Catastrophic costs for tuberculosis patients in India: Impact of methodological choices.

As financial risk protection is one of the goals towards universal health coverage, detailed information on costs, catastrophic costs and other economic consequences related to any disease are required for designing social protection measures. End Tuberculosis (TB) Strategy set a milestone of achieving zero catastrophic cost by 2020. However, a recent literature review noted that 7%-32% TB affected households in India faced catastrophic cost. Studies included in the review were small scale cross-sectional. We followed a cohort of 1482 notified drug-susceptible TB patients from four states in India: Assam, Maharashtra, Tamil Nadu, and West Bengal to provide a comprehensive picture of economic burden associated with TB treatment. Treatment cost was calculated using World Health Organization guidelines on TB patient cost survey and both human capital and output approaches of indirect cost (time, productivity, and income loss related to an episode) calculation were used to provide the range of households currently facing catastrophic cost. Depending on choice of indirect cost calculation method, 30%-61% study participants faced catastrophic cost. For over half of them, costs became catastrophic even before starting TB treatment as there was average 7-9 weeks delay from symptom onset to treatment initiation which was double the generally accepted delay of 4 weeks. During that period, they made average 8-11 visits to different providers and spent money on consultations, drugs, tests, and travel. Following the largest cohort of drug-susceptible TB patients till date, the study concluded that a significant proportion of study participants faced catastrophic cost and the proportion was much higher when income loss was considered as indirect cost calculation method. Therefore, ensuring uninterrupted livelihood during TB treatment is an absolute necessity. Another reason of high cost was the delay in diagnosis and costs incurred during pre-diagnosis period. This delay and consequently, economic burden, can be reduced by both supply side (intense private sector engagement, rapid diagnosis) and demand side (community engagement) initiatives. Reimbursement of expenses incurred before treatment initiation could be used as short-term measure for mitigating financial hardship.

Health impact and cost-effectiveness of expanding routine immunization coverage in India through Intensified Mission Indradhanush.

Many children do not receive a full schedule of childhood vaccines, yet there is limited evidence on the cost-effectiveness of strategies for improving vaccination coverage. Evidence is even scarcer on the cost-effectiveness of strategies for reaching "zero-dose children," who have not received any routine vaccines. We evaluated the cost-effectiveness of periodic intensification of routine immunization (PIRI), a widely applied strategy for increasing vaccination coverage. We focused on Intensified Mission Indradhanush (IMI), a large-scale PIRI intervention implemented in India in 2017-2018. In 40 sampled districts, we measured the incremental economic cost of IMI using primary data, and used controlled interrupted time-series regression to estimate incremental vaccination doses delivered. We estimated deaths and disability-adjusted life years (DALYs) averted using the Lives Saved Tool and reported cost-effectiveness from immunization program and societal perspectives. We found that, in sampled districts, IMI had an estimated incremental cost of 2021US$13.7 (95% uncertainty interval: 10.6 to 17.4) million from an immunization program perspective and increased vaccine delivery by an estimated 2.2 (-0.5 to 4.8) million doses over a 12-month period, averting an estimated 1,413 (-350 to 3,129) deaths. The incremental cost from a program perspective was $6.21 per dose ($2.80 to dominated), $82.99 per zero-dose child reached ($39.85 to dominated), $327.63 ($147.65 to dominated) per DALY averted, $360.72 ($162.56 to dominated) per life-year saved, and $9,701.35 ($4,372.01 to dominated) per under-five death averted. At a cost-effectiveness threshold of 1x per-capita GDP per DALY averted, IMI was estimated to be cost-effective with 90% probability. This evidence suggests IMI was both impactful and cost-effective for improving vaccination coverage, though there is a high degree of uncertainty in the results. As vaccination programs expand coverage, unit costs may increase due to the higher costs of reaching currently unvaccinated children.

Cost of implementing the QualityRights programme in public hospitals in Gujarat providing mental healthcare.

