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.

Decentralization and Integration of Advanced Cardiac Care for the World's Poorest Billion Through the PEN-Plus Strategy for Severe Chronic Non-Communicable Disease.

Rheumatic and congenital heart disease, cardiomyopathies, and hypertensive heart disease are major causes of suffering and death in low- and lower middle-income countries (LLMICs), where the world's poorest billion people reside. Advanced cardiac care in these counties is still predominantly provided by specialists at urban tertiary centers, and is largely inaccessible to the rural poor. This situation is due to critical shortages in diagnostics, medications, and trained healthcare workers. The Package of Essential NCD Interventions - Plus (PEN-Plus) is an integrated care model for severe chronic noncommunicable diseases (NCDs) that aims to decentralize services and increase access. PEN-Plus strategies are being initiated by a growing number of LLMICs. We describe how PEN-Plus addresses the need for advanced cardiac care and discuss how a global group of cardiac organizations are working through the PEN-Plus Cardiac expert group to promote a shared operational strategy for management of severe cardiac disease in high-poverty settings.

Experiences and practices of traditional healers on snakebite treatment and prevention in rural Malawi.

Snakebite envenoming remains a public health threat in many tropical countries including Malawi. Traditional healers (THs) have been consulted by victims of snakebites as primary caregivers for millennia. There are no studies in Malawi to understand this phenomenon, therefore, our study aimed to explore the experiences and practices of THs regarding snakebite treatment and prevention in rural Malawi. Between August and September 2022, we conducted semi-structured interviews with 16 THs who were purposefully selected from various locations across Neno District, Malawi. We analysed the interview data using Dedoose software, where we generated codes and grouped them into themes. Out of the 16 THs interviewed, 68.8% (n = 11) were male, and 43.8% were aged between 40 and 60 years. Our study identified five themes: THs' knowledge of snakes and treatment, the continuum of care they provide, payment procedures, snakebite prevention, and their relationship with health facilities. They claimed a good understanding of the snakes in their area, including the seasons with more snakebites, and were confident in their ability to provide treatment, however, this was not scientifically proven. They offered a comprehensive care package, including diagnosis, first aid, main treatment, and follow-up care to monitor the victim's condition and adjust treatment as needed. THs provide free treatment for snakebites or use a "pay later" model of service delivery. All THs claimed a "vaccine" for snakebites that could prevent bites or neutralize the venom. However, no formal relationship existed between THs and Health Care Workers (HCWs). We recommend collaboration between HCWs and THs, establishing clear referral pathways for snakebite victims and educating THs on identifying danger signs requiring prompt referral to healthcare facilities.

Decentralized Heart Failure Management in Neno, Malawi.

Background: Cardiovascular disease (CVD) is a major cause of death in Malawi. In rural districts, heart failure (HF) care is limited and provided by non-physicians. The causes and patient outcomes of HF in rural Africa are largely unknown. In our study, non-physician providers performed focused cardiac ultrasound (FOCUS) for HF diagnosis and longitudinal clinical follow-up in Neno, Malawi. Objectives: We described the clinical characteristics, HF categories, and outcomes of patients presenting with HF in chronic care clinics in Neno, Malawi. Methods: Between November 2018 and March 2021, non-physician providers performed FOCUS for diagnosis and longitudinal follow-up in an outpatient chronic disease clinic in rural Malawi. A retrospective chart review was performed for HF diagnostic categories, change in clinical status between enrollment and follow-up, and clinical outcomes. For study purposes, cardiologists reviewed all available ultrasound images. Results: There were 178 patients with HF, a median age of 67 years (IQR 44 - 75), and 103 (58%) women. During the study period, patients were enrolled for a mean of 11.5 months (IQR 5.1-16.5), after which 139 (78%) were alive and in care. The most common diagnostic categories by cardiac ultrasound were hypertensive heart disease (36%), cardiomyopathy (26%), and rheumatic, valvular or congenital heart disease (12.3%).At follow-up, the proportion of New York Heart Association (NYHA) class I patients increased from 24% to 50% (p < 0.001; 95% CI: 31.5 - 16.4), and symptoms of orthopnea, edema, fatigue, hypervolemia, and bibasilar crackles all decreased (p < 0.05). Conclusion: Hypertensive heart disease and cardiomyopathy are the predominant causes of HF in this elderly cohort in rural Malawi. Trained non-physician providers can successfully manage HF to improve symptoms and clinical outcomes in limited resource areas. Similar care models could improve healthcare access in other rural African settings.

