refining and validating an innovative vital signs monitor for patients in resource-limited settings. Further research and development are underway to optimize neoGuard's performance and to examine its clinical impact and cost effectiveness.

The BLOODSAFE program: Building the future of access to safe blood in Sub-Saharan Africa.

BACKGROUND: The supply of blood in many low- and middle-income nations in Sub-Saharan Africa (SSA) does not meet the patient care needs. Lack and delay of blood transfusion cause harm to patients and slow the rate of progress in other parts of the health system. Recognizing the power of implementation science, the BLOODSAFE Program was initiated which supports three SSA research study teams and one data coordinating center (DCC) with the goal to improve access to safe blood transfusion in SSA. STUDY DESIGN AND METHODS: The study team in Ghana is focusing on studying and decreasing iron deficiency in blood donors and evaluating social engagement of blood donors through different approaches. The study team in Kenya is building a "vein to vein" workflow model to elucidate and devise strategies to overcome barriers to blood donation and improve infrastructural components of blood product production and use. The Malawi team is studying the infectious disease ramifications of blood donation as well as blood donor retention strategies aimed at blood donors who commence their donation career in secondary schools. RESULTS AND DISCUSSION: Together the project teams and the DCC work as a consortium to support each other through a shared study protocol that will study donor motivations, outcomes, and adverse events across all three countries. The BLOODSAFE Program has the potential to lead to generalizable improvement approaches for increasing access to safe blood in SSA as well as mentoring and building the research capacity and careers of many investigators.

A Comprehensive Approach to Medical Oxygen Ecosystem Building: An Implementation Case Study in Kenya, Rwanda, and Ethiopia.

Medical oxygen is an essential treatment for life-threatening hypoxemic conditions and is commonly indicated for the clinical management of most leading causes of mortality in children aged younger than 5 years, obstetric complications at delivery, and surgical procedures. In resource-constrained settings, access to medical oxygen is unreliable due to cost, distance from production centers, undermaintained infrastructure, and a fragmented supply chain. To increase availability of medical oxygen in underserved communities, Assist International, the GE Foundation, Grand Challenges Canada, the Center for Public Health and Development (Kenya), Health Builders (Rwanda), and the National Ministries of Health and Regional Health Bureaus in Kenya, Rwanda, and Ethiopia partnered to implement a social enterprise model for the production and distribution of medical oxygen to hospitals at reduced cost. This model established pressure swing adsorption (PSA) plants at large referral hospitals and equipped them to serve as localized supply hubs to meet regional demand for medical oxygen while using revenues from cylinder distribution to subsidize ongoing costs. Since 2014, 4 PSA plants have successfully been established and sustained using a social enterprise model in Siaya, Kenya; Ruhengeri, Rwanda; and Amhara Region, Ethiopia. These plants have cumulatively delivered more than 209,708 cylinders of oxygen to a network of 183 health care facilities as of October 2022. In Ethiopia, this model costs an estimated US$7.34 per patient receiving medical oxygen over a 20-year time horizon. Altogether, this business model has enabled the sustainable provision of medical oxygen to communities with populations totaling more than 33 million people, including an estimated 5 million children aged younger than 5 years.

Assessing the global burden of hemorrhage: The global blood supply, deficits, and potential solutions.

There is a critical shortage of blood available for transfusion in many low- and middle-income countries. The consequences of this scarcity are dire, resulting in uncounted morbidity and mortality from trauma, obstetric hemorrhage, and pediatric anemias, among numerous other conditions. The process of collecting blood from a donor to administering it to a patient involves many facets from donor availability to blood processing to blood delivery. Each step faces particular challenges in low- and middle-income countries. Optimizing existing strategies and introducing new approaches will be imperative to ensure a safe and sufficient blood supply worldwide.

A feasibility study evaluating a reservoir storage system for continuous oxygen delivery for children with hypoxemia in Kenya.

