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.

Prevalence and Associated Factors of Chronic Obstructive Pulmonary Disease Among Adults in Neno District, Malawi: A Cross-Sectional Analytical Study.

Introduction: Chronic obstructive pulmonary disease (COPD) continues to pose a global public health challenge. However, literature is scarce on the burden of COPD in Malawi. We assessed the prevalence and risk factors for COPD among adults in Neno, Malawi. Methodology: We conducted a population-based analytical cross-sectional study in Neno District between December 2021 and November 2022. Using a multi-stage sampling technique, we included 525 adults aged≥40 years. All participants underwent spirometry according to the American Thoracic Society (ATS) guidelines and were interviewed using the IMPALA questionnaire. For this study, we utilized the definition of COPD as a post-bronchodilator FEV1/FVC <0.70. We collected data using Kobo collect, exported to Microsoft Excel, and analysed using R software. We used descriptive statistics and logistic regression analysis; a p-value of <0.05 was considered statistically significant. Results: Out of 525 participants, 510 participants were included in the final analysis. Fifty-eight percent of the participants were females (n=296), and 62.2% (n=317) were between 40 and 49 years with a median (IQR) age of 46 (40-86). For patient characteristics, 15.1% (n=77) were current smokers, and 4.1% (n=21) had a history of pulmonary tuberculosis (PTB). Cough was the most commonly reported respiratory symptom (n=249, 48.8%). The prevalence of COPD was 10.0% (n=51) and higher (15.0%) among males compared to females (6.4%). Factors significantly associated with COPD were age 60 years and above (adjusted odds ratio [aOR] = 3.27, 95% CI: 1.48-7.34, p<0.004), ever smoked (aOR = 6.17, 95% CI:1.89-18.7, p<0.002), current smoker (aOR = 17.6, 95% CI: 8.47-38.4, p<0.001), and previous PTB (aOR = 4.42, 95% CI: 1.16-15.5, p<0.023). Conclusion: The cross-sectional prevalence of COPD in rural Malawi is high, especially among males. Factors significantly associated were older age (60 years and above), cigarette smoking, and previous PTB. Longitudinal studies are needed to better understand disease etiology and progression in this setting.

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.

Depressive disorder at the household level: prevalence and correlates of depressive symptoms among household members.

BACKGROUND: Globally, an estimated five percent of adults have major depressive disorder. However, little is known about the relationship between these individuals' depressive symptoms and their household members' mental health and well-being. OBJECTIVES: We aimed to investigate the prevalence and predictors of depressive symptoms among adult household members of patients living with major depressive disorder in Neno District, Malawi. METHODS: As part of a cluster randomized controlled trial providing depression care to adults with major depressive disorder, we conducted surveys with patients' household members (n = 236) and inquired about their overall health, depressive symptoms, disability, and social support. We calculated prevalence rates of depressive disorder and conducted multivariable linear regression and multivariable logistic regression analyses to assess correlates of depressive symptom severity and predictors of having depressive disorder (PHQ-9), respectively, among household members. RESULTS: We observed that roughly one in five household members (19%) screened positive for a depressive disorder (PHQ-9 > 9). More than half of household members endorsed six or more of the nine symptoms, with 68% reporting feeling 'down, depressed, or hopeless' in the prior two weeks. Elevated depression symptom severity was associated with greater disability (ß = 0.17, p < 0.001), less social support (ß = -0.04, p = 0.016), and lower self-reported overall health (ß = 0.54, p = 0.001). Having depressive disorder was also associated with greater disability (adjusted Odds Ratio [aOR] = 1.12, p = 0.001) and less social support (aOR = 0.97, p = 0.024). CONCLUSIONS: In the Malawian context, we find that depressive disorder and depression symptoms are shared attributes among household members. This has implications for both screening and treatment, and it suggests that mental health should be approached from the vantage point of the broader social ecology of the household and family unit. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04777006) - March 2, 2021.

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.

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.

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.

Prevalence and correlates of internalized stigma among adults with HIV and major depressive disorder in rural Malawi.

Internalized stigma is common among individuals with sexually transmitted infections such as HIV and among those with mental health conditions such as major depressive disorder (MDD). As part of a cluster randomized trial, we investigated the prevalence and correlates of internalized stigma among adults living with comorbid HIV and MDD in rural Malawi (n = 339). We found heightened stigma toward HIV and mental illness among those in the cohort: more than half of respondents (54%) endorsed negative perceptions associated with each health condition. Internalized HIV-related stigma was higher among those with no education (p = 0.04), younger adults (p = 0.03), and those with less social support (p = 0.001). Mental illness-related stigma was elevated among those with no source of income (p = 0.001), and it was also strongly associated with HIV-related stigma (p < 0.001). Our findings highlight potential avenues for reducing internalized stigma associated with high-prevalence health conditions in Malawi.Trial registration: ClinicalTrials.gov identifier: NCT04777006.

Training Mid-Level Providers to Treat Severe Non-Communicable Diseases in Neno, Malawi through PEN-Plus Strategies.

Background: Non-communicable diseases (NCDs) are a leading cause of worldwide morbidity and mortality, yet access to care in lower-income countries is limited. Rural communities, where poverty levels are high, feel the greatest burden. In Malawi, as elsewhere in the African region, it is particularly challenging for patients in rural districts to obtain care for locally endemic and severe NCDs such as type 1 diabetes, rheumatic heart disease, and sickle cell disease. The Package of Essential NCD Interventions - Plus (PEN-Plus) is a strategy to decentralize care for these severe conditions by enabling local clinicians at intermediate-care facilities to provide services otherwise available only through specialty clinics at central hospitals. Objectives: The primary objective of this study was to evaluate the impact of training mid-level providers to treat severe and chronic NCDs in newly established PEN-Plus clinics in Neno, Malawi. Methods: Our team developed a logic model to describe the anticipated impacts of the intervention on provider knowledge, patient recruitment, and care provision. We applied a retrospective review of routinely collected clinical and administrative data to assess changes along these hypothesized pathways. Findings: Didactic trainings improved provider test scores immediately following training (25-point improvement; p < 0.01), with demonstrated retention of knowledge after 6 months (21-point improvement, p < 0.01). Over 350 patients were enrolled in the first 18 months of program initiation. The PEN-Plus clinic led to significant improvement in the provision of medications and testing across a range of services. Conclusion: Mid-level providers can be successfully trained to treat severe NCDs with physician-guided education, mentorship, and supervision. The PEN-Plus clinic improved patient enrollment, the quality of clinical care and access to essential medications and laboratory supplies. These lessons learned can guide decentralization of NCD care to district hospitals in Malawi and expansion of PEN-Plus services in the African region.

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.

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.

Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi.

Problem Management Plus (PM+) is a low-intensity psychological intervention developed by the World Health Organization that can be delivered by nonspecialists to address common mental health conditions in people affected by adversity. Emerging evidence demonstrates the efficacy of PM+ across a range of settings. However, the published literature rarely documents the adaptation processes for psychological interventions to context or culture, including curriculum or implementation adaptations. Practical guidance for adapting PM+ to context while maintaining fidelity to core psychological elements is essential for mental health implementers to enable replication and scale. This paper describes the process of contextually adapting PM+ for implementation in Rwanda, Peru, Mexico and Malawi undertaken by the international nongovernmental organization Partners In Health. To our knowledge, this initiative is among the first to adapt PM+ for routine delivery across multiple public sector primary care and community settings in partnership with Ministries of Health. Lessons learned contribute to a broader understanding of effective processes for adapting low-intensity psychological interventions to real-world contexts.

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. METHODS: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. DISCUSSION: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.