Mental health is just an Addendum: Assessing stakeholder's perceptions on COVID-19 and mental health services provision in Malawi.

INTRODUCTION: The World Health Organization declared COVID-19 as a pandemic in March 2020. COVID-19 has since caused a significant increase in mental health problems at national and global levels. This study assessed the views of key mental health stakeholders regarding the state of mental health service provision in Malawi and the pandemic's impact on the sector. METHODS: The study utilised a qualitative approach through key informant interviews (KIIs) conducted using a semi-structured interview guide. The interviews were audio recorded in English language and were manually transcribed for thematic analysis by generating codes re-classified into themes, sub-themes and quotes. RESULTS: The results are categorised into five themes. Firstly, the availability of mental health services. All experts confirmed the lack of availability of the mental health services especially at the lower levels of care. Currently, only 0.3% of facilities offer mental health services in Malawi. Moreover, although mental health services are part of the essential health care package and, therefore, are supposed to be provided for free in public facilities at all levels, the services are centralised and only functional at a tertiary level of care in public facilities. Secondly, funding sources for mental health in public and private facilities. We learnt that public facilities depend on donor sources and there is lack of prioritisation in budget allocation for mental health services. Whereas private facilities, their major source of funding is user fees. Thirdly, government's response in the provision of mental health services during COVID-19. Almost all experts echoed that government took a proactive approach to address the mental health needs of its population during the pandemic. There was increased collaboration between the government and the private sector to provide psychosocial and counselling services to health workers working directly with COVID-19 patients in isolation centres. Furthermore, to increase awareness of the general population on where to seek counselling services. Lastly, challenges in the provision of mental health services were highlighted and how the pandemic acerbated the challenges including shortage in human resources for health and inadequate funding. CONCLUSION: This study underscores the urgency of addressing mental health challenges in Malawi. Policymakers must prioritize the decentralization of mental health services, explore funding opportunities, and build on the successful collaboration with the private sector. These measures will not only enhance the accessibility and quality of mental health services but also ensure that mental well-being is a central component of public health efforts in Malawi.

Primary health care challenges: insights from older people with multimorbidity in Malawi - a qualitative study.

BACKGROUND: The global population is undergoing a significant surge in aging leading to increased susceptibility to various forms of progressive illnesses. This phenomenon significantly impacts both individual health and healthcare systems. Low and Middle Income Countries face particular challenges, as their Primary Health Care (PHC) settings often lack the necessary human and material resources to effectively address the escalating healthcare demands of the older people. This study set out to explore the experiences of older people living with progressive multimorbidity in accessing PHC services in Malawi. METHODS: Between July 2022 and January 2023, a total of sixty in-depth interviews were conducted with dyads of individuals aged ≥ 50 years and their caregivers, and twelve healthcare workers in three public hospitals across Malawi's three administrative regions. The study employed a stratified selection of sites, ensuring representation from rural, peri-urban, and urban settings, allowing for a comprehensive comparison of diverse perspectives. Guided by the Andersen-Newman theoretical framework, the study assessed the barriers, facilitators, and need factors influencing PHC service access and utilization by the older people. RESULTS: Three themes, consistent across all sites emerged, encompassing barriers, facilitators, and need factors respectively. The themes include: (1) clinic environment: inconvenient clinic setup, reliable PHC services and research on diabetic foods; (2) geographical factors: available means of transportation, bad road conditions, lack of comprehensive PHC services at local health facility and need for community approaches; and (3) social and personal factors: encompassing use of alternative medicine, perceived health care benefit and support with startup capital for small-scale businesses. CONCLUSION: This research highlights the impact of various factors on older people's access to and use of PHC services. A comprehensive understanding of the barriers, facilitators, and specific needs of older people is essential for developing tailored services that effectively address their unique challenges and preferences. The study underscores the necessity of community-based approaches to improve PHC access for this demographic. Engaging multiple stakeholders is important to tackle the diverse challenges, enhance PHC services at all levels, and facilitate access for older people living with progressive multimorbidity.

Comprehensive assessment of pediatric acute and inpatient care at a tertiary referral hospital in Malawi: opportunities for quality improvement.

