Background Evidence is limited on the effectiveness of mobile health programs which provide stage-based health information messages to pregnant and postpartum women. Kilkari is an outbound service that delivers weekly, stage-based audio messages about pregnancy, childbirth, and childcare directly to families in 13 states across India on their mobile phones. In this protocol we outline methods for measuring the effectiveness and cost-effectiveness of Kilkari. Methods The study is an individually randomized controlled trial (iRCT) with a parallel, partially concurrent, and unblinded design. Five thousand pregnant women will be enrolled from four districts of Madhya Pradesh and randomized to an intervention or control arm. The women in the intervention arm will receive Kilkari messages while the control group will not receive any Kilkari messages as part of the study. Women in both arms will be followed from enrollment in the second and early third trimesters of pregnancy until one year after delivery. Differences in primary outcomes across study arms including early and exclusive breastfeeding and the adoption of modern contraception at 1 year postpartum will be assessed using intention to treat methodology. Surveys will be administered at baseline and endline containing modules on phone ownership, geographical and demographic characteristics, knowledge, practices, respectful maternity care, and coverage for antenatal care, delivery, and postnatal care. In-depth interviews and focus group discussions will be carried out to understand user perceptions of Kilkari, and more broadly, experiences providing phone numbers and personal health information to health care providers. Costs and consequences will be estimated from a societal perspective for the 2018–2019 analytic time horizon. Discussion Kilkari is the largest maternal messaging program, in terms of absolute numbers, currently being implemented globally. Evaluations of similar initiatives elsewhere have been small in scale and focused on summative outcomes, presenting limited evidence on individual exposure to content. Drawing upon system-generated data, we explore linkages between successful receipt of calls, user engagement with calls, and reported outcomes. This is the first study of its kind in India and is anticipated to provide the most robust and comprehensive evidence to date on maternal messaging programs globally. Trial registration Clinicaltrials.gov, 90075552, NCT03576157 . Registered on 22 June 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3369-5) contains supplementary material, which is available to authorized users.

BackgroundBihar, India has higher rates of intimate partner violence (IPV) and maternal and infant mortality relative to India as a whole. This study assesses whether IPV is associated with poor reproductive and maternal health outcomes, as well as whether poverty exacerbates any observed associations, among women who gave birth in the preceding 23 months in Bihar, India.MethodsA cross-sectional analysis of data from a representative household sample of mothers of children 0–23 months old in Bihar, India (N = 13,803) was conducted. Associations between lifetime IPV (physical and/or sexual violence) and poor reproductive health outcomes ever (miscarriage, stillbirth, and abortion) as well as maternal complications for the index pregnancy (early and/or prolonged labor complications, other complications during pregnancy or delivery) were assessed using multivariable logistic regression, adjusting for demographics and fertility history of the mother. Models were then stratified by wealth index to determine whether observed associations were stronger for poorer versus wealthier women.ResultsIPV was reported by 45% of women in the sample. A history of miscarriage, stillbirth, and abortion was reported by 8.7, 4.6, and 1.3% of the sample, respectively. More than one in 10 women (10.7%) reported labor complications during the last pregnancy, and 16.3% reported other complications during pregnancy or delivery. Adjusted regressions revealed significant associations between IPV and miscarriage (AOR = 1.35, 95% CI = 1.11–1.65) and stillbirth (AOR = 1.36, 95% CI = 1.02–1.82) ever, as well as with labor complications (AOR = 1.27, 95% CI = 1.04–1.54) and other pregnancy/delivery complications (AOR = 1.68, 95% CI = 1.42–1.99). Women in the poorest quartile (Quartile 1) saw no associations between IPV and miscarriage (Quartile 1 AOR = 0.98, 95% CI = 0.67–1.45) or stillbirth (Quartile 1 AOR = 1.17, 95% CI = 0.69–1.98), whereas women in the higher wealth quartile (Quartile 3) did see associations between IPV and miscarriage (Quartile 3 AOR = 1.55, 95% CI = 1.07, 2.25) and stillbirth (Quartile 3 AOR = 1.79, 95% CI = 1.04, 3.08).DiscussionIPV is highly prevalent in Bihar and is associated with increased risk for miscarriage, stillbirth, and maternal health complications. Associations between IPV and miscarriage and stillbirth do not hold true for the poorest women, possibly because other risks attached to poverty and deprivation may be greater contributors.

