Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication. METHODS: The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done. DISCUSSION: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment. TRIAL REGISTRATION: The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

Delivery cost of the first public sector introduction of typhoid conjugate vaccine in Navi Mumbai, India.

Navi Mumbai Municipal Corporation (NMMC), a local government in Mumbai, India, implemented the first public sector TCV campaign in 2018. This study estimated the delivery costs of this TCV campaign using a Microsoft Excel-based tool based on a micro-costing approach from the government (NMMC) perspective. The campaign's financial (direct expenditures) and economic costs (financial costs plus the monetized value of additional donated or existing items) incremental to the existing immunization program were collected. The data collection methods involved consultations with NMMC staff, reviews of financial and programmatic records of NMMC and the World Health Organization (WHO), and interviews with the health staff of sampled urban health posts (UHPs). Three UHPs were purposively sampled, representing the three dominant residence types in the catchment area: high-rise, slum, and mixed (high-rise and slum) areas. The high-rise area UHP had lower vaccination coverage (47%) compared with the mixed area (71%) and slum area UHPs (76%). The financial cost of vaccine and vaccination supplies (syringes, safety boxes) was $1.87 per dose, and the economic cost was $2.96 per dose in 2018 US dollars. Excluding the vaccine and vaccination supplies cost, the financial delivery cost across the 3 UHPs ranged from $0.37 to $0.53 per dose, and the economic delivery cost ranged from $1.37 to $3.98 per dose, with the highest delivery costs per dose in the high-rise areas. Across all 11 UHPs included in the campaign, the weighted average financial delivery cost was $0.38 per dose, and the economic delivery cost was $1.49 per dose. WHO has recommended the programmatic use of TCV in typhoid-endemic countries, and Gavi has included TCV in its vaccine portfolio. This first costing study of large-scale TCV introduction within a public sector immunization program provides empirical evidence for policymakers, stakeholders, and future vaccine campaign planning.

A simple six-step guide to National-Scale Hypertension Control Program implementation.

Hypertension is the leading single preventable risk factor for death worldwide, and most of the disease burden attributed to hypertension weighs on low-and middle-income countries. Effective large-scale public health hypertension control programs are needed to control hypertension globally. National programs can follow six important steps to launch a successful national-scale hypertension control program: establish an administrative structure and survey current resources, select a standard hypertension treatment protocol, ensure supply of medication and blood pressure devices, train health care workers to measure blood pressure and control hypertension, implement an information system for monitoring patients and the program overall, and enroll and monitor patients with phased program expansion. Resolve to Save Lives, an initiative of global public health organization Vital Strategies, and its partners organized these six key steps and materials into a structured, stepwise guide to establish best practices in hypertension program design, launch, maintenance, and scale-up.

Cost-Effectiveness of Improved Hypertension Management in India through Increased Treatment Coverage and Adherence: A Mathematical Modeling Study.

Background: Despite the availability of effective and affordable treatments, only 14% of hypertensive Indians have controlled blood pressure. Increased hypertension treatment coverage (the proportion of individuals initiated on treatment) and adherence (proportion of patients taking medicines as recommended) promise population health gains. However, governments and other payers will not invest in a large-scale hypertension control program unless it is both affordable and effective. Objective: To investigate if a national hypertension control intervention implemented across the private and public sector facilities in India could save overall costs of CVD prevention and treatment. Methods: We developed a discrete-time microsimulation model to assess the cost-effectiveness of population-level hypertension control intervention in India for combinations of treatment coverage and adherence targets. Input clinical parameters specific to India were obtained from large-scale surveys such as the Global Burden of Disease as well as local clinical trials. Input hypertensive medication cost parameters were based on government contracts. The model projected antihypertensive treatment costs, avoided CVD care costs, changes in disability-adjusted life year (DALYs) and incremental cost per DALY averted (represented as incremental cost-effectiveness ratio or ICER) over 20 years. Results: Over 20 years, at 70% coverage and adherence, the hypertension control intervention would avert 1.68% DALYs and be cost-saving overall. Increasing adherence (while keeping coverage constant) resulted in greater improvement in cost savings compared to increasing coverage (while keeping adherence constant). Results were most sensitive to the cost of antihypertensive medication, but the intervention remained highly cost-effective under all one-way sensitivity analyses. Conclusion: A national hypertension control intervention in India would most likely be budget neutral or cost-saving if the intervention can achieve and maintain high levels of both treatment coverage and adherence.

Cross-sectional Serologic Assessment of Immunity to Poliovirus in Differential Risk Areas of India: India Seroprevalence Survey - 2014.

OBJECTIVE: To assess the seroprevalence against all three poliovirus serotypes in traditional high risk areas in Bihar, lowest routine immunization coverage areas in Madhya Pradesh and migrant population living in Mumbai urban slums. DESIGN: Cross-sectional Survey. SETTING: Subjects selected by house to house visit (community based) and transported to government health facilities for further study procedures. PARTICIPANTS: 1137 randomly selected healthy infants 6-11 months of age residing in the selected high-risk areas. METHODS: Serum samples from the study site were shipped to Enterovirus Research Centre (ERC), Mumbai to determine the neutralizing antibodies against all three poliovirus serotypes. Children with a reciprocal antibody titer ≥1:8 were considered seropositive to the specific poliovirus. RESULTS: Overall, seroprevalence in all the three study areas was 98%, 98% and 91% against poliovirus type-1, type-2 and type-3, respectively. Bihar had a seroprevalence of 99%, 99% and 92% against type-1, type-2 and type-3 respectively. Corresponding figures for Madhya Pradesh and Mumbai were 98%, 99% and 88% and 98%, 97% and 94%, respectively. CONCLUSION: The study found high seroprevalence against all three poliovirus types not only in the traditional high-risk areas for polio in India, but even in the areas known to have low routine immunization coverage and among the migratory clusters living in Mumbai urban slums. Type-2 seroprevalence was found to be high. These findings are reassuring against the threat of emergence of circulating vaccine derived polioviruses (cVDPVs) in the country subsequent to switch from trivalent oral polio vaccine to bivalent oral polio vaccine in the routine immunization schedule from April 2016.