Non-Medical Determinants of Access and Quality of Maternal Health Services in India-Protocol for a Scoping Review.

Introduction: The Maternal Mortality Rate (MMR) is one of the most important health indicators of a country. In India, MMR has decline from 130 to 113 per 100,000 live births between 2014 and 2018, however, there are wide disparities in utilization of maternal health services (MHS) among different states and across different socioeconomic groups within the states. Although the government is providing MHS through various health programs in India, there are several non medical factors leading to the underutilization of MHS services. Objective: To map and summarise the non-medical determinants of access and quality of MHS in India. Methods: We are conducting a scoping review of the published literature from 2000 till date in databases such as PubMed, Cochrane, Science Direct and CINAHL by including eligible qualitative as well as quantitative studies conducted in India. Data extraction and analysis will be conducted through a narrative integrative synthesis approach to summarize the non-medical determinants of access and quality of MHS in India and understand their mechanisms of influence.At the third SPINE20 summit 2022 which took place in Bali, Indonesia, in August 2022, 17 associations endorsed its recommendations. Results: We will summarise the non-medical determinants that influence the access and quality of MHS. Conclusion: This scoping review would help to understand and summarise the existing non-medical determinants of access and quality of MHS, highlight the research gaps and suggest potential modalities for improvement of access and quality of MHS.

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.

Effect of IV ferric carboxy maltose for moderate/severe anemia: a systematic review and meta-analysis.

Introduction: Anemia remains a prevalent global health issue with varying severity. Intravenous iron supplementation, particularly with ferric carboxymaltose (FCM), has appeared as a possible therapeutic intervention for individuals with moderate to severe anemia. The study aimed to assess the efficacy and safety of ferric carboxymaltose (FCM) in reducing anemia. Methods: We searched electronic databases, registries, websites, e-libraries, reference lists of reviews, citations, etc. We included randomized control trials (RCTs), non-RCTs, and single-arm studies, while observational studies, case series, and case studies were excluded. Two reviewers independently screened the studies and extracted the data. We included studies of moderate-to-severely anemic Indians and excluded Indians with other comorbidities. We assessed the risk of bias and the overall quality of evidence (QoE) using GRADE GDT. Result: We identified 255 studies and included 14 studies (11 RCT, one non-RCT, and two single-arm studies) with 1,972 participants for qualitative analysis and 10 studies in the meta-analysis. All the included studies detailed the use of FCM for anemia. The primary outcomes assessed in the included studies were anemia, hemoglobin, and adverse events. The outcomes assessed ranged from 2 weeks to 12 weeks. The risk of bias varied across different studies with different outcomes. FCM is consistent with a fewer number of adverse events as compared to other interventions and provides "moderate" to "very low" QoE. Conclusion: A slow single infusion of 1 gram of FCM is well-tolerated, safe, and effective in treating iron deficiency anemia (IDA) and surpasses other interventions (Iron Sucrose Complex (ISC), Iron sucrose, and ferrous ascorbate) in elevating hemoglobin levels and replenishing iron stores. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459363, CRD42023459363.

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.

Acceptability of PrEP among MSM and transgender communities-Qualitative findings from two metropolitan cities in India.

BACKGROUND: Global evidence suggests that Pre-Exposure Prophylaxis (PrEP) plays a pivotal role in reducing new HIV-infections among key populations (KP). However, the acceptability of PrEP differs across different geographical and cultural settings and among different KP typologies. Men who have sex with men (MSM) and transgender (TG) communities in India have around 15-17 times higher prevalence of human immunodeficiency virus (HIV) than the general population. The low rates of consistent condom use and poor coverage of HIV testing and treatment among the MSM and transgender communities highlight the need for alternative HIV prevention options. METHODS: We used data from 20 in-depth interviews and 24 focused group discussions involving 143 MSM and 97 transgender individuals from the two metropolitan cities (Bengaluru and Delhi) in India to qualitatively explore their acceptability of PrEP as a HIV prevention tool. We coded data in NVivo and conducted extensive thematic content analysis. RESULTS: Awareness and use of PrEP were minimal among the MSM and transgender communities in both cities. However, on being provided with information on PrEP, both MSM and transgender communities expressed willingness to use PrEP as an additional HIV-prevention tool, to complement inability to consistently use condoms. PrEP was also perceived as a tool that could enhance the uptake of HIV-testing and counseling services. PrEP awareness, availability, accessibility and affordability were identified as determining factors that could influence its acceptability. Challenges such as stigma and discrimination, interrupted supply of drugs and non-community-friendly drug dispensing sites were identified barriers to continuing PrEP. CONCLUSIONS: Using qualitative data from two Indian settings, this study provides community perspectives and recommendations to stakeholders and policymakers for introduction of PrEP into programs as a prevention tool among MSM and transgender communities in India.

Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial.

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.

WASH to control COVID-19: A rapid review.

