Magnitude and determinants of psychological morbidities among pregnant women: Results from a pregnancy cohort in rural Central India.

Background: Psychological morbidities are one of the emerging global health problems. It affects a considerable number of ante-natal women leading to consequences during the postnatal period as well. We conducted this research to study the magnitude and determinants of psychological morbidities during pregnancy. Methods: In this study, we included 650 pregnant women from an established cohort of 2500 pregnant women and assessed the psychological morbidities among them using the GMHAT/PC tool. Results: The overall prevalence of psychological morbidities during pregnancy was 14.6%, with anxiety and depression being the leading ones. Low education levels, lower socio-economic status, unintended pregnancy, complicated previous pregnancy, lack of family and social support, and domestic violence increased the odds of psychological morbidity. On Multivariate logistic regression, Low education levels increased the odds to more than twice [illiterate/primary schooling OR: 4.00, p = 0.026; secondary schooling OR: 2.64, p = 0.034; high school OR: 2.60, p = 0.033] unintended pregnancy [OR: 1.91, p = 0.043] and lack of family support [OR: 7.19, p < 0.001] increased the odds of psychological morbidity among pregnant women. Conclusion: Bringing these issues to the mainstream and addressing them by developing interventions to address them during the lifecycle of a female will help to prevent episodes of psychological stress and morbidity among pregnant females.

Effectiveness of Japanese encephalitis vaccination among children in central India.

Japanese encephalitis (JE) disease among children continues in central India despite vaccination implemented in the routine immunization program. Therefore, we planned to estimate the JE vaccination effectiveness among children by undertaking a 1:2 individually-matched population-based case-control study from August 2018 to October 2020. The laboratory-confirmed JE cases aged 1-15 years were enrolled along with neighborhood controls without fever and encephalitis matched on the residence area, age and sex. The JE vaccination history was enquired from parents and verified independently from the vaccination cards available at home and records at health facilities. We enrolled 35 JE cases and 70 matched controls. The vaccination effectiveness of 86.7% (95% confidence interval [CI]: 30.8-94.7) was estimated on the per-protocol analysis of 31 case-control sets. The screening method provided an effectiveness of 89.5% (CI: 78.9-94.7) on using the population vaccination coverage of 90% reported earlier in the same area. In conclusion, JE vaccination offered a moderate level of protection among children in JE medium-endemic central India, similar to reports from high-endemic areas in India. The operational aspects of vaccination program implementation need to be evaluated to assess the impact of vaccination on the disease burden of JE in medium-endemic regions of India.

"We are working for seven days a week" :Time motion study of accredited social health activists from central India.

Background: The role of Accredited Social Health Activist (ASHA) the key worker is primely surrounded to be mainly a link-worker or facilitator, a community health worker, and a social activist under National Rural Health Mission (NRHM). This study was conducted to study the workload and work pattern of ASHAs and identify the causes for improving work. Methods: This was an observational cross-sectional study conducted using a time-motion study as the tool among seventeen ASHAs from two primary health centers (PHC) in central India for four months. An ASHA's work pattern and workload were studied by constructing a 24-h recall. An focus group discussion (FGD) was conducted with the ASHAs to identify the factors affecting their effective functioning, after which content analysis was done. Result: It was observed that activities under National programs consumed most of the time of ASHAs, followed by Maternal-Child Health (MCH) activities and Register maintenance. There was no homogenous work distribution among ASHAs. In content analysis, 30 concepts were categorized into four themes (responses from villages- an important drive, work pressure, survey a double-edged sword, demands of ASHAs). Conclusion: We conclude that the ASHAs are overburdened, and hence, not effectively utilizing their role as social activists. Clarity about job responsibilities, training, support, and coordination among seniors, frontiers trust-building can improve their work efficiency.

Coverage of Japanese encephalitis routine vaccination among children in Central India.

