Barriers and enablers to improving integrated primary healthcare for non-communicable diseases and mental health conditions in Ethiopia: a mixed methods study.

BACKGROUND: The Ethiopian Primary Healthcare Clinical Guidelines (EPHCG) seek to improve quality of primary health care, while also expanding access to care for people with Non-Communicable Diseases and Mental Health Conditions (NCDs/MHCs). The aim of this study was to identify barriers and enablers to implementation of the EPHCG with a particular focus on NCDs/MHCs. METHODS: A mixed-methods convergent-parallel design was employed after EPHCG implementation in 18 health facilities in southern Ethiopia. Semi-structured interviews were conducted with 10 primary healthcare clinicians and one healthcare administrator. Organisational Readiness for Implementing Change (ORIC) questionnaire was self-completed by 124 health workers and analysed using Kruskal Wallis ranked test to investigate median score differences. Qualitative data were mapped to the Consolidated Framework for Implementation Science (CFIR) and the Theoretical Domains Framework (TDF). Expert Recommendations for Implementing Change (ERIC) were employed to select implementation strategies to address barriers. RESULTS: Four domains were identified: EPHCG training and implementation, awareness and meeting patient needs (demand side), resource constraints/barriers (supply side) and care pathway bottlenecks. The innovative facility-based training to implement EPHCG had a mixed response, especially in busy facilities where teams reported struggling to find protected time to meet. Key barriers to implementation of EPHCG were non-availability of resources (CFIR inner setting), such as laboratory reagents and medications that undermined efforts to follow guideline-based care, the way care was structured and lack of familiarity with providing care for people with NCDs-MHCs. Substantial barriers arose because of socio-economic problems that were interlinked with health but not addressable within the health system (CFIR outer setting). Other factors influencing effective implementation of EPHCG (TDF) included low population awareness about NCDs/MHCs and unaffordable diagnostic and treatment services (TDF). Implementation strategies were identified. ORIC findings indicated high scores of organisational readiness to implement the desired change with likely social desirability bias. CONCLUSION: Although perceived as necessary, practical implementation of EPHCG was constrained by challenges across domains of internal/external determinants. This was especially marked in relation to expansion of care responsibilities to include NCDs/MHCs. Attention to social determinants of health outcomes, community engagement and awareness-raising are needed to maximize population impact.

Challenges for research uptake for health policymaking and practice in low- and middle-income countries: a scoping review.

BACKGROUND: An estimated 85% of research resources are wasted worldwide, while there is growing demand for context-based evidence-informed health policymaking. In low- and middle-income countries (LMICs), research uptake for health policymaking and practice is even lower, while little is known about the barriers to the translation of health evidence to policy and local implementation. We aimed to compile the current evidence on barriers to uptake of research in health policy and practice in LMICs using scoping review. METHODS: The scoping review followed the Preferred Reporting Items for Systematic Review and Meta-Analyses-extension for Scoping Reviews (PRISMA-ScR) and the Arksey and O'Malley framework. Both published evidence and grey literature on research uptake were systematically searched from major databases (PubMed, Cochrane Library, CINAHL (EBSCO), Global Health (Ovid)) and direct Google Scholar. Literature exploring barriers to uptake of research evidence in health policy and practice in LMICs were included and their key findings were synthesized using thematic areas to address the review question. RESULTS: A total of 4291 publications were retrieved in the initial search, of which 142 were included meeting the eligibility criteria. Overall, research uptake for policymaking and practice in LMICs was very low. The challenges to research uptake were related to lack of understanding of the local contexts, low political priority, poor stakeholder engagement and partnership, resource and capacity constraints, low system response for accountability and lack of communication and dissemination platforms. CONCLUSION: Important barriers to research uptake, mainly limited contextual understanding and low participation of key stakeholders and ownership, have been identified. Understanding the local research and policy context and participatory evidence production and dissemination may promote research uptake for policy and practice. Institutions that bridge the chasm between knowledge formation, evidence synthesis and translation may play critical role in the translation process.

Mapping digital health ecosystems in Africa in the context of endemic infectious and non-communicable diseases.