Background & objectives: Investment in mental health is quite meagre worldwide, including in India. The costs of new interventions must be clarified to ensure the appropriate utilization of available resources. The government of Gujarat implemented QualityRights intervention at six public mental health hospitals. This study was aimed to project the costs of scaling up of the Gujarat QualityRights intervention to understand the additional resources needed for a broader implementation. Methods: Economic costs of the QualityRights intervention were calculated using an ingredients-based approach from the health systems' perspective. Major activities within the QualityRights intervention included assessment visits, meetings, training of trainers, provision of peer support and onsite training. Results: Total costs of implementing the QualityRights intervention varied from Indian Rupees (₹) 0.59 million to ₹ 2.59 million [1United States Dollars (US $) = ₹ 74.132] across six intervention sites at 2020 prices with 69-79 per cent of the cost being time cost. Scaling up the intervention to the entire State of Gujarat would require about two per cent increase in financial investment, or about 7.5 per cent increase in total cost including time costs over and above the costs of usual care for people with mental health conditions in public health facilities across the State. Interpretation & conclusions: The findings of this study suggest that human resources were the major cost contributor of the programme. Given the shortage of trained human resources in the mental health sector, appropriate planning during the scale-up phase of the QualityRights intervention is required to ensure all staff members receive the required training, and the treatment is not compromised during this training phase. As only about two per cent increase in financial cost can improve the quality of mental healthcare significantly, the State government can plan for its scale-up across the State.

Journey of the tuberculosis patients in India from onset of symptom till one-year post-treatment.

Historically, economic studies on tuberculosis estimated out-of-pocket expenses related to tuberculosis treatment and catastrophic cost, however, no study has yet been conducted to understand the post-treatment economic conditions of the tuberculosis patients in India. In this paper, we add to this body of knowledge by examining the experiences of the tuberculosis patients from the onset of symptoms till one-year post-treatment. 829 adult drug-susceptible tuberculosis patients from general population and from two high risk groups: urban slum dwellers and tea garden families were interviewed during February 2019 to February 2021 at their intensive and continuation phases of treatment and about one-year post-treatment using adapted World Health Organization tuberculosis patient cost survey instrument. Interviews covered socio-economic conditions, employment status, income, out-of-pocket expenses and time spent for outpatient visits, hospitalization, drug-pick up, medical follow-ups, additional food, coping strategies, treatment outcome, identification of post-treatment symptoms and treatment for post-treatment sequalae/recurrent cases. All costs were calculated in 2020 Indian rupee (INR) and converted into US dollar (US$) (1 US$ = INR 74.132). Total cost of tuberculosis treatment since the onset of symptom till one-year post-treatment ranged from US$359 (Standard Deviation (SD) 744) to US$413 (SD 500) of which 32%-44% of costs incurred in pre-treatment phase and 7% in post-treatment phase. 29%-43% study participants reported having outstanding loan with average amount ranged from US $103 to US$261 during the post-treatment period. 20%-28% participants borrowed during post-treatment period and 7%-16% sold/mortgaged personal belongings. Therefore, economic impact of tuberculosis persists way beyond treatment completion. Major reasons of continued hardship were costs associated with initial tuberculosis treatment, unemployment, and reduced income. Therefore, policy priorities to reduce treatment cost and to protect patients from the economic consequences of the disease by ensuring job security, additional food support, better management of direct benefit transfer and improving coverage through medical insurances need consideration.

Protocol for the implementation and evaluation of a community-based behavior change intervention to reduce dietary salt intake in India.

Excess dietary salt intake is well established as a leading cause of high blood pressure and associated cardiovascular disease, yet current salt intake in India is nearly 11 g per day, more than twice World Health Organization maximum recommended intake of 5 g per day. Although dietary survey data from India indicate that the main sources of dietary salt are salt added during cooking at home, and few salt reduction efforts have focused on interventions at the household level. As a result, there is little evidence of the effectiveness of behavior change programs to reduce salt intake at the household level. The study aims to develop and implement a community based behavioral change intervention to reduce salt intake delivered by front line community-based health volunteers; and evaluate the preliminary effectiveness, acceptability, and feasibility of delivering a salt reduction behavior change program and potential to support future scale-up. The study is a pre-post intervention design, and outcomes will be evaluated from a random sample of 1500 participants from 28 villages in two primary health centers in Siddipet, Telangana. Primary outcome is change in salt-related KAB (knowledge, attitude, and behavior) score, and secondary outcomes will be changes in salt intake measured by 24 h urinary sodium excretion and change in scores using the subscales of the COM-B ("capability", "opportunity", "motivation" and "behavior") tool. Findings will be used to inform future public health policies to support implementation of scalable community-based interventions to reduce salt intake and control hypertension, the leading-cause of death in India.

Examining decentralization and managerial decision making for child immunization program performance in India.