BACKGROUND: We aimed to estimate the coverage of Japanese encephalitis (JE) vaccination in central India to help explain the continued occurrence of JE disease despite routine vaccination. METHODS: We implemented a 30-cluster survey for estimating the coverage of JE vaccination in the medium-endemic areas implemented with JE vaccination in central India. The parents were enquired about the uptake of the JE vaccine by their children aged 2 to 6 years, followed by verification of the immunization cards at home along with reasons for non-vaccination. Vaccination coverage was reported as a percentage with 95% confidence intervals. RESULTS: We estimated high coverage of live-attenuated SA 14-14-2 JE vaccination in Maharashtra (94.8%, 95% CI 92.7-96.3) and Telangana (92.8%, 90.0-94.9). The vaccination card retention was 90.3% in Maharashtra and 70.4% in Telangana state. There were no gender differences in coverage in both states. A similar level of JE vaccination coverage was observed during the year 2013 to 2021 in both states. In Maharashtra, the maximum age-wise coverage was 96.6% in the >60 months age category, whereas in Telangana it was in the <24 months age category (97.2%). The timeliness of JE vaccination was appropriate and similar in both states. We found very good agreement between JE and Measles-Rubella vaccinations administered simultaneously. The reasons for non-vaccination were the shortage of vaccines and the parental migration for work. CONCLUSIONS: The coverage of Japanese encephalitis vaccination was high in medium-endemic regions in central India. Vaccination effectiveness studies may help further explain the continued incidence of Japanese encephalitis. This article is protected by copyright. All rights reserved.

Scrub typhus in urban areas of Wardha district in central India.

Background & objectives: Scrub typhus caused by Orientia tsutsugamushi presents as acute undifferentiated fever and can be confused with other infectious causes of fever. We studied scrub typhus as part of a study on hospital-based surveillance of zoonotic and vector-borne zoonotic diseases at a tertiary care hospital located in the Wardha district, Maharashtra, India. We report here descriptive epidemiology and climatic factors affecting scrub typhus. Methods: Patients of any age and sex with fever of ≥5 days were enrolled for this study. Data on sociodemographic variables were collected by personal interviews. Blood samples were tested by IgM ELISA to diagnose scrub typhus. Confirmation of scrub typhus was done by indirect immunofluorescence assay for IgM (IgM IFA). The climatic determinants were determined using time-series Poisson regression analysis. Results: It was found that 15.9 per cent of the study participants were positive for scrub typhus by IgM ELISA and IgM IFA, both. Positivity was maximum (23.0%) in 41-60 yr of age and more females were affected than males (16.6 vs. 15.5%). Farmworkers were affected more (23.6%) than non-farm workers (12.9%). The disease positivity was found to be high in monsoon and post-monsoon seasons (22.9 and 19.4%) than in summer and winter. Interpretation & conclusions: There were three hot spots of scrub typhus in urban areas of Wardha district. Rainfall and relative humidity in the previous month were the significant determinants of the disease.

Reflection and peer feedback for augmenting emotional intelligence among undergraduate students: A quasi-experimental study from a rural medical college in central India.

Background: Professionalism is the foundation of the doctor-patient relationship with emotional competency at its core. This competency is based on emotional intelligence (EI), contributing to effective work performance. As EI is reasonably new in health professions education in India, this study was conducted to assess the effect of reflection and peer feedback on EI scores among undergraduate medical students and explore facilitating and hindering factors for augmenting EI. Methods: This pre- and post interventional study was conducted among 94 final-year (Part I) medical students from a rural medical college in Central India. Baseline assessment of EI scores was done using a self-reported validated EI scale, and then, a mini-workshop was conducted to sensitize students on EI and to train them in writing reflection and giving peer feedback. Between the pretest and posttest, students were asked to write weekly reflection and take monthly feedback from the "peer" of their choice. Posttest assessment was done at 1 week, 1 month, and 3 months. Force-field analysis was undertaken with 10 students each with highest and lowest EI scores to assess facilitating and hindering factors. Results: There was a significant improvement (P < 0.0001) in the EI scores at each subsequent time point from baseline. Students who were male, from nuclear families and considered themselves spiritual had significantly higher median EI scores. Students reported self-motivation, social support, and openness to learn new things as enabling forces for augmenting EI. Hindering factors were time constraint and lack of mutual trust in the relationship between students. Discussion: Based on the findings, it can be concluded that personal introspection methods such as self-reflection and peer feedback help to improve the EI of undergraduate students. Therefore, it is imperative that the students are trained in these skills for building their emotional competencies.