BACKGROUND: Supplemental oxygen is an essential treatment for childhood pneumonia but is often unavailable in low-resource settings or unreliable due to frequent and long-lasting power outages. We present a novel medium pressure reservoir (MPR) which delivers continuous oxygen to pediatric patients through power outages. METHODS: An observational case series pilot study assessing the capacity, efficacy and user appraisal of a novel MPR device for use in low-resource pediatric wards. We designed and tested a MPR in a controlled preclinical setting, established feasibility of the device in two rural Kenyan hospitals, and sought user feedback and satisfaction using a standardized questionnaire. RESULTS: Preclinical data showed that the MPR was capable of bridging power outages and delivering a continuous flow of oxygen to a simulated patient. The MPR was then deployed for clinical testing in nine pediatric patients at Ahero and Suba Hospitals. Power was unavailable for 2% of the total time observed due to 11 power outages (median 4.6 min, IQR 3.6-13.0 min) that occurred during treatment with the MPR. Oxygen flowrates remained constant across all 11 power outages. Feedback on the MPR was uniformly positive; all respondents indicated that the MPR was easy to use and provided clinically significant help to their patients. CONCLUSION: We present a MPR oxygen delivery device that has the potential to mitigate power insecurity and improve the standard of care for hypoxemic pediatric patients in resource-limited settings.

Improving Hospital Oxygen Systems for COVID-19 in Low-Resource Settings: Lessons From the Field.

Oxygen therapy is an essential medicine and core component of effective hospital systems. However, many hospitals in low- and middle-income countries lack reliable oxygen access-a deficiency highlighted and exacerbated by the coronavirus disease (COVID-19) pandemic. Oxygen access can be challenged by equipment that is low quality and poorly maintained, lack of clinical and technical training and protocols, and deficiencies in local infrastructure and policy environment. We share learnings from 2 decades of oxygen systems work with hospitals in Africa and the Asia-Pacific regions, highlighting practical actions that hospitals can take to immediately expand oxygen access. These include strategies to: (1) improve pulse oximetry and oxygen use, (2) support biomedical engineers to optimize existing oxygen supplies, and (3) expand on existing oxygen systems with robust equipment and smart design. We make all our resources freely available for use and local adaptation.

Oxygen insecurity and mortality in resource-constrained healthcare facilities in rural Kenya.

INTRODUCTION: Pneumonia is the leading cause of death globally in children. Supplemental oxygen reduces mortality but is not available in many low-resource settings. Inadequate power supply to drive oxygen concentrators is a major contributor to this failure. The objectives of our study were to (a) assess the availability of therapeutic oxygen; (b) evaluate the reliability of the electrical supply; and (c) investigate the effects of suboptimal oxygen delivery on patient outcomes in selected healthcare facilities in rural Kenya. MATERIALS AND METHODS: A cross-sectional descriptive study on oxygen availability and descriptive case series of Kenyan children and youth hospitalized with hypoxemia. RESULTS: Two of 11 facilities had no oxygen equipment and nine facilities had at least one concentrator or cylinder. Facilities had a median of seven power interruptions per week (range: 2-147). The median duration of the power outage was 17 minutes and the longest was more than 6 days. The median proportion of time without power was out 7% (range: 1%-58%). Fifty-seven patients hospitalized with hypoxemia (median oxygen saturation 85% [interquartile range {IQR}: 82-87]) were included in our case series. Patients received supplemental oxygen for a median duration of 4.6 hours (IQR: 3.0-7.8). Eighteen patients (32%) faced an oxygen interruption of the median duration of 11 minutes (IQR: 9-20). A back-up cylinder was used in 5/18 (28%) cases. The case fatality rate was 11/57 (19%). CONCLUSION: Mortality due to hypoxemia remains unacceptably high in low-resource healthcare facilities and may be associated with oxygen insecurity, related to lack of equipment and/or reliable power.

Effective training-of-trainers model for the introduction of continuous positive airway pressure for neonatal and paediatric patients in Kenya.