COVID-19-Related Testing, Knowledge and Behaviors among Severe and Chronic Non-Communicable Disease Patients in Neno District, Malawi: A Prospective Cohort Study.

COVID-19-related knowledge and behaviors remain essential for controlling the spread of disease, especially among vulnerable patients with advanced, chronic diseases. We prospectively assessed changes over 11 months in COVID-19-related testing, knowledge, and behaviors among patients with non-communicable diseases in rural Malawi using four rounds of telephone interviews between November 2020 to October 2021. The most commonly reported COVID-19-related risks among patients included visiting health facilities (35-49%), attending mass gatherings (33-36%), and travelling outside the district (14-19%). Patients reporting having experienced COVID-like symptoms increased from 30% in December 2020 to 41% in October 2021. However, only 13% of patients had ever received a COVID-19 test by the end of the study period. Respondents answered 67-70% of the COVID-19 knowledge questions correctly, with no significant changes over time. Hand washing, wearing face masks and maintaining a safe distance were the most frequently reported strategies to prevent the spreading of COVID-19. Wearing face masks significantly improved over time (p < 0.001). Although the majority reported accurate knowledge about COVID-19 and enhanced adherence to infection prevention measures over time, patients commonly visited locations where they could be exposed to COVID-19. Government and other stakeholders should increase COVID-19 testing accessibility to primary and secondary facilities.

Non-communicable disease burden among inpatients at a rural district hospital in Malawi.

BACKGROUND: The burden of non-communicable diseases (NCDs) is high in Malawi. However, resources and training for NCD care remain scarce, especially in rural hospitals. Current care for NCDs in the developing world focuses on the WHO's traditional 4 × 4 set. However, we do not know the full burden of NCDs outside of that scope, like neurological disease, psychiatric illness, sickle cell disease, and trauma. The goal of this study was to understand the burden of NCDs among inpatients in a rural district hospital in Malawi. We broadened our definition of NCDs beyond the traditional 4 × 4 set of NCDs, and included neurological disease, psychiatric illness, sickle cell disease, and trauma. METHODS: We conducted a retrospective chart review of all inpatients who were admitted to the Neno District Hospital between January 2017 and October 2018. We broke patients down by age, date of admission, type, and number of NCD diagnoses, and HIV status, and constructed multivariate regression models for length of stay and in-hospital mortality. RESULTS: Of 2239 total visits, 27.5% were patients with NCDs. Patients with NCDs were older (37.6 vs 19.7 years, p < 0.001) and made up 40.2% of total hospital time. We also found two distinct populations of NCD patients. The first were patients 40 years and older with primary diagnoses of hypertension, heart failure, cancer, and stroke. The second were patients under 40 years old with primary diagnoses of mental health conditions, burns, epilepsy, and asthma. We also found significant trauma burden, accounting for 40% of all NCD visits. In multivariate analysis, carrying a medical NCD diagnosis was associated with longer length of stay (coefficient 5.2, p < 0.001) and a higher risk of in-hospital mortality (OR 1.9, p = 0.03). Burn patients also had significantly longer length of stay (coefficient 11.6, p < 0.001). CONCLUSIONS: There is a significant burden of NCDs in a rural hospital in Malawi, including those outside of the traditional 4 × 4 set. We also found high rates of NCDs in the younger population (under 40 years of age). Hospitals must be equipped with adequate resources and training to meet this burden of disease.

Economic evaluation of integrated services for non-communicable diseases and HIV: costs and client outcomes in rural Malawi.

OBJECTIVE: To evaluate the costs and client outcomes associated with integrating screening and treatment for non-communicable diseases (NCDs) into HIV services in a rural and remote part in southeastern Africa. DESIGN: Prospective cohort study. SETTING: Primary and secondary level health facilities in Neno District, Malawi. PARTICIPANTS: New adult enrollees in Integrated Chronic Care Clinics (IC3) between July 2016 and June 2017. MAIN OUTCOME MEASURES: We quantified the annualised total and per capita economic cost (US$2017) of integrated chronic care, using activity-based costing from a health system perspective. We also measured enrolment, retention and mortality over the same period. Furthermore, we measured clinical outcomes for HIV (viral load), hypertension (controlled blood pressure), diabetes (average blood glucose), asthma (asthma severity) and epilepsy (seizure frequency). RESULTS: The annualised total cost of providing integrated HIV and NCD care was $2 461 901 to provide care to 9471 enrollees, or $260 per capita. This compared with $2 138 907 for standalone HIV services received by 6541 individuals, or $327 per capita. Over the 12-month period, 1970 new clients were enrolled in IC3, with a retention rate of 80%. Among clients with HIV, 81% achieved an undetectable viral load within their first year of enrolment. Significant improvements were observed among clinical outcomes for clients enrolled with hypertension, asthma and epilepsy (p<0.05, in all instances), but not for diabetes (p>0.05). CONCLUSIONS: IC3 is one of the largest examples of fully integrated HIV and NCD care. Integrating screening and treatment for chronic health conditions into Malawi's HIV platform appears to be a financially feasible approach associated with several positive clinical outcomes.