BACKGROUND: Despite the reduction in global under-5 mortality over the last decade, childhood deaths remain high. To combat this, there has been a shift in focus from disease-specific interventions to use of healthcare data for resource allocation, evaluation of performance and impact, and accountability. This is a descriptive analysis of data derived from a prospective cohort study describing paediatric admissions to a tertiary referral hospital in Malawi for the purpose of process evaluation and quality improvement. METHODS: Using a REDCap database, we collected data for patients admitted acutely to Kamuzu Central Hospital, a tertiary referral centre in the central region. Data were collected from 17 123 paediatric inpatients from 2017 to 2020. RESULTS: Approximately 6% of patients presented with either two or more danger signs or severely abnormal vital signs. Infants less than 6 months, who had the highest mortality rate, were also the most critically ill on arrival to the hospital. Sepsis was diagnosed in about 20% of children across all age groups. Protocols for the management of high-volume, lower-acuity conditions such as uncomplicated malaria and pneumonia were generally well adhered to, but there was a low rate of completion for labs, radiology studies and subspecialty consultations required to provide care for high acuity or complex conditions. The overall mortality rate was 4%, and 60% of deaths occurred within the first 48 hours of admission. CONCLUSION: Our data highlight the need to improve the quality of care provided at this tertiary-level centre by focusing on the initial stabilisation of high-acuity patients and augmenting resources to provide comprehensive care. This may include capacity building through the training of specialists, implementation of clinical processes, provision of specialised equipment and increasing access to and reliability of ancillary services. Data collection, analysis and routine use in policy and decision-making must be a pillar on which improvement is built.

Primary health care preparedness to integrate diabetes care in Blantyre, Malawi: A mixed methods study.

BACKGROUND: There is limited access to diabetes care services at primary care facilities in Malawi. Assessing the capacity of facilities to provide diabetes care is an initial step to integrating services at primary care. AIM: To assess the preparedness for delivering diabetes services at primary care level within the Blantyre District Health Office (DHO) to support the response to NCD epidemic in Malawi. SETTING: Blantyre DHO primary care facilities. MATERIALS AND METHODS: A mixed methods approach nested in a national needs assessment for NCD response in Malawi was used. Fourteen primary healthcare facilities from Blantyre DHO were assessed. A tool adapted from the WHO rapid assessment questionnaire was used to identify human resource, equipment, supplies, and medication needed for comprehensive diabetes care. Descriptive statistics were done to analyze the quantitative data. Fisher's exact test was used to assess if there was a statistically significant difference between urban and rural facilities. Seventeen health care workers from the selected facilities participated in key informant interviews. Framework analysis method guided the qualitative data analysis. The quantitative and qualitative data were merged and displayed jointly. RESULTS: The quantitative assessment showed that none of the facilities assessed had capacity to provide all the interventions recommended by WHO for diabetes care at primary level. Eight (57%) of the facilities had the capacity to diagnose diabetes, monitor glucose, prevent limb amputations and manage hypoglycemia and hyperglycemia. Four themes emerged from the qualitative data: differences in level of preparedness and implementation of diabetes care; disparities in resources between urban and rural facilities; low utilization of diabetes services; and strategy and policy recommendations for improvement of diabetes care. CONCLUSION: Inadequate health financing resulted in significant disparities in the available resources between the rural and urban facilities to offer diabetes care services. There is need to develop national policies and guidelines for diabetes care to strengthen the capacity of primary care facilities to facilitate achievement of universal health coverage.

Modeling time to death for under-five children in Malawi using 2015/16 Demographic and Health Survey: a survival analysis.

