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Abstract Background This review aims to assess the effect of oral administration of probiotics and/or prebiotics in children and women of reproductive age (WRA) to improve intestinal iron absorption, hemoglobin, and ferritin levels. Methods Randomized controlled trials from published literature on probiotics and or prebiotics for prevention or treatment of anemia as a supplement or fortification in children or WRA till Jan 31, 2023, were included. Studies on probiotics and prebiotics in patients with anemia due to other causes were excluded. Screening and data extraction was done using Distiller SR and meta-analysis was performed using Revman 5.4.1. Results A total of 1925 records were identified from Pubmed, Embase, and Cochrane, of which 29 were included in the systematic review (14 supplementation and 15 fortification studies; 15 studies in children and 14 studies in WRA). The major interventions included galacto-oligosaccharide, inulin, heat-killed H61, Lactobacillus plantarum 299v, Lactobacillus reuteri, Lactobacillus acidophilus. Meta-analysis of 5 studies in WRA showed that the use of prebiotics and/or probiotics with or without iron was associated with little or no effect on hemoglobin. However, there is low certainty of evidence that the intervention led to improvement in fractional absorption of iron as compared to placebo or iron [8 studies, n = 335, mean increase 0.74%, 95%CI-0.11–1.38, p = 0.02]. Meta-analysis of 6 studies in WRA using prebiotics and/or probiotics with or without iron led to a significant increase in ferritin levels in WRA (mean increase 2.45 ng/ml, 95% CI 0.61–4.3, p = 0.009, n = 320) [Moderate certainty of evidence]. In children, meta-analysis of up to 8 studies did not result in any significant change in hemoglobin, ferritin and fractional iron absorption [low or very low certainty of evidence]. Conclusion There is some evidence to show that the use of prebiotics or probiotics (especially Lp299v and GOS) with or without oral iron can improve iron absorption in women and lead to improvement in ferritin levels in women. However, the current evidence does not conclusively show the benefit of these interventions in improving hemoglobin levels in women and children.

Objectives: The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied. Methods: Women infected with HIV with confirmed BV diagnosis (Nugent score ≥7 and Amsel criteria >3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV. Results: Of the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recurrence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups. Conclusion: The lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry- India, (CTRI) Number: CTRI/2018/04/013298

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.

Abstract Background India lacks epidemiological information on the disease burden of pediatric HIV. The National AIDS Control Program (NACP) estimates the numbers of HIV-positive children as a proportion of adult persons living with HIV. A third of HIV-positive children die before their first birthday and a half before they reach their second birthday. The early detection of HIV is crucial for the prevention of morbidities, growth delays, and death among HIV-positive children. Methods The study aimed to estimate the disease burden of pediatric HIV among children in ‘A’ category district of a high HIV prevalence state. An ‘A’ category district is defined by the presence of > 1% HIV prevalence among the general population, as estimated by HIV Sentinel Surveillance. The study used an innovative three-pronged strategy combining cross-sectional and longitudinal methods. The overall burden of pediatric HIV was calculated as a product of cases detected multiplied by a net inflation factor, for each of three strategies. Results The existing pool of HIV infection in the district is estimated to be 3266 (95% CI: 2621–4197) HIV positive children

BackgroundPreventive public health has been suggested as methods for reducing the transmission of COVID-19. Safety and efficacy of one such public health measure: WASH intervention for COVID-19 has not been systematically reviewed. We undertook a rapid review to assess the effect of WASH intervention in reducing the incidence of COVID-19.MethodsWe conducted searches in PubMed, MEDLINE, and EMBASE. We undertook screening of studies in two stages and extracted data and assessed the quality of evidence for the primary outcome using GRADE recommendations.Main resultsWe included a total of 13 studies with three studies on COVID-19 and 10 on SARS. The study found that hand washing, sterilization of hands, gargling, cleaning/shower after attending patients of COVID-19, or SARS was protective. Evidence also found that frequent washes can prevent SARS transmission among HCWs. However; one study reported that due to enhanced infection-prevention measures, front-line HCWs are more prone to hand-skin damage. The certainty of the evidence for our primary outcome as per GRADE was very low. We did not find any studies that assessed the effect of WASH on hospitalizations, and mortality due to COVID-19. Also; we did not find any study that compared WASH interventions with any other public health measures.ConclusionsCurrent evidence of WASH interventions for COVID-19 is limited as it is largely based on indirect evidence from SARS. Findings from the included studies consistently show that WASH is important in reducing the number of cases during a pandemic. Timely implementation of WASH along with other public health interventions can be vital to ensure the desired success. Further good-quality studies providing direct evidence of the efficacy of WASH on COVID-19 are needed.

