Table 1

Schedule of evaluations

Prescreening
(3–7 days)
Screening
(2 weeks)
Entry
(4 weeks)
8 weeks12 weeks16 weeks20 weeks24 weeks36 weeks48 weeks
Maternal
 HIV statusX
 Informed consent for dyadX
 BF counselling and supportXXXXXXXXX
 Intervention training and supportXXXXX
 Behavioural assessment of adherence with interventionXXXXX
 Sociodemographic dataX
 Maternal clinical and pregnancy historyX
 Maternal health status and BF practice updateXXXXXXXX
 Maternal blood taken and residual storedXX
 Soluble markers (SCFAs, metabolites and inflammatory markers)X (10 mL)X (10 mL)
 Viral load and CD4 count (only for HIV+)X (10 mL)
 BreastmilkXXX
 HMO measuredXXX
 Soluble markers (SCFAs, metabolites and inflammatory markers)XXX
Infant
 HIV status (routine care not study)XX (10 Wk)X
 HIV status (study)X
 Infant clinical historyX
 Infant clinical updateXXXXXXXX
 Infant anthropometryXXXXXXXX
 Developmental Screening QuestionnaireXX
 Infant blood taken and residual storedX (4–6 mL)X (4–6 mL)X (10 mL)X (10 mL)
 HMO measuredXX
 MetabolomeXX
 Soluble markers (SCFAs and inflammatory markers)XXXX
 Stool collectionXXXXXXXX
 Microbiome compositionXXXXXXXX
 SCFAsXXXX
  • 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.