Despite widespread adoption of decentralization reforms, the impact of decentralization on health system attributes, such as access to health services, responsiveness to population health needs, and effectiveness in affecting health outcomes, remains unclear. This study examines how decision space, institutional capacities, and accountability mechanisms of the Intensified Mission Indradhanush (IMI) in India relate to measurable performance of the immunization program. Data on decision space and its related dimensions of institutional capacity and accountability were collected by conducting structured interviews with managers based in 24 districts, 61 blocks, and 279 subcenters. Two measures by which to assess performance were selected: (1) proportion reduction in the DTP3 coverage gap (i.e., effectiveness), and (2) total IMI doses delivered per incremental USD spent on program implementation (i.e., efficiency). Descriptive statistics on decision space, institutional capacity, and accountability for IMI managers were generated. Structural equation models (SEM) were specified to detect any potential associations between decision space dimensions and performance measures. The majority of districts and blocks indicated low levels of decision space. Institutional capacity and accountability were similar across areas. Increases in decision space were associated with less progress towards closing the immunization coverage gap in the IMI context. Initiatives to support health workers and managers based on their specific contextual challenges could further improve outcomes of the program. Similar to previous studies, results revealed strong associations between each of the three decentralization dimensions. Health systems should consider the impact that management structures have on the efficiency and effectiveness of health services delivery. Future research could provide greater evidence for directionality of direct and indirect effects, interaction effects, and/or mediators of relationships.

Impact of COVID-19 restrictive measures on income and health service utilization of tuberculosis patients in India.

BACKGROUND: The nationwide lockdown (March 25 to June 8, 2020) to curb the spread of coronavirus infection had significant health and economic impacts on the Indian economy. There is limited empirical evidence on how COVID-19 restrictive measures may impact the economic welfare of specific groups of patients, e.g., tuberculosis patients. We provide the first such evidence for India. METHODS: A total of 291 tuberculosis patients from the general population and from a high-risk group, patients from tea garden areas, were interviewed at different time points to understand household income loss during the complete lockdown, three and eight months after the complete lockdown was lifted. Income loss was estimated by comparing net monthly household income during and after lockdown with prelockdown income. Tuberculosis service utilization patterns before and during the lockdown period also were examined. Household income loss, travel and other expenses related to tuberculosis drug pickup were presented in 2020 US dollars (1 US$ = INR 74.132). RESULTS: 26% of households with tuberculosis patients in tea garden areas and 51% of households in the general population had zero monthly income during the complete lockdown months (April-May 2020). Overall income loss slowly recovered during July-August compared to April-May 2020. Approximately 7% of patients in the general population and 4% in tea garden areas discontinued their tuberculosis medicines because of the complete lockdown. CONCLUSION: Discontinuation of medicine will have an additional burden on the tuberculosis elimination program in terms of additional cases, including multidrug resistant tuberculosis cases. Income loss for households and poor restoration of income after the lockdown will likely have an impact on the nutrition of tuberculosis patients and families. Tuberculosis patients working in the informal sector were the worst affected group during the nationwide lockdown. This emphasizes that a policy priority must continue to protect those working in informal sectors from the economic consequences of such restrictive measures, including paid sick leave, additional food support, and direct benefit transfers. Alongside ensuring widespread access to COVID-19 vaccines, these policy actions remain pivotal in ensuring the well-being of those who are unfortunate enough to be living with tuberculosis.

An intervention to reduce stigma and improve management of depression, risk of suicide/self-harm and other significant emotional or medically unexplained complaints among adolescents living in urban slums: protocol for the ARTEMIS project.

