A cluster randomized controlled trial of a community-based initiative to reduce stunting in rural Indonesia.

We evaluate the impacts of a $120 million project in Indonesia conducted between 2014 and 2018 that sought to reduce stunting through a combination of (1) community-driven development grants targeted at health and education outcomes, (2) training for health providers on infant and young child feeding and growth monitoring and (3) training for sanitarians on a local variation of community-led total sanitation. This cluster randomized controlled trial involved 95 treatment and 95 control subdistricts across South Sumatra, West Kalimantan, and Central Kalimantan provinces. Overall, we find no significant impacts on stunting, the study's primary outcome measure (0.5 pp; 95% confidence interval [CI]: -3.0 to 4.1 percentage points [pp]), or other longer-term undernutrition outcomes about 1 year after the end of the project. The project had a modest impact on some secondary, more proximal outcomes related to maternal and child nutrition, including the percentage of mothers consuming the recommended number of iron-folic acid pills during pregnancy (8.7 pp; 95% CI: 4.1-13.3 pp), 0-5-month-olds being exclusively breastfed (8.7 pp; 95% CI: 1.8-15.6 pp) and 6-23-month-olds receiving the number of recommended meals per day (8.5 pp; 95% CI: 3.8-13.2 pp). However, there were no significant impacts on other proximal outcomes like the number of pre-natal and post-natal checkups, child dietary diversity, child vitamin A receipt or the incidence of child diarrhoea. Our findings highlight that successfully implementing an integrated package of interventions to reduce child stunting may be challenging in practice. Project design needs to consider implementation reality along with best practice-for example, by piloting the synchronous implementation of multifaceted interventions or phasing them in more gradually over a longer timeframe.

Impact of mHealth interventions for reproductive, maternal, newborn and child health and nutrition at scale: BBC Media Action and the Ananya program in Bihar, India.

BACKGROUND: Mobile health (mHealth) tools have potential for improving the reach and quality of health information and services through community health workers in low- and middle-income countries. This study evaluates the impact of an mHealth tool implemented at scale as part of the statewide reproductive,maternal, newborn and child health and nutrition (RMNCHN) program in Bihar, India. METHODS: Three survey-based data sets were analysed to compare the health-related knowledge, attitudes and behaviours amongst childbearing women exposed to the Mobile Kunji and Dr. Anita mHealth tools during their visits with frontline workers compared with those who were unexposed. RESULTS: An evaluation by Mathematica (2014) revealed that exposure to Mobile Kunji and Dr. Anita recordings were associated with significantly higher odds of consuming iron-folic acid tablets (odds ratio (OR) = 2.3, 95% confidence interval (CI) = 1.8-3.1) as well as taking a set of three measures for delivery preparedness (OR = 2.8, 95% CI = 1.9-4.2) and appropriate infant complementary feeding (OR = 1.9, 95% CI = 1.0-3.5). CARE India's Community-based Household Surveys (2012-2017) demonstrated significant improvements in early breastfeeding (OR = 1.64, 95% CI = 1.5-1.78) and exclusive breastfeeding (OR = 1.46, 95% CI = 1.33-1.62) in addition to birth preparedness practices. BBC Media Action's Usage & Engagement Survey (2014) demonstrated a positive association between exposure to Mobile Kunji and Dr. Anita and exclusive breastfeeding (58% exposed vs 43% unexposed, P < 0.01) as well as maternal respondents' trust in their frontline worker. CONCLUSIONS: Significant improvements in RMNCHN-related knowledge and behaviours were observed for Bihari women who were exposed to Mobile Kunji and Dr. Anita. This analysis is unique in its rigorous evaluation across multiple data sets of mHealth interventions implemented at scale. These results can help inform global understanding of how best to use mHealth tools, for whom, and in what contexts. STUDY REGISTRATION: ClinicalTrials.gov number NCT02726230.

Evaluation of a large-scale reproductive, maternal, newborn and child health and nutrition program in Bihar, India, through an equity lens.

BACKGROUND: Despite increasing focus on health inequities in low- and middle income countries, significant disparities persist. We analysed impacts of a statewide maternal and child health program among the most compared to the least marginalised women in Bihar, India. METHODS: Utilising survey-weighted logistic regression, we estimated programmatic impact using difference-in-difference estimators from Mathematica data collected at the beginning (2012, n = 10 174) and after two years of program implementation (2014, n = 9611). We also examined changes in disparities over time using eight rounds of Community-based Household Surveys (CHS) (2012-2017, n = 48 349) collected by CARE India. RESULTS: At baseline for the Mathematica data, least marginalised women generally performed desired health-related behaviours more frequently than the most marginalised. After two years, most disparities persisted. Disparities increased for skilled birth attendant identification [+16.2% (most marginalised) vs +32.6% (least marginalized), P < 0.01) and skin-to-skin care (+14.8% vs +20.4%, P < 0.05), and decreased for immediate breastfeeding (+10.4 vs -4.9, P < 0.01). For the CHS data, odds ratios compared the most to the least marginalised women as referent. Results demonstrated that disparities were most significant for indicators reliant on access to care such as delivery in a facility (OR range: 0.15 to 0.48) or by a qualified doctor (OR range: 0.08 to 0.25), and seeking care for complications (OR range: 0.26 to 0.64). CONCLUSIONS: Disparities observed at baseline generally persisted throughout program implementation. The most significant disparities were observed amongst behaviours dependent upon access to care. Changes in disparities largely were due to improvements for the least marginalised women without improvements for the most marginalised. Equity-based assessments of programmatic impacts, including those of universal health approaches, must be undertaken to monitor disparities and to ensure equitable and sustainable benefits for all. STUDY REGISTRATION: ClinicalTrials.gov number NCT02726230.

