Schedule of evaluations
Prescreening (3–7 days) | Screening (2 weeks) | Entry (4 weeks) | 8 weeks | 12 weeks | 16 weeks | 20 weeks | 24 weeks | 36 weeks | 48 weeks | |
Maternal | ||||||||||
HIV status | X | |||||||||
Informed consent for dyad | X | |||||||||
BF counselling and support | X | X | X | X | X | X | X | X | X | |
Intervention training and support | X | X | X | X | X | |||||
Behavioural assessment of adherence with intervention | X | X | X | X | X | |||||
Sociodemographic data | X | |||||||||
Maternal clinical and pregnancy history | X | |||||||||
Maternal health status and BF practice update | X | X | X | X | X | X | X | X | ||
Maternal blood taken and residual stored | X | X | ||||||||
Soluble markers (SCFAs, metabolites and inflammatory markers) | X (10 mL) | X (10 mL) | ||||||||
Viral load and CD4 count (only for HIV+) | X (10 mL) | |||||||||
Breastmilk | X | X | X | |||||||
HMO measured | X | X | X | |||||||
Soluble markers (SCFAs, metabolites and inflammatory markers) | X | X | X | |||||||
Infant | ||||||||||
HIV status (routine care not study) | X | X (10 Wk) | X | |||||||
HIV status (study) | X | |||||||||
Infant clinical history | X | |||||||||
Infant clinical update | X | X | X | X | X | X | X | X | ||
Infant anthropometry | X | X | X | X | X | X | X | X | ||
Developmental Screening Questionnaire | X | X | ||||||||
Infant blood taken and residual stored | X (4–6 mL) | X (4–6 mL) | X (10 mL) | X (10 mL) | ||||||
HMO measured | X | X | ||||||||
Metabolome | X | X | ||||||||
Soluble markers (SCFAs and inflammatory markers) | X | X | X | X | ||||||
Stool collection | X | X | X | X | X | X | X | X | ||
Microbiome composition | X | X | X | X | X | X | X | X | ||
SCFAs | X | X | X | X |
Mother–infant dyads will be evaluated on the schedule shown above to 48 weeks. The schedule above is for dyads where the mother is living with HIV. Dyads where the mother does not have HIV will be on the same schedule but will omit procedures related to the intervention and maternal HIV status. Windows for each visit includes half of the time period until the next visit, after which it will be part of the next visit.
HMO, human milk oligosaccharides; SCFAs, short chain fatty acids.