BACKGROUND: There are around 250 million adolescents in India. Adolescents are vulnerable to common mental disorders with depression and self-harm accounting for a major share of the burden of death and disability in this age group. Around 20% of children and adolescents are diagnosed with/ or live with a disabling mental illness. A national survey has found that suicide is the third leading cause of death among adolescents in India. The authors hypothesise that an intervention involving an anti-stigma campaign co-created by adolescents themselves, and a mobile technology-based electronic decision support system will help reduce stigma, depression, and suicide risk and improve mental health for high-risk adolescents living in urban slums in India. METHODS: The intervention will be implemented as a cluster randomised control trial in 30 slum clusters in each of the cities of Vijayawada and New Delhi in India. Adolescents aged 10 to 19 years will be screened for depression and suicide ideation using the Patient Health Questionnaire (PHQ-9). Two evaluation cohorts will be derived-a high-risk cohort with an elevated PHQ-9 score ≥ 10 and/or a positive response (score ≥ 2) to the suicide risk question on the PHQ-9, and a non-high-risk cohort comprising an equal number of adolescents not at elevated risk based on these scores. DISCUSSION: The key elements that ARTEMIS will focus on are increasing awareness among adolescents and the slum community on these mental health conditions as well as strengthening the skills of existing primary healthcare workers and promoting task sharing. The findings from this study will provide evidence to governments about strategies with potential for addressing the gaps in providing care for adolescents living in urban slums and experiencing depression, other significant emotional or medically unexplained complaints or increased suicide risk/self-harm and should have relevance not only for India but also for other low- and middle-income countries. TRIAL STATUS: Protocol version - V7, 20 Dec 2021 Recruitment start date: tentatively after 15th July 2022 Recruitment end date: tentatively 14th July 2023 (1 year after the trial start date) TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries ( https://www.who.int/clinical-trials-registry-platform/network/primary-registries ) Reference No. CTRI/2022/02/040307 . Registered on 18 February 2022. The tentative start date of participant recruitment for the trial will begin after 15th July 2022.

Public finance of universal routine childhood immunization in India: district-level cost estimates.

India's Universal Immunization Programme (UIP) is among the largest routine childhood vaccination programmes in the world. However, only an estimated 65% of Indian children under the age 2 years were fully vaccinated in 2019. We estimated the cost of raising childhood vaccination coverage to a minimum of 90% in each district in India. We obtained vaccine price data from India's comprehensive multi-year strategic plan for immunization. Cost of vaccine delivery by district was derived from a 2018 field study in 24 districts. We used propensity score matching methods to match the remaining Indian districts with these 24, based on indicators from the National Family Health Survey (2015-16). We assumed the same unit cost of vaccine delivery in matched pair districts and estimated the total and incremental cost of providing routine vaccines to 90% of the current cohort of children in each district. The estimated national cost of providing basic vaccinations-one dose each of Bacillus Calmette-Guerin (BCG) and measles vaccines, and three doses each of oral polio (OPV) and diphtheria, pertussis and tetanus vaccines-was $784.91 million (2020 US$). Considering all childhood vaccines included in UIP during 2018-22 (one dose each of BCG, hepatitis B and measles-rubella; four doses of OPV; two doses of inactivated polio; and three doses each of rotavirus, pneumococcal and pentavalent vaccines), the estimated national cost of vaccines and delivery to 90% of target children in each district was $1.73 billion. The 2018 UIP budget for vaccinating children, pregnant women and adults was $1.17 billion (2020 US$). In comparison, $1.73 billion would be needed to vaccinate 90% of children in all Indian districts with the recommended schedule of routine childhood vaccines. Additional costs for infrastructural investments and communication activities, not incorporated in this study, may also be necessary.

Cost of conducting Measles-Rubella vaccination campaign in India.

A Measles-Rubella (MR) vaccination campaign was launched in India in a phased manner in February 2017 to cover children aged 9 months to 15 years. As evidence on campaign vaccine delivery costs is limited, the delivery cost for MR campaign from a government provider perspective was estimated in four Indian states, namely, Assam, Gujarat, Himachal Pradesh, and Uttar Pradesh. Costs were calculated in top-down and bottom-up approaches using data collected from 84 sites at different administrative levels and immunization partners in the study states from August 2019 to March 2020. All costs were presented in 2019 US$ and Indian Rupee (INR). The financial cost per dose of the MR campaign including all partner support ranged from US$0.16 (INR 10.95) in Uttar Pradesh to US$0.34 (INR 24.13) in Gujarat. In Uttar Pradesh, the full economic cost per dose was US$0.87 (INR 61.39). The key financial cost drivers were incentives related to service delivery and supervision, the printing of reporting formats for record-keeping, social mobilization, and advocacy. The financial delivery cost per dose estimated was higher than the government pre-fixed budget per child for the MR campaign, probably indicating an insufficient budget. However, the study found underutilization of MR budget in two states and use of other sources of funding for the campaign indicating the need for proper utilization of the campaign budgets by the states. Unit cost information generated from this study will be useful for planning, cost projections, and economic analysis of future vaccination campaigns in India.

Return on investment of the electronic vaccine intelligence network in India.

