EMPOWER: Toward the Global Dissemination of Psychosocial Interventions.

Even before the COVID-19 pandemic, the needs for care of persons with mental illness remained largely unmet worldwide, testifying to the inadequacy of current approaches to mental health care and their unsuitability for the rising demand. One hurdle to improved access to quality care is the reliance on expensive specialist providers, particularly for the delivery of psychosocial interventions. This article describes EMPOWER, a not-for-profit program that builds on the clinical science demonstrating the effectiveness of brief psychosocial interventions for a range of psychiatric conditions; implementation science demonstrating the effectiveness of delivery of these interventions by non-specialist providers (NSPs); and pedagogical science demonstrating the effectiveness of digital approaches for training and quality assurance. The EMPOWER program leverages digital tools for training and supervising NSPs, designing competency-based curricula, assessing treatment-specific competencies, implementing measurement-based peer supervision for support and quality assurance, and evaluating impacts to enhance the effectiveness of the delivery system.

Continuity of CVD treatment during the COVID-19 pandemic: evidence from East Java, Indonesia.

BACKGROUND: In Indonesia, the world's fourth most populous country, cardiovascular diseases (CVDs) are a leading cause of death and disability. Government efforts to reduce the burden of CVD include a community-based prevention and early detection programme, and the provision of medicines to prevent cardiovascular events. Disruptions to medicine supply chains, service provision, and movement during the COVID-19 pandemic potentially threatened the continuity of these efforts. We investigated the distribution and dispensing of common CVD medicines in Malang district, East Java, before the pandemic and early in its course. METHODS: From January to October 2020, we collected monthly data on stock levels, sales or dispensing volumes, and price for five common CVD medicines (amlodipine, captopril, furosemide, glibenclamide and simvastatin), from a public and a private distributor, and from public health facilities (n = 4) and private pharmacies (n = 2). We further complied monthly data on patient numbers in two primary health centres. We tracked changes in stocks held and volumes dispensed by medicine type and sector, comparing the three months before the local COVID-19 response was mobilised with the subsequent seven months. We conducted interviews with pharmacists (n = 12), community health workers (n = 2) and a supply chain logistics manager to investigate the reasons for observed changes, and to learn details of any impacts or mitigation measures. RESULTS: The pandemic affected demand more than supply, causing medicine stocks to rise. Restricted service provision, lock-down measures and fear of infection contributed to a sharp drop in patient numbers and dispensing volumes in the public sector. Meanwhile private sector sales, especially of lower-priced CVD medicines, rose. Community health workers attributed some poor health outcomes to interruption in regular patient check-ups; this interruption was aggravated by formal mitigation policies. CONCLUSIONS: Fears that COVID-19 would interrupt medicine availability were unfounded in East Java. Public sector patients may have compensated for reduced service access by switching to private pharmacies. Mitigation policies that ignored administrative procedures were not effective.

Protocol for process evaluation of SMART Mental Health cluster randomised control trial: an intervention for management of common mental disorders in India.

INTRODUCTION: In India about 95% of individuals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health. METHODS AND ANALYSIS: The process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms. TRIAL REGISTRATION NUMBER: CTRI/2018/08/015355.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.

Importance: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. Objective: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. Design, Setting, and Participants: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. Interventions: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. Main Outcomes and Measures: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. Results: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. Conclusions and Relevance: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.