Background: Continuous positive airway pressure (CPAP) is a relatively low-cost technology which can improve outcome in neonatal and paediatric patients with respiratory distress. Prior work in a lower middle-income country demonstrated degradation of CPAP skills and knowledge after the initial training. Aims: To determine if a training-of-trainers (ToT) curriculum can decrease gaps in skills and knowledge between first-generation (trained by a United States physician and nurse) and second-generation healthcare providers (trained by local trainers) in Kenya, and to describe the usage pattern, outcome and safety in patients who received CPAP following the trainings. Methods: The first day of training entailed didactic and simulation sessions. On the second day participants were taught how to train others to use CPAP. First- and second-generation healthcare providers were tested on their skills and knowledge. Unpaired t-tests were used to test for equivalence. Prospective data on CPAP usage was collected following the initial trainings. Results: 37 first-generation healthcare providers (16 nurses; 21 physicians, medical/clinical officers) were trained as trainers and 40 second-generation healthcare providers (19 nurses, 21 physicians, medical/clinical officers) trained by first-generation healthcare providers were available for skills and knowledge testing. There were no statistically significant differences between first- and second-generation healthcare providers' skills (90%, 95% CI 87-93 vs 89%, 95% CI 86-92) or knowledge scores (91%, 95% CI 88-93 vs 90%, 95% CI 88-93). A total of 1111 patients were placed on CPAP mostly by nurses (61%), prematurity/acute respiratory distress syndrome was the most common indication, nasal injury/bleeding (2%) was the most common reported adverse event, and the overall mortality rate was 24%. Conclusion: The ToT model was successful, nurses initiated CPAP most commonly, prematurity with acute respiratory distress syndrome was the most common indication, and adverse events were uncommon.

Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients.

BACKGROUND: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. OBJECTIVE: The aim of this study was to validate an alternative post-market surveillance model to complement existing models. METHODS: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients. RESULTS: Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities. CONCLUSION: The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.

The African Health Fund and Nairobi Women's Hospital--a successful model for improving access to capital for health businesses.

Nairobi Women's Hospital is a private for profit hospital that has been in operation since 2001. Its main target is reaching women and children with affordable high-quality services. Its initial growth plan was stranded by lack of capital. The Africa Health Fund managed by Aureos Capital took a stake in the hospital in December 2009 to provide the needed capital for expansion. The investment has seen the hospital expand rapidly from 57 beds to 226 beds in three campuses. The affiliated nursing school has also opened. Based on its recent successes, NWH is now currently looking at borrowing an additional US$10 million from IFC to expand in the East Africa region.

Millennium Global Village-Net: bringing together Millennium Villages throughout sub-Saharan Africa.

The Millennium Villages Project (MVP), based at The Earth Institute at Columbia University, is a bottom-up, community led approach to show how villages in developing countries can get out of the poverty trap that afflicts more than a billion people worldwide. With well-targeted, practical inputs can help the community invest in a path leading to self-sustaining development. There are 80 Millennium Villages clustered in 10 countries throughout sub-Saharan Africa. MVP is an important development process for empowering communities to invest in a package of integrated interventions aiming to increase food production, improve access to safe water, health care, education and infrastructure. The process benefits from synergies of the integrated approach and relies on community leadership as empowered by proven technological inputs. MVP is committed to a science-based approach to assess and monitor the progress of the communities towards clear objectives; the Millennium Development Goals (MDGs) and to do so with mechanisms that are scalable and sustainable. This approach offers much more than simply collecting and analyzing data since the mechanism used for recording progress would provide a bridge over the divide which separates the haves and the have-nots (by facilitating the sharing of solutions from one community to another bidirectionally). By so doing, it allows people to enhance their own futures in a sustainable manner. Solutions found in one community are transferable to similar communities in other MVP villages. To achieve this goal, the MVP requires an information and communication system which can provide both necessary infrastructure for monitoring and evaluation, and tools for communicating among the villages, cities and countries. This system is called the Millennium Global Village-Net (MGV-Net). It takes advantage of the latest in open source software (OpenMRS), databases (MySQL), interface terminology, a centralized concept dictionary, and uses appropriate technology locally for data entry.