BACKGROUND: Malawi has one of the highest under-five mortality rates in Sub Sahara Africa. Understanding the factors that contribute to child mortality in Malawi is crucial for the development and implementation of effective interventions to reduce child mortality. The aim of this study is to use survival analysis in modeling time to death for under-five children in Malawi. In turn, identify potential risk factors for child mortality and inform the development of interventions to reduce child mortality in the country. METHOD: This study used data from all births that occurred in the five years leading up to the 2015/16 Malawi Demographic and Health Survey. The Frailty hazard model was applied to predict infant survival in Malawi. In this analysis, the outcome of interest was death and it had two possible outcomes: "dead" or "alive". Age at death was regarded as the survival time variable. Infants who were still alive at the time of the study as of the day of the interview were considered as censored observations in the analysis. RESULTS: A total of 17,286 live births born during the 5 years preceding the survey were analysed. The study found that the risk of death was higher among children born to mothers aged 30-39 and 40 or older compared to teen mothers. Infants whose mothers attended fewer than four antenatal care visits were also found to be at a higher risk of death. On the other hand, the study found that using mosquito nets and early breastfeeding were associated with a lower risk of death, as were being male and coming from a wealthier household. CONCLUSION: The study reveals a notable decline in infant mortality rates as under-five children age, underscoring the challenge of ensuring newborn survival. Factors such as maternal age, birth order, socioeconomic status, mosquito net usage, early breastfeeding initiation, geographic location, and child's sex are key predictors of under-five mortality. To address this, public health strategies should prioritize interventions targeting these predictors to reduce under-five mortality rates.

Pilot Trial Results of Mlambe: An Economic and Relationship-Strengthening Intervention to Address Heavy Drinking and Adherence to Antiretroviral Therapy in Malawi.

We evaluated the feasibility, acceptability, and preliminary efficacy of an economic and relationship-strengthening intervention to reduce heavy alcohol use among couples living with HIV in Malawi (Mlambe). Mlambe consisted of training on financial literacy and relationship skills, combined with 1:1 matched savings accounts to invest in an income-generating activity. In a randomized controlled trial, we compared Mlambe to enhanced usual care (EUC). We enrolled 78 married couples having a partner on antiretroviral therapy (ART) who reported heavy alcohol use based on the AUDIT-C. Using targets of 75%, primary outcomes included retention rates at 10 and 15-months, session attendance rates, and satisfaction with Mlambe. Exploratory outcomes were heavy alcohol use (AUDIT-C and/or PEth positive), number of drinking days in the past month, AUDIT-C score, optimal adherence to ART (95% or higher), and viral suppression. We exceeded our targets for feasibility and acceptability metrics. Retention rates were 96% at 15-months. Session attendance and satisfaction levels were both 100%. From baseline to 15-months, Mlambe participants reported decreases in mean number of drinking days (from 6.8 to 2.1) and AUDIT-C scores (from 7.5 to 3.1); while ART adherence rates improved across the same period (from 63.2 to 73.9%). Participants in Mlambe, as compared to those in EUC, had lower rates of heavy alcohol use (89.5% vs. 97.2%) and higher rates of viral suppression (100% vs. 91.9%) at 10-months. Differences between arms were not statistically significant in this small pilot study. Mlambe was highly feasible and acceptable, and shows promise for reducing heavy alcohol use and viral non-suppression among couples with HIV in a larger efficacy study.

Intimate partner violence and excess fertility among women of reproductive age in Malawi.

PURPOSE: Gender inequity and adverse health outcomes continue to be of concern among women in sub-Saharan Africa. We determined prevalence of intimate partner violence and excess fertility (having more children than desired) in reproductive age women in Malawi. We also explored factors associated with these outcomes and with spousal fertility intentions. PATIENTS AND METHODS: In a cross-sectional study, a total of 360 women and 410 men were recruited using multi-stage sampling from communities in a peri-urban setting in Blantyre District, Southern Malawi in 2021. Women and men were separately interviewed by trained study workers using a structured questionnaire. In addition to descriptive analyses, we used univariate and multivariate logistic regression models to assess associations of risk factors with the outcomes of intimate partner violence and excess fertility. RESULTS: Among women, lifetime prevalence of intimate partner violence was 23.1%, and excess fertility was experienced by 25.6%. Intimate partner violence was associated with male partners alcohol consumption (adjusted odds ratio 2.13; P = 0.019). Women were more likely to report excess fertility if they were older (adjusted odds ratio 2.0, P<0.001, for a 5-year increase). Alcohol consumption by the male partner (adjusted odds ratio 2.14; P = 0.025) and women being able to refuse sex with their male partner (adjusted odds ratio 0.50; P = 0.036) were associated with discordant fertility preferences. CONCLUSIONS: Intimate partner violence, excess fertility, and social and health inequities continue to be prevalent in Malawi. These data suggest the underlying proximal and distal factors associated with these adverse outcomes such as alcohol consumption may be addressed through education, couple interactive communication, and community dialogue. To ensure sustainability and effectiveness, strong leadership involvement, both governmental and non-governmental, is needed.