Background: Universal access to maternal new-born and child healthcare services (MNCH) is detrimental for attainment of Sustainable Development Goal (SDG) three pertaining to promotion of health at all ages. Incentivization in the form of cash, vouchers, and goods have been used as part of strategies to improve maternal and neonatal health outcomes around the world. However, there exists uncertainties regarding the effectiveness of various incentive-based programmes targeted for pregnant mothers in low- and middle-income countries during their antenatal period. Methods: We will search six electronic databases, namely the Medical Literature Analysis and Retrieval System Online (Medline), Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science, and Embase in addition to Google Scholar. Manual searching of the reference lists of included studies will also be done. The reporting of this protocol will follow the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 statement [29]. Only interventional studies that follow randomized, quasi randomized, and cluster randomized controlled study designs will be included. A three-stage screening process will be adopted to select articles. Risk of bias for the included studies will be assessed using the tools and criteria specified in the Cochrane handbook. In addition, the GRADE approach will be used to assess the quality of evidence for the maternal and neonatal health outcomes. Conclusion: This review of trials is essential to inform the effectiveness of incentive-based programmes targeted for pregnant women in low- and middle-income countries. It will help the policy makers to utilise the resources more effectively and to integrate the evidence based public health initiatives into the health system. This can also help build the continuum of care financial packages for all pregnant women.

Introduction Current anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population.Methods and analysis An open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering.Ethics and dissemination The study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders.Trial registration number CTRI/2019/01/016918.

Abstract Background India lacks data on the incidence of Paediatric HIV. In 2010, the Indian Council of Medical Research commissioned a task force study to estimate the paediatric HIV burden in Belgaum district, Karnataka, India. We estimated the HIV incidence, prevalence and associated risk factors of mother to child transmission of HIV among children exposed to maternal HIV by age 24 months. Methods We included Belgaum resident pregnant women who tested HIV positive between January 1st, 2011 and May 31st, 2013 and who provided consent. Their babies were tested for HIV at three time intervals using DNA PCR dry blood spot (DBS) method at 6–10 weeks and 6–9 months, and using Antibody tests at 18–24 months of age. We estimated cumulative incidence using survival analysis that considered censoring of cases and prevalence rates of HIV by age 24 months. Using competing-risk survival regression model, we examined the correlates of transmission of HIV among babies exposed to maternal HIV. Results Among 487 children of HIV positive mothers recruited in the study, the cumulative incidence rate by 24 months of age was 4.8 per 1000 person months [95% CI: 3.5–6.6]. The HIV prevalence rate among babies exposed to maternal HIV until 24 months was 7.8% [95% CI: 5.7–10.7]. Mother’s age above 30 years, and breastfeeding duration of more than six months were factors that significantly increased the HIV transmission; adjusted hazard ratio (AHR) 6.98 [95% CI: 1.73–28.16] and 5.28 [95% CI, 1.75–15.90], respectively. The risk of MTCT was significantly reduced if both mother and baby had received Nevirapine at delivery [AHR 0.25; 95%CI: 0.10–0.61] and if either mother or baby had been given Nevirapine at delivery [AHR 0.12; 95%CI: 0.03–0.49]. Conclusion The study findings suggest that mother’s age above 30 years and breastfeeding beyond 26 weeks is associated with higher rates of HIV transmission from mother to child. It confirms the benefits of providing anti-retrovirals (Nevirapine) in reducing mother to child transmission of HIV. Effective strategies to promote safe infant feeding practices, including avoidance of mixed feeding beyond 26 weeks among HIV infected mothers, is critical to reduce incidence of paediatric HIV in India.