Background The disruptive potential of mobile phones in catalyzing development is increasingly being recognized. However, numerous gaps remain in access to phones and their influence on health care utilization. In this cross-sectional study from India, we assess the gaps in women’s access to phones, their influencing factors, and their influence on health care utilization. Methods Data drawn from the 2015 National Family Health Survey (NFHS) in India included a national sample of 45,231 women with data on phone access. Survey design weighted estimates of household phone ownership and women’s access among different population sub-groups are presented. Multilevel logistic models explored the association of phone access with a wide range of maternal and child health indicators. Blinder-Oaxaca (BO) decomposition is used to decompose the gaps between women with and without phone access in health care utilization into components explained by background characteristics influencing phone access (endowments) and unexplained components (coefficients), potentially attributable to phone access itself. Findings Phone ownership at the household level was 92·8% (95% CI: 92·6–93·0%), with rural ownership at 91·1% (90·8–91·4%) and urban at 97.1% (96·7–97·3%). Women’s access to phones was 47·8% (46·7–48·8%); 41·6% in rural areas (40·5–42·6%) and 62·7% (60·4–64·8%) in urban. Phone access in urban areas was positively associated with skilled birth attendance, postnatal care and use of modern contraceptives and negatively associated with early antenatal care. Phone access was not associated with improvements in utilization indicators in rural settings. Phone access (coefficient components) explained large gaps in the use of modern contraceptives, moderate gaps in postnatal care and early antenatal care, and smaller differences in the use of skilled birth attendance and immunization. For full antenatal car, phone access was associated with reducing gaps in utilization. Interpretation Women of reproductive age have significantly lower phone access use than the households they belong to and marginalized women have the least phone access. Existing phone access for rural women did not improve their health care utilization but was associated with greater utilization for urban women. Without addressing these biases, digital health programs may be at risk of worsening existing health inequities.

IntroductionMillions of children in India still suffer from poor health and under-nutrition, despite substantial improvement over decades of public health programmes. The Anganwadi centres under the Integrated Child Development Scheme (ICDS) provide a range of health and nutrition services to pregnant women, children <6 years and their mothers. However, major gaps exist in ICDS service delivery. The government is currently strengthening ICDS through an mHealth intervention called Common Application Software (ICDS-CAS) installed on smart phones, with accompanying multilevel data dashboards. This system is intended to be a job aid for frontline workers, supervisors and managers, aims to ensure better service delivery and supervision, and enable real-time monitoring and data-based decision-making. However, there is little to no evidence on the effectiveness of such large-scale mHealth interventions integrated with public health programmes in resource-constrained settings on the service delivery and subsequent health and nutrition outcomes.Methods and analysisThis study uses a village-matched controlled design with repeated cross-sectional surveys to evaluate whether ICDS-CAS can enable more timely and appropriate services to pregnant women, children <12 months and their mothers, compared with the standard ICDS programme. The study will recruit approximately 1500 Anganwadi workers and 6000+ mother-child dyads from 400+ matched-pair villages in Bihar and Madhya Pradesh. The primary outcomes are the proportion of beneficiaries receiving (a) adequate number of home visits and (b) appropriate level of counselling by the Anganwadi workers. Secondary outcomes are related to improvements in other ICDS services, and knowledge and practices of the Anganwadi workers and beneficiaries.Ethics and disseminationEthical oversight is provided by the Committee for the Protection of Human Subjects at the University of California at Berkeley, and the Suraksha Independent Ethics Committee in India. The results will be published in peer-reviewed journals and analysis data will be made public.Trial registration numberISRCTN83902145