Access to quality care after injury in Northern Malawi: results of a household survey.

BACKGROUND: Most injury care research in low-income contexts such as Malawi is facility centric. Community-derived data is needed to better understand actual injury incidence, health system utilisation and barriers to seeking care following injury. METHODS: We administered a household survey to 2200 households in Karonga, Malawi. The primary outcome was injury incidence, with non-fatal injuries classified as major or minor (> 30 or 1-29 disability days respectively). Those seeking medical treatment were asked about time delays to seeking, reaching and receiving care at a facility, where they sought care, and whether they attended a second facility. We performed analysis for associations between injury severity and whether the patient sought care, stayed overnight in a facility, attended a second facility, or received care within 1 or 2 h. The reason for those not seeking care was asked. RESULTS: Most households (82.7%) completed the survey, with 29.2% reporting an injury. Overall, 611 non-fatal and four fatal injuries were reported from 531 households: an incidence of 6900 per 100,000. Major injuries accounted for 26.6%. Three quarters, 76.1% (465/611), sought medical attention. Almost all, 96.3% (448/465), seeking care attended a primary facility first. Only 29.7% (138/465), attended a second place of care. Only 32.0% (142/444), received care within one hour. A further 19.1% (85/444) received care within 2 h. Major injury was associated with being more likely to have; sought care (94.4% vs 69.8% p < 0.001), stayed overnight at a facility (22.9% vs 15.4% P = 0.047), attended a second place of care (50.3% vs 19.9%, P < 0.001). For those not seeking care the most important reason was the injury not being serious enough for 52.1% (74/142), followed by transport difficulties 13.4% (19/142) and financial costs 5.6% (8/142). CONCLUSION: Injuries in Northern Malawi are substantial. Community-derived details are necessary to fully understand injury burden and barriers to seeking and reaching care.

Perceptions of the COVID-19 Vaccine and Other Adult Vaccinations in Malawi: A Qualitative Assessment.

In Malawi, various brands of the COVID-19 vaccine have been offered to the population, but factors including fear of side effects or other risks, uncertainty about benefits, and misinformation created hesitancy toward them. In early 2022, 4% of Malawians were fully vaccinated for COVID-19. Despite multiple promotion efforts, by August 2022, COVID-19 vaccination nationwide was around 15%. To increase COVID-19 vaccination uptake, the research team collected qualitative data in 4 districts with vaccine coverage levels ranging from 1% to 11%. This data collection happened during a cholera outbreak that began in March 2022 and the vaccination efforts to address it. Study participants included male and female members of the general population, social workers, people with comorbidities, health workers, and community leaders (224 participants total, 47% female). In focus group discussions (n=27) and in-depth interviews (n=17), participants compared COVID-19 vaccines with other adult vaccines, such as cholera and tetanus toxoid. A thematic analysis identified themes related to 3 research questions on COVID-19 vaccine concerns, confidence, and delivery affecting uptake. Differences in promotion, delivery (oral versus injection), COVID-19 vaccine card structure, the various brands and boosters, and vaccines being described as required or optional all played a role in distinguishing COVID-19 vaccines from other vaccines and creating suspicion or indifference. Barriers to vaccination in general, such as rumors or knowledge gaps, were amplified by how novel the COVID-19 vaccines were perceived to be and the changing guidance provided over time. By April 2023, more targeted campaign efforts helped increase vaccination rates to 28%. The findings contribute information about how individuals conceptualize and make decisions about adult vaccination, which can, in turn, inform strategies to integrate COVID-19 promotion and delivery with other disease responses in Malawi as well as routine health services in similar settings.