Understanding the Psychosocial Impact of Oral Cancer on the Family Caregivers and Their Coping up Mechanism: A Qualitative Study in Rural Wardha, Central India.

BACKGROUND: A family caregiver is the one who provides care to their near and dear one who is suffering from some debilitating disease like oral cancer. Apart from providing physical care, they also provide emotional and financial support to their close relatives. They can be the patient's spouse, children, and siblings. This study was, hence, designed to understand the psychosocial impact of caregivers of oral cancer patients. METHODOLOGY: This was a qualitative study using in-depth interviews of 24 purposively chosen family caregivers irrespective of age, sex, and relationship with patients, who provided deep insight into the psychosocial impact of the disease on themselves during caregiving of their loved ones and how they coped with it. Interviews were taken in Hindi, in the houses of caregivers. Care was taken to maintain utmost privacy while taking the interviews, which were either audio recorded or noted down. Informed written consent was obtained from participants before the start of the study. Themes were evolved from the interviews and content analysis was performed using ATLAS.ti. RESULTS: Six themes emerged after data analysis. Those were the impact on physical health and lifestyle, emotional impact, impact on family and social relationship, impact on financial and work status, improvement of hospital services, spiritual concern, and acceptance of the disease. A concept map was made to provide a vivid explanation of how oral cancer caused these impacts on caregivers and their interrelationship. CONCLUSION: Caregiving is not an easy job. This study recommends extra care to be taken in preparing them for caregiving to the oral cancer patients with adequate knowledge of the disease process and its consequences along with counseling facilities in the hospital to address the different psychosocial needs of the patients.

Socio-demographic determinants of out-of-pocket health expenditure in a rural area of Wardha district of Maharashtra, India.

Background & objectives: In India, health expenditure accounts for less than 5 per cent of the Gross Domestic Product and the level of out-of-pocket (OOP) spending is 69.5 per cent of total health expenditures. OOP expenditure exacerbates poverty and has a negative impact on equity and can increase the risk of vulnerable groups slipping into poverty. This study was conducted to estimate the OOP expenditure on health and catastrophic health expenditure and their socio-demographic determinants in a rural area of Maharashtra, India. Methods: This was a prospective observational study involving monthly follow up visits, done in 180 households of three villages under a primary health centre in Wardha district, India. Results: Of the 180 families, 18.9 per cent had catastrophic health expenditure over a period of one year. The median total out-of-pocket health expenditure was '1105.00 with median medical expenditure being '863.85 and median non-medical health expenditure being '100.00. A total of 151 (83.9%) had enough money, 27 (15%) borrowed money and two (1.1%) of them sold assets. The significant correlates for the ratio of out-of-pocket health expenditure to total annual income of the family were the occupation of head of family, caste category and type of village. The significant correlate for catastrophic health expenditure was type of village. Interpretation & conclusions: Around one-fifth of the households had catastrophic health expenditure. People with no healthcare facility located in their village had higher odds of having catastrophic health expenditure. Private providers were preferred for the treatment of acute illnesses and medical college hospitals for hospitalization.

Evaluating Maternal Health Services Within the Reproductive, Maternal, Newborn, Child Health and Adolescents (RMNCH+A) Framework Amidst the COVID-19 Pandemic in Rural India: A Comprehensive Mixed-Methods Analysis.