BackgroundReducing neonatal mortality is a global priority, and improvements in postnatal health (PNH) practices in India are needed to do so. Intimate partner violence (IPV) may be associated with PNH practices, but little research has assessed this relationship.MethodsA cross-sectional analysis of data from a representative household sample of mothers of neonates 0–11 months old in Bihar, India was conducted. The relationship between lifetime IPV experience (physical violence only, sexual violence only, or both physical and sexual violence) and PNH practices [clean cord care, kangaroo mother care, early initiation of breastfeeding (EIBF), delayed bathing, receipt of a postnatal care visit, exclusive breastfeeding, and current post-partum contraceptive use] was assessed using multivariate logistic regression.ResultsOver 45% of the 10,469 mothers experienced IPV in their lifetime. The three types of IPV experiences differentially related to PNH practices. Adjusted analyses revealed that compared to those who had never experienced IPV, women who experienced physical violence only (29.0%) had higher odds of skin-to-skin care (AOR = 1.67, 95% CI = 1.42, 1.96) and delayed bathing (AOR = 1.19, 95% CI = 1.03, 1.37), but lower odds of EIBF (AOR = 0.81, 95% CI = 0.70, 0.93) and exclusive breastfeeding (AOR = 0.83, 95% CI = 0.71, 0.96). Mothers who had experienced sexual violence only (2.3%) had lower odds of practicing EIBF (AOR = 0.52, 95% CI = 0.36, 0.76). Those who had both experiences of physical and sexual violence (14.0%) had increased odds of postpartum modern contraceptive use (AOR = 1.35, 95% CI = 1.07, 1.71) and lower odds of delayed bathing (AOR = 0.76, 95% CI = 0.63, 0.91).ConclusionsThe results of this study found differing patterns of vulnerability to poor PNH practices depending on the type of IPV experienced. Efforts to increase access to health services for women experiencing IPV and to integrate IPV intervention into such service may increase PNH practices, and as a result, reduce neonatal mortality.

Background Respectful maternity care (RMC) is a key barometer of the underlying quality of care women receive during pregnancy and childbirth. Efforts to measure RMC have largely been qualitative, although validated quantitative tools are emerging. Available tools have been limited to the measurement of RMC during childbirth and confined to observational and face-to-face survey modes. Phone surveys are less invasive, low cost, and rapid alternatives to traditional face-to-face methods, yet little is known about their validity and reliability. Objective The primary objective of this study was to develop validated face-to-face and phone survey tools for measuring RMC during pregnancy and childbirth for use in India and other low resource settings. The secondary objective was to optimize strategies for improving the delivery of phone surveys for use in measuring RMC. Methods To develop face-to-face and phone surveys for measuring RMC, we describe procedures for assessing content, criterion, and construct validity as well as reliability analyses. To optimize the delivery of phone surveys, we outline plans for substudies, which aim to assess the effect of survey modality, and content on survey response, completion, and attrition rates. Results Data collection will be carried out in 4 districts of Madhya Pradesh, India, from July 2018 to March 2019. Conclusions To our knowledge, this is the first RMC phone survey tool developed for India, which may provide an opportunity for the rapid, routine collection of data essential for improving the quality of care during pregnancy and childbirth. Elsewhere, phone survey tools are emerging; however, efforts to develop these surveys are often not inclusive of rigorous pretesting activities essential for ensuring quality data, including cognitive, reliability, and validity testing. In the absence of these activities, emerging data could overestimate or underestimate the burden of disease and health care practices under assessment. In the context of RMC, poor quality data could have adverse consequences including the naming and shaming of providers. By outlining a blueprint of the minimum activities required to generate reliable and valid survey tools, we hope to improve efforts to develop and deploy face-to-face and phone surveys in the health sector. International Registered Report Identifier (IRRID) DERR1-10.2196/12173

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