Health care workers' knowledge on identification, management and treatment of snakebite cases in rural Malawi: A descriptive study.

Snakebite envenoming remains a public health threat in many African countries, including Malawi. However, there is a shortage of literature on the knowledge of Health Care Workers (HCWs) and the prevalence of snakebite cases in Malawi. We interviewed HCWs in Neno District to assess their knowledge of snake identification and management of snakebites. We further reviewed patient registers from 2018 to 2021 in all 15 health facilities in the district. We used descriptive statistics to characterize the survey population, knowledge, snake antivenom (SAV) administration, and snake identification. Using "shapefiles" from Open Street Maps, we mapped villages with snakebite cases. Of the 105 HCWs interviewed, 58% were males, and 60% had worked for less than five years. The majority (n = 93, 89%) reported that snakebite envenoming was a problem in the district. Among the clinicians, 42% said they had prescribed SAV previously, while among nurses, only 26% had ever administered SAV. There were discrepancies among clinicians regarding the dosing of snake antivenom. Significant gaps in knowledge also existed regarding snake identification. While two-thirds of HCWs could correctly name and identify venomous snake species, most (> 90%) failed for non-venomous snakes. Most (n = 100, 95%) reported that snakebite victims visit traditional healers more than the hospital. Between 2018 and 2021, the Neno District registered 185 snakebites with a yearly average of 36 cases per 100,000 population. Fifty-two percent (n = 97) were treated as an inpatient; of these cases, 72% were discharged in less than three days, and two died. More snakebite cases were recorded in the eastern part of the district. Significant knowledge gaps exist among HCWs in Neno regarding prescription and administration of SAV and snake identification, which likely challenges the quality of services offered to snakebite victims.

Attitudes toward COVID-19 Vaccines among Patients with Complex Non-Communicable Disease and Their Caregivers in Rural Malawi.

Current low COVID-19 vaccination rates in low- and middle-income countries reflect an inequitable global vaccine distribution; however, local attitudes towards the COVID-19 vaccine are an important factor to meet vaccination benchmarks. We describe attitudes toward the uptake of the COVID-19 vaccine and perceptions among patients with NCDs and their caregivers using cross-sectional data collected through telephone interviews in Neno, Malawi. Out of 126 survey respondents, 71% were patients, and 29% were caregivers. Twenty-two percent of respondents had received at least one dose at the interview (95% CI: 15-30%), with 19% being fully vaccinated. Only 24% (95% CI: 12-40%) of unvaccinated respondents reported that they would accept an approved vaccine if it were offered today. Vaccines were perceived as unsafe or designed to harm and commonly associated with death, severe disability, infertility, and evil. However, over two-thirds reported high levels of trust in health care workers (73%) and community health workers (72%) as sources of information for the COVID-19 vaccine. Although the uptake of COVID-19 vaccine in this vulnerable population was three times than the national average, a low intention to be vaccinated persists among the unvaccinated. Strong trust in health care workers suggests that community engagement could help increase vaccine acceptance.

Expanding access to non-communicable disease care in rural Malawi: outcomes from a retrospective cohort in an integrated NCD-HIV model.