Background Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.Methods This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms—SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at ‘endline’ period (2008–2009) assessed by an independent team from January to April 2010 in the study clusters.Findings A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.Interpretation Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.Trial registration number The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Background: To inform actions at the district level under the National Nutrition Mission (NNM), we assessed the prevalence trends of child growth failure (CGF) indicators for all districts in India and inequality between districts within the states. Methods: We assessed the trends of CGF indicators (stunting, wasting and underweight) from 2000 to 2017 across the districts of India, aggregated from 5 × 5 km grid estimates, using all accessible data from various surveys with subnational geographical information. The states were categorised into three groups using their Socio-demographic Index (SDI) levels calculated as part of the Global Burden of Disease Study based on per capita income, mean education and fertility rate in women younger than 25 years. Inequality between districts within the states was assessed using coefficient of variation (CV). We projected the prevalence of CGF indicators for the districts up to 2030 based on the trends from 2000 to 2017 to compare with the NNM 2022 targets for stunting and underweight, and the WHO/UNICEF 2030 targets for stunting and wasting. We assessed Pearson correlation coefficient between two major national surveys for district-level estimates of CGF indicators in the states. Findings: The prevalence of stunting ranged 3.8-fold from 16.4% (95% UI 15.2–17.8) to 62.8% (95% UI 61.5–64.0) among the 723 districts of India in 2017, wasting ranged 5.4-fold from 5.5% (95% UI 5.1–6.1) to 30.0% (95% UI 28.2–31.8), and underweight ranged 4.6-fold from 11.0% (95% UI 10.5–11.9) to 51.0% (95% UI 49.9–52.1). 36.1% of the districts in India had stunting prevalence 40% or more, with 67.0% districts in the low SDI states group and only 1.1% districts in the high SDI states with this level of stunting. The prevalence of stunting declined significantly from 2010 to 2017 in 98.5% of the districts with a maximum decline of 41.2% (95% UI 40.3–42.5), wasting in 61.3% with a maximum decline of 44.0% (95% UI 42.3–46.7), and underweight in 95.0% with a maximum decline of 53.9% (95% UI 52.8–55.4). The CV varied 7.4-fold for stunting, 12.2-fold for wasting, and 8.6-fold for underweight between the states in 2017; the CV increased for stunting in 28 out of 31 states, for wasting in 16 states, and for underweight in 20 states from 2000 to 2017. In order to reach the NNM 2022 targets for stunting and underweight individually, 82.6% and 98.5% of the districts in India would need a rate of improvement higher than they had up to 2017, respectively. To achieve the WHO/UNICEF 2030 target for wasting, all districts in India would need a rate of improvement higher than they had up to 2017. The correlation between the two national surveys for district-level estimates was poor, with Pearson correlation coefficient of 0.7 only in Odisha and four small north-eastern states out of the 27 states covered by these surveys. Interpretation: CGF indicators have improved in India, but there are substantial variations between the districts in their magnitude and rate of decline, and the inequality between districts has increased in a large proportion of the states. The poor correlation between the national surveys for CGF estimates highlights the need to standardise collection of anthropometric data in India. The district-level trends in this report provide a useful reference for targeting the efforts under NNM to reduce CGF across India and meet the Indian and global targets.

Background: Substance abuse is one of the most significant global public health issues among youths. Electronic media has become a part of day-to-day life for all. This systematic review is undertaken to comprehensively explore the effect of electronic media on substance abuse among children and adolescents. Methodology: Two review authors independently searched various electronic databases and other sources. Selection Criteria: Randomized control trials that assessed the effect of exposure of electronic media (defined as television, internet, gaming, mobile phones/phones, and radio) among participants in the age range of 5–19 years on substance abuse were included in the review. Data Collection and Analysis: Two reviewers independently extracted data. We used an approach proposed by the Cochrane Collaboration. We used GRADE profiler to assess the overall quality of the evidence. Main Results: We retrieved 6003 studies and found 15 studies that fulfilled our inclusion criteria. Since included studies differed in the type of intervention and reporting of outcomes, we did not undertake meta-analysis and choose to describe studies narratively. Quality of evidence was rated as “very low” due to too little information or too few data to be able to reach any conclusions. Authors' Conclusions: Clinicians, policymakers, and educators to partner with caregivers and youth to support electronic media use that promotes positive outcome in these areas. Registration of Systematic Review: This systematic review has been registered at PROSPERO International prospective register of systematic reviews (Registration number: PROSPERO 2018 CRD42018086935) available at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID = 86935.