Facility HIV Self-Testing in Outpatient Departments: An Assessment of Characteristics and Concerns of Outpatients Who Opt Out of Testing in Malawi.

BACKGROUND: Facility HIV self-testing (HIVST) in outpatient departments can dramatically increase testing among adult outpatients. However, it is still unclear why populations opt out of facility HIVST and reasons for opt outing. Using data from a parent facility HIVST trial, we sought to understand individual characteristics associated with opting out of facility HIVST and reported reasons for not testing. METHODS: Exit surveys were conducted with outpatients aged ≥15 years at 5 facilities in Central and Southern Malawi randomized to the facility HIVST arm of the parent trial. Outpatients were eligible for our substudy if they were offered HIVST and eligible for HIV testing (ie, never previously tested HIV positive and tested ≥12 months ago or never tested). Summary statistics and multivariate regression models were used. RESULTS: Seven hundred seventy-one outpatients were included in the substudy. Two hundred sixty-three (34%) opted out of HIVST. Urban residency (adjusted risk ratios [aRR] 3.48; 95% CI: 1.56 to 7.76) and self-reported poor health (aRR 1.86; 95% CI: 1.27 to 2.72) were associated with an increased risk of opting out. Male participants had a 69% higher risk of opting out (aRR 1.69; 95% CI: 1.14 to 2.51), with risk being 38% lower among working male participants. Primary reasons for not testing were feeling unprepared to test (49·4%) and perceived low risk of HIV infection (30·4%)-only 2.6% believed that HIVST instructions were unclear, and 1.7% were concerned about privacy. CONCLUSION: Working, risky sexual behavior, rural residence, and good self-rated health were positively associated with opting out of HIVST among outpatients. Strategies to address internalized barriers, such as preparedness to test and perceived need to test, should be incorporated into facility HIVST interventions.

Modeling Pathways to Describe How Maternal Health Care Providers' Mental Health Influences the Provision of Respectful Maternity Care in Malawi.

INTRODUCTION: Maternal health (MH) providers may experience traumatic events, such as maternal or fetal death, that can contribute to stress and burnout. Past trauma, poor working relationships, and under-resourced environments not only affect providers' own emotional well-being but also reduce their ability to provide respectful maternity care (RMC). METHODS: Data were collected in mid-2021 as a cross-sectional survey with 302 MH providers working in 25 maternities in 3 districts in Malawi to measure burnout, depression, and post-traumatic stress disorder (PTSD). We present a pathway model describing how these factors interact and influence RMC. We used the provider-reported person-centered maternity care scale to measure RMC; the Maslach Burnout Inventory, which examines emotional exhaustion, depersonalization, and professional accomplishment; and standard validated screening tools to measure the prevalence of depression and PTSD. RESULTS: Although levels of burnout varied, 30% of MH providers reported high levels of exhaustion, feelings of cynicism manifesting as depersonalization toward their clients (17%), and low levels of professional accomplishment (42%). Moderate to severe depression (9%) and suicidal ideation within the past 2 weeks (10%) were also recorded. Many (70%) reported experiencing an event that could trigger PTSD, and 12% reported at least 4 of 5 symptoms in the PTSD scale. Path analysis suggests that depression and emotional exhaustion negatively influence RMC, and depersonalization is mediated through depression. PTSD has no direct effect on RMC, but increased PTSD scores were associated with increased burnout and depression scores. Positive relationships with facility managers were significantly associated with increased RMC and decreased emotional exhaustion and depersonalization. CONCLUSION: Burnout will continue to be a challenge among MH providers. However, pragmatic approaches for improving teamwork, psychosocial, and managerial support for MH providers working in challenging environments may help mitigate burnout, improve MH provider well-being, and, in turn, RMC for women seeking MH services.

A facility-based assessment of maternal mortality among all deaths in reproductive-aged women in Mzimba South District, Malawi.