Investments in digital health technologies such as artificial intelligence, wearable devices, and telemedicine may support Africa achieve United Nations (UN) Sustainable Development Goal for Health by 2030. We aimed to characterize and map digital health ecosystems of all 54 countries in Africa in the context of endemic infectious and non-communicable diseases (ID and NCD). We performed a cross-national ecological analysis of digital health ecosystems using 20-year data from the World Bank, UN Economic Commission for Africa, World Health Organization, and Joint UN Programme on HIV/AIDS. Spearman's rank correlation coefficients were used to characterize ecological correlations between exposure (technology characteristics) and outcome (IDs and NCDs incidence/mortality) variables. Weighted linear combination model was used as the decision rule, combining disease burden, technology access, and economy, to explain, rank, and map digital health ecosystems of a given country. The perspective of our analysis was to support government decision-making. The 20-year trend showed that technology characteristics have been steadily growing in Africa, including internet access, mobile cellular and fixed broadband subscriptions, high-technology manufacturing, GDP per capita, and adult literacy, while many countries have been overwhelmed by a double burden of IDs and NCDs. Inverse correlations exist between technology characteristics and ID burdens, such as fixed broadband subscription and incidence of tuberculosis and malaria, or GDP per capita and incidence of tuberculosis and malaria. Based on our models, countries that should prioritize digital health investments were South Africa, Nigeria, and Tanzania for HIV; Nigeria, South Africa, and Democratic Republic of the Congo (DROC) for tuberculosis; DROC, Nigeria, and Uganda for malaria; and Egypt, Nigeria, and Ethiopia for endemic NCDs including diabetes, cardiovascular disease, respiratory diseases, and malignancies. Countries such as Kenya, Ethiopia, Zambia, Zimbabwe, Angola, and Mozambique were also highly affected by endemic IDs. By mapping digital health ecosystems in Africa, this study provides strategic guidance about where governments should prioritize digital health technology investments that require preliminary analysis of country-specific contexts to bring about sustainable health and economic returns. Building digital infrastructure should be a key part of economic development programs in countries with high disease burdens to ensure more equitable health outcomes. Though infrastructure developments alongside digital health technologies are the responsibility of governments, global health initiatives can cultivate digital health interventions substantially by bridging knowledge and investment gaps, both through technology transfer for local production and negotiation of prices for large-scale deployment of the most impactful digital health technologies.

