Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial.

INTRODUCTION: In South Asia, younger women have high rates of unmet need for family planning and low empowerment. Life skills interventions can equip young women with agency, but the effectiveness of these interventions in reproductive and sexual autonomy and contraception has not been examined. METHODS AND ANALYSIS: A two-arm, parallel, cluster randomised controlled trial will evaluate the impact of TARANG (Transforming Actions for Reaching and Nurturing Gender Equity and Empowerment), a life skills and reproductive health empowerment group-based intervention for newly married women, compared with usual services in the community in rural and tribal Rajasthan, India. TARANG will also provide light-touch sessions to husbands and mothers-in-law of newly married women. We will test the impact of TARANG in 80 village clusters among 800 eligible households comprising newly married women aged 18-25 years who are at risk of pregnancy but do not want a pregnancy within 1 year at the time of enrolment, their husbands and mothers-in-law who consent to participate. Women in the intervention villages will receive 14 sessions over a 6-month period, while husbands and mothers-in-law will receive 1 and 4 sessions (respectively) each. Three rounds of surveys will be collected over 18 months. Control villages will receive the intervention after the endline surveys. Primary outcomes include rate of unintended pregnancy and modern contraceptive use. We plan to start recruitment of participants and data collection in April 2024. We will estimate unadjusted and adjusted intention-to-treat effects using survival analysis and mixed models. ETHICS AND DISSEMINATION: Study protocols have been reviewed and approved by the human subjects review boards at the University of California, San Francisco, and the Centre for Media Studies, India (IRB00006230) and ACE Independent Ethics Committee, Bangalore (NET0062022). Results will be disseminated in international peer-reviewed journals and conferences, to stakeholders including local government and non-governmental organisations, and directly to the communities and individuals that participated in the intervention. TRIAL REGISTRATION NUMBER: NCT06024616.

Markets, incentives, and health promotion can improve family planning and maternal health practices: a quasi-experimental evaluation of a tech-enabled social franchising and social marketing platform in India.

BACKGROUND: Improving family planning and maternal health outcomes are critical to achieving the Sustainable Development Goals. While evidence on the effectiveness of government-driven public health programs is extensive, more research is needed on effectiveness of private-sector interventions, especially in low- and middle-income countries. We evaluated the impacts of a commercial social-franchising and social-marketing program - Tiko Platform - which created a local ecosystem of health promoters, healthcare providers, pharmacies, stockists/wholesalers, and lifestyle shops. It provided economic incentives through discounts and reward points to nudge health-seeking behaviors from enrolled women consumers/beneficiaries. METHODS: An ex-post facto evaluation was commissioned, and we employed a quasi-experimental design to compare outcomes related to the use of family planning, and antenatal and postnatal services between users and non-users who had registered for Tiko in three North Indian cities. Between March and April 2021, 1514 married women were surveyed, and outcome indicators were constructed based on recall. Despite statistical approaches to control for confounding, the effect of COVID-19 lockdown on Tiko operations and methodological limitations preclude inferring causality or arguing generalizability. RESULTS: We found a strong association between the use of the Tiko platform and the current use of temporary modern contraceptives [non-users: 9.5%, effect: +9.4 percentage points (pp), p-value < 0.001], consumption of 100 or more iron-folic-acid tablets during pregnancy [non-users: 25.5%, effect: +14 pp, p-value < 0.001], receiving four or more antenatal check-ups [non-users: 18.3%, effect: +11.3 pp, p-value 0.007], and receiving postnatal check-up within six weeks of birth [non-users: 50.9%, effect: +7.5 pp, p-value 0.091]. No associations were found between the use of the Tiko platform and the current use of any type of contraceptive (temporary, permanent, or rudimentary). Effects were pronounced when a community health worker of the National Health Mission also worked as a health promoter for the Tiko Platform. CONCLUSION: Commercial interventions that harness market-driven approaches of incentives, social marketing, and social franchising improved family planning and maternal health practices through higher utilization of private market providers while maintaining access to government health services. Findings support a unifying approach to public health without separating government versus private services, but more rigorous and generalizable research is needed. TRIAL REGISTRATION: NCT05725278 at clinicaltrials.gov (retrospective); 13/02/2023.