Background Around half of the pregnant women in India do not receive full antenatal care. During the year 2020, routine health services were further affected by COVID-19. This study was conducted to assess the effect of the pandemic on the delivery/utilization of reproductive, maternal, newborn, child health, and adolescent (RMNCH+A) services. Methodology The study, conducted in Wardha district, Maharashtra, from July to December 2020, aimed to assess maternal health. In Wardha block, 200 pregnant and postnatal women were surveyed using a multistage sampling approach. Adequate knowledge was gauged through Mother and Child Protection Card comprehension. Health system data for April to December 2020 was compared with 2019 district-wide. In-depth interviews were conducted with beneficiaries, including pregnant and post-natal women and healthcare workers. The qualitative inquiries involved medical officers, supervisory staff, community health officers, an auxiliary nurse and midwife (ANMs), Taluka Health Officers, and focus group discussions with accredited social health activists (ASHA), Anganwadi workers (AWW), and Village Health Nutrition and Sanitation Committee members. Results Essential services were delivered to both antenatal and postpartum women, though family planning services and health education were the worst affected. Among the survey respondents, 75% of the post-partum women were not using any contraceptives. District-wide coverage of post-abortion/MTP contraception fell by around 90% as compared to the previous year. The most common difficulties faced by the respondents in availing of the services were related to finances and arranging transport to visit health facilities. Conclusion Learning from the current pandemic for system strengthening, adequate manpower, and planning to prevent disruption of essential services and promoting e-health and m-health initiatives may prevent such catastrophic events in the future from affecting the delivery of routine services.

Effect of Inclusive Early Childhood Development (IECD) on Growth and Development of Children in the Rural Part of the Central India: A Cohort Study.

OBJECTIVES: To compare the difference between the growth and developmental status of the children who were residing in the area where Inclusive Early Childhood Development (IECD) project was being implemented and who had received interventions through trained Anganwadi workers (Frontline workers) under Integrated Child Development Services (ICDS) scheme with the children who had not received the Inclusive ECD project interventions. METHODS: It was a mixed method cohort study, nested in an ongoing project in a medical college in which Inclusive ECD was used as an intervention through International Guide for Monitoring Child Development (GMCD) which is a tool for both monitoring and assessment with the help of existing government structures and personnel such as Anganwadi workers, Anganwadi supervisors and their contact points with communities. A sample of 200 children was selected; 100 each from intervention group (IECD cohort) and comparison group (Usual care cohort) and were followed till the child became 2 y of age. RESULTS: IECD intervention showed statistically significant effect on weight (p = 0.04) and height (p = 0.03) of the IECD cohort. Overall developmental assessment showed that the identified developmental issues (Concerns + Delays) were approximately half in IECD cohort (9.67% + 5.37% = 15.04%) as compared to usual care cohort (17.20% + 11.82% = 29.02%). The results from binomial logistic regression performed for developmental outcomes were statistically significant (p = 0.04) suggesting that children with IECD intervention have lower odds of developing developmental issues. CONCLUSIONS: The study indicates that it is possible to implement IECD interventions through frontline workers, which significantly improves the growth and development of the children.

Methodology for adapting a co-created early childhood development intervention and implementation strategies for use by frontline workers in India and Guatemala: a systematic application of the FRAME-IS framework.

There is little evidence on optimizing the effectiveness and implementation of evidence-based early childhood development (ECD) interventions when task-shifted to frontline workers. In this Methods Forum paper, we describe our adaptation of the International Guide for Monitoring Child Development (GMCD) for task-shifting to frontline workers in Guatemala and India. In 2021-2022, implementers, trainers, frontline workers, caregivers, and international GMCD experts collaborated to adapt the GMCD for a task shifted implementation by frontline workers. We used an eight-step co-creating process: assembling a multidisciplinary team, training on the existing package, working groups to begin modifications, revision of draft modifications, tailoring of visual materials and language, train-the-trainers activities, pilot frontline worker trainings, final review and feedback. Preliminary effectiveness of adaptations was evaluated through narrative notes and group-based qualitative feedback following pilot trainings with 16 frontline workers in India and 6 in Guatemala. Final adaptations included: refining training techniques to match skill levels and learning styles of frontline workers; tailoring all visual materials to local languages and contexts; design of job aids for providing developmental support messages; modification of referral and triage processes for children in need of enhanced support and speciality referral; and creation of post-training support procedures. Feedback from pilot trainings included: (1) group consensus that training improved ECD skills and knowledge across multiple domains; and (2) feedback on ongoing needed adjustments to pacing, use of video-based vs. role-playing materials, and time allocated to small group work. We use the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) framework to document our adaptations. The co-creating approach we use, as well as systematic documentation of adaptation decisions will be of use to other community-based early childhood interventions and implementation strategies.

