Our study utilized stored plasma samples and existing data collected in pregnant women who previously participated in the “Tshipidi” study in Botswana [29 (link)]. The Tshipidi study enrolled WLHIV and women without HIV (≥18 years of age) during pregnancy or shortly after delivery from 2010 to 2012 and followed mothers and babies for 2 years postpartum to evaluate pediatric neurodevelopmental outcomes. The majority (88%) of women were enrolled before delivery at a median gestational age of 27 weeks. Maternal and infant blood samples were collected at enrollment, delivery, and 1, 6 and 24 months postpartum. Demographic information, HIV history (including the date of diagnosis, antiretroviral [ARV] regimen and date of ARV initiation, and most recent CD4 count and viral load), general medical history, and pregnancy outcome were recorded for all participants. Gestational age was estimated by the last menstrual period (which was ascertained using a combination of maternal self-report and written obstetric records that are completed for all pregnant women during antenatal care and labor/delivery, which nearly universally occur during admission to maternity wards). Written obstetric records also served as the source of birthweight and stillbirth data. Small for gestational age was calculated using estimated gestational age and birthweight.
Women received antiretroviral regimens according to Botswana national guidelines at the time. From 2008 to 2012, pregnant women with baseline CD4 count >250 cells/mm3 and no WHO Clinical Stage 3 or 4 HIV illness received zidovudine. Women with baseline CD4 <250 cells/mm3 or with WHO Clinical Stage 3 or 4 received 3-drug ART (generally zidovudine + lamivudine + nevirapine); the CD4 threshold was changed to <350 cells/mm3 in 2012. Multiple gestations were excluded from this analysis.
The Tshipidi study (from which the de-identified data for this analysis came from) was approved by the Botswana Health Research Development Committee and the Office of Human Research Administration at the Harvard T.H. Chan School of Public Health. Mothers provided written informed consent for study participation. The work summarized in this paper was consistent with original study aims, and was also approved by IRBs as an amendment.
Women received antiretroviral regimens according to Botswana national guidelines at the time. From 2008 to 2012, pregnant women with baseline CD4 count >250 cells/mm3 and no WHO Clinical Stage 3 or 4 HIV illness received zidovudine. Women with baseline CD4 <250 cells/mm3 or with WHO Clinical Stage 3 or 4 received 3-drug ART (generally zidovudine + lamivudine + nevirapine); the CD4 threshold was changed to <350 cells/mm3 in 2012. Multiple gestations were excluded from this analysis.
The Tshipidi study (from which the de-identified data for this analysis came from) was approved by the Botswana Health Research Development Committee and the Office of Human Research Administration at the Harvard T.H. Chan School of Public Health. Mothers provided written informed consent for study participation. The work summarized in this paper was consistent with original study aims, and was also approved by IRBs as an amendment.
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