Can digitally enabling community health and nutrition workers improve services delivery to pregnant women and mothers of infants? Quasi-experimental evidence from a national-scale nutrition programme in India.

BACKGROUND: India's 1.4 million community health and nutrition workers (CHNWs) serve 158 million beneficiaries under the Integrated Child Development Services (ICDS) programme. We assessed the impact of a data capture, decision support, and job-aid mobile app for the CHNWs on two primary outcomes-(1) timeliness of home visits and (2) appropriate counselling specific to the needs of pregnant women and mothers of children <12 months. METHODS: We used a quasi-experimental pair-matched controlled trial using repeated cross-sectional surveys to evaluate the intervention in Bihar and Madhya Pradesh (MP) separately using an intention-to-treat analysis. The study was powered to detect difference of 5-9 percentage points (pp) with type I error of 0.05 and type II error of 0.20 with endline sample of 6635 mothers of children <12 months and 2398 pregnant women from a panel of 841 villages. RESULTS: Among pregnant women and mothers of children <12 months, recall of counselling specific to the trimester of pregnancy or age of the child as per ICDS guidelines was higher in both MP (11.5pp (95% CI 7.0pp to 16.0pp)) and Bihar (8.0pp (95% CI 5.3pp to 10.7pp)). Significant differences were observed in the proportion of mothers of children <12 months receiving adequate number of home visits as per ICDS guidelines (MP 8.3pp (95% CI 4.1pp to 12.5pp), Bihar: 7.9pp (95% CI 4.1pp to 11.6pp)). Coverage of children receiving growth monitoring increased in Bihar (22pp (95% CI 0.18 to 0.25)), but not in MP. No effects were observed on infant and young child feeding practices. CONCLUSION: The at-scale app integrated with ICDS improved provision of services under the purview of CHNWs but not those that depended on systemic factors, and was relatively more effective when baseline levels of services were low. Overall, digitally enabling CHNWs can complement but not substitute efforts for strengthening health systems and addressing structural barriers. TRIAL REGISTRATION NUMBER: ISRCTN83902145.

Anganwadi worker time use in Madhya Pradesh, India: a cross-sectional study.

BACKGROUND: Anganwadi Workers (AWWs) are a group of 1.4 million community health workers that operate throughout rural India as a part of the Integrated Child Development Services program. AWWs are responsible for disseminating key health information regarding nutrition, family planning, and immunizations to the women and children in their catchment area, while maintaining detailed registers that track key beneficiary data, updates on health status, and supply inventory beneficiaries. There is a need to understand how AWWs spend their time on all of these activities given all of their responsibilities, and the factors that are associated with their time use. METHODS: This cross-sectional study conducted in Madhya Pradesh, collected time use data from AWWs using a standard approach in which we asked participants how much time they spent on various activities. Additionally, we estimated a logistic regression model to elucidate what AWW characteristics are associated with time use. RESULTS: We found that AWWs spend substantial amounts of time on administrative tasks, such as filling out their paper registers. Additionally, we explored the associations between various AWW characteristics and their likelihood of spending the expected amount of time on preschool work, filling out their registers, feeding children, and conducting home visits. We found a positive significant association between AWW education and their likelihood of filling out their registers. CONCLUSIONS: AWWs spend substantial amounts of time on administrative tasks, which could take away from their ability to spend time on providing direct care. Additionally, future research should explore why AWW characteristics matter and how such factors can be addressed to improve AWWs' performance and should explore the associations between Anganwadi Center characteristics and AWW time use.

Effects of an mHealth intervention for community health workers on maternal and child nutrition and health service delivery in India: protocol for a quasi-experimental mixed-methods evaluation.

INTRODUCTION: Millions 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 ANALYSIS: This 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 DISSEMINATION: Ethical 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 NUMBER: ISRCTN83902145.

The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

BACKGROUND: Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). METHODS AND FINDINGS: We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. CONCLUSIONS: The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

Consumer preferences for household water treatment products in Andhra Pradesh, India.