Main findings: The International Guide for Monitoring Child Development, an early childhood development support and monitoring tool, was successfully adapted for use by frontline workers in rural India and Guatemala.Added knowledge: Our Methods Forum paper uses a detailed framework to document the collaborative, co-creating process used and the adaptive decisions taken.Global health impact for policy and action: Evidence on how best to adapt and optimize early childhood interventions for frontline workers will be useful or scaling up support for children globally.

Social Support Status of the Elderly Population in Selected Villages in a Central India District.

Background: Social support has been considered an important social determinant of health because it assists individuals in reaching their physical and emotional needs. The current study was proposed to assess the social support status of the elderly in rural central India. Material and Methods: This observational cross-sectional study was conducted in selected four villages in central India on 460 elderly individuals for 5 months (Aug-Dec 2021) with the use of the MSPSS (Multi-dimensional Scale Perceived Social Support) questionnaire. Univariate analysis and multivariate analysis were carried out using R software. Result: Out of 460, 37 (8.04%) of the elderly were found to have low, 177 (38.47%) were moderate, and 246 (53.48%) were having high social support. The result showed age and education of the elderly were significantly associated with social support. Conclusion: Intergenerational activities, provision and strengthening of social platforms, and the addition social support components with comprehensive geriatric assessment can improve the current status.

School Health Services in India: Status, Challenges and the Way Forward.

Schools provide a crucial platform for health and well-being interventions targeting children and adolescents. Early promotive and preventive initiatives are vital for enabling children and adolescents to reach their optimal potential, thereby adding to the country's social return-on-investment, creating a favourable demographic dividend. This review analyses the evolution of school health initiatives in India, including the current curriculum proposed under the Ayushman Bharat program. The manuscript highlights the challenges, and gaps in implementation of the current school health programs and proposes potential pathways for bridging these gaps for promotion of adolescent well-being. The review also discusses the concept of Health Promoting Schools and suggests adaptations and key recommendations to Indian context regarding 'how' to translate it into on-field reality based on the appraisal of successful case studies from other countries. Though India started school health services more than 100 y ago, the school health programmes in most Indian states are weak and fragmented, with piecemeal health screening with minimal focus on health promotion and well-being. The recently launched School Health and Wellness initiative under the Ayushman Bharat program has lots of promise. However, it needs to be translated into effective implementation to prevent it from meeting the fate of its forerunner programs. The school health program needs to move beyond the screening centric approach and be aspirational and holistic in nature focusing upon the overall well-being of the adolescents. Concerted efforts through intersectoral convergence are needed to optimally utilise the platforms of schools for promotion of adolescent well-being.

Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0-2-month old low-birth weight infants in India: the ProSPoNS trial.

INTRODUCTION: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. METHODS AND ANALYSIS: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost-utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. ETHICS AND DISSEMINATION: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. REGISTRATION: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. TRIAL REGISTRATION NUMBER: CTRI/2019/05/019197; Clinical Trial Registry.

Vitalizing Community for Health Promotion Against Modifiable Risk Factors of Noncommunicable Diseases (V-CaN) in Rural Central India: Protocol for a Hybrid Type II Implementation Effectiveness Trial.

