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.

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.

Compensation in Neonatal Clinical Trials: A Perspective.

Well conducted clinical trials are the mainstay for generating evidence on preferred treatments. In order to adequately protect the interests of the trial participants, the Central Licensing Authority of India has formulated guidelines to determine the quantum of compensation in cases of regulatory clinical trial related injury or death. However, these guidelines do not address the nuances of trials recruiting children aged under 16 years, within which, neonates are the most vulnerable population. Thus, there is a need for addressing this lacuna in the current guidelines. This article examines the challenges in determining the quantum of compensation in neonatal clinical trials using the current formula, which is a corollary to the challenges faced by the authors in procuring clinical trial insurance for the Probiotic supplementation for Prevention of Neonatal Sepsis (ProSPoNS) trial. Further, it suggests a template for a differential formula using birthweight of infants, which is one of the many important factors impacting neonatal mortality.

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.

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.

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.

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.

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.

Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. METHODS: A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites. DISCUSSION: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019.

Qualitative Assessment of Life Skill Development of Adolescent Girls through Kishori Panchayat: An Adolescents for Health Action Model in Selected Villages of Rural Central India.

BACKGROUND: The "Adolescents for Health Action model," Kishori Panchayat (KP) is an innovative approach for mobilizing and empowering adolescent girls by enhancing their life skills by participating in various community health activities, a platform for interaction with peer-groups, villagers, community leaders, and health-care providers. AIM: The aim of the study is to follow-up the quantitative data regarding the effectiveness of KP in enhancing life skill education among adolescent girls who are members of KP compared to Non-KP girls. OBJECTIVES: The main objectives are: (1) to study the knowledge and perceptions regarding life skills among adolescent girls (12-18 years) of KP and non-KP and (2) to identify features of KP and related contextual factors that contributed to the outcome. METHODOLOGY: The qualitative study was carried out among 100 KP girls and non-KP girls, respectively (12-18 years), under 20 villages of rural Wardha district over 1-year period after obtaining consent in writing from participants and Institutional Ethics Committee. Focus group discussion was conducted in each village. Key informant interviews of social workers of KPs and school teachers conducted until data saturation. RESULTS: Findings suggest that KP girls had more knowledge and perception regarding life skills and their application compared to non-KP girls. Life skill education program by KP was found to be received positively by adolescent girls. CONCLUSION: Institutionalization of this can help in building a sustainable model for empowerment of adolescent girls.

Epidemiology of confirmed coronary heart disease among population older than 60 years in rural central India-A community-based cross-sectional study.

BACKGROUND: Three-fifths of total deaths in India are attributed to noncommunicable diseases, and coronary heart disease (CHD) is one of the dominant causes. There are only few studies available in India to find confirmed CHD by pragmatic approach. This study aims to find prevalence of confirmed CHD and its risk factors in rural community of central India. MATERIALS AND METHODS: This was a community-based cross-sectional study during 2013-2014 involving adults ≥60 years from 13 villages in rural central India. We screened CHD on the basis of history and standard 12-lead ECG. Apart from the past documentation of CHD, we diagnosed confirmed CHD in symptomatic patients or with resting ECG changes by means of echocardiography, exercise ECG test or coronary angiography whenever needed. RESULTS: We screened 1190 of 1415 individuals ≥60 years for CHD. Five hundred eighty were men and 610 were women. Diagnosis of CHD was confirmed in 61 individuals (29 men and 32 women). The prevalence of CHD in individuals older than 60 years was 51.3 per 1000 population. Hypertension was the only independent risk factor associated with CHD, whereas association of diabetes mellitus, obesity, socioeconomic status and smoking with CHD was not significant. CONCLUSION: Prevalence of confirmed CHD has increased in agrarian rural community in central India, which requires further studies to find out causative factors.

Nonalbuminuric chronic kidney disease: A dominant presentation in noncommunicable disease population of rural central India.

