Long-term impacts of a cash plus program on marriage, fertility, and education after six years in pastoralist Kenya: A cluster randomized trial.

Background: Preventing early marriage by increasing girls education has shown promise. We assessed the effects of a two-year cash plus program on marriage and fertility in a pastoralist setting in Northeastern Kenya, six years after it began. Methods: A prospective 80-cluster randomized trial followed 2,147 girls 11-14 years old starting in 2015, re-interviewing 94.2% in 2021. Interventions included community dialogues (violence prevention), a conditional cash transfer (education), health and life skills training (health), and financial literacy (wealth creation). Villages were randomized to one of four study arms: (1) violence prevention only (V-only); (2) + education (VE); (3) + health (VEH); or (4) + wealth creation (VEHW). We used analysis of covariance to estimate intent-to-treat impacts of each study arm with an education component, as well as a pooled (weighted average) study arm combining VE, VEH and VEHW, in reference to V-only, four years after the intervention ended when girls were 17-20 years old. Findings: Base specification estimates show reductions in the primary outcomes, though none statistically significant in the full sample. Estimates with extended controls are larger and the pooled study arm had significantly lower marriage and pregnancy. There are considerably larger statistically significant effects for the baseline out-ofschool subsample. Pooled estimates indicate 18.2 percentage point lower marriage compared to V-only and 15.1 percentage point lower pregnancy. For the same group pooled estimates indicate a 27.9 percentage point increase in current enrollment (compared to 7.1% in V-only) and a 1.8 grades increase (compared to 1.2 in V-only). Conclusion: This study shows the potential for interventions in early adolescence with an education component to delay marriage and fertility into late adolescence and early adulthood in a marginalized and socially conservative setting with low education and high rates of child marriage.

Effects of a single cash transfer on school re-enrollment during COVID-19 among vulnerable adolescent girls in Kenya: Randomized controlled trial.

COVID-19 related school closures in Kenya were among the longest in Africa, putting older adolescent girls nearing the end of secondary school at risk of permanent dropout. Using a randomized-controlled trial we evaluated a logistically simple cash transfer intervention in urban areas designed to promote their return to school. There were no required conditions for receiving the transfer and the intervention is interpreted as a labeled cash transfer. It had substantial significant effects on re-enrollment of adolescent girls, with greater effectiveness for older girls and even for some not enrolled earlier in the school year. The program effectiveness demonstrates feasibility of the approach and underscores the potential importance of additional resources for schooling during the pandemic, when a large majority of households had suffered income losses.

Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial.

BACKGROUND: The vast majority of adolescent births occur in low- and middle-income countries and are associated with negative outcomes for both the mother and her child. A multitude of risk factors may explain why few programs have been successful in delaying childbearing and suggest that multisectoral interventions may be necessary. This study examines the longer-term impact of a two-year (2015-17) multisectoral program on early sexual debut and fertility in an urban informal settlement in Kenya. METHODS: The study used a randomized trial design, longitudinally following 2,075 girls 11-14 years old in 2015 until 2019. The interventions included community dialogues on unequal gender norms and their consequences (violence prevention), a conditional cash transfer (education), health and life skills training (health), and financial literacy training and savings activities (wealth). Girls were randomized to one of four study arms: 1) violence prevention only (V-only); 2) V-only and education (VE); 3) VE and health (VEH); or 4) all four interventions (VEHW). We used ANCOVA to estimate intent-to-treat (ITT) impacts of each study arm and of pooled study arms VE, VEH, and VEHW relative to the V-only arm, on primary outcomes of fertility and herpes simplex virus-2 (HSV-2) infection, and secondary outcomes of education, health knowledge, and wealth creation. Post-hoc analysis was carried out on older girls who were 13-14-years-old at baseline. In 2018, in the VEHW arm, in-depth qualitative evaluation were carried out with adolescent girls, their parents, school staff, mentors, community conversation facilitators, and community gatekeepers. The trial is registered at ISRCTN: ISRCTN77455458. RESULTS: At endline in the V-only study arm, 21.0 percent of girls reported having had sex, 7.7 percent having ever been pregnant and 6.6 percent having ever given birth, with higher rates for the older subsample at 32.5 percent, 11.8 percent, and 10.1 percent, respectively. In the full sample, ever having given birth was reduced by 2.3 percentage points (pp) in the VE and VEHW study arms, significant at 10 percent. For the older subsample there were larger and significant reductions in the percent ever having had sex (8.2 pp), HSV-2 prevalence (7.5 pp) and HSV-2 incidence (5.6 pp) in the VE arm. Two years after the end of the interventions, girls continued to have increased schooling, sexual and reproductive health knowledge, and improved financial savings behaviors. Qualitatively, respondents reported that girls were likely to have sex as a result of child sexual exploitation, peer pressure or influence from the media, as well as for sexual adventure and as a mark of maturity. CONCLUSION: This study demonstrates that multisectoral cash plus interventions targeting the community and household level, combined with interventions in the education, health, and wealth-creation sectors that directly target individual girls in early adolescence, generate protective factors against early pregnancy during adolescence. Such interventions, therefore, potentially have beneficial impacts on the longer-term health and economic outcomes of girls residing in impoverished settings. CLINICAL TRIAL REGISTRATION: ISRCTN registry: ISRCTN77455458; https://doi.org/10.1186/ISRCTN77455458.

