Secondary outcomes | |
---|---|
1. Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent of clinically relevant infections. | |
2. To determine any association of ART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development. | |
3. To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission. | |
4. To determine the association between maternal baseline and delivery ART levels in different compartments and infant HIV infection, mortality and morbidity. | |
5. To determine HIV drug resistance profiles in mother and infants unresponsive to ART. | |
6. To assess abnormalities including lipid profiles, bone, haematological and hepatic toxicities associated with exposure to ART among mothers and infants. | |
7. To determine antenatal co-infections including HBV, HCV, CMV, syphilis, intestinal helminths and parasites as single infection or combined infections in HIV-infected and HIV -uninfected - women and determine the impact on pregnancy outcome, infant mortality and morbidity. | |
8. To determine the prevalence of infant infectious comorbidities; HBV, HCV, CMV, syphilis, including time points of infections and impact on mortality and morbidity. | |
9. To determine the prevalence of maternal NCDs (malnutrition/ obesity, anaemia, diabetes, hypertensive disorders) and determine their impact on pregnancy outcomes, infant mortality and morbidity. | |
10. To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity. | |
11. To determine maternal household non-biological factors (socioeconomic state, hygiene) and determine their impact on pregnancy outcome, infant mortality and morbidity. | |
12. To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in pregnant women with a favourable outcome of pregnancy. | |
13. To assess delayed neurological development using the Denver II tool in HUU, HEU and HEI infants from 6 weeks to 2 years of age. | |
14. To determine humoural immune responses to EPI vaccines (e.g. antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants. | |
15. To determine maternal intestinal parasites load using 18S 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. | |
16. To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants at delivery, 6, 48 and 96 weeks of age. | |
17. To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants at delivery, 6, 48 and 96 weeks of age. | |
18. To determine host genetic markers for infectious disease susceptibility including HLA and KIRÂ gene variants and their association with infection rates of HIV and co-infections in mothers and their infants. | |
19. To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection/ earliest available samples and/or at 2 years. |