Effect of Digital Medication Event Reminder and Monitor-Observed Therapy vs Standard Directly Observed Therapy on Health-Related Quality of Life and Catastrophic Costs in Patients With Tuberculosis: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Little is known about whether digital adherence technologies are economical for patients with tuberculosis (TB) in resource-constrained settings. Objective: To test the hypothesis that for patients with TB, a digital medication event reminder monitor (MERM)-observed therapy provides higher health-related quality of life (HRQoL) and lower catastrophic costs compared with standard directly observed therapy (DOT). Design, Setting, and Participants: This study was a secondary analysis of a randomized, 2-arm, open-label trial conducted in 10 health care facilities in Ethiopia. Eligible participants were adults with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who were eligible to start first-line anti-TB therapy. Participants were enrolled between June 2, 2020, and June 15, 2021, with the last participant completing follow-up on August 15, 2021. Interventions: Participants were randomly assigned (1:1) to receive a 15-day TB medication supply dispensed with a MERM device to self-administer and return every 15 days (intervention arm) or the standard in-person DOT (control arm). Both groups were observed throughout the standard 2-month intensive treatment phase. Main Outcomes and Measures: Prespecified secondary end points of the original trial were HRQoL using the EuroQoL 5-dimension 5-level (EQ-5D-5L) tool and catastrophic costs, direct (out-of-pocket) and indirect (guardian and coping) costs from the individual patient perspective using the World Health Organization's Tool to Estimate Patient Costs, and common factors associated with lower HRQoL and higher catastrophic costs. Results: Among 337 patients screened for eligibility, 114 were randomly assigned, and 109 were included in the final complete-case intention-to-treat analysis (57 control and 52 intervention participants). The mean (SD) age was 33.1 (11.1) years; 72 participants (66.1%) were men, and 15 (13.9%) had HIV coinfection. EQ-5D-5L overall median (IQR) index value was 0.964 (0.907-1). The median (IQR) value was significantly higher in intervention (1 [0.974-1]) vs control (.908 [0.891-0.964]) (P < .001). EQ-5D-5L minimum and maximum health state utility values in intervention were 0.906 and 1 vs 0.832 and 1 in control. Patients' overall median (IQR) postdiagnosis cost was Ethiopian birr (ETB) 80 (ETB 16-ETB 480) (US $1.53). The median cost was significantly lower in intervention (ETB 24 [ETB 16-ETB 48]) vs control (ETB 432 [ETB 210-ETB 1980]) (P < .001), with median possible cost savings of ETB 336 (ETB 156-ETB 1339) (US $6.44) vs the control arm. Overall, 42 participants (38.5%; 95% CI, 29.4%-48.3%) faced catastrophic costs, and this was significantly lower in the intervention group (11 participants [21.2%]; 95% CI, 11.1%-34.7%) vs control (31 participants [54.4%]; 95% CI, 40.7%-67.6%) (P < .001). Trial arm was the single most important factor in low HRQoL (adjusted risk ratio [ARR], 1.49; 95% CI, 1.35-1.65; P < .001), while trial arm (ARR, 2.55; 95% CI, 1.58-4.13; P < .001), occupation (ARR, 2.58; 95% CI, 1.68-3.97; P < .001), number of cohabitants (ARR, 0.64; 95% CI, 0.43-0.95; P = .03), and smoking (ARR, 2.71; 95% CI, 1.01-7.28; P = .048) were the most important factors in catastrophic cost. Conclusions and Relevance: In patients with TB, MERM-observed therapy was associated with higher HRQoL and lower catastrophic costs compared with standard DOT. Patient-centered digital health technologies could have the potential overcoming structural barriers to anti-TB therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT04216420.

Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial.

BACKGROUND: There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia. METHODS: In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956. FINDINGS: We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI -0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of -US$299·82 (95% CI -454·95 to -144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months. INTERPRETATION: WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings. FUNDING: US National Institute of Mental Health.

Impact of COVID-19 on population health and economic wellbeing in Ethiopia: A national pilot survey.

Introduction: The COVD-19 pandemic has resulted in unprecedented global health and economic crisis, particularly in countries struggling with poverty. We conducted a national survey to understand the economic and health impacts of COVID-19 in Ethiopia. Methods: A pilot, population-based, cross-sectional survey was conducted among adults randomly selected from the Ethio Telecom list of mobile phone numbers. Participants underwent a comprehensive phone interview about the impact of COVID-19 on their economic well-being and the health-related risks associated with COVID-19. Results: Of 4,180 calls attempted, 1194 were answered, of which a successful interview was made with 614 participants. COVID-19 affected the family income of 343 [55.9%] participants, 56 [9.1%] lost their job, 105 [17.1%] perceived high stress in their household, and 7 [1.14%] reported death in their family in the past month. The odds of having a decreased income due to COVID-19 were 2.4 times higher among self-employed [adjusted odds ratio (AOR) 2.4, 95% CI (1.58-3.77)] and 2.8 times higher among unemployed [AOR 2.8, 95% CI (1.35-5.85)] participants. Two-hundred twenty-one [36%] participants had comorbidity in their household with hypertension, 72 [11.7%], diabetes,50 [8.1%], asthma, 48 [7.8%], and other chronic diseases, 51 [8.4%]. Forty-six [7.5%] participants had COVID-like symptoms in the previous month, where cough, headache, and fatigue were the most common. Conclusion: COVID-19 posed serious economic pressure on households. Self-employed and unemployed were the most affected. Continuous surveillance is needed to actively monitor the impact of COVID-19 in the community and safeguard the economic and health well-being of individuals and households.

Towards effective and sustainable global academic partnerships through a maturity model informed by the capability approach.