Impacts of Multisectoral Cash Plus Programs on Marriage and Fertility After 4 Years in Pastoralist Kenya: A Randomized Trial.

PURPOSE: Early marriage has multiple drivers including cultural and social norms alongside lack of educational and economic opportunities. This complexity may explain why few programs have demonstrated marriage delays and suggests multisectoral interventions are necessary. This study examined a 2-year multisectoral program designed to delay marriage in a marginalized setting. METHODS: The study used a prospective 80-cluster randomized trial following up 2,147 girls aged 11-14 years from 2015 to 2019. Interventions included community dialogs about inequitable gender norms (violence prevention), a conditional cash transfer (education), weekly group meetings with health and life skills training (health), and financial literacy training (wealth creation). Villages were randomized to one of four study arms: (1) violence prevention only (V-only); (2) violence prevention and education (VE); (3) VE and health (VEH); or (4) all four interventions (VEHW). We used analysis of covariance to estimate intent-to-treat impacts of each study arm with an education component, as well as a pooled study arm combining the VE, VEH, and VEHW arms, in reference to V-only, 2 years after the intervention ended, when girls were 15-18 years old. RESULTS: There were small but insignificant reductions on primary outcomes in unadjusted analyses that were larger and significant in adjusted analyses. Effects were particularly large for girls not in school at baseline-the pooled study arm reduced marriage by 18.0 and pregnancy by 15.6 percentage points, a relative reduction of 34% and 43%, respectively. DISCUSSION: The article demonstrates the potential for multisectoral interventions with education components to delay early marriage in an impoverished, socially conservative, pastoral setting.

Prevalence, risk factors and short-term consequences of adverse birth outcomes in Zimbabwean pregnant women: a secondary analysis of a cluster-randomized trial.

BACKGROUND: Globally, 15 million children are born preterm each year and 10.7 million are born at term but with low birthweight (<2500 g). METHODS: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) cluster-randomized trial enrolled 5280 pregnant women between 22 November 2012 and 27 March 2015 to test the impact of improved water supply, sanitation and hygiene, and improved infant feeding, on child growth and anaemia. We conducted a secondary analysis to estimate the prevalence and risk factors of miscarriage, stillbirth, preterm birth, size small for gestational age (SGA), low birthweight (LBW), perinatal mortality, and neonatal mortality, and to estimate the effects of adverse birth outcomes on infant survival and growth. RESULTS: The prevalence of adverse birth outcomes was: miscarriage: 5.0% [95% confidence interval (CI), 4.4, 5.7]; stillbirth: 2.3% (95% CI 1.9, 2.7); preterm birth: 18.2% (95% CI 16.9, 19.5); SGA: 16.1% (95% CI 15.0, 17.3); LBW: 9.8% (95% CI 9.0, 10.7); and neonatal mortality: 31.4/1000 live births (95% CI 26.7, 36.5). Modifiable risk factors included maternal HIV infection, anaemia, lack of antenatal care and non-institutional delivery. Preterm infants had higher neonatal mortality [risk ratio (RR): 6.1 (95% CI 4.0, 9.2)], post-neonatal infant mortality [hazard ratio (HR): 2.1 (95% CI 1.1, 4.1)] and stunting at 18 months of age [RR: 1.5 (95% CI 1.4, 1.7)] than term infants; 56% of stillbirths and 57% of neonatal deaths were among preterm births. CONCLUSIONS: Neonatal mortality and stillbirth are high in Zimbabwe and appear to be driven by high preterm birth. Interventions for primary prevention of preterm birth and strengthened management of preterm labour and ill and small neonates are required to reduce neonatal mortality in Zimbabwe and other African countries with similar profiles.

