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Background Neonatal sepsis is a major cause of death in India, which needs hospital management but many families cannot access hospitals. The World Health Organization and the Government of India developed a guideline to manage possible serious bacterial infection (PSBI) when a referral is not feasible. We implemented this guideline to achieve high coverage of treatment of PSBI with low mortality. Methodology The implementation research study was conducted in over 50 villages of Palwal district, Haryana during August 2017-March 2019 and covered a population of 199143. Policy dialogue with central, state and district health authorities was held before initiation of the study. A baseline assessment of the barriers in the implementation of the PSBI intervention was conducted. The intervention was implemented in the program setting. The research team collected data throughout and also co-participated in the implementation of the intervention for the first six months to identify bottlenecks in the health system and at the community level. RE-AIM framework was utilized to document implementation strategies of PSBI management guideline. Implementation strategies by the district technical support unit (TSU) included: (i) empower mothers and families through social mobilization to improve care-seeking of sick young infants 0–59 days of age, (ii) build capacity through training and build confidence through technical support of health staff at primary health centers (PHC), community health centers (CHC) and sub-centers to manage young infants with PSBI signs and (iii) improve performance of accredited social health activists (ASHAs). Findings A total of 370 young infants with signs of PSBI were identified and managed in 5270 live births. Treatment coverage was 70% assuming that 10% of live births would have PSBI within the first two months of life. Mothers identified 87.6% (324/370) of PSBI cases. PHCs and CHCs became functional and managed 150 (40%) sick young infants with PSBI. Twenty four young infants (7-59days) who had only fast breathing were treated with oral amoxicillin without a referral. Referral to a hospital was refused by 126 (84%); 119 had clinical severe infection (CSI), one 0–6 days old had fast breathing and six had critical illness (CI). Of 119 CSI cases managed on outpatient injection gentamicin and oral amoxicillin, 116 (96.7%) recovered, 55 (45.8%) received all seven gentamicin injections and only one died. All 7–59 day old infants with fast breathing recovered, 23 on outpatient oral amoxicillin treatment; and 19 (79%) received all doses. Of 65 infants managed at either district or tertiary hospital, two (3.1%) died, rest recovered. Private providers managed 155 (41.9%) PSBI cases, all except one recovered, but sub-classification and treatment were unknown. Sub-centers could not be activated to manage PSBI. Conclusion The study demonstrated resolution of implementation bottlenecks with existing resources, activated PHCs and CHCs to manage CSI and fast breathers (7–59 day old) on an outpatient basis with low mortality when a referral was not feasible. TSU was instrumental in these achievements. We established the effectiveness of oral amoxicillin alone in 7–59 days old fast breathers and recommend a review of the current national policy.

BackgroundTwo rounds of integrated biological and behavioural assessment (IBBA) surveys were done among men who have sex with men (MSM) in Andhra Pradesh during 2006 and 2009. Avahan, the India AIDS initiative, funded by the Bill and Melinda Gates Foundation implemented HIV prevention interventions among MSM starting around the time of the first round of IBBA.MethodsData on socio-demographic, sex behaviour characteristics and HIV status of MSM from the two IBBA rounds were used. Changes in the rates of consistent condom use over the past one month by MSM with various types of partners between the two rounds were assessed. Multivariate analysis was performed to assess associations between various factors and inconsistent condom use for sex with regular partners as well as HIV in MSM.ResultsA significant increase in consistent condom use by MSM was noted from 2006 to 2009 for paid male partners (19.5% to 93.8%), occasional male partners (13.2% to 86.2%), and paid female partners (25.9% to 94.2%). Consistent condom use with regular sex partners also increased but remained lower with regular male partner (75.8%) and very low with regular female partners (15.7%). MSM who used condoms inconsistently with their regular male partner were also more likely to use condoms inconsistently with their regular female partner. Multivariate analysis showed MSM who used condoms inconsistently with regular male partner had higher odds of HIV (odds ratio 1.8; 95% CI 1.2-2.7). MSM who received condoms from Avahan had the lowest odds (odds ratio 0.3; 95% CI 0.1-0.5) of inconsistent condom use with regular male partners.ConclusionsCondom use by MSM increased markedly after implementation of Avahan, though a causal association cannot be assessed with the available data. The relatively lower condom use with regular partners of MSM suggests that additional programme effort is needed to address this aspect specifically.