The electronic vaccine intelligence network (eVIN) was introduced by India's Ministry of Health and Family Welfare in 12 states and was implemented by the United Nations Development Programme through the Gavi health system strengthening support during 2014-17 to replace the traditional paper-based cold-chain management system with an electronic vaccine logistics management system. An economic assessment was conducted as part of the overall assessment of eVIN. The objective of the economic assessment was to conduct a return on investment analysis of eVIN implementation. Return on investment was defined as the ratio of total benefits (savings) from eVIN to total investment in eVIN. All costs were calculated in 2020 prices and reported in Indian rupees (1 US dollar = INR 74.132). A one-rupee investment in eVIN led to a return of INR 0.52 for traditional vaccines. The highest cost savings from eVIN was from better vaccine stock management. When same percentage of savings from the new vaccines were incorporated into the analysis, one-rupee investment in eVIN led to a return of INR 1.41. In the future, when only recurrent costs will exist, the return from eVIN will be even higher: a one-rupee investment in eVIN will yield a return of INR 2.93. The assessment of eVIN showed promising results in streamlining the vaccine flow network and ensuring equity in vaccine stock management along with good return on investment; hence, there was a rapid expansion of eVIN in all 731 districts across 36 states and union territories in the country.

The incremental cost of improving immunization coverage in India through the Intensified Mission Indradhanush programme.

Intensified Mission Indradhanush (IMI) was a strategic endeavour launched by the Government of India aiming to achieve 90% full immunization coverage in the country by 2018. The basic strategy of this special drive involved identifying missed children and vaccinating them in temporary outreach sites for 1 week over consecutive 4-month period starting from October 2017. This study estimated the incremental economic and financial cost of conducting IMI in India from a government provider perspective. Five states-Assam, Bihar, Maharashtra, Rajasthan and Uttar Pradesh were purposefully selected because of high concentration of IMI activities. The stratified random sample of 40 districts, 90 sub-districts and 289 sub-centres were included in this study. Cost data were retrospectively collected at all levels from administrative records, financial records and staff interviews involved in IMI. The weighted incremental economic cost per dose (including vaccine costs) was lowest in Uttar Pradesh (US$3.45) and highest in Maharashtra (U$12.23). Incremental economic cost per IMI dose was found to be higher than a recent routine immunization costing study by Chatterjee and colleagues in 2018, suggesting that it requires additional resources to immunize children through an intensified push in hard-to-reach areas. Incremental financial cost of the IMI programme estimated in this study will be helpful for the government for any future planning of such special initiative. The reasons for variation of unit costs of IMI across the study districts are not known, but lower baseline coverage, high population density, migration, geography and terrain and vaccinating small numbers of children per session could account for the range of findings. Further analysis is required to understand the determinants of cost variations of the IMI programme, which may aid in better planning and more efficient use of resources for future intensified efforts.

Impact of campaign-style delivery of routine vaccines: a quasi-experimental evaluation using routine health services data in India.

The world is not on track to achieve the goals for immunization coverage and equity described by the World Health Organization's Global Vaccine Action Plan. Many countries struggle to increase coverage of routine vaccination, and there is little evidence about how to do so effectively. In India in 2016, only 62% of children had received a full course of basic vaccines. In response, in 2017-18 the government implemented Intensified Mission Indradhanush (IMI), a nationwide effort to improve coverage and equity using a campaign-style strategy. Campaign-style approaches to routine vaccine delivery like IMI, sometimes called 'periodic intensification of routine immunization' (PIRI), are widely used, but there is little robust evidence on their effectiveness. We conducted a quasi-experimental evaluation of IMI using routine data on vaccine doses delivered, comparing districts participating and not participating in IMI. Our sample included all districts that could be merged with India's 2016 Demographic and Health Surveys data and had available data for the full study period. We used controlled interrupted time-series analysis to estimate the impact of IMI during the 4-month implementation period and in subsequent months. This method assumes that, if IMI had not occurred, vaccination trends would have changed in the same way in the participating and not participating districts. We found that, during implementation, IMI increased delivery of 13 infant vaccines, with a median effect of 10.6% (95% confidence interval 5.1% to 16.5%). We did not find evidence of a sustained effect during the 8 months after implementation ended. Over the 12 months from the beginning of implementation, we estimated reductions in the number of under-immunized children that were large but not statistically significant, ranging from 3.9% (-6.9% to 13.7%) to 35.7% (-7.5% to 77.4%) for different vaccines. The largest effects were for the first doses of vaccines against diphtheria-tetanus-pertussis and polio: IMI reached approximately one-third of children who would otherwise not have received these vaccines. This suggests that PIRI can be successful in increasing routine immunization coverage, particularly for early infant vaccines, but other approaches may be needed for sustained coverage improvements.