Impacts of two-year multisectoral cash plus programs on young adolescent girls' education, health and economic outcomes: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial.

BACKGROUND: Early adolescence is a critical window for intervention when it is possible to lay a foundation for a safe transition to adulthood, before negative outcomes occur. The Adolescent Girls Initiative-Kenya randomized trial tested the effects of combinations of interventions for young adolescent girls in two sites - the Kibera informal settlement in Nairobi and rural Wajir County in the Northeastern region. METHODS: The interventions included community dialogues on the role and value of girls (violence prevention), a conditional cash transfer (education), weekly group meetings for girls with health and life skills training (health), and training and incentives for financial literacy and savings activities (wealth creation). Participants were randomized to one of four study arms: 1) violence prevention only, 2) violence prevention and education, 3) violence prevention, education and health or 4) violence prevention, education, health and wealth creation. An intent-to-treat (ITT) analysis was conducted using longitudinal data to estimate the impact of each combination of interventions and various sensitivity analyses conducted addressing potential attrition bias and multiple hypothesis testing concerns. RESULTS: In Kibera, the education conditional cash transfer had small effects on grade attainment but larger impacts on completion of primary school and the transition to secondary school in the most comprehensive arm; the health intervention improved sexual and reproductive health knowledge and condom self-efficacy; and the wealth intervention improved financial literacy and savings behavior. In Wajir, the education conditional cash transfer increased school enrollment and grade attainment, and the wealth intervention improved savings behavior. CONCLUSIONS: The results indicate that when trying to improve a range of outcomes related to adolescent wellbeing for young girls, a multisectoral intervention with components addressing household economic constraints is a promising approach. TRIAL REGISTRATION: Trial Registry: ISRCTN, ISRCTN77455458 . Registered 24/12/2015 - Retrospectively registered.

Development of a temporally harmonized asset index: evidence from across 50 years of follow up of a birth cohort in Guatemala.

BACKGROUND: Asset-based indices are widely-used proxy measures of wealth in low and middle-income countries (LMIC). The stability of these indices within households over time is not known. METHODS: We develop a harmonized household asset index using Principal Component Analysis for the participants (n = 2392) of INCAP Longitudinal Study, Guatemala using data from six waves of follow-up over the period of 1965-2018. We estimate its cross-sectional association with parental schooling (in 1967-75) and attained schooling (in 2015-18) of cohort members. We study how patterns of cross-sectional loadings change over time and between urban-rural settings. We assess its robustness to omission of assets or study waves and alternate specifications of factor extraction procedure (exploratory factor analysis, multiple correspondence analysis). RESULTS: The harmonized index constructed using 8 assets and 11 housing characteristics explained 32.4% of the variance. Most households increased in absolute wealth over time with median wealth (25th percentile, 75th percentile; households) increasing from - 3.74 (- 4.42, - 3.07; 547) in 1967 to 2.08 (1.41, 2.67; 1145) in 2017-18. Ownership of television, electricity, quality of flooring and sanitary installation explained the largest proportion of variance. The index is positively associated with measures of schooling (maternal: r = 0.16; paternal: r = 0.10; attained: r = 0.35, all p < 0.001). In 2015-18, house ownership versus housing characteristics and ownership of electronic goods differentiate households in urban and rural areas respectively. The index is robust for omission of assets or study waves, indicator categorization and factor extraction method. CONCLUSION: A temporally harmonized asset index constructed from consistently administered surveys in a cohort setting over time may allow study of associations of life-course social mobility with human capital outcomes in LMIC contexts. The approach permits exploration of trends in household wealth of the sample over a follow-up period against repeated cross-sectional surveys which permit the estimation of only the mean trajectory.

