ZVITAMBO trial data collection
The ZVITAMBO trial has been described previously (10). Briefly, mother–baby pairs were enrolled, following written consent, within 96 h of delivery at one of 14 maternity clinics in greater Harare, being eligible if neither had an acutely life-threatening condition, the baby was a singleton with birth weight > 1500 g, and the mother planned to stay in Harare after delivery. Written informed consent included permission to test mothers for HIV. Mothers could learn their results at any time during the study with appropriate pre- and post-test counseling, but they were not required to do so. This feature makes ZVITAMBO unique. All other studies of infant feeding and HIV have been conducted among mothers who knew their HIV status.
Socioeconomic, demographic, breast-feeding initiation, and prelacteal feeding data were collected by interview at enrollment. Details of the pregnancy and the delivery were transcribed from hospital records. At delivery, 32% of the mothers were HIV positive (10). Follow-up visits at 6 wk, 3 mo, and at 3-mo intervals for up to 24 mo included maternal and infant blood collection. Detailed infant feeding information, including breast-feeding status and whether or not any of 22 nonmilk liquids, nonhuman milks (animal milks and commercial formula), medicines (traditional fluids, oral rehydration salts, other prescribed), or solid foods had ever been given to the infant were collected at enrollment, 6 wk, 3 mo, and 6 mo after delivery.
Infants who provided infant-feeding information at enrollment, 6 wk, and 3 mo were classified into 1 of 3 early breast-feeding patterns: 1) EBF—only breast milk, vitamins, or prescribed medicines at all 3 time points, or at 2 of 3 time points. One lapse in exclusivity of EBF at 1 of the 3 time points was allowed only if the nonbreast milk item consumed was a nonmilk liquid; 2) predominant breast-feeding—breast milk plus nonmilk liquids; 3) mixed breast-feeding—breast milk plus nonhuman milks and/or solid foods at one or more time points. Classification was limited to the first 3 mo, because 93% of study infants were mixed breast-feeding by 6 mo.
Psychosocial counseling was available throughout the study. The date and reason for each individual counseling session, and whether HIV test results were obtained, was documented.