Background: Preventive 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. Methods: We 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 results: We 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. Conclusions: Current 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.

Incentives for pregnant mothers during antenatal care for better maternal and neonatal health outcomes in low and middle income countries: A systematic review protocol.

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.

Estimating the burden of pediatric HIV in an 'A' category district in India: an epidemiological study.

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 < 15 years of age, in a mid-year (2013) projected child population of about 1.4 million, thus giving an HIV prevalence of 0.23% (CI: 0.19-0.30) among children (0-14 years of age). The proportion of children among all people living with HIV in the district works out to 10.4% (CI: 8.6-13.5%). CONCLUSIONS: The study estimate of 0.23% HIV prevalence among children (0-14 years of age) is higher than the NACP estimates (0.02) and is 2.5 higher than the Karnataka state estimate (0.09)22. Similarly, the proportion of children among all persons living with HIV in Belgaum district is 10.4% in this study, as against 6.54% for India. The study methodology is replicable for other settings and other diseases.

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.

Effectiveness of School-Based Interventions in Reducing Unintentional Childhood Injuries: A Cluster Randomized Trial.

OBJECTIVE: To evaluate the effectiveness of school-based interventions in promoting child safety and reducing unintentional childhood injuries. METHODS: This cluster randomized trial with 1:1 allocation of clusters to intervention and control arm was conducted in the public and private schools of Dakshina Kannada district, Karnataka, over a period of 10 months. Study participants included children from standard 5-7 in schools selected for the study. 10 schools that could accommodate 1100 students each, were randomly allocated to the interventional and control arm. A comprehensive child safety and injury prevention module was developed based on the opinions of school teachers through focus group discussions. This module was periodically taught to the students of intervention arm by the teachers. The children in control arm did not receive any intervention. Outcome was assessed by determining the incidence of unintentional injuries and type of injuries from the questionnaire used at the baseline, and at the end of three, six, and ten months. RESULTS: Unintentional injuries declined progressively from baseline until the end of the study in both the interventional arm (from 52.9% to 2.5%) and control arm (from 44.7% to 32%) [AOR (95% CI) 0.458 (0.405-0.518); P value <0.001]. The decline in incidence of injuries in the interventional arm was higher than that in the control arm (50.4% vs 12.7%; P <0.001). CONCLUSIONS: School based educational intervention using child safety and injury prevention modules is effective in reducing unintentional injuries among school children over a 10-month period.

Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial 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).

Modified Integrated Algorithm for Detection of HIV Among Sick Children Aged 0-14 Year Seeking Care at Healthcare Facilities in India.

OBJECTIVE: To test the ability and to identify unique criteria in a Modified Integrated Algorithm developed by Indian Council of Medical Research (ICMR) to detect HIV infection among sick children 0 to 14 years, seeking care in a health care facility. DESIGN: Facility based cross-sectional survey. SETTING: Four talukas of Belgaum District, Karnataka, India during 2013-2014. PATIENTS: Sick children 0-14 years seeking care at healthcare facilities in the study area. PROCEDURE: A total of 10 health care facilities were selected using specific criteria. Trained health care providers in these facilities used the WHO generic Integrated Management of Childhood Illnesses screening algorithm for HIV, applicable for children to 0-5 years and ICMR modified integrated algorithm for >5-14 years, to screen and test children for HIV, when they sought care in these facilities. MAIN OUTCOME MEASURE: Prevalence of HIV in children screened positive by the Modified Integrated Algorithm. RESULTS: Of the total 33342 children who visited the 10 health care facilities, 24342 were screened by the physician. Of the 527 screened positive sick children with suspected signs/ symptoms, 509 consented and were tested with age appropriate HIV testing. 97 children tested positive (HIV prevalence 19.1%: 5% in <5yrs and 28% in ≥5-14 years). The result of Classification and Regression Tree and logistics regression consistently identified parents with HIV and orphan child, as important predictor of HIV infection. CONCLUSIONS: ICMR Modified integrated algorithm may be used as a screening tool in the public and private health care facilities to increase case detection of pediatric HIV.

Interventions for Addressing Anemia Among Children and Adolescents: An Overview of Systematic Reviews.

Context: Anemia is a public health problem that can lead to growth, cognitive, and motor impairments. Objective: To collate evidence on interventions for addressing childhood and adolescent anemia. Methods: In this overview of systematic reviews, we included Cochrane as well as non-Cochrane systematic reviews (SRs) irrespective of language and publication status. Two sets of review authors independently screened articles for eligibility and extracted data from relevant SRs. We present data in a tabular format and summarize results based on outcome reported, age of participants, and type of interventions. We also adopt a "measurement for change" approach to assess the utility of measurement for development of interventions in childhood and adolescent anemia. Results: Our search yielded 2,601 records of which 31 SRs were found eligible for inclusion. Results were favorable for fortification and supplementation with clear reduction in the risk of anemia and increase in hemoglobin levels across all age groups. Other interventions reported by the SRs were inconclusive and suggest further research. Conclusions: Current evidence suggests that fortification or supplementation with iron and micronutrients leads to better reduction in the risk of anemia and improvements in hemoglobin levels among children and adolescents. Results of this overview can help decision makers in informing selection of interventions to address childhood and adolescent anemia. Review Registration: PROSPERO CRD42016053687.

mHealth intervention "ImTeCHO" to improve delivery of maternal, neonatal, and child care services-A cluster-randomized trial in tribal areas of Gujarat, India.