Impact of the Ananya program on reproductive, maternal, newborn and child health and nutrition in Bihar, India: early results from a quasi-experimental study.

BACKGROUND: The Government of Bihar (GoB) in India, the Bill and Melinda Gates Foundation and several non-governmental organisations launched the Ananya program aimed to support the GoB to improve reproductive, maternal, newborn and child health and nutrition (RMNCHN) statewide. Here we summarise changes in indicators attained during the initial two-year pilot phase (2012-2013) of implementation in eight focus districts of approximately 28 million population, aimed to inform subsequent scale-up. METHODS: The quasi-experimental impact evaluation included statewide household surveys at two time points during the pilot phase: January-April 2012 ("baseline") including an initial cohort of beneficiaries and January-April 2014 ("midline") with a new cohort. The two arms were: 1) eight intervention districts, and 2) a comparison arm comprised of the remaining 30 districts in Bihar where Ananya interventions were not implemented. We analysed changes in indicators across the RMNCHN continuum of care from baseline to midline in intervention and comparison districts using a difference-in-difference analysis. RESULTS: Indicators in the two arms were similar at baseline. Overall, 40% of indicators (20 of 51) changed significantly from baseline to midline in the comparison districts unrelated to Ananya; two-thirds (n = 13) of secular indicator changes were in a direction expected to promote health. Statistically significant impact attributable to the Ananya program was found for 10% (five of 51) of RMNCHN indicators. Positive impacts were most prominent for mother's behaviours in contraceptive utilisation. CONCLUSIONS: The Ananya program had limited impact in improving health-related outcomes during the first two-year period covered by this evaluation. The program's theories of change and action were not powered to observe statistically significant differences in RMNCHN indicators within two years, but rather aimed to help inform program improvements and scale-up. Evaluation of large-scale programs such as Ananya using theory-informed, equity-sensitive (including gender), mixed-methods approaches can help elucidate causality and better explain pathways through which supply- and demand-side interventions contribute to changes in behaviour among the actors involved in the production of population-level health outcomes. Evidence from Bihar indicates that deep structural constraints in health system organisation and delivery of interventions pose substantial limitations on behaviour change among health care providers and beneficiaries. STUDY REGISTRATION: ClinicalTrials.gov number NCT02726230.

Improving primary health care delivery in Bihar, India: Learning from piloting and statewide scale-up of Ananya.

In 2010, the Bill and Melinda Gates Foundation (BMGF) partnered with the Government of Bihar (GoB), India to launch the Ananya program to improve reproductive, maternal, newborn and child health and nutrition (RMNCHN) outcomes. The program sought to address supply- and demand-side barriers to the adoption, coverage, quality, equity and health impact of select RMNCHN interventions. Approaches included strengthening frontline worker service delivery; social and behavior change communications; layering of health, nutrition and sanitation into women's self-help groups (SHGs); and quality improvement in maternal and newborn care at primary health care facilities. Ananya program interventions were piloted in approximately 28 million population in eight innovation districts from 2011-2013, and then beginning in 2014, were scaled up by the GoB across the rest of the state's population of 104 million. A Bihar Technical Support Program provided techno-managerial support to governmental Health as well as Integrated Child Development Services, and the JEEViKA Technical Support Program supported health layering and scale-up of the GoB's SHG program. The level of support at the block level during statewide scale-up in 2014 onwards was approximately one-fourth that provided in the pilot phase of Ananya in 2011-2013. This paper - the first manuscript in an 11-manuscript and 2-viewpoint collection on Learning from Ananya: Lessons for primary health care performance improvement - seeks to provide a broad description of Ananya and subsequent statewide adaptation and scale-up, and capture the background and context, key objectives, interventions, delivery approaches and evaluation methods of this expansive program. Subsequent papers in this collection focus on specific intervention delivery platforms. For the analyses in this series, Stanford University held key informant interviews and worked with the technical support and evaluation grantees of the Ananya program, as well as leadership from the India Country Office of the BMGF, to analyse and synthesise data from multiple sources. Capturing lessons from the Ananya pilot program and statewide scale-up will assist program managers and policymakers to more effectively design and implement RMNCHN programs at scale through technical assistance to governments.