BACKGROUND: Low- and middle-income countries are facing the emerging burden of chronic noncommunicable diseases (NCDs). Apart from loss of human lives and premature deaths, NCDs result in huge costs for treatment to individuals and the health system. Although NCDs develop in later life, the risk factors begin at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. OBJECTIVE: This study aims to develop, implement, and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanisms of Village Health Nutrition and Sanitation Committees (VHNSCs), women's self-help groups (SHGs), and schools on modifiable risk factors for NCDs among young people aged 10-30 years. METHODS: The proposed type II hybrid effectiveness implementation cluster randomized field trial will be conducted in the catchment area of 4 primary health centers (PHCs) in Wardha district, India, comprising 100 villages with a population of 144,000. Each PHC will be randomly allocated to one of the 3 intervention arms or the control arm. The 3-intervention arm PHCs will utilize a unique strategy with either VHNSC or SHG members or school students as change agents for health action against common modifiable NCD risk factors. This study will be implemented in 3 phases from January 2022 to December 2024. First, the preparatory phase for baseline assessments includes anthropometry, behavioral and biochemical risk factors for NCDs, and participatory development of the health promotion intervention modules. Second, the implementation phase will focus on capacity building of the change agents and implementation of the participatory health promotion initiative. The implementation will include organization of community-based events, 6-monthly participatory assessment of change, and preparation of a sustainability and exit plan toward the end of this phase. Third, the evaluation phase will consist of studying the effectiveness of each intervention strategy in the reduction of risk factor prevalence at the population level. RESULTS: We will assess 12,000 (3000 in each arm) randomly selected individuals for behavioral risk factors and 1600 (400 in each arm) individuals for biochemical risk factors during baseline as well as endline assessments. Difference in differences, ANOVA or multivariate analysis of covariance, and regression analysis will be performed to assess the effectiveness of the interventions. Qualitative methods such as focus group discussions and stories of change will be documented and analyzed using thematic framework analysis. The implementation outcomes will be reported using the PRISM (Practical Robust Implementation and Sustainability Model) RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The results are expected to be published by mid-2025. CONCLUSIONS: This study will show the magnitude of risk factors for NCDs, its determinants, feasibility, effectiveness of community-based interventions, and health promotion models for NCD prevention. TRIAL REGISTRATION: Clinical Trials Registration India CTRI/2020/10/028700; https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47597&EncHid=&userName=V-CaN. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42450.

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India: A Phase 2-3 Randomized Clinical Trial.

Importance: The recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown. Objective: To assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety in comparison with placebo. Design, Setting, and Participants: This phase 2-3 observer-blind randomized clinical trial was conducted in 2 cohorts, children (aged 2 to 11 years) and adolescents (aged 12 to 17 years) between August 2021 and August 2022. Participants were randomized 3:1 to SII-NVX-CoV2373 or placebo and monitored for 179 days. The participants, study team, and laboratory staff were blinded. This was a multicenter study conducted across 10 tertiary care hospitals in India. Exclusion criteria included previous COVID-19 infection or vaccination, immunocompromised condition, and immunosuppressive medications. Interventions: Two doses of 0.5-mL SII-NVX-CoV2373 or placebo were administered intramuscularly on days 1 and 22. Main Outcomes and Measures: Primary outcomes were geometric mean titer ratio of both anti-spike (anti-S) IgG and neutralizing antibodies (NAbs) between both pediatric age groups to that of adults on day 36. Noninferiority was concluded if the lower bound of 95% CI of this ratio was greater than 0.67 for each age group. Both the antibodies were assessed for the index strain and for selected variants at various time points. Solicited adverse events (AEs) were recorded for 7 days after each vaccination, unsolicited AEs were recorded for 35 days, and serious AEs and AEs of special interest were recorded for 179 days. Results: A total of 460 children in each age cohort were randomized to receive vaccine or placebo. The mean (SD) age was 6.7 (2.7) years in the child cohort and 14.3 (1.6) years in the adolescent cohort; 231 participants (50.2%) in the child cohort and 218 in the adolescent cohort (47.4%) were female. Both anti-S IgG and NAb titers were markedly higher in the SII-NVX-CoV2373 group than in the placebo group on both day 36 and day 180. The geometric mean titer ratios compared to those in adults were 1.20 (95% CI, 1.08-1.34) and 1.52 (95% CI, 1.38-1.67) for anti-S IgG in adolescents and children, respectively; while for NAbs, they were 1.33 (95% CI, 1.17-1.50) and 1.93 (95% CI, 1.70-2.18) in adolescents and children, respectively, indicating noninferiority. SII-NVX-CoV2373 also showed immune responses against variants studied. Injection site reactions, fever, headache, malaise, and fatigue were common solicited AEs. There were no AEs of special interest and no causally related serious AEs. Conclusions and Relevance: SII-NVX-CoV2373 was safe and well tolerated in children and adolescents in this study. The vaccine was highly immunogenic and may be used in pediatric vaccination against COVID-19. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2021/02/031554.