Context: Electronic media has become a part of day-to-day life for all, and particularly more so for children and adolescents. Exposure to electronic media may be beneficial as well as harmful. Aim: The aim of the study is to systematically synthesize existing published and non-published empirical evidence on the effect of exposure to electronic media on diet, exercise, and sexual activity. Methodology: Two reviewers independently searched online databases such as MEDLINE, CENTRAL, and EMBASE. We applied no language, date, or publication restrictions. Selection Criteria: We included randomized control trials that assessed the effect of exposure of electronic media on diet, exercise, and sexual activity in participants between 5 and 19 years. Study Selection, Data Extraction: Two reviewers independently screened studies identified in electronic search and independently extracted data and assessed the risk of bias of included studies. Data Analysis: We had planned to use the risk ratio or odds ratio for dichotomous data, and mean difference (MD) or standardized MD for continuous data. However, as included studied differed in types of intervention and reporting of outcomes, we did not undertake meta-analysis. Main Results: All included trials were parallel randomized controlled trials except for one that was a crossover trial. Eight studies reported the effect of electronic media on diet and exercise, two on diet, two on exercise, and one on sexual activity. Quality of evidence was rated as “very low” for all outcomes due to too little information or too few data to be able to reach to any conclusions. Conclusions: There is a little body of evidence that limits conclusions. We need to comprehend as to how to swap undesirable effects of electronic media and make it more desirable. Registration of Systematic Review: This systematic review has been registered at PROSPERO International prospective register of systematic reviews (Registration number: PROSPERO 2018 CRD42018086935) available at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=86935.

BackgroundThe coverage of community-based maternal, neonatal, and child health (MNCH) services remains low, especially in hard-to-reach areas. We evaluated the effectiveness of a mobile-phone-and web-based application, Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO), as a job aid to the government's Accredited Social Health Activists (ASHAs) and Primary Health Center (PHC) staff to improve coverage of MNCH services in rural tribal communities of Gujarat, India.Methods and findingsThis open cluster-randomized trial was conducted in 22 PHCs in six tribal blocks of Bharuch and Narmada districts in India. The ImTeCHO mobile-phone-and web-based application included various technology-based job aids to facilitate scheduling of home visits, screening for complications, counseling during home visits, and supportive supervision by PHC staff. Primary outcome indicators were a composite index calculated based on coverage of important MNCH services and coverage of at least two home visitations by ASHA within the first week of birth. Primary analysis was intention to treat (ITT). Generalized Estimating Equation (GEE) was used to account for clustering. Eleven PHCs each were randomly allocated to the intervention (280 ASHAs, population: 234,134) and control (281 ASHAs, population: 242,809) arms. The intervention was implemented from February, 2016 to January, 2017. At the end of the implementation, 6,493 mothers were surveyed. Most of the surveyed women were tribal (5,571, 85.8%), and reported having a government-issued certificate for living below poverty line (4,916, 75.7%). The coverage of at least two home visits within first week of birth was 32.4% in the intervention clusters compared to 22.9% in the control clusters (adjusted effect size 10.2 [95% CI: 6.4, 14.0], p < 0.001). Mean number of home visits within first week of birth was 1.11 and 0.80 for intervention and control clusters, respectively (adjusted effect size 0.34 [95% CI: 0.23, 0.45], p < 0.001). The composite coverage index was 43.0% in the intervention clusters compared to 38.5% (adjusted effect size 4.9 [95% CI: 0.2, 9.5], p = 0.03) in the control clusters. There were substantial improvements in coverage home visits by ASHAs during antenatal period (adjusted effect size 15.7 [95% CI: 11.0, 20.4], p < 0.001), postnatal period (adjusted effect size 6.4, [95% CI: 3.2, 9.6], p ConclusionsIn this study, we found that use of ImTeCHO mobile- and web-based application as a job aid by government ASHAs and PHC staff improved coverage and quality of MNCH services in hard-to-reach areas. Supportive supervision, change management, and timely resolution of technology-related issues were critical implementation considerations to ensure adherence to the intervention.Trial registrationStudy was registered at the Clinical Trial Registry of India (www.ctri.nic.in). Trial number: CTRI/2015/06/005847. The trial was registered (prospective) on 3 June, 2015. First enrollment was done on 26 August, 2015.