BACKGROUND: Shortage of skilled workforce is a global concern but represents a critical bottleneck to Africa's development. While global academic partnerships have the potential to help tackle this development bottleneck, they are criticised for inadequate attention to equity, impact, and sustainability. We propose a new values-driven partnership model for sustainable and equitable global partnerships that achieve impact. METHOD: The model was based on the authors' experiences of participation in over 30 partnerships and used insights from the Capability Approach. RESULTS: We developed an Academic Partnership Maturity Model, with five levels of maturity, extending from pre-contemplative to mature partnerships. The level of maturity increases depending on the level of freedom, equity, diversity, and agency afforded to the partners. The approach offers a framework for establishing a forward-looking partnership anchored in mutual learning, empowerment, and autonomy. CONCLUSION: This is a pragmatic model limited by the biases of experiential knowledge. Further development of the concept, including metrics and an evaluation tool kit are needed to assist partners and funders.

A qualitative study on the implementation of a holistic care package for control and management of lymphoedema: experience from a pilot intervention in northern Ethiopia.

BACKGROUND: Neglected Tropical Diseases (NTDs) such as podoconiosis, lymphatic filariasis (LF) and leprosy mainly affect communities in low resource settings. These diseases are associated with physical disability due to lymphoedema as well as poor mental health and psychosocial outcomes. Integration of care across these NTDs at primary health care level, which includes mental health and psychosocial care alongside physical health care, is increasingly recommended. METHODS: A holistic integrated care package was developed and piloted as part of the EnDPoINT project in Gusha district, Awi zone, Ethiopia. The intervention was conducted at the health care organization, health facility and community levels. To assess the impact of the care package in terms of acceptability, scalability, sustainability and barriers to implementation, a qualitative study was conducted in January 2020. This included four focus group discussions (29 participants) and ten key informant interviews with decision makers, health professionals, patients, and community representatives. RESULTS: The integrated lymphoedema care package was found to be efficient compared to vertical programs in saving time and resources. It also resulted in improved awareness of the causes, treatment and prevention of lymphoedema, in marked improvements in the lymphoedema, and in reduced stigma and discrimination. The care package was found to be acceptable to patients, health professionals and decision makers. The barriers to integrated care were unrealistic patient expectations, inadequate dissemination across health workers, and poor transportation access. Health professionals, decision makers and patients believed the integrated lymphoedema care package to be scalable and sustainable. CONCLUSION: The integrated holistic care package was found to be acceptable to patients, health professionals and decision makers. We recommend its scale-up to other endemic districts.

Development of an integrated, holistic care package for people with lymphoedema for use at the level of the Primary Health Care Unit in Ethiopia.

BACKGROUND: Neglected Tropical Diseases (NTDs) are a group of several communicable and non-communicable diseases prevalent in tropical and subtropical areas. The co-endemicity of these diseases, the similarity of their clinical signs, and the need to maximize limited financial and human resources suggest the importance of adoptingan integratedapproach to their prevention and treatment. AIMS: This study describes the development of a comprehensive package of physical, mental health and psychosocial care for people with lower-limb lymphoedema caused bypodoconiosis, lymphatic filariasis (LF)or leprosy as part of the EnDPoINT program in Ethiopia. METHOD: The care package was developed using a mixed-methods approach, consisting of a literature review, situational analysis, Theory of Change (ToC) workshops, qualitative research, and additional workshops to fine-tune the draft care package. The care package was developed between March 2018 and January 2020 in Addis Ababa and the implementation research site, Awi zone in the North-West of Ethiopia. RESULTS: The holistic care package includes components implemented at three levels of the health care system:health organization, facility, and community. Sections of the care package are directed at strengthening capacity building, program management, community engagement, awareness-raising, stigma-reduction, morbidity management, disability prevention, follow-up visits, referral linkage, community-based rehabilitation, and monitoring and evaluation. CONCLUSIONS: The study developed a holistic integrated care package for lower limb disorder and co-morbid mental health problems caused by podoconiosis, LF or leprosy. The approach has the potential to significantly reduce lower limb disorder-associated morbidity, disability, and psychosocial problems. It also standardizes a scalable approach appropriate for the Ethiopian setting and, most likely, other countries where these NTDs are present.