Nutrition, Adult Cognitive Skills, and Productivity: Results and Influence of the INCAP Longitudinal Study.

This article summarizes research based on the INCAP Longitudinal Study that demonstrates the positive effects of the atole intervention on prime-age adult cognitive skills and productivities. The findings are interpreted in the context of a life-cycle stages model in which various factors and investments at each stage of life influence outcomes not only in that stage but in subsequent ones. The results point to the likely importance of improvements in adult cognitive skills due to better early-life nutrition on adult male labor market outcomes as well as on women's "home productivity" in terms of anthropometrics for the next generation. Possible mechanisms are also explored, including the impacts of early-life exposure to atole on children's height when starting school, on grades of schooling attainment, and on the extent of experience with higher-skilled jobs, as well as the impacts of improved cognitive skills on wages. Not only are investments in early-life nutrition important for immediate welfare but also they have significant productivity payoffs in adulthood.

Social and Economic Development and Change in 4 Guatemalan Villages Over a Half Century.

This article describes nearly 50 years of social and economic development and changes that have occurred in the 4 villages of the Institute of Nutrition of Central America and Panama (INCAP) Longitudinal Study (1969-1977). In doing so, it contextualizes the changes in health and nutrition for the study population over that period. Since the start of the INCAP Longitudinal Study, the original 4 villages, like their home country, have undergone tremendous demographic, social, and economic change. Originally rather isolated, road and transportation access for the villages has improved steadily and substantially. The population in the villages has more than doubled. Schooling access and outcomes have also improved substantially, with average grades of schooling tripling and literacy doubling, reaching levels currently on par with national averages. Occupations have also changed over the course of a generation. Early on, subsistence farming and agriculture in general were dominant but are now much less common. Much of this change is associated with declining agricultural markets alongside increased access to nonagricultural jobs near the villages and in the capital. With all these changes have come improvements in living standards. It is within this dynamic context that study participants for the INCAP Longitudinal Study were born and raised and where most now live as adults.

Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.

BACKGROUND: Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe. METHODS: We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940. FINDINGS: Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported. INTERPRETATION: Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone. FUNDING: Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.

Exposure to improved nutrition from conception to age 2 years and adult cardiometabolic disease risk: a modelling study.

BACKGROUND: Low-income and middle-income countries with populations that are chronically undernourished in early life are undergoing a nutrition transition and are experiencing an epidemic of cardiometabolic disease. These dual burdens are thought to be causally related; therefore, the extent to which improvements in early-life nutrition can offset adult-onset disease is important. The aim of this study was to examine whether improvement of protein-energy nutrition from conception to age 2 years can attenuate the risk of cardiometabolic disease. METHODS: We followed up a cohort of 2392 individuals born between Jan 1, 1962, and Feb 28, 1977, in four villages in Guatemala who had participated in a cluster-randomised protein-energy nutritional supplementation (Atole) trial. Of 1661 participants available for follow-up from Feb 26, 2015, to April 29, 2017, we studied 684 women and 455 men. We assessed cardiometabolic disease risk at ages 37-54 years using anthropometry, fasting and post-challenge glucose, fasting lipid concentrations, and blood pressure. We used generalised linear and logistic regression modelling to estimate the effect of Atole from conception to age 2 years (the first 1000 days) on cardiometabolic disease risk. FINDINGS: Exposure to Atole from conception to age 2 years was associated with increased fatness (body-mass index [1·29 kg/m2, 95% CI 0·08 to 2·50], body fat [1·73%, 0·20 to 3·26], and obesity [odds ratio 1·94, 1·11 to 3·40]), diastolic blood pressure (1·59 mm Hg, -0·74 to 3·92), and blood lipids (total cholesterol [10·10 mg/dL, 0·80 to 19·40] and non-HDL cholesterol [10·41 mg/dL, 1·51 to 19·31]), reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97). We found stratum heterogeneity by sex in pooled models for non-HDL cholesterol (4·34 mg/dL, 95% CI -6·86 to 15·55 for women vs 19·84 mg/dL, 5·86 to 33·82 for men) and post-challenge glucose (-0·19 mg/dL, -8·63 to 8·24 for women vs -13·10 mg/dL, -23·64 to -2·56 for men). p values for interaction of sex and exposure to Atole from conception to age 2 years were 0·09 and 0·04, respectively. INTERPRETATION: Improved protein-energy nutrition from conception to the 2nd birthday reduced the odds of diabetes at ages 37-54 years; however, this protein-energy supplementation also increased the risk of obesity and several obesity-related conditions. Our findings suggest a mixed ability of protein-energy nutritional supplementation in early life to prevent adult cardiometabolic disease incidence in the context of high childhood stunting and high adult overweight and obesity. FUNDING: National Institutes of Health.