Control of pneumonia and diarrhea mortality in India requires understanding of their etiologies. We combined time series analysis of seasonality, climate region, and clinical syndromes from 243,000 verbal autopsies in the nationally representative Million Death Study. Pneumonia mortality at 1 month-14 years was greatest in January (Rate ratio (RR) 1.66, 99% CI 1.51–1.82; versus the April minimum). Higher RRs at 1–11 months suggested respiratory syncytial virus (RSV) etiology. India’s humid subtropical region experienced a unique summer pneumonia mortality. Diarrhea mortality peaked in July (RR 1.66, 1.48–1.85) and January (RR 1.37, 1.23–1.48), while deaths with fever and bloody diarrhea (indicating enteroinvasive bacterial etiology) showed little seasonality. Combining mortality at ages 1–59 months with prevalence surveys, we estimate 40,600 pneumonia deaths from Streptococcus pneumoniae, 20,700 from RSV, 12,600 from influenza, and 7200 from Haemophilus influenzae type b and 24,700 diarrheal deaths from rotavirus occurred in 2015. Careful mortality studies can elucidate etiologies and inform vaccine introduction.

Abstract Background Pediatric HIV is poised to become a major public health problem in India with the rising trend of HIV infection in pregnant women (Department of AIDS Control, Ministry of Health and Family Welfare, http://www.naco.gov.in). There is lack of information on the epidemiology of pediatric HIV infection in India. Existing surveillance systems tend to underestimate the Pediatric burden. The overall aim of the present study is to estimate the disease burden of pediatric HIV among children in Belgaum district in the state of Karnataka in Southern India. An innovative multipronged epidemiological approach to comb the district is proposed. Methods The primary objectives of the study would be attained under three strategies. A prospective cohort design for objective (i) to determine the incidence rate of HIV by early case detection in infants and toddlers (0–18 months) born to HIV infected pregnant women; and cross sectional design for objectives (ii) to determine the prevalence of HIV infection in children (0–14 years) of HIV infected parents and (iii) to determine the prevalence of HIV in sick children (0–14 years) presenting with suspected signs and symptoms using age specific criteria for screening. Burden of pediatric HIV will be calculated as a product of cases detected in each strategy multiplied by a net inflation factor for each strategy. Study participants (i) (ii) (iii): HIV infected pregnant women and their live born children (ii) Any HIV-infected man/woman, of age 18–49 years, having a biological child of age 0–14 years (iii) Sick children of age 0–14 years presenting with suspected signs and symptoms and satisfying age-specific criteria for screening. Setting and conduct: Belgaum district which is a Category ‘A’ district (with more than 1 % antenatal prevalence in the district over the last 3 years before the study). Age-appropriate testing is used to detect HIV infection. Discussion There is a need to strengthen existing pediatric HIV estimation methods in India and other developing countries. We hope that the novel methodology emanating from this study would be applicable for estimating the burden of HIV in other settings and it would be adaptable for estimating the burden of other infectious/chronic diseases. Findings from this study will give future direction to the national program for prevention and control of HIV in India and other developing countries.

Summary: Introduction: India accounts for about a fifth of cardiovascular deaths globally, but nationally representative data on mortality trends are not yet available. In this nationwide mortality study, we aimed to assess the trends in ischaemic heart disease and stroke mortality over 15 years using the Million Death Study. Methods: We determined national and subnational cardiovascular mortality rates and trends by sex and birth cohort using cause of death ascertained by verbal autopsy from 2001 to 2013 among 2·4 million households. We derived mortality rates for ischaemic heart disease and stroke by applying mortality proportions to UN mortality estimates for India and projected the rates from 2000 to 2015. Findings: Cardiovascular disease caused more than 2·1 million deaths in India in 2015 at all ages, or more than a quarter of all deaths. At ages 30–69 years, of 1·3 million cardiovascular deaths, 0·9 million (68·4%) were caused by ischaemic heart disease and 0·4 million (28·0%) by stroke. At these ages, the probability of dying from ischaemic heart disease increased during 2000–15, from 10·4% to 13·1% in men and 4·8% to 6·6% in women. Ischaemic heart disease mortality rates in rural areas increased rapidly and surpassed those in urban areas. By contrast, the probability of dying from stroke decreased from 5·7% to 5·0% in men and 5·0% to 3·9% in women. A third of premature stroke deaths occurred in the northeastern states, inhabited by a sixth of India's population, where rates increased significantly and were three times higher than the national average. The increased mortality rates of ischaemic heart disease nationally and stroke in the northeastern states were higher in the cohorts of adults born in the 1970s onwards, than in earlier decades. A large and growing proportion of the ischaemic heart disease nationally and stroke deaths in high-burden states reported earlier diagnosis of cardiovascular disease, but low medication use. Interpretation: The unexpectedly diverse patterns of cardiovascular mortality require investigation to identify the role of established and new cardiovascular risk factors. Secondary prevention with effective and inexpensive long-term treatment and adult smoking cessation could prevent substantial numbers of premature deaths. Without progress against the control of cardiovascular disease in India, global goals to reduce non-communicable diseases by 2030 will be difficult to achieve. Funding: Fogarty International Center of the US National Institutes of Health, Dalla Lana School of Public Health, University of Toronto, Indian Council of Medical Research, and the Disease Control Priorities.

Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data. Methods: We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India. We first outlined each of the core data components required for the conduct of HTA, and their availability in India, drawing attention to where data can be accessed, and different ways in which researchers can overcome the challenges of missing or low quality data. Results: We grouped data into the following categories: clinical efficacy; cost; epidemiology; quality of life; service use/consumption; and equity. We identified numerous large local data sources containing epidemiological information. There was a marked absence of other locally-collected data necessary for informing HTA, particularly data relating to cost, service use, and quality of life. Conclusions: The introduction of HTA into the health policy space in India provides an opportunity to comprehensively assess the availability and quality of health data capture across the country. While epidemiological information is routinely collected across India, other data inputs necessary for HTA are not readily available. This poses a significant bottleneck to the efficient generation and deployment of HTA into the health decision space. Overcoming these data gaps by strengthening the routine collection of comprehensive and verifiable health data will have important implications not only for embedding economic analyses into the priority setting process, but for strengthening the health system as a whole.

Background: p63, a member of p53 family, known to be expressed in embryonic tissues and basal regenerative layers of many epithelial tissues in the adult, is also expressed in various benign and malignant lesions of body including lesions of oral cavity. To evaluate the expression of p63 and compare the expression qualitatively and quantitatively in normal buccal mucosa, epithelial dysplasia, oral submucous fibrosis (OSMF), and oral squamous cell carcinoma (OSCC). Methods: The study material consisted of 45 archival cases which were divided into Group I with 5 cases of normal buccal mucosa, Group II with 15 cases of epithelial dysplasia, and Group III with 10 cases of OSMF and 15 cases of OSCC. Immunohistochemical expression of p63 was assessed by using mean, standard deviation, and analysis of variance. Results: Overexpression of p63 was seen in epithelial dysplasia, OSMF, and squamous cell carcinoma with an increased suprabasal expression in cases of epithelial dysplasia. The mean labeling index (LI) of p63 was found to be in increasing order from normal oral mucosa (33.75%), OSMF (57.37%), epithelial dysplasia (63.87%) to squamous cell carcinoma (69.76%). Conclusion: The results suggest a possible role of p63 in oral carcinogenesis, and an increased LI as well as increased suprabasal expression of this gene in dysplastic lesions may have a potential to be utilized as a marker for premalignancy.

Introduction: The present study was undertaken to assess the caries activity by comparing the pH, buffering capacity, calcium, phosphorous, amylase along with the association of mutans in saliva for caries-free and caries-active children and to find out the interrelationship amongst the two groups. Methodology: The study sample of 80 children, aged between 4 and 8 years were included in the study. Caries status of each child was recorded using DMFS. They were divided into two groups: (i) caries-free group (40) and (ii) caries-active group (40). After collecting the salivary samples, mutans were determined using Saliva-Check mutans kit and buffering capacity by Saliva-Check Buffer kit. The remaining samples were sent to laboratory for analyzing pH by electrode pH meter, calcium by OCPC(o-cresolphthalein complexone) photometric method, phosphorous by phosphomolybdate/UV method, amylase by CNP-G3(2chloro-4-nitrophenyl-alpha-maltotrioside) method using semi-autoanalyzer. Results: The results obtained were tabulated and subjected to statistical analysis. The pH, buffering capacity, calcium and phosphorous level were found to be increased with the decrease in the caries activity of the children whereas amylase activity was increased with the increase in caries activity. It was observed that 77.5% children were tested positive and 22.5% were tested negative for mutans in caries-active group whereas 100% children were tested negative for mutans in caries-free group. Conclusion: The physicochemical properties of saliva, such as pH, buffering capacity, calcium, phosphorous, amylase and Streptococcus mutans has a definite relationship with caries activity.