Accurate reporting of maternal mortality is essential for effective health policy planning and achieving maternal death reduction in Sustainable Development Goals Target 3 (SDGs). This study aimed to identify gaps between facility-based maternal death reviews and the hospital Health Management Information System (HMIS) reports in Mzimba South District, Malawi from July 2013 to June 2018. A retrospective hospital-based medical record review was conducted to identify maternal deaths among women aged 15 to 49 years with all death causes. Out of 447 mortality records identified from the hospital wards, 89 maternal mortality cases were identified by the study review compared to 83 cases in the HMIS report. The HMIS report showed an underreporting rate of 6.7% (6/89) and a misclassification rate of 13.5% (12/89) within five years. These findings highlight the need for establishing mechanisms for the verification and monitoring of maternal mortality data reporting in health facilities. Improving the quality of maternal death reporting could help inform evidence-based interventions and policies that address the root causes of maternal mortality, and achieve SDGs in Malawi.

Low-cost molecular methods to characterise gastrointestinal nematode co-infections of goats in Africa.

BACKGROUND: Veterinary diagnostics aid intervention strategies, track zoonoses, and direct selective breeding programs in livestock. In ruminants, gastrointestinal nematode (GIN) parasites are a major cause of production losses, but morphologically similar species limit our understanding of how specific GIN co-infections impact health in resource-limited settings. To estimate the presence and relative abundance of GINs and other helminths at the species level, we sought to develop a low-cost and low-resource molecular toolkit applied to goats from rural Malawi smallholdings. METHODS: Goats were subjected to health scoring and faecal sampling on smallholdings in Lilongwe district, Malawi. Infection intensities were estimated by faecal nematode egg counts with a faecal subsample desiccated for DNA analysis. Two DNA extraction methods were tested (low-resource magbead kit vs high-resource spin-column kit), with resulting DNA screened by endpoint polymerase chain reaction (PCR), semi-quantitative PCR, quantitative PCR (qPCR), high-resolution melt curve analysis (HRMC), and 'nemabiome' internal transcribed spacer 2 (ITS-2) amplicon sequencing. RESULTS: Both DNA isolation methods yielded comparable results despite poorer DNA purity and faecal contaminant carryover from the low-resource magbead method. GINs were detected in 100% of samples regardless of infection intensity. Co-infections with GINs and coccidia (Eimeria spp.) were present in most goats, with GIN populations dominated by Haemonchus contortus, Trichostrongylus colubriformis, Trichostrongylus axei, and Oesophagostomum columbianum. Both multiplex PCR and qPCR were highly predictive of GIN species proportions obtained using nemabiome amplicon sequencing; however, HRMC was less reliable than PCR in predicting the presence of particular species. CONCLUSIONS: These data represent the first 'nemabiome' sequencing of GINs from naturally infected smallholder goats in Africa and show the variable nature of GIN co-infections between individual animals. A similar level of granularity was detected by semi-quantitative PCR methods, which provided an accurate summary of species composition. Assessing GIN co-infections is therefore possible using cost-efficient low-resource DNA extraction and PCR approaches that can increase the capacity of molecular resources in areas where sequencing platforms are not available; and also open the door to affordable molecular GIN diagnostics. Given the diverse nature of infections in livestock and wildlife, these approaches have potential for disease surveillance in other areas.

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.

The Cost of Providing Comprehensive HIV Services to Key Populations: An Analysis of the LINKAGES Program in Kenya and Malawi.

INTRODUCTION: Timely data on HIV service costs are critical for estimating resource needs and allocating funding, but few data exist on the cost of HIV services for key populations (KPs) at higher risk of HIV infection in low- and middle-income countries. We aimed to estimate the total and per contact annual cost of providing comprehensive HIV services to KPs to inform planning and budgeting decisions. METHODS: We collected cost data from the Linkages across the Continuum of HIV Services for Key Populations Affected by HIV (LINKAGES) program in Kenya and Malawi serving female and male sex workers, men who have sex with men, and transgender women. Data were collected prospectively for fiscal year (FY) 2019 and retrospectively for start-up activities conducted in FY2015 and FY2016. Data to estimate economic costs from the provider's perspective were collected from LINKAGES headquarters, country offices, implementing partners (IPs), and drop-in centers (DICs). We used top-down and bottom-up cost estimation approaches. RESULTS: Total economic costs for FY2019 were US$6,175,960 in Kenya and US$4,261,207 in Malawi. The proportion of costs incurred in IPs and DICs was 66% in Kenya and 42% in Malawi. The costliest program areas were clinical services, management, peer outreach, and monitoring and data use. Mean cost per contact was US$127 in Kenya and US$279 in Malawi, with a mean cost per contact in DICs and IPs of US$63 in Kenya and US$104 in Malawi. CONCLUSION: Actions undertaken above the service level in headquarters and country offices along with those conducted below the service level in communities, comprised important proportions of KP HIV service costs. The costs of pre-service population mapping and size estimation activities were not negligible. Costing studies that focus on the service level alone are likely to underestimate the costs of delivering HIV services to KPs.