OBJECTIVES: Non-communicable diseases (NCDs) account for one-third of disability-adjusted life years in Malawi, and access to care is exceptionally limited. Integrated services with HIV are widely recommended, but few examples exist globally. We report descriptive outcomes from an Integrated Chronic Care Clinic (IC3). DESIGN: This is a retrospective cohort study. SETTING: The study includes an HIV-NCD clinic across 14 primary care facilities in the rural district of Neno, Malawi. PARTICIPANTS: All new patients, including 6233 HIV-NCD diagnoses, enrolled between January 2015 and December 2017 were included. This included 3334 patients with HIV (59.7% women) and 2990 patients with NCD (67.3% women), 10% overall under age 15 years. INTERVENTIONS: Patients were seen at their nearest health centre, with a hospital team visiting routinely to reinforce staffing. Data were collected on paper forms and entered into an electronic medical record. PRIMARY AND SECONDARY OUTCOME MEASURES: Routine clinical measurements are reported at 1-year post-enrolment for patients with more than one visit. One-year retention is reported by diagnosis. RESULTS: NCD diagnoses were 1693 hypertension, 668 asthma, 486 epilepsy, 149 diabetes and 109 severe mental illness. By December 2018, 8.3% of patients with NCD over 15 years were also on HIV treatment. One-year retention was 85% for HIV and 72% for NCDs, with default in 8.4% and 25.5% and deaths in 4.0% and 1.4%, respectively. Clinical outcomes showed statistically significant improvement for hypertension, diabetes, asthma and epilepsy. Of the 1807 (80%) of patients with HIV with viral load results, 85% had undetectable viral load. CONCLUSIONS: The IC3 model, built on an HIV platform, facilitated rapid decentralisation and access to NCD services in rural Malawi. Clinical outcomes and retention in care are favourable, suggesting that integration of chronic disease care at the primary care level poses a way forward for the large dual burden of HIV and chronic NCDs.

Leveraging HIV platforms to work toward comprehensive primary care in rural Malawi: the Integrated Chronic Care Clinic.

This case study describes an integrated chronic care clinic that utilizes a robust HIV program as a platform for NCD screening and treatment. A unique model, the integrated chronic care clinic provides longitudinal care for patients with an array of chronic diseases including HIV and common NCDs, allowing for a single visit for all of a patient's conditions. Set in Malawi's remote Neno District, this clinic structure aims to (1) increase access to care for NCD patients, (2) maximize efficiency given the severe human resource shortages, and (3) replicate strong HIV outcomes for patients with other chronic conditions. The goal is to increase the number of health facilities in Neno capable of fully delivering Malawi's Essential Health Package, the set of cost-effective interventions endorsed by Malawi MOH to reduce burden of disease and leading causes of death. While implementation is ongoing and processes are evolving, this model of healthcare delivery has already improved the accessibility of NCD care by allowing patients to have all of their chronic conditions treated on the same day at their nearest health facility, notably without additional investment of human and financial resources. Currently, 6781 patients on antiretroviral therapy and 721 patients with NCDs are benefitting, including 379 with hypertension, 187 with asthma, 144 with epilepsy, and 76 with diabetes. Among the NCD patient population, 15.1% are HIV-positive. Success hinged largely on several factors, including clear leadership and staff ownership of their specific duties, and a well-defined and uniform patient flow process. Furthermore, deliberate and regular conversations about challenges allowed for constant iteration and improvement of processes. Moving forward, several tasks remain. We are refining the data management process to further consolidate medical records, along with integrating our tracking processes for clients who miss appointments. Additionally, we are exploring opportunities for further integration, including family planning. A follow-up patient satisfaction survey is planned for the coming months to track the impact of the clinic's redesign. Given limited human and financial resources, innovative solutions are required to address the growing burden of chronic disease in Malawi. We have found that an integrated, patient-centered approach maximizes efficiency and reduces barriers to care for the hardest to reach patients.

Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi.

INTRODUCTION: HIV-associated Kaposi sarcoma (HIV-KS) is the most common cancer in Malawi. In 2008, the non-governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV-KS in rural Neno district. We aimed to evaluate 12-month clinical outcomes and retention in care for HIV-KS patients in the NKSC, and to describe our implementation model, which featured protocol-guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers. METHODS: We conducted a retrospective cohort study using routine clinical data from 114 adult HIV-KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012. RESULTS: At enrolment 97% of patients (n/N=103/106) had advanced HIV-KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29-42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36-252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first-line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second-line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74-89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06-15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03-2.25) were associated with increased death or loss to follow-up at 12 months. CONCLUSIONS: The NKSC model resulted in infrequent adverse events, low loss to follow-up and excellent OS. Our results suggest it is safe, effective and feasible to provide standard-of-care chemotherapy regimens from the developed world, integrated with ART, to treat HIV-KS in rural Malawi. Baseline BMI and haemoglobin may represent important patient characteristics associated with HIV-KS survival in rural sub-Saharan Africa.