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study.

Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. Methods: This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants were randomized 3:1 to SII-NVX-CoV2373 or placebo. In phase 3, 1400 participants were randomized 3:1 to SII-NVX-CoV2373 or NVX-CoV2373 (940 safety cohort and 460 immunogenicity cohort). Two doses of study products (SII-NVX-CoV2373, NVX-CoV2373 or placebo) were given 3 weeks apart. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 to NVX-CoV2373 in terms of geometric mean ELISA units (GMEU) ratio of anti-S IgG antibodies 14 days after the second dose (day 36) and to determine the incidence of causally related serious adverse events (SAEs) through 180 days after the first dose. Anti-S IgG response was assessed using an Enzyme-Linked Immunosorbent Assay (ELISA) and neutralizing antibodies (nAb) were assessed by a microneutralization assay using wild type SARS CoV-2 in participants from the immunogenicity cohort at baseline, day 22, day 36 and day 180. Cell mediated immune (CMI) response was assessed in a subset of 28 participants from immunogenicity cohort by ELISpot assay at baseline, day 36 and day 180. The total follow-up was for 6 months. Trial registration: CTRI/2021/02/031554. Findings: Total 1596 participants (200 in Phase 2 and 1396 in Phase 3) received the first dose. SII-NVX-CoV2373 was found non-inferior to NVX-CoV2373 (anti-S IgG antibodies GMEU ratio 0.91; 95% CI: 0.79, 1.06). At day 36, there was more than 58-fold rise in anti-S IgG and nAb titers compared to baseline in both the groups. On day 180 visit, these antibody titers declined to levels slightly lower than those after the first dose (13-22 fold-rise above baseline). Incidence of unsolicited and solicited AEs was similar between the SII-NVX-CoV2373 and NVX-CoV2373 groups. No adverse event of special interest (AESI) was reported. No causally related SAE was reported. Interpretation: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. Funding: SIIPL, Indian Council of Medical Research, Novavax.

Incidence of Japanese Encephalitis and Acute Encephalitis Syndrome Hospitalizations in the Medium-Endemic Region in Central India.