Use of mobile technology by frontline health workers to promote reproductive, maternal, newborn and child health and nutrition: a cluster randomized controlled Trial in Bihar, India.

BACKGROUND: mHealth technology holds promise for improving the effectiveness of frontline health workers (FLWs), who provide most health-related primary care services, especially reproductive, maternal, newborn, child health and nutrition services (RMNCHN), in low-resource - especially hard-to-reach - settings. Data are lacking, however, from rigorous evaluations of mHealth interventions on delivery of health services or on health-related behaviors and outcomes. METHODS: The Information Communication Technology-Continuum of Care Service (ICT-CCS) tool was designed for use by community-based FLWs to increase the coverage, quality and coordination of services they provide in Bihar, India. It consisted of numerous mobile phone-based job aids aimed to improve key RMNCHN-related behaviors and outcomes. ICT-CCS was implemented in Saharsa district, with cluster randomization at the health sub-center level. In total, evaluation surveys were conducted with approximately 1100 FLWs and 3000 beneficiaries who had delivered an infant in the previous year in the catchment areas of intervention and control health sub-centers, about half before implementation (mid-2012) and half two years afterward (mid-2014). Analyses included bivariate and difference-in-difference analyses across study groups. RESULTS: The ICT-CCS intervention was associated with more frequent coordination of AWWs with ASHAs on home visits and greater job confidence among ASHAs. The intervention resulted in an 11 percentage point increase in FLW antenatal home visits during the third trimester (P = 0.04). In the post-implementation period, postnatal home visits during the first week were increased in the intervention (72%) vs the control (60%) group (P < 0.01). The intervention also resulted in 13, 12, and 21 percentage point increases in skin-to-skin care (P < 0.01), breastfeeding immediately after delivery (P < 0.01), and age-appropriate complementary feeding (P < 0.01). FLW supervision and other RMNCHN behaviors were not significantly impacted. CONCLUSIONS: Important improvements in FLW home visits and RMNCHN behaviors were achieved. The ICT-CCS tool shows promise for facilitating FLW effectiveness in improving RMNCHN behaviors.

Effects of team-based goals and non-monetary incentives on front-line health worker performance and maternal health behaviours: a cluster randomised controlled trial in Bihar, India.

INTRODUCTION: We evaluated the impact of a 'Team-Based Goals and Incentives' (TBGI) intervention in Bihar, India, designed to improve front-line (community health) worker (FLW) performance and health-promoting behaviours related to reproductive, maternal, newborn and child health and nutrition. METHODS: This study used a cluster randomised controlled trial design and difference-in-difference analyses of improvements in maternal health-related behaviours related to the intervention's team-based goals (primary), and interactions of FLWs with each other and with maternal beneficiaries (secondary). Evaluation participants included approximately 1300 FLWs and 3600 mothers at baseline (May to June 2012) and after 2.5 years of implementation (November to December 2014) who had delivered an infant in the previous year. RESULTS: The TBGI intervention resulted in significant increases in the frequency of antenatal home visits (15 absolute percentage points (PP), p=0.03) and receipt of iron-folic acid (IFA) tablets (7 PP, p=0.02), but non-significant changes in other health behaviours related to the trial's goals. Improvements were seen in selected attitudes related to coordination and teamwork among FLWs, and in the provision of advice to beneficiaries (ranging from 8 to 14 PP) related to IFA, cord care, breast feeding, complementary feeding and family planning. CONCLUSION: Results suggest that combining an integrated set of team-based coverage goals and targets, small non-cash incentives for teams who meet targets and team building to motivate FLWs resulted in improvements in FLW coordination and teamwork, and in the quality and quantity of FLW-beneficiary interactions. These improvements represent programmatically meaningful steps towards improving health behaviours and outcomes. TRIAL REGISTRATION NUMBER: NCT03406221.

Solid-state chemistry of ambroxol theophylline-7-acetate.

Ambroxol theophylline-7-acetate (ACE) is the salt obtained by reaction of equimolar amounts of ambroxol (AMB), a drug showing mucolytic and expectorant properties, and theophylline-7-acetic acid (TAA), a xanthine derivative with specific bronchodilator activity. ACE is used for the treatment of bronchial and pulmonary diseases (bronchitis, asthma, emphysema, chronic obstructive disease). Recrystallization experiments of ACE resulted in the isolation of two polymorphs (monotropically related) and four solvated forms. X-ray diffractometry, DSC, TGA, and HSM techniques were used to investigate the forms that are obtained by thermal desolvation of the solvates. The phase diagram of the TAA-AMB binary system was constructed by performing thermal analyses on mixtures of TAA-AMB and of each component plus the interaction compound (TAA-ACE and ACE-AMB). The Schroeder-Van Laar equation proved to be a very useful tool for checking the consistency between the experimental data and the theoretical model related to the general system, showing complete miscibility in the liquid phase and complete immiscibility in the solid phase.