Over 5 billion people worldwide are exposed to unsafe water. Given the obstacles to ensuring sustainable improvements in water supply infrastructure and the unhygienic handling of water after collection, household water treatment and storage (HWTS) products have been viewed as important mechanisms for increasing access to safe water. Although studies have shown that HWTS technologies can reduce the likelihood of diarrheal illness by about 30%, levels of adoption and continued use remain low. An understanding of household preferences for HWTS products can be used to create demand through effective product positioning and social marketing, and ultimately improve and ensure commercial sustainability and scalability of these products. However, there has been little systematic research on consumer preferences for HWTS products. This paper reports the results of the first state-of-the-art conjoint analysis study of HWTS products. In 2008, we conducted a conjoint analysis survey of a representative sample of households in Andhra Pradesh (AP), India to elicit and quantify household preferences for commercial HWTS products. Controlling for attribute non-attendance in an error components mixed logit model, the study results indicate that the most important features to respondents, in terms of the effect on utility, were the type of product, followed by the extent to which the product removes pathogens, the retail outlet and, the time required to treat 10 L. Holding all other product attributes constant, filters were preferred to combination products and chemical additives. Department stores and weekly markets were the most favorable sales outlets, followed by mobile salespeople. In general, households do not prefer to purchase HWTS products at local shops. Our results can inform the types of products and sales outlets that are likely to be successful in commercial HWTS markets in AP, as well as the influence of different pricing and financing strategies on product demand and uptake.

Shame or subsidy revisited: social mobilization for sanitation in Orissa, India.

OBJECTIVE: To determine the effectiveness of a sanitation campaign that combines 'shaming' (i.e. emotional motivators) with subsidies for poor households in rural Orissa, an Indian state with a disproportionately high share of India's child mortality. METHODS: Using a cluster-randomized design, we selected 20 treatment and 20 control villages in the coastal district of Bhadrak, rural Orissa, for a total sample of 1050 households. We collected sanitation and health data before and after a community-led sanitation project, and we used a difference-in-difference estimator to determine the extent to which the campaign influenced the number of households building and using a latrine. FINDINGS: Latrine ownership did not increase in control villages, but in treatment villages it rose from 6% to 32% in the overall sample, from 5% to 36% in households below the poverty line (eligible for a government subsidy) and from 7% to 26% in households above the poverty line (not eligible for a government subsidy). CONCLUSION: Subsidies can overcome serious budget constraints but are not necessary to spur action, for shaming can be very effective by harnessing the power of social pressure and peer monitoring. Through a combination of shaming and subsidies, social marketing can improve sanitation worldwide.

Of taps and toilets: quasi-experimental protocol for evaluating community-demand-driven projects.

Sustainable and equitable access to safe water and adequate sanitation are widely acknowledged as vital, yet neglected, development goals. Water supply and sanitation (WSS) policies are justified because of the usual efficiency criteria, but also major equity concerns. Yet, to date there are few scientific impact evaluations showing that WSS policies are effective in delivering social welfare outcomes. This lack of an evaluation culture is partly because WSS policies are characterized by diverse mechanisms, broad goals and the increasing importance of decentralized delivery, and partly because programme administrators are unaware of appropriate methods. We describe a protocol for a quasi-experimental evaluation of a community-demand-driven programme for water and sanitation in rural India, which addresses several evaluation challenges. After briefly reviewing policy and implementation issues in the sector, we describe key features of our protocol, including control group identification, pre-post measurement, programme theory, sample sufficiency and robust indicators. At its core, our protocol proposes to combine propensity score matching and difference-in-difference estimation. We conclude by briefly summarizing how quasi-experimental impact evaluations can address key issues in WSS policy design and when such evaluations are needed.

Consumer food safety knowledge, practices, and demographic differences: findings from a meta-analysis.

Risk communication and consumer education to promote safer handling of food can be the best way of managing the risk of foodborne illness at the consumer end of the food chain. Thus, an understanding of the overall status of food handling knowledge and practices is needed. Although traditional qualitative reviews can be used for combining information from several studies on specific food handling behaviors, a structured approach of meta-analysis can be more advantageous in a holistic assessment. We combined findings from 20 studies using meta-analysis methods to estimate percentages of consumers engaging in risky behaviors, such as consumption of raw food, poor hygiene, and cross-contamination, separated by various demographic categories. We estimated standard errors to reflect sampling error and between-study random variation. Then we evaluated the statistical significance of differences in behaviors across demographic categories and across behavioral measures. There were considerable differences in behaviors across demographic categories, possibly because of socioeconomic and cultural differences. For example, compared with women, men reported greater consumption of raw or undercooked foods, poorer hygiene, poorer practices to prevent cross-contamination, and less safe defrosting practices. Mid-age adults consumed more raw food (except milk) than did young adults and seniors. High-income individuals reported greater consumption of raw foods, less knowledge of hygiene, and poorer cross-contamination practices. The highest raw ground beef and egg consumption and the poorest hygiene and cross-contamination practices were found in the U.S. Mountain region. Meta-analysis was useful for identifying important data gaps and demographic groups with risky behaviors, and this information can be used to prioritize further research.