Measuring wealth in rural communities: Lessons from the Sanitation, Hygiene, Infant Nutrition Efficacy (SHINE) trial.

BACKGROUND: Poverty and human capital development are inextricably linked and therefore research on human capital typically incorporates measures of economic well-being. In the context of randomized trials of health interventions, for example, such measures are used to: 1) assess baseline balance; 2) estimate covariate-adjusted analyses; and 3) conduct subgroup analyses. Many factors characterize economic well-being, however, and analysts often generate summary measures such as indices of household socio-economic status or wealth. In this paper, a household wealth index is developed and tested for participants in the cluster-randomized Sanitation, Hygiene, Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. METHODS: Building on the approach used in the Zimbabwe Demographic and Health Survey (ZDHS), we combined a set of housing characteristics, ownership of assets and agricultural resources into a wealth index using principal component analysis (PCA) on binary variables. The index was assessed for internal and external validity. Its sensitivity was examined considering an expanded set of variables and an alternative statistical approach of polychoric PCA. Correlation between indices was determined using the Spearman's rank correlation coefficient and agreement between quintiles using a linear weighted Kappa statistic. Using the 2015 ZDHS data, we constructed a separate index and applied the loadings resulting from that analysis to the SHINE study population, to compare the wealth distribution in the SHINE study with rural Zimbabwe. RESULTS: The derived indices using the different methods were highly correlated (r>0.9), and the wealth quintiles derived from the different indices had substantial to near perfect agreement (linear weighted Kappa>0.7). The indices were strongly associated with a range of assets and other wealth measures, indicating both internal and external validity. Households in SHINE were modestly wealthier than the overall population of households in rural Zimbabwe. CONCLUSION: The SHINE wealth index developed here is a valid and robust measure of wealth in the sample.

Assessing the Impact of Food Assistance on Stigma Among People Living with HIV in Uganda Using the HIV/AIDS Stigma Instrument-PLWA (HASI-P).

HIV-related stigma among persons living with HIV/AIDS (PLHIV) is prevalent throughout sub-Saharan Africa. There is limited evidence, however, on which interventions are effective in reducing it. We used data from a prospective impact evaluation of a 12-month food assistance intervention among 904 antiretroviral therapy (ART)- naïve PLHIV in Uganda to examine the program impact on stigma. Stigma was measured using the comprehensive HASI-P scale, which demonstrated good internal consistency (Cronbach's alpha = 0.87) and was correlated with several related constructs including physical and mental health-related quality of life, disclosure, and physical health symptoms in the sample. Using quasi-experimental difference-in-difference matching methods to better infer causality, we tested whether the intervention improved the overall stigma scale and its subscales. The food assistance intervention had a significant effect on reported internalized (but not external) stigma of approximately 0.2 SD (p < 0.01). The HASI-P stigma scale is a useful tool for measuring and tracking stigma. Food assistance interventions, embedded in an HIV care program, can reduce internalized stigma.

Early life height and weight production functions with endogenous energy and protein inputs.

We examine effects of protein and energy intakes on height and weight growth for children between 6 and 24 months old in Guatemala and the Philippines. Using instrumental variables to control for endogeneity and estimating multiple specifications, we find that protein intake plays an important and positive role in height and weight growth in the 6-24 month period. Energy from other macronutrients, however, does not have a robust relation with these two anthropometric measures. Our estimates indicate that in contexts with substantial child undernutrition, increases in protein-rich food intake in the first 24 months can have important growth effects, which previous studies indicate are related significantly to a range of outcomes over the life cycle.

