SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project
SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project
Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of
 their mortality and leads to long-term cognitive deficits, fewer years and poorer performance
 in school, lower adult economic productivity, and a higher risk that their own children will
 also be stunted, perpetuating the problem into future generations. Stunting begins
 antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score
 (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young
 children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal
 illness has also been implicated. However, the effect of diarrhea on permanent stunting is
 relatively small, maybe because children grow at "catch-up" rates between illness episodes.

 The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part
 premise:

 -  A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED).
 EED is a subclinical disorder of the small intestine, which is virtually ubiquitous
 among asymptomatic people living in low-income settings throughout the world. EED is
 characterized by increased permeability which facilitates microbial translocation into
 the systemic circulation and triggers chronic immune activation.

 -  The primary cause of EED is infant ingestion of fecal microbes due to living in
 conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).
The Sanitation Hygiene Infant Nutrition Efficacy ("SHINE") trial will test the effects of two
 packages of interventions: 1) improved water, sanitation and hygiene (WASH) and 2) improved
 infant and young child feeding (IYCF) on child stunting and anemia in the first 18 months of
 life. The trial will be conducted in rural Zimbabwe where WASH is poor, food insecurity high,
 and where about 15% of pregnant women are infected with HIV. The study will enroll 5282 women
 early in pregnancy and follow them and their infants until 18 months after delivery. The
 study will be a cluster-randomized controlled trial: two entire districts in central Zimbabwe
 have been divided into 212 geographic areas, each of about 100 households. The areas will be
 randomly allocated (that is, assigned by according to chance like the flip of a coin) to one
 of four interventions:

 1. Improved WASH (a ventilated pit latrine, hand washing facilities with soap, drinking
 water treatment, a protected play space and health lessons to adopt improved hygiene
 behaviors)

 2. Improved Infant Nutrition (health lessons on best infant feeding practices and a
 nutritional supplement (Nutributter) to be fed daily to babies from 6 to 18 months).

 3. Improved WASH and Infant Nutrition (both interventions)

 4. Standard of Care

 All women living in the two districts who become pregnant during the recruitment period of
 the study will be invited to enroll. They will receive one of the 4 packages of interventions
 according to the area where they live. Health lessons will be given by Village Health
 Workers. Latrines and hand washing facilities will be constructed by building teams. Mothers
 will be followed up by research nurses at 7 months gestation, and at 1, 3, 6, 12, and 18
 months after delivery. Primary outcomes are infant height and hemoglobin at 18 months of age.

 Within SHINE we will measure two causal pathways: the biomedical pathway and the program
 impact pathway.

 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. The investigators will also ask these mothers to record
 daily any episodes of diarrhea; blood/mucus in the stool; cough; fast or difficult breathing;
 fever; and lethargy preventing breastfeeding, that the child has between 1 month and 18
 months of age. A subgroup of infants will also have stool samples collected during diarrhoeal
 episodes to evaluate reductions in pathogen-specific diarrhoea following WASH interventions.

 Since the mothers enrolled in SHINE will have lived in unsanitary living conditions
 throughout their lives, it is anticipated that most will have some degree of EED themselves.
 It is hypothesized that resulting chronic inflammation contributes to adverse birth outcomes,
 such as prematurity and low birth weight. This question will be investigated through an
 observational design. For all mothers enrolled in SHINE, the sugar absorption test described
 above will be conducted and specimens of saliva, stool and blood collected and archived at
 the 10-12 week gestation visit for subsequent assessment of EED biomarkers. The association
 of severity of EED with risk of adverse birth outcomes (low birth length and weight;
 miscarriage, stillbirth, and premature delivery) will be assessed.

 The program impact pathway comprises the series of processes and behaviors linking
 implementation of the interventions with the two child health 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.
Study participants will be women who are rural residents of Chirumanzu or Shurugwi
 districts in Zimbabwe and who become pregnant during the enrollment period of the trial and
 are identified and consent to participation during pregnancy, and their live born infants.
 A total of 5280 women will be enrolled.

 Inclusion Criteria:

 Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine
 pregnancy test.

 Exclusion Criteria:

 -  Women residing in the study districts who become pregnant during the enrollment period
 but do not consent to join the trial

 -  Women who reside in urban areas of these two districts

 -  Infants with major non-fatal abnormalities will not be excluded from study procedures,
 but will be excluded from the final analytic sample if the abnormality is likely to
 directly affect gut health/function or stature (e.g. neural tube defects, cerebral
 palsy, Down syndrome)