An application of meta-analysis in food safety consumer research to evaluate consumer behaviors and practices.

Meta-analysis provides a structured method for combining results from several studies and accounting for and differentiating between study variables. Numerous food safety consumer research studies often focus on specific behaviors among different subpopulations but fail to provide a holistic picture of consumer behavior. Combining information from several studies provides a broader understanding of differences and trends among demographic subpopulations, and thus, helps in developing effective risk communication messages. In the illustrated example, raw/undercooked ground beef consumption and hygienic practices were evaluated according to gender, ethnicity, and age. Percentages of people engaging in each of the above behaviors (referred to as effect sizes) were combined using weighted averages of these percentages. Several measures, including sampling errors, random variance between studies, sample sizes of studies, and homogeneity of findings across studies, were used in the meta-analysis. The statistical significance of differences in behaviors across demographic segments was evaluated using analysis of variance. The meta-analysis identified considerable variability in effect sizes for raw/undercooked ground beef consumption and poor hygienic practices. More males, African Americans, and adults between 30 and 54 years (mid-age) consumed raw/undercooked ground beef than other demographic segments. Males, Caucasians, and Hispanics and young adults between 18 and 29 years were more likely to engage in poor hygienic practices. Compared to traditional qualitative review methods, meta-analysis quantitatively accounts for interstudy differences, allows greater consideration of data from studies with smaller sample sizes, and offers ease of analysis as newer data become available, and thus, merits consideration for its application in food safety consumer research.

Comparison of sensitivity analysis methods based on applications to a food safety risk assessment model.

Sensitivity analysis (SA) methods are a valuable tool for identifying critical control points (CCPs), which is one of the important steps in the hazard analysis and CCP approach that is used to ensure safe food. There are many SA methods used across various disciplines. Furthermore, food safety process risk models pose challenges because they often are highly nonlinear, contain thresholds, and have discrete inputs. Therefore, it is useful to compare and evaluate SA methods based upon applications to an example food safety risk model. Ten SA methods were applied to a draft Vibrio parahaemolyticus (Vp) risk assessment model developed by the Food and Drug Administration. The model was modified so that all inputs were independent. Rankings of key inputs from different methods were compared. Inputs such as water temperature, number of oysters per meal, and the distributional assumption for the unrefrigerated time were the most important inputs, whereas time on water, fraction of pathogenic Vp, and the distributional assumption for the weight of oysters were the least important inputs. Most of the methods gave a similar ranking of key inputs even though the methods differed in terms of being graphical, mathematical, or statistical, accounting for individual effects or joint effect of inputs, and being model dependent or model independent. A key recommendation is that methods be further compared by application on different and more complex food safety models. Model independent methods, such as ANOVA, mutual information index, and scatter plots, are expected to be more robust than others evaluated.

Identification and review of sensitivity analysis methods.

Identification and qualitative comparison of sensitivity analysis methods that have been used across various disciplines, and that merit consideration for application to food-safety risk assessment models, are presented in this article. Sensitivity analysis can help in identifying critical control points, prioritizing additional data collection or research, and verifying and validating a model. Ten sensitivity analysis methods, including four mathematical methods, five statistical methods, and one graphical method, are identified. The selected methods are compared on the basis of their applicability to different types of models, computational issues such as initial data requirement and complexity of their application, representation of the sensitivity, and the specific uses of these methods. Applications of these methods are illustrated with examples from various fields. No one method is clearly best for food-safety risk models. In general, use of two or more methods, preferably with dissimilar theoretical foundations, may be needed to increase confidence in the ranking of key inputs.