Low-coverage sequencing cost-effectively detects known and novel variation in underrepresented populations.

Genetic studies in underrepresented populations identify disproportionate numbers of novel associations. However, most genetic studies use genotyping arrays and sequenced reference panels that best capture variation most common in European ancestry populations. To compare data generation strategies best suited for underrepresented populations, we sequenced the whole genomes of 91 individuals to high coverage as part of the Neuropsychiatric Genetics of African Population-Psychosis (NeuroGAP-Psychosis) study with participants from Ethiopia, Kenya, South Africa, and Uganda. We used a downsampling approach to evaluate the quality of two cost-effective data generation strategies, GWAS arrays versus low-coverage sequencing, by calculating the concordance of imputed variants from these technologies with those from deep whole-genome sequencing data. We show that low-coverage sequencing at a depth of ≥4× captures variants of all frequencies more accurately than all commonly used GWAS arrays investigated and at a comparable cost. Lower depths of sequencing (0.5-1×) performed comparably to commonly used low-density GWAS arrays. Low-coverage sequencing is also sensitive to novel variation; 4× sequencing detects 45% of singletons and 95% of common variants identified in high-coverage African whole genomes. Low-coverage sequencing approaches surmount the problems induced by the ascertainment of common genotyping arrays, effectively identify novel variation particularly in underrepresented populations, and present opportunities to enhance variant discovery at a cost similar to traditional approaches.

Understanding the key processes of excellence as a prerequisite to establishing academic centres of excellence in Africa.

BACKGROUND: Africa's economic transformation relies on a radical transformation of its higher education institutions. The establishment of regional higher education Centres of Excellence (CoE) across Africa through a World Bank support aims to stimulate the needed transformation in education and research. However, excellence is a vague, and often indiscriminately used concept in academic circles. More importantly, the manner in which aspiring institutions can achieve academic excellence is described inadequately. The main objective of this paper is to describe the core processes of excellence as a prerequisite to establishing academic CoE in Africa. METHODS: The paper relies on our collaborative discussions and real-world insight into the pursuit of academic excellence, a narrative review using Pubmed search for a contextual understanding of CoEs in Africa supplemented by a Google search for definitions of CoEs in academic contexts. RESULTS: We identified three key, synergistic processes of excellence central to institutionalizing academic CoEs: participatory leadership, knowledge management, and inter-disciplinary collaboration. (1) Participatory leadership encourages innovations to originate from the different parts of the organization, and facilitates ownership as well as a culture of excellence. (2) Centers of Excellence are future-oriented in that they are constantly seeking to achieve best practices, informed by the most up-to-date and cutting-edge research and information available. As such, the process by which centres facilitate the flow of knowledge within and outside the organization, or knowledge management, is critical to their success. (3) Such centres also rely on expertise from different disciplines and 'engaged' scholarship. This multidisciplinarity leads to improved research productivity and enhances the production of problem-solving innovations. CONCLUSION: Participatory leadership, knowledge management, and inter-disciplinary collaborations are prerequisites to establishing academic CoEs in Africa. Future studies need to extend our findings to understand the processes key to productivity, competitiveness, institutionalization, and sustainability of academic CoEs in Africa.

Economic assessment of a community-based care package for people with lower limb disorder caused by lymphatic filariasis, podoconiosis and leprosy in Ethiopia.

We conducted an implementation research study to integrate a holistic package of physical health, mental health and psychosocial care for podoconiosis, lymphatic filariasis and leprosy into routine healthcare in Gusha cluster, Guagusa Shikudad district, northwest Ethiopia. The healthcare package included training patients in lower limb hygiene and skin care and provision of shoes, hygiene supplies and medication. The implementation activities included training events, workshops, awareness raising, self-help groups, supportive supervision, staff secondments and advisory board meetings. The cost of implementing the care package in Gusha cluster, with a population of 30 558 people, was 802 655 Ethiopian birr (ETB) (£48 159) and the cost of delivering care to 235 participants was 204 388 ETB (£12 263), or 870 ETB (£52) per person. There was a 35% decrease in the mean disability scores (measured using the World Health Organization Disability Assessment Schedule 2.0) and a 45% improvement in the dermatology-specific quality of life (measured using the Dermatology Life Quality Index) at the 3-month follow-up compared with baseline. There were reductions in the number of days with symptoms, days off usual activities/work and days with reduced activity due to illness, all of which were statistically significant. Our pilot suggests that integration of the care package into routine healthcare in Ethiopia may be effective in improving health-related quality of life and disability and reducing time out of economic activity due to illness.

Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial.

BACKGROUND: To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended that countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives. METHODS: This is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen. Participants in the intervention arm (n = 72) will receive 15 days of HRZE-isoniazid, rifampicin, pyrazinamide, and ethambutol-fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration. When returned, providers will count any remaining tablets in the device, download the pill-taking data, and refill based on preset criteria. Participants can consult the provider in cases of illness or adverse events outside of scheduled visits. Providers will handle participants in the control arm (n = 72) according to the standard in-person DOT. Both arms will be followed up throughout the 2-month intensive phase. The primary outcomes will be medication adherence and sputum conversion. Adherence to medication will be calculated as the proportion of patients who missed doses in the intervention (pill count) versus DOT (direct observation) arms, confirmed further by IsoScreen urine isoniazid test and a self-report of adherence on eight-item Morisky Medication Adherence Scale. Sputum conversion is defined as the proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase BACTEC MGIT TB liquid culture. Pre-post treatment MGIT drug susceptibility testing will determine whether resistance to anti-TB drugs could have impacted culture conversion. Secondary outcomes will include other clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness-individual and societal costs with quality-adjusted life years-and acceptability and usability of the intervention by patients and providers. DISCUSSION: This study will be the first in Ethiopia, and of the first three in sub-Saharan Africa, to determine whether electronic pillbox-enabled SAT improves adherence to TB medication and treatment outcomes, all without affecting the inherent dignity and economic wellbeing of patients with TB. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.

Health service costs and their association with functional impairment among adults receiving integrated mental health care in five low- and middle-income countries: the PRIME cohort study.

This study examines the level and distribution of service costs-and their association with functional impairment at baseline and over time-for persons with mental disorder receiving integrated primary mental health care. The study was conducted over a 12-month follow-up period in five low- and middle-income countries participating in the Programme for Improving Mental health carE study (Ethiopia, India, Nepal, South Africa and Uganda). Data were drawn from a multi-country intervention cohort study, made up of adults identified by primary care providers as having alcohol use disorders, depression, psychosis and, in the three low-income countries, epilepsy. Health service, travel and time costs, including any out-of-pocket (OOP) expenditures by households, were calculated (in US dollars for the year 2015) and assessed at baseline as well as prospectively using linear regression for their association with functional impairment. Cohort samples were characterized by low levels of educational attainment (Ethiopia and Uganda) and/or high levels of unemployment (Nepal, South Africa and Uganda). Total health service costs per case for the 3 months preceding baseline assessment averaged more than US$20 in South Africa, $10 in Nepal and US$3-7 in Ethiopia, India and Uganda; OOP expenditures ranged from $2 per case in India to $16 in Ethiopia. Higher service costs and OOP expenditure were found to be associated with greater functional impairment in all five sites, but differences only reached statistical significance in Ethiopia and India for service costs and India and Uganda for OOP expenditure. At the 12-month assessment, following initiation of treatment, service costs and OOP expenditure were found to be lower in Ethiopia, South Africa and Uganda, but higher in India and Nepal. There was a pattern of greater reduction in service costs and OOP spending for those whose functional status had improved in all five sites, but this was only statistically significant in Nepal.

Household economic costs associated with mental, neurological and substance use disorders: a cross-sectional survey in six low- and middle-income countries.