Estimating the cost of HIV services for key populations provided by the LINKAGES program in Kenya and Malawi.

BACKGROUND: Data remain scarce on the costs of HIV services for key populations (KPs). The objective of this study was to bridge this gap in the literature by estimating the unit costs of HIV services delivered to KPs in the LINKAGES program in Kenya and Malawi. We estimated the mean total unit costs of seven clinical services: post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), HIV testing services (HTS), antiretroviral therapy (ART), sexually transmitted infection (STI) services, sexual and reproductive health (SRH) services, and management of sexual violence (MSV). These costs take into account the costs of non-clinical services delivered alongside clinical services and the pre-service and above-service program management integral to the LINKAGES program. METHODS: Data were collected at all implementation levels of the LINKAGES program including 30 drop-in-centers (DICs) in Kenya and 15 in Malawi. This study was conducted from the provider's perspective. We estimated economic costs for FY 2019 and cost estimates include start-up costs. Start-up and capital costs were annualized using a discount rate of 3%. We used a combination of top-down and bottom-up costing approaches. Top-down methods were used to estimate the costs of headquarters, country offices, and implementing partners. Bottom-up micro-costing methods were used to measure the quantities and prices of inputs used to produce services in DICs. Volume-weighted mean unit costs were calculated for each clinical service. Costs are presented in 2019 United States dollars (US$). RESULTS: The mean total unit costs per service ranged from US$18 (95% CI: 16, 21) for STI services to US$635 (95% CI: 484, 785) for PrEP in Kenya and from US$41 (95% CI: 37, 44) for STI services to US$1,240 (95% CI 1156, 1324) for MSV in Malawi. Clinical costs accounted for between 21 and 59% of total mean unit costs in Kenya, and between 25 and 38% in Malawi. Indirect costs-including start-up activities, the costs of KP interventions implemented alongside clinical services, and program management and data monitoring-made up the remaining costs incurred. CONCLUSIONS: A better understanding of the cost of HIV services is highly relevant for budgeting and planning purposes and for optimizing HIV services. When considering all service delivery costs of a comprehensive HIV service package for KPs, costs of services can be significantly higher than when considering direct clinical service costs alone. These estimates can inform investment cases, strategic plans and other budgeting exercises.

Assessing suicidality during the SARS-CoV-2 pandemic: Lessons learned from adaptation and implementation of a telephone-based suicide risk assessment and response protocol in Malawi.

The SARS-CoV-2 pandemic led to the rapid transition of many research studies from in-person to telephone follow-up globally. For mental health research in low-income settings, tele-follow-up raises unique safety concerns due to the potential of identifying suicide risk in participants who cannot be immediately referred to in-person care. We developed and iteratively adapted a telephone-delivered protocol designed to follow a positive suicide risk assessment (SRA) screening. We describe the development and implementation of this SRA protocol during follow-up of a cohort of adults with depression in Malawi enrolled in the Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP) randomized control trial during the COVID-19 era. We assess protocol feasibility and performance, describe challenges and lessons learned during protocol development, and discuss how this protocol may function as a model for use in other settings. Transition from in-person to telephone SRAs was feasible and identified participants with suicidal ideation (SI). Follow-up protocol monitoring indicated a 100% resolution rate of SI in cases following the SRA during this period, indicating that this was an effective strategy for monitoring SI virtually. Over 2% of participants monitored by phone screened positive for SI in the first six months of protocol implementation. Most were passive risk (73%). There were no suicides or suicide attempts during the study period. Barriers to implementation included use of a contact person for participants without personal phones, intermittent network problems, and pre-paid phone plans delaying follow-up. Delays in follow-up due to challenges with reaching contact persons, intermittent network problems, and pre-paid phone plans should be considered in future adaptations. Future directions include validation studies for use of this protocol in its existing context. This protocol was successful at identifying suicide risk levels and providing research assistants and participants with structured follow-up and referral plans. The protocol can serve as a model for virtual SRA development and is currently being adapted for use in other contexts.

Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi.

Heavy alcohol use among people with HIV in sub-Saharan Africa is driven by household economics such as poverty and unemployment and has negative impacts on couple relationships. Multilevel interventions have the potential to reduce alcohol use and improve relationship outcomes by addressing the web of co-occurring economic, social, and dyadic factors. This objective of this study was to develop an economic and relationship-strengthening intervention for couples in Malawi, consisting of matched savings accounts with financial literacy training and a couples counseling component to build relationship skills. Informed by the ADAPT-ITT framework, we collected multiple rounds of focus group data with key stakeholders and couples to gain input on the concept, session content, and procedures, held team meetings with field staff and an international team of researchers to tailor the intervention to couples in Malawi, and refined the intervention manual and components. The results describe a rigorous adaptation process based on the eight steps of ADAPT-ITT, insights gained from formative data and modifications made, and a description of the final intervention to be evaluated in a pilot randomized clinical trial. The economic and relationship-strengthening intervention shows great promise of being feasible, acceptable, and efficacious for couples affected by HIV and heavy alcohol use in Malawi.

Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial.

BACKGROUND: HIV-associated cryptococcal meningitis is a leading cause of AIDS-related mortality. The AMBITION-cm trial showed that a regimen based on a single high dose of liposomal amphotericin B deoxycholate (AmBisome group) was non-inferior to the WHO-recommended treatment of seven daily doses of amphotericin B deoxycholate (control group) and was associated with fewer adverse events. We present a five-country cost-effectiveness analysis. METHODS: The AMBITION-cm trial enrolled patients with HIV-associated cryptococcal meningitis from eight hospitals in Botswana, Malawi, South Africa, Uganda, and Zimbabwe. Taking a health service perspective, we collected country-specific unit costs and individual resource-use data per participant over the 10-week trial period, calculating mean cost per participant by group, mean cost-difference between groups, and incremental cost-effectiveness ratio per life-year saved. Non-parametric bootstrapping and scenarios analyses were performed including hypothetical real-world resource use. The trial registration number is ISRCTN72509687, and the trial has been completed. FINDINGS: The AMBITION-cm trial enrolled 844 participants, and 814 were included in the intention-to-treat analysis (327 from Uganda, 225 from Malawi, 107 from South Africa, 84 from Botswana, and 71 from Zimbabwe) with 407 in each group, between Jan 31, 2018, and Feb 17, 2021. Using Malawi as a representative example, mean total costs per participant were US$1369 (95% CI 1314-1424) in the AmBisome group and $1237 (1181-1293) in the control group. The incremental cost-effectiveness ratio was $128 (59-257) per life-year saved. Excluding study protocol-driven cost, using a real-world toxicity monitoring schedule, the cost per life-year saved reduced to $80 (15-275). Changes in the duration of the hospital stay and antifungal medication cost showed the greatest effect in sensitivity analyses. Results were similar across countries, with the cost per life-year saved in the real-world scenario ranging from $71 in Botswana to $121 in Uganda. INTERPRETATION: The AmBisome regimen was cost-effective at a low incremental cost-effectiveness ratio. The regimen might be even less costly and potentially cost-saving in real-world implementation given the lower drug-related toxicity and the potential for shorter hospital stays. FUNDING: European Developing Countries Clinical Trials Partnership, Swedish International Development Cooperation Agency, Wellcome Trust and Medical Research Council, UKAID Joint Global Health Trials, and the National Institute for Health Research. TRANSLATIONS: For the Chichewa, Isixhosa, Luganda, Setswana and Shona translations of the abstract see Supplementary Materials section.

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.