1,200 pregnant women (600 HIV+ mothers and 600 HIV-controls) in their third trimester were enrolled from January 2016 to June 2019. Participants are being followed as mother-baby pairs at birth, within 10 days of life 6, 10, 14 24, 48, 72 and 96 weeks of age. At each visit clinical examinations are being used to assess health and the impact of environmental factors. In addition, questionnaires are administered and bio-samples for laboratory tests. The design of the study is non-interventional cohort but participants are being offered advice regarding health and hygiene.

maternal urine, stool, plasma, milk, cord blood, amniotic fluid, placenta, infant serum/plasma, dried blood spots and stool

HIV Infections

Immune Activation

Cormobidities

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)

Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent clinically relevant infections

To determine any association of maternal HIV infection, HAART exposure.

To determine any association with maternal HIV and HAART exposure.

To determine any association of HAART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development.

To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission

HIV incidence rate among mother sero-negative at enrollment

To determine the association between maternal baseline and delivery HAART levels in different compartments and the relation of those to infant HIV transmission, mortality and morbidity.

To determine the association between antenatal immune dysregulation and infant death, growth and immune responses to vaccines.

To determine HIV drug resistance profiles in mother and infants unresponsive to HAART

To determine how CMV DNA is influenced by HIV infection, HAART use and as single infection or combined infections in HIV+ and HIV- women and determine the impact on pregnancy outcome and infant cmv vertical transmission

To determine how HBV infection infections in HIV+ and HIV- women and determine the impact on pregnancy outcome, infant vertical transmission

To determine HCV infections proportion in HIV positives and negatives and HIV+ and HIV- women and determine the impact on pregnancy outcome, infant incidence of congenital cmv infection

To determine syphilis infections proportion in HIV positives and negatives and the impact on pregnancy outcome, infant incidence of congenital syphilis infection

To determine the prevalence of helminthes infection using 18s sequencing and correlate with infant development of atopic dermatitis.

To determine the prevalence of maternal under and overnutrition using BMI and MUAC impact on pregnancy outcomes, infant mortality and morbidity.

To assess abnormalities in HIV + and HIV- including lipid profiles, bone, haematological (anemia) and hepatic toxicities associated with exposure to HAART among mothers and infants.

To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity.

To assess delayed neuro-cognitive development using the Denver II tool in HUU, HEU and HEI infants and correlated with socio economic status and infectious diseases.

To determine humoural immune responses to EPI vaccines including antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants.

To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants

To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants and association with household hygiene at delivery, 6, 48 and 96 weeks of age.

To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in mothers with a favourable outcome of pregnancy

To determine maternal- infant microbiota16S sequencing in pregnancy and relate it to infant immune development and atopy (anti-inflammatory (IL-4, -5, -13) and regulatory cytokines (IL-10, TGF-β) at delivery, 6 weeks 48 and 96 weeks of age.

Bacterial full genome metagenomics shotgun sequencing to identify the microbiota metabolic potential (i.e. bacterial genes present will be done) and mass spectrometry will be performed for analysis of small intestinal content (metabolome).

Wide range of nutritional profiles and HAART levels spectrometry will be performed for analysis of at least 700 metabolites including amino acids and lipids will be performed in plasma, breast milk and stool samples

To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection

To determine host genetic markers for infectious disease susceptibility including human leukocyte antigen (HLA) and killer immunoglobulin like receptor (KIR) gene variants and their association with infection rates of HIV and co-infections in mothers and their infants.

Only anonymous data will be stored at local sites and transferred between sites for collaborative research efforts. All original data will be stored locally at the UZ-CHS for at least 10 years on suitable electronic devices. Data transfer with collaborating partners will be encrypted. using EGAcryptor. With our European partners we will follow the current European General Data Protection Regulation effective May 25, 2018.

Kerina Duri

Associate Professor

University of Zimbabwe

University Hospital Inselspital, Berne

University of Hamburg

University of Oxford

Wellcome Trust

University of Yaounde

University of Cape Town

Midlands State University, Zimbabwe

National Institute of Health Research, Zimbabwe

Fifty diabetic children diagnosed under the age of one year subjected to genetic analysis to study human leucocytic antigen haplotype class two (DR-DQ) and detection of mutations in the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel also possible risk factors associated with the disease.

Twenty five diabetic children diagnosed after the age of one year subjected to genetic study to study human leucocytic antigen and possible of presence of gene mutation of the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel and possible risk factors associated with disease .

Twenty five healthy children matched by age subjected to genetic study to study human leucocytic antigen and possible of presence of gene mutation of the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel and exposure to similar risk factors associated with disease .

Study Genetic Basis of Infantile Onset Diabetes Mellitus

Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.

Gene Study for Infantile Onset Diabetes

Human Leucocytic Antigen Typing and Mutation of Adenosine Triphosphate Sensitive Potassium Channel Gene in Diabetic Patients Diagnosed Under the Age of One Year.

Polymerase chain reaction / Deoxyribonucleic acid sequencing

Total coverage of all diabetic cases diagnosed under the age of one year

Identification of prenatal, perinatal, natal history,nutritional history, vaccination history and hygiene measures

Shimaa Kamal

Principle Investigator

Assiut University

Anemia

Malnutrition

Stunting

Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals

Iron and Folic Acid (IFA)

Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals

Multiple Micronutrient (MMN) group

Pregnant women will receive 20 g of LNS-P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age.
The LNS products (LNS-P&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.

measles/potassium

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

Gene Study for Infantile Onset Diabetes

Efficacy of Lipid-Based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants

La base de dades d’herbes medicinals més completa avalada per la ciència