The Adolescent Girls Initiative-Kenya (AGI-K): study protocol.

BACKGROUND: Many adolescent girls in Kenya and elsewhere face considerable risks and vulnerabilities that affect their well-being and hinder a safe, healthy, and productive transition into early adulthood. Early adolescence provides a critical window of opportunity to intervene at a time when girls are experiencing many challenges, but before those challenges have resulted in deleterious outcomes that may be irreversible. The Adolescent Girls Initiative-Kenya (AGI-K) is built on these insights and designed to address these risks for young adolescent girls. The long-term goal of AGI-K is to delay childbearing for adolescent girls by improving their well-being. INTERVENTION: AGI-K comprises nested combinations of different single-sector interventions (violence prevention, education, health, and wealth creation). It will deliver interventions to over 6000 girls between the ages of 11 and 14 years in two marginalized areas of Kenya: 1) Kibera in Nairobi and 2) Wajir County in Northeastern Kenya. The program will use a combination of girl-, household- and community-level interventions. The violence prevention intervention will use community conversations and planning focused on enhancing the value of girls in the community. The educational intervention includes a cash transfer to the household conditioned on school enrollment and attendance. The health intervention is culturally relevant, age-appropriate sexual and reproductive health education delivered in a group setting once a week over the course of 2 years. Lastly, the wealth creation intervention provides savings and financial education, as well as start-up savings. METHODS/DESIGN: A randomized trial will be used to compare the impact of four different packages of interventions, in order to assess if and how intervening in early adolescence improves girls' lives after four years. The project will be evaluated using data from behavioural surveys conducted before the start of the program (baseline in 2015), at the end of the 2-year intervention (endline in 2017), and 2 years post-intervention (follow-up in 2019). Monitoring data will also be collected to track program attendance and participation. Primary analyses will be on an intent-to-treat basis. Qualitative research including semi-structured interviews of beneficiaries and key adult stakeholders in 2016 and 2018 will supplement and complement the quantitative survey results. In addition, the cost-effectiveness of the interventions will be assessed. DISCUSSION: AGI-K will provide critical evidence for policy-makers, donors and other stakeholders on the most effective ways to combine interventions for marginalized adolescent girls across sectors, and which packages of interventions are most cost-effective. TRIAL REGISTRATION: ISRCTN77455458 , December 24, 2015.

Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach.

Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy (theory failure), and failure to implement interventions as designed (program failure). These failures are important for both public health programs and randomized trials. In the Sanitation Hygiene and Infant Nutrition Efficacy (SHINE) Trial, we utilize the program impact pathway (PIP) approach to track intervention implementation and behavior uptake. In this article, we present the SHINE PIP including definitions and measurements of key mediating domains, and discuss the implications of this approach for randomized trials. Operationally, the PIP can be used for monitoring and strengthening intervention delivery, facilitating course-correction at various stages of implementation. Analytically, the PIP can facilitate a richer understanding of the mediating and modifying determinants of intervention impact than would be possible from an intention-to-treat analysis alone.

The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods.

UNLABELLED: Child stunting and anemia are intractable public health problems in developing countries and have profound short- and long-term consequences. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by the premise that environmental enteric dysfunction (EED) is a major underlying cause of both stunting and anemia, that chronic inflammation is the central characteristic of EED mediating these adverse effects, and that EED is primarily caused by high fecal ingestion due to living in conditions of poor water, sanitation, and hygiene (WASH). SHINE is a proof-of-concept, 2 × 2 factorial, cluster-randomized, community-based trial in 2 rural districts of Zimbabwe that will test the independent and combined effects of protecting babies from fecal ingestion (factor 1, operationalized through a WASH intervention) and optimizing nutritional adequacy of infant diet (factor 2, operationalized through an infant and young child feeding [IYCF] intervention) on length and hemoglobin at 18 months of age. Within SHINE we will measure 2 causal pathways. The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the 2 child health primary outcomes; it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices. We will also measure a range of household and individual characteristics, social interactions, and maternal capabilities for childcare, which we hypothesize will explain heterogeneity along these pathways. The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age; it will be elucidated by measuring biomarkers of intestinal structure and function (inflammation, regeneration, absorption, and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy. This article describes the rationale, design, and methods underlying the SHINE trial. CLINICAL TRIALS REGISTRATION: NCT01824940.