BACKGROUND: We estimated the incidence of Japanese encephalitis (JE) and acute encephalitis syndrome (AES) following routine immunization with the live-attenuated SA 14-14-2 JE vaccine. METHODS: We implemented enhanced surveillance of AES and JE hospitalizations in endemic districts in Maharashtra and Telangana States during 2015-2016 and 2018-2020. We estimated incidence and compared differences in the incidence of JE and AES between two states, and vaccinated and unvaccinated districts during two study periods. We also considered secondary data from public health services to understand long-term trends from 2007 to 2020. RESULTS: The annual AES incidence rate of 2.25 cases per 100,000 children in Maharashtra during 2018-2020 was significantly lower than 3.36 cases per 100,000 children during 2015-2016. The six JE-vaccinated districts in Maharashtra had significantly lower incidence rates during 2018-2020 (2.03, 95% CI 1.73-2.37) than in 2015-16 (3.26, 2.86-3.70). In addition, the incidence of both JE and AES in two unvaccinated districts was higher than in the vaccinated districts in Maharashtra. Telangana had a lower incidence of both JE and AES than Maharashtra. The AES incidence rate of 0.95 (0.77-1.17) during 2018-2020 in Telangana was significantly lower than 1.67 (1.41-1.97) during 2015-2016. CONCLUSIONS: The annual incidence rate of Japanese encephalitis was < 1 case per 100,000 children. It indicated accelerated control of Japanese encephalitis after routine immunization. However, the annual incidence of acute encephalitis syndrome was still > 1 case per 100,000 children. It highlights the need for improving surveillance and evaluating the impacts of vaccination.

Perceived burden, causes and consequences of adolescent pregnancy in the rural Maharashtra: a cultural domain analysis.

OBJECTIVES: The existing level of the early age pregnancy necessitates in-depth discussions and study. The objective of this study is to explore the perception of rural population regarding adolescent pregnancy with reference to the perceived burden, causes and consequences. METHODS: A cross-sectional study through cultural domain analysis using free listing and participatory learning and action (PLA) tool of ten seed analysis was used for exploring the perceptions of the community. Cognitive salience was estimated using the Sutrop (Su) index. RESULTS: The perceived burden of adolescent pregnancy was around 18%. Early marriage (Su index = 0.274), love/relationship (Su index = 0.246), pre-marital sex (Su index = 0.215), rape/incest (Su index = 0.162), and poor educational status (Su index = 0.152) were the salient causes of adolescent pregnancy. The salient consequences identified were weak baby (Su index = 0.170), social stigma (Su index = 0.124), excessive bleeding during delivery (Su index = 0.114), mother may die (Su index = 0.112) and abortion (Su index = 0.109). CONCLUSIONS: Teenage pregnancy is perceived as a problem by the community. The causes of teenage pregnancy in this setting are multi-dimensional and are deeply embedded in the system of local values, beliefs and practices.

Infectious causes of acute encephalitis syndrome hospitalizations in Central India, 2018-20.

BACKGROUND: We enhanced surveillance of hospitalizations of all ages for acute encephalitis syndrome (AES) along with infectious aetiologies, including the Japanese encephalitis virus (JEV). METHODS: From October 2018 to September 2020, we screened neurological patients for AES in all age groups in Maharashtra and Telangana States. AES cases were enrolled at study hospitals along with other referrals and sampled with cerebrospinal fluid, acute and convalescent sera. We tested specimens for non-viral aetiologies viz. leptospirosis, typhoid, scrub typhus, malaria and acute bacterial meningitis, along with viruses - JEV, Dengue virus (DENV), Chikungunya virus (CHIKV), Chandipura virus (CHPV) and Herpes simplex virus (HSV). RESULTS: Among 4977 neurological hospitalizations at three study site hospitals over two years period, 857 (17.2%) were AES. However, only 287 (33.5%) AES cases were eligible. Among 278 (96.9%) enrolled AES cases, infectious aetiologies were identified in 115 (41.4%) cases, including non-viral in 17 (6.1%) cases - leptospirosis (8), scrub-typhus (3) and typhoid (6); and viral in 98 (35.3%) cases - JEV (58, 20.9%), HSV (22, 7.9%), DENV (15, 5.4%) and CHPV (3, 1.1%). JEV confirmation was significantly higher in enrolled cases than referred cases (10.2%) (p < 0.05). However, the contribution of JEV in AES cases was similar in both children and adults. JE was reported year-round and from adjacent non-endemic districts. CONCLUSIONS: The Japanese encephalitis virus continues to be the leading cause of acute encephalitis syndrome in central India despite vaccination among children. Surveillance needs to be strengthened along with advanced diagnostic testing for assessing the impact of vaccination.