While under-nutrition (underweight and stunting) is still prevalent in India, the rates of overweight and obesity are steadily increasing, especially among adults. In Kerala, the rates of overweight and obese exceeded underweight. This paper examines the trends in the shift from underweight to overweight and identify the major determinants of the co-existence of 'double burden' of malnutrition among women of reproductive age 15-49 years using the data from National Nutrition Monitoring Bureau (NNMB) diet and nutrition surveys and the second National Family Health Survey (NFHS-2). Results of the multivariate logistic regression analyses on NFHS-2 data show that household standard of living and age are significantly associated with both underweight and overweight or obesity. On the other hand, work status, residence and caste are not significant on women's nutritional status. Among others, Muslim and Christian women, women who watch television more than once a week and women who reported eating fruits daily and consume chicken or meat or fish are more likely to be overweight or obese than their counterparts. The risk of chronic energy deficiency or underweight is significantly higher among never married women and lower among literate women. In summary, both underweight and overweight or obesity are equally present in Kerala and there is a need for public health programs that are able to address both simultaneously.

Background: Progress has been made in 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 SDG-3. Prevention of sepsis among the high risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising.Methods/design: A phase III, multicentre, randomized, double blind, placebo-controlled is being conducted at six sites in India. A total of 6144 Healthy LBW infants fulfilling the eligibility criteria would be enrolled within 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 R 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 1ml/day dose for 30 days. The follow-up of enrolled infants 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, blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performingsepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. Study would be implemented as per the MRC guideline for management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A Contract Research Organization would be enaged 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 sepsis, possible serious Bacterial Infection (PSBI) & secondary outcomes. The codes will be broken after DMEC 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 sitesDiscussion: 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: The study is registered at the Clinical Trial Registry of India (CTRI; 1 http://ctri.nic.in); Number CTRI/2019/05/019197, date 16 May 2019).

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

Background An association between rotavirus vaccination and intussusception has been documented in post-licensure studies in some countries. We evaluated the risk of intussusception associated with monovalent rotavirus vaccine (Rotavac) administered at 6, 10 and 14 weeks of age in India. Methods Active prospective surveillance for intussusception was conducted at 22 hospitals across 16 states from April 2016 through September 2017. Data on demography, clinical features and vaccination were documented. Age-adjusted relative incidence for 1–7, 8–21, and 1–21 days after rotavirus vaccination in children aged 28–364 days at intussusception onset was estimated using the self-controlled case-series (SCCS) method. Only Brighton Collaboration level 1 cases were included. Results Out of 670 children aged 2–23 months with intussusception, 311 (46.4%) children were aged 28–364 days with confirmed vaccination status. Out of these, 52 intussusception cases with confirmed receipt of RVV were included in the SCCS analysis. No intussusception case was observed within 21 days of dose 1. Only one case occurred during 8–21 days after the dose 2. Post-dose 3, two cases in 1–7 days and 7 cases during 8–21 days period were observed. There was no increased risk of intussusception during 1–7 days after the doses 1 and 2 (zero cases observed) or dose 3 (relative incidence [RI], 1.71 [95% confidence interval {CI} 0.0–5.11]). Similarly, no increased risk during 8–21 days after the dose 1 (zero cases observed), dose 2 (RI, 0.71 [95% CI, 0.0–3.28]) or dose 3 (RI, 2.52 [95% CI, 0.78–5.61]). The results were similar for 1–21 day periods after the doses separately or pooled. Conclusions The risk of intussusception during the first 21 days after any dose of rotavirus vaccine (Rotavac) was not higher among the Indian infants than the background risk, based on limited SCCS analysis of 52 children.