BACKGROUND: The 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 FINDINGS: This 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 <0.001), early initiation of breastfeeding (adjusted effect size 7.8 [95% CI: 4.2, 11.4], p < 0.001), and exclusive breastfeeding (adjusted effect size 13.4 [95% CI: 8.9, 17.9], p < 0.001). Number of infant and neonatal deaths was similar in the two arms in the ITT analysis. The limitations of the study include potential risk of inaccuracies in reporting events that occurred during pregnancy by the mothers and the duration of intervention being 12 months, which might be considered short. CONCLUSIONS: In 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 REGISTRATION: Study 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.

Seasonal variation and etiologic inferences of childhood pneumonia and diarrhea mortality in India.

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.

Incidence, prevalence and associated factors of mother-to-child transmission of HIV, among children exposed to maternal HIV, in Belgaum district, Karnataka, India.

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.

Parenteral Versus Oral Iron for Treatment of Iron Deficiency Anaemia During Pregnancy and post-partum: A Systematic Review.

INTRODUCTION: The burden of iron deficiency anaemia during pregnancy and post-partum continues to remain high especially in India. Challenges to treatment include gastrointestinal side effects and non compliance to oral iron therapy. Newer parenteral formulations need to be explored as alternatives. METHODS: Meta-analysis of randomized controlled trials published between years 2011 and 2018 comparing anaemic pregnant and post-partum women treated with intravenous iron sucrose versus oral iron was performed. The primary outcomes were mean maternal haemoglobin, serum ferritin and haematocrit at the end of 1st, 2nd, 4th and 6th weeks and comparison of adverse effects. RESULTS: Eighteen studies including 1633 antenatal women were randomly assigned to intravenous iron sucrose (n = 821) or oral iron [ferrous sulphate, ferrous ascorbate or fumarate] group (n = 812) in ten trials . Another eight studies compared iron sucrose infusion with oral iron in 713 post-partum women who were randomly assigned to intravenous iron sucrose group (n = 351) or oral iron group (n = 362). Cumulative analysis of all the time points indicates that the estimated mean values of Hb in the intravenous iron sucrose and oral iron groups were 10.11 g/dl and 9.33 g/dl, respectively, in antenatal group, while it was 10.57 g/dl and 9.74 g/dl in post-partum. The estimated mean ferritin level from first week to six weeks was 63.1 µg/l and 28.6 µg/l, respectively, in intravenous and oral iron groups. Cumulative estimate of haematocrit in the intravenous sucrose and oral iron over 6 weeks showed that the mean values in the respective groups were 30.5% and 29.5% in antenatal and 33.8% and 31.6%, respectively, in post-partum groups. Sensitivity analysis confirmed the reliability and consistency of the results. Oral iron was associated with significant gastrointestinal side effects. There was no significant difference in birthweight between the groups. CONCLUSION: This meta-analysis demonstrates that intravenous iron sucrose is more effective than oral iron therapy for pregnant and post-partum women with iron deficiency anaemia. It is an effective and safe alternative to address the problem of iron deficiency especially in those who require rapid replacement of iron stores though medical personnel for intravenous administration of drug is required.Trial registration CRD42015024343.

Profile of Published Cochrane Systematic Reviews in Child Health From Low- and Middle-Income Countries.

OBJECTIVE: Setting priorities in health research is a challenge at the global and national levels. Use of evidence-based approach is uncommon and needs to be promoted in low-and middle-income countries (LMIC). We describe profile of Cochrane systematic reviews focussing on participation from LMIC. METHODS: We searched six Cochrane review groups producing reviews relevant to child health in low- and middle-income countries for published Cochrane systematic reviews from 1 March, 2009 till 18 March, 2015 in the Cochrane Library. RESULTS: A total of 669 Cochrane systematic reviews from six review groups were found. Low proportion of lead authors from low- and middle-income countries was found in 4 out of 6 review groups. About 50% of the reviews showed inconclusive evidence. 101/669 (15%) empty reviews were found needing more primary studies. CONCLUSION: The proportion of Cochrane authors from low- and middle-income countries is low. Capacity-building in systematic reviews and good quality primary research in these countries is warranted.

Identification of publicly available data sources to inform the conduct of Health Technology Assessment in India.

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.