Plasma Concentrations of Hepcidin in Anemic Zimbabwean Infants.

OBJECTIVE: Anemia in infancy is a global public health problem. We evaluated the relative contributions of iron deficiency and inflammation to infant anemia. METHODS: We measured plasma hepcidin, ferritin, soluble transferrin receptor (sTfR), alpha-1-acid glycoprotein and C-reactive protein (CRP) by ELISA on archived plasma from 289 HIV-unexposed anemic or non-anemic Zimbabwean infants at ages 3 mo, 6 mo and 12 mo. Among anemic infants, we determined the proportion with iron-deficiency anemia (IDA) and anemia of inflammation (AI). We undertook regression analyses of plasma hepcidin and anemia status, adjusting for sex, age and birthweight. RESULTS: Anemic infants at 3 mo were more stunted and had higher CRP (median 0.45 vs 0.21 mg/L; P = 0.037) and hepcidin (median 14.7 vs 9.7 ng/mL; P = 0.022) than non-anemic infants, but similar levels of ferritin and sTfR; 11% infants had IDA and 15% had AI. Anemic infants at 6 mo had higher hepcidin (median 7.9 vs 4.5 ng/mL; P = 0.016) and CRP (median 2.33 vs 0.32 mg/L; P<0.001), but lower ferritin (median 13.2 vs 25.1 µg/L; P<0.001) than non-anemic infants; 56% infants had IDA and 12% had AI. Anemic infants at 12 mo had lower ferritin (median 3.2 vs 22.2 µg/L; P<0.001) and hepcidin (median 0.9 vs 1.9 ng/mL; P = 0.019), but similar CRP levels; 48% infants had IDA and 8% had AI. Comparing anemic with non-anemic infants, plasma hepcidin was 568% higher, 405% higher and 64% lower at 3 mo, 6 mo and 12 mo, respectively, after adjusting for sex and birthweight (all p<0.01). Plasma hepcidin declined significantly with age among anemic but not non-anemic infants. Girls had 61% higher hepcidin than boys, after adjusting for age, anemia and birthweight (p<0.001). CONCLUSION: Anemia is driven partly by inflammation early in infancy, and by iron deficiency later in infancy, with plasma hepcidin concentrations reflecting the relative contribution of each. However, there is need to better characterize the drivers of hepcidin during infancy in developing countries.

Improving Health-Related Quality of Life among People Living with HIV: Results from an Impact Evaluation of a Food Assistance Program in Uganda.

INTRODUCTION: Widespread food insecurity in Africa continues to compromise an effective response to the AIDS epidemic. Health-related quality of life (HRQoL) is a comprehensive indicator of physical, mental, and social well-being that is associated with food insecurity and increasingly used to assess the well-being of people living with HIV/AIDS (PLHIV). We examined the impact of a food assistance intervention, previously shown to have reduced household food insecurity and improved nutritional status, on HRQoL of PLHIV. METHODS: We capitalized on an existing intervention targeting antiretroviral therapy (ART)- naïve PLHIV in Uganda, and conducted a prospective impact evaluation including a treatment and a comparison group. Data analyzed included 640 participants from two districts (318 in the intervention district) interviewed in both clinic and household settings at baseline and again approximately one year later. The main outcomes considered were physical and mental health dimensions of HRQoL, and other outcomes included self- and healthcare provider-reported symptoms. We utilized difference-in-difference propensity score matching methodologies to infer causality and examine program impacts. RESULTS: Over 12 months, food assistance significantly increased physical health scores (PHS) by 2.85 (P < .01) or approximately 0.35 SD, and reduced substantially the number of self- and healthcare provider-reported HIV-related symptoms by 3.83 and 2.68, respectively (P < .01). There was no significant impact, however, on mental health scores (MHS). CONCLUSIONS: This study demonstrates the potential importance for HRQoL of including food assistance programming as part of the standard of care for PLHIV in areas of widespread food insecurity.