An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme.

BACKGROUND: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75-95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. METHODS: We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived-a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. EXPECTED OUTCOMES: The primary study outcome is the difference in mean behaviour scores at 12 months in the combined 'high-risk' and 'non-high-risk' cohort and the mean difference in PHQ-9 scores at 12 months in the 'high-risk' cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. SIGNIFICANCE: The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.

Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India.

BACKGROUND: Suicide is a major public health challenge globally and specifically in India where 36.6% and 24.3% of all suicides worldwide occur in women and men, respectively. The United Nations Sustainable Development Goals uses suicide rate as one of two indicators for Target 3.4, aimed at reducing these deaths by one third by 2030. India has no examples of large-scale implementation of evidence-based interventions to prevent suicide; however, there is a sizeable evidence base to draw on for suicide prevention strategies that have been piloted in India or proven to be effective regionally or internationally. METHOD: The SPIRIT study is designed as a cluster-randomized superiority trial and uses mixed methods to evaluate the implementation, effectiveness and costs of an integrated suicide prevention programme consisting of three integrated interventions including (1) a secondary-school-based intervention to reduce suicidal ideation among adolescents, (2) a community storage facility intervention to reduce access to pesticides and (3) training for community health workers in recognition, management, and appropriate referral of people identified with high suicidal risk. DISCUSSION: Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India. Examination of implementation processes throughout the trial will also help to prepare a roadmap for policymakers and researchers looking to implement suicide prevention interventions in other countries and at scale. TRIAL REGISTRATION: Clinical Trial Registry of Indian Council of Medical Research, India: CTRI/2017/04/008313. Registered on 7 April 2017. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18256&EncHid=&userName=SPIRIT Trial registry was last modified on 28 June 2019.

Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India.

BACKGROUND: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide a package of community-based interventions for mental health, including evidence-based counseling for persons with common mental disorders (CMD). METHODS: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial is implemented across 10 sub-blocks (645 villages) in Mehsana district in the state of Gujarat, with a catchment area of 1.52 million rural adults. There are 56 primary health centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each. The intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at a 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the World Health Organization's Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire (GAD-7), and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model is employed for binary outcomes and linear mixed effects model for continuous outcomes. A Return on Investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project. DISCUSSION: Stepped wedge designs are increasingly used a design to evaluate the real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a low- and middle-income country evaluating the impact of the implementation of a community mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in low- and middle-income countries. TRIAL REGISTRATION: The trial is registered prospectively with the Clinical Trial Registry in India and the Clinical Trial Registry number- CTRI/2017/03/008139. URL http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=70845.17209. Date of registration- 20/03/2017.

A home-based, primary-care model for epilepsy care in India: Basis and design.

OBJECTIVES: A cluster-randomized trial of home-based care using primary-care resources for people with epilepsy has been set up to optimize epilepsy care in resource-limited communities in low- and middle-income countries. The primary aim is to determine whether treatment adherence to antiepileptic drugs is better with home-based care or with routine clinic-based care. The secondary aims are to compare the effects of the two care pathways on seizure control and quality of life. METHODS: The home-based intervention comprises epilepsy medication provision, adherence reinforcement, and epilepsy self-management and stigma management guidance provided by an auxiliary nurse-midwife equivalent. The experimental group will be compared to a routine clinic-based care group using a cluster-randomized design in which the unit of analysis is a cluster of 10 people with epilepsy residing in an area cared for by a single accredited government grass-roots health care worker. The primary outcome is treatment adherence as measured by monthly tablet counts supplemented by two self-completed questionnaires. The secondary outcomes include monthly seizure frequency, time to first seizure (in days) after enrollment, proportion of patients experiencing seizure freedom for the duration of the study, and quality of life measured by the "Personal Impact of Epilepsy Scale," all assessed by an independent study nurse. RESULTS: The screening phase and neurologic evaluations and randomizations have been recently completed and follow-up is underway. SIGNIFICANCE: The results of the trial are likely to have substantial bearing on the development of governmental policies and strategies to provide coverage and care for patients with epilepsy in resource-limited countries.