BACKGROUND: India has largest number of people with diabetes mellitus (DM), and hypertension (HTN) is expected to double in next 25 years, which are common causes of chronic kidney disease (CKD). The focus for prevention of end-stage renal disease has shifted to detection of the iceberg of DM and HTN and its adequate control. Prevalence studies of CKD in India rural community are lacking. METHODOLOGY: We did community-based cross-sectional study with 3 monthly diagnostic camps in adults ≥20 years (n = 6278), from 13 villages for early detection of CKD in rural population around Sevagram in a group of noncommunicable disease (NCD) with DM, HTN, ischemic heart diseases (IHD), and stroke in year 2015-2016. RESULTS: Study achieved 87% (5440/6278) coverage for albuminuria screening. Prevalence of CKD in NCD population was 19.6% (220/1121) where 86% (181/220) were nonalbuminuric CKD. Prevalence of persistent albuminuria in the study population was 0.8% (45/5440); in NCD population (DM, HTN, IHD, and stroke), it was 2.8% (31/1121). Prevalence of CKD was 19% in HTN and 18.9% in diabetes. The prevalence of nonalbuminuric versus albuminuric CKD was 17.1% versus 1.9% (9 times) in hypertensive individuals and 11.3% versus 7.5% (1.5 times) in individuals with DM. CONCLUSION: Predominance of nonalbuminuric CKD in NCD participants raises suspicion of CKD with undetermined risk factors. Further studies are needed to find the prevalence of nonalbuminuric CKD in overall population and to find out if exposure of pesticides, chemical fertilizers over long duration play an important role in agrarian rural community.

Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.

OBJECTIVES: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Community setting in rural India. PARTICIPANTS: LBW infants aged 3-7 days. INTERVENTIONS: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. MAIN OUTCOME MEASURE: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. RESULTS: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). CONCLUSIONS: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants. TRIAL REGISTRATION NUMBER: The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).

More evidence on the impact of India's conditional cash transfer program, Janani Suraksha Yojana: quasi-experimental evaluation of the effects on childhood immunization and other reproductive and child health outcomes.

BACKGROUND: In 2005, India established a conditional cash transfer program called Janani Suraksha Yojana (JSY), to increase institutional delivery and encourage the use of reproductive and child health-related services. OBJECTIVE: To assess the effect of maternal receipt of financial assistance from JSY on childhood immunizations, post-partum care, breastfeeding practices, and care-seeking behaviors. METHODS: We use data from the latest district-level household survey (2007-2008) to conduct a propensity score matching analysis with logistic regression. We conduct the analyses at the national level as well as separately across groups of states classified as high-focus and non-high-focus. We carry out several sensitivity analyses including a subgroup analysis stratified by possession of an immunization card. RESULTS: Receipt of financial assistance from JSY led to an increase in immunization rates ranging from 3.1 (95%CI 2.2-4.0) percentage points for one dose of polio vaccine to 9.1 (95%CI 7.5-10.7) percentage points in the proportion of fully vaccinated children. Our findings also indicate JSY led to increased post-partum check-up rates and healthy early breastfeeding practices around the time of childbirth. No effect of JSY was found on exclusive breastfeeding practices and care-seeking behaviors. Effect sizes were consistently larger in states identified as being a key focus for the program. In an analysis stratified by possession of an immunization card, there was little to no effect of JSY among those with vaccination cards, while the effect size was much larger than the base case results for those missing vaccination cards, across nearly all immunization outcomes. CONCLUSIONS: Early results suggest the JSY program led to a significant increase in childhood immunization rates and some healthy reproductive health behaviors, but the structuring of financial incentives to pregnant women and health workers warrants further review. Causal interpretation of our results relies on the assumption that propensity scores balance unobservable characteristics.

Effect of improvement of pre-school education through Anganwadi center on intelligence and development quotient of children.

OBJECTIVE: To find usefulness of a package of interventions to improve preschool education through Anganwadi centers on psychosocial development of children. METHODS: A case-control study was undertaken to evaluate an intervention. Eight Anganwadi centers were selected using simple random sampling out of sixteen Anganwadi centers in Talegaon PHC area where intervention was done. Ten children in age group of 4-6 years were selected randomly from each of the eight Anganwadi center in intervention arm. For each child from intervention arm, one agematched child was selected from the matched Anganwadi center. For each subject, Intelligence Quotient and Development Quotient were assessed. RESULTS: Mean Development Quotient (DQ) and Intelligence Quotient (IQ) values were higher among children in intervention Anganwadi centers (16.2 points for DQ and 10.2 points for IQ). This difference was found statistically significant (p = <0.01). Mean DQ among boys was found 10.1 points higher than that among the girls in control arm, this was statistically significant. According to multivariate linear regression model, the determinants of DQ were: intervention; age of the child; education of mother; sex of child; and PEM grade and the determinants for IQ were: intervention; age of the child; and income. CONCLUSION: This study shows that intervention to improve the Early Childhood Education and Development component through Anganwadi centers results in improvement in Developmental and Intelligence Quotient of children.