BACKGROUND: Little is known about the household economic costs associated with mental, neurological and substance use (MNS) disorders in low- and middle-income countries. AIMS: To assess the association between MNS disorders and household education, consumption, production, assets and financial coping strategies in Ethiopia, India, Nepal, Nigeria, South Africa and Uganda. METHOD: We conducted an exploratory cross-sectional household survey in one district in each country, comparing the economic circumstances of households with an MNS disorder (alcohol-use disorder, depression, epilepsy or psychosis) (n = 2339) and control households (n = 1982). RESULTS: Despite some heterogeneity between MNS disorder groups and countries, households with a member with an MNS disorder had generally lower levels of adult education; lower housing standards, total household income, effective income and non-health consumption; less asset-based wealth; higher healthcare expenditure; and greater use of deleterious financial coping strategies. CONCLUSIONS: Households living with a member who has an MNS disorder constitute an economically vulnerable group who are susceptible to chronic poverty and intergenerational poverty transmission. DECLARATION OF INTEREST: D.C. is a staff member of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the World Health Organization.

Catastrophic health expenditure and impoverishment in households of persons with depression: a cross-sectional, comparative study in rural Ethiopia.

BACKGROUND: The extent of catastrophic health expenditure and impoverishment associated with depression in low-and middle-income countries is not known. The aim of this study was to estimate the incidence and intensity of catastrophic out-of-pocket (OOP) health expenditure, level of impoverishment and coping strategies used by households of persons with and without depression in a rural Ethiopian district. METHODS: A comparative cross-sectional survey was conducted, including 128 households of persons with depression and 129 households without. Depression screening was conducted using the Patient Health Questionnaire, nine item version (PHQ-9). People in the depression group were classified into high and low disability groups based on the median value on the World Health Organization Disability Assessment Schedule (WHODAS) polytomous summary score. Health expenditure greater than thresholds of 10 and 25% of total household consumption was used for the primary analyses. The poverty headcount, poverty gap and normalized poverty gap were estimated using retrospective recall of total household expenditure pre- and post-OOP payments for health care. Linear probability model using binreg command in STATA with rr option was used to estimate risk ratio for the occurrence of outcomes among households with and without depression based on level of disability. RESULTS: Catastrophic OOP payments at any threshold level for households with depression and high disability were higher than control households. At the 10% threshold level, 24.0% of households of persons with depression and high disability faced catastrophic payments compared with 15.3% for depression and low disability and 12.1% for control households (p = 0.041). Depression and high disability level was an independent predictor of catastrophic OOP payments: RR 2.1; 95% CI:1.1, 4.6. An estimated 5.8% of households of persons with depression and high disability were pushed into poverty because of paying for health care compared with 3.5% for households of persons with depression and low disability and 2.3% for control households (p = 0.039). CONCLUSIONS: Households of people with depression and high disability were more likely to face catastrophic expenditures and impoverishment from OOP payments. Financial protection interventions through prepayment schemes, exemptions and fee waiver strategies need to target households of persons with depression.

Equitable access to mental healthcare integrated in primary care for people with severe mental disorders in rural Ethiopia: a community-based cross-sectional study.

BACKGROUND: Integration of mental healthcare into non-specialist settings is advocated to expand access to care for people with severe mental disorders (SMD) in low-income countries. However, the impact upon equitable access for disenfranchised members of society has not been investigated. The purpose of this study was to (1) estimate contact coverage for SMD of a new service in primary healthcare (PHC) in a rural Ethiopian district, and (2) investigate equity of access for rural residents, women, people with physical impairments and people of low socio-economic status. METHODS: Community key informants were trained to identify and refer people with probable SMD in Sodo district, south-central Ethiopia, using vignettes of typical presentations. Records of those referred to the new PHC-based service were linked to healthcare records to identify people who engaged with care and non-engagers over a 6 month period. Standardised interviews by psychiatric nurses were used to confirm the diagnosis in those attending PHC. Non-engagers were visited in their homes and administered the Psychosis Symptom Questionnaire. Socio-economic status, discrimination, disability, substance use, social support and distance to the nearest health facility were measured. RESULTS: Contact coverage for the new service was estimated to be 81.3% (300 engaged out of 369 probable cases of SMD identified). Reimbursement for transport and time may have elevated coverage estimates. In the fully adjusted multivariable model, rural residents had 3.81 increased odds (95% CI 1.22, 11.89) of not accessing care, in part due to geographical distance from the health facility (odds ratio 3.37 (1.12, 10.12)) for people living more than 180 min away. There was no association with lower socioeconomic status, female gender or physical impairment. Higher levels of functional impairment were associated with increased odds of engagement. Amongst non-engagers, the most frequently endorsed barriers were thinking the problem would get better by itself and concerns about the cost of treatment. CONCLUSION: Integrating mental healthcare into primary care can achieve high levels of coverage in a rural African setting, which is equitable with respect to gender and socio-economic status. Service outreach into the community may be needed to achieve better contact coverage for rural residents.