Background Universal access to maternal, newborn, and child healthcare is essential for achieving Sustainable Development Goal 3, but the effectiveness of various incentive-based programs for pregnant mothers in low- and middle-income countries (LMICs) remains uncertain. Objective of this systematic review was to determine if incentive-based interventions influenced maternal and neonatal health outcomes. Methods We conducted a search in various databases from inception. All incentive-based interventional studies conducted on pregnant women in LMICs were included. Evidence from the included trials was synthesized using risk ratios (RRs) to compare the outcomes between groups receiving incentives and not receiving incentives. The meta-analysis was conducted using random-effects model. We assessed the quality of the included studies using the Cochrane Risk of Bias 2.0 tool and reviewed the collected data to determine its suitability for meta-analysis. This study is registered in PROSPERO (CRD42021247681). Results Of the 3,897 records that were identified, 11 met eligibility criteria, all of which exhibited varying degrees of risk of bias, ranging from high to some concerns. Analysis of maternal outcomes across studies revealed no significant differences in the likelihood of delivering at a healthcare facility (RR 1.13, 95% CI: 0.86 to 1.47) and in frequency of prenatal care (RR 0.99, 95% CI: 0.88 to 1.12) between intervention and control groups. However, high levels of statistical heterogeneity were observed for both outcomes indicating variability among study results. Similarly, analysis of tetanus vaccine coverage showed no significant difference between groups (RR 1.00, 95% CI: 0.92 to 1.08), with moderate statistical heterogeneity observed. Conclusion The maternal and neonatal outcomes examined in this review did not have any significant differences in intervention group when compared to the control group. The interventions to address maternal health concerns need to follow a multifactorial approach. There is a need for extensive primary research studies in the future.

Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India.This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC)/non-circumcising communities (NCC); including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs) such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision.Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence.HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility studies on MC as an individual specific option for the high risk groups in health care setting needs to be explored.

Background : Universal access to maternal new-born and child healthcare services (MNCH) is detrimental for attainment of Sustainable Development Goal (SDG) three pertaining to promotion of health at all ages. Incentivization in the form of cash, vouchers, and goods have been used as part of strategies to improve maternal and neonatal health outcomes around the world. However, there exists uncertainties regarding the effectiveness of various incentive-based programmes targeted for pregnant mothers in low- and middle-income countries during their antenatal period. Methods: We will search six electronic databases, namely the Medical Literature Analysis and Retrieval System Online (Medline), Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science, and Embase in addition to Google Scholar. Manual searching of the reference lists of included studies will also be done. The reporting of this protocol will follow the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 statement [29]. Only interventional studies that follow randomized, quasi randomized, and cluster randomized controlled study designs will be included. A three-stage screening process will be adopted to select articles. Risk of bias for the included studies will be assessed using the tools and criteria specified in the Cochrane handbook. In addition, the GRADE approach will be used to assess the quality of evidence for the maternal and neonatal health outcomes. Conclusion: This review of trials is essential to inform the effectiveness of incentive-based programmes targeted for pregnant women in low- and middle-income countries. It will help the policy makers to utilise the resources more effectively and to integrate the evidence based public health initiatives into the health system. This can also help build the continuum of care financial packages for all pregnant women.

Background : Universal access to maternal new-born and child healthcare services (MNCH) is detrimental for attainment of Sustainable Development Goal (SDG) three pertaining to promotion of health at all ages. Incentivization in the form of cash, vouchers, and goods have been used as part of strategies to improve maternal and neonatal health outcomes around the world. However, there exists uncertainties regarding the effectiveness of various incentive-based programmes targeted for pregnant mothers in low- and middle-income countries during their antenatal period. Methods: We will search six electronic databases, namely the Medical Literature Analysis and Retrieval System Online (Medline), Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science, and Embase in addition to Google Scholar. Manual searching of the reference lists of included studies will also be done. The reporting of this protocol will follow the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 statement [29]. Only interventional studies that follow randomized, quasi randomized, and cluster randomized controlled study designs will be included. A three-stage screening process will be adopted to select articles. Risk of bias for the included studies will be assessed using the tools and criteria specified in the Cochrane handbook. In addition, the GRADE approach will be used to assess the quality of evidence for the maternal and neonatal health outcomes. Conclusion: This review of trials is essential to inform the effectiveness of incentive-based programmes targeted for pregnant women in low- and middle-income countries. It will help the policy makers to utilise the resources more effectively and to integrate the evidence based public health initiatives into the health system. This can also help build the continuum of care financial packages for all pregnant women.

Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data. Methods: We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India. We first outlined each of the core data components required for the conduct of HTA, and their availability in India, drawing attention to where data can be accessed, and different ways in which researchers can overcome the challenges of missing or low quality data. Results: We grouped data into the following categories: clinical efficacy; cost; epidemiology; quality of life; service use/consumption; and equity. We identified numerous large local data sources containing epidemiological information. There was a marked absence of other locally-collected data necessary for informing HTA, particularly data relating to cost, service use, and quality of life. Conclusions: The introduction of HTA into the health policy space in India provides an opportunity to comprehensively assess the availability and quality of health data capture across the country. While epidemiological information is routinely collected across India, other data inputs necessary for HTA are not readily available. This poses a significant bottleneck to the efficient generation and deployment of HTA into the health decision space. Overcoming these data gaps by strengthening the routine collection of comprehensive and verifiable health data will have important implications not only for embedding economic analyses into the priority setting process, but for strengthening the health system as a whole.

Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data. Methods: We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India. We first outlined each of the core data components required for the conduct of HTA, and their availability in India, drawing attention to where data can be accessed, and different ways in which researchers can overcome the challenges of missing or low quality data. Results: We grouped data into the following categories: clinical efficacy; cost; epidemiology; quality of life; service use/consumption; and equity. We identified numerous large local data sources containing epidemiological information. There was a marked absence of other locally-collected data necessary for informing HTA, particularly data relating to cost, service use, and quality of life. Conclusions: The introduction of HTA into the health policy space in India provides an opportunity to comprehensively assess the availability and quality of health data capture across the country. While epidemiological information is routinely collected across India, other data inputs necessary for HTA are not readily available. This poses a significant bottleneck to the efficient generation and deployment of HTA into the health decision space. Overcoming these data gaps by strengthening the routine collection of comprehensive and verifiable health data will have important implications not only for embedding economic analyses into the priority setting process, but for strengthening the health system as a whole.

Population-based surveys commonly use point-of-care (POC) methods with capillary blood samples for estimating Hb concentrations; these estimates need to be validated by comparison with reference methods using venous blood. In a cross-sectional study in 748 participants (17–86 years, 708 women, Hb: 5·1 to 18·2 g/dl) from Hyderabad, India, we validated Hb measured from a pooled capillary blood sample by a POC autoanalyser (Horiba ABX Micros 60OT, Hb-C-AA) by comparison with venous blood Hb measured by two reference methods: POC autoanalyser (Hb-V-AA) and cyanmethemoglobin method (Hb-V-CM). These comparisons also allowed estimation of blood sample-related and equipment-related differences in the Hb estimates. We also conducted a longitudinal study in 426 participants (17–21 years) to measure differences in the Hb response to iron folate (IFA) treatment by the capillary blood POC method compared with the reference methods. In the cross-sectional study, Bland–Altman analyses showed trivial differences between source of blood (Hb-C-AA and Hb-V-AA; mean difference, limits of agreement: 0·1, −0·8 to 1·0 g/dl) and between analytical methods (Hb-V-AA and Hb-V-CM; mean difference, limits of agreement: < 0·1, −1·8 to 1·8 g/dl). Cross-sectional anaemia prevalence estimated using Hb-C-AA did not differ significantly from Hb-V-CM or Hb-V-AA. In the longitudinal study, the Hb increment in response to IFA intervention was not different when using Hb-C-AA (1·6 ± 1·7 g/dl) compared with Hb-V-AA (1·7 ± 1·7 g/dl) and Hb-V-CM (1·7 ± 1·7 g/dl). The pooled capillary blood–autoanalyzer method (Hb-C-AA) offers a practical and accurate way forward for POC screening of anaemia. [ABSTRACT FROM AUTHOR]