Multidimensional impact of severe mental illness on family members: systematic review.

OBJECTIVE: The impact of severe mental illnesses (SMIs) is not limited to the person with the illness but extends to their family members and the community where the patient comes from. In this review, we systematically analyse the available evidence of impacts of SMI on family members, including parents, grandparents, siblings, spouses and children. DATA SOURCES: PubMed, PsycINFO, Embase and Global Index Medicus were searched from the inception of each database up to 9 November 2019. We also did manual searches of grey literature. ELIGIBILITY CRITERIA: We included studies that assessed the impacts of SMI on any family member. We excluded studies in admitted clinics and acute wards to rule out the acute effect of hospitalisation. DATA EXTRACTION: Two reviewers extracted data independently using the Cochrane handbook guideline for systematic reviews and agreed on the final inclusion of identified studies. RISK OF BIAS: The quality of the included studies was assessed using effective public health practice project quality assessment tool for quantitative studies.The review protocol was registered in the PROSPERO database. RESULTS: We screened a total of 12 107 duplicate free articles and included 39 articles in the review. The multidimensional impact of SMI included physical health problems (sleeplessness, headache and extreme tiredness.), psychological difficulties (depression and other psychological problems) and socioeconomic drift (less likely to marry and higher divorce rate and greater food insecurity). Impacts on children included higher mortality, poor school performance and nutritional problems. However, the quality of one in five studies was considered weak. CONCLUSIONS: Our review indicated a high level of multidimensional impact across multiple generations. The serious nature of the impact calls for interventions to address the multidimensional and multigenerational impact of SMI, particularly in low/middle-income countries. Given the relatively high number of studies rated methodologically weak, more robust studies are indicated. PROSPERO REGISTRATION NUMBER: CRD42018064123.

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): a 12 month mixed methods pilot study.

BACKGROUND: Community-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia. METHODS: This mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members. RESULTS: The RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale. CONCLUSION: In low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.

Functional impairment among people with severe and enduring mental disorder in rural Ethiopia: a cross-sectional study.

PURPOSE: Evidence regarding functional impairment in people with severe mental disorders (SMD) is sparse in low- and middle-income countries. The aim of this study was to identify factors associated with functional impairment in people with enduring SMD in a rural African setting. METHODS: A cross-sectional study was conducted at the baseline of a health service intervention trial. A total of 324 participants were recruited from an existing community-ascertained cohort of people with SMD (n = 218), and attendees at the Butajira General Hospital psychiatric clinic (n = 106). Inclusion criteria defined people with SMD who had ongoing need for care: those who were on psychotropic medication, currently symptomatic or had a relapse in the preceding 2 years. The World Health Organization Disability Assessment schedule (WHODAS-2.0) and the Butajira Functioning Scale (BFS) were used to assess functional impairment. Multivariable negative binomial regression models were fitted to investigate the association between demographic, socio-economic and clinical characteristics, and functional impairment. RESULTS: Increasing age, being unmarried, rural residence, poorer socio-economic status, symptom severity, continuous course of illness, medication side effects, and internalized stigma were associated with functional impairment across self-reported and caregiver responses for both the WHODAS and the BFS. Diagnosis per se was not associated consistently with functional impairment. CONCLUSION: To optimize functioning in people with chronic SMD in this setting, services need to target residual symptoms, poverty, medication side effects, and internalized stigma. Testing the impact of community interventions to promote recovery will be useful. Advocacy for more tolerable treatment options is warranted.