Principal Investigator - Professor Roger L. Shapiro, MD, MPH

Study Objectives

Primary Objectives

• To estimate the incidence of preterm delivery, small for gestational age infants, stillbirth, congenital abnormalities and in-hospital neonatal death among infants born to HIV-infected and HIV-uninfected women in Botswana, and to determine if Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) use is associated with these adverse birth outcomes.
• To estimate and compare the incidence of neural tube defects and other congenital abnormalities among all live-born and stillborn infants born to: A) HIV-negative women, B) HIV-infected women not receiving ART from conception, C) HIV-infected women on EFV-containing ART from conception, and D) HIV-infected women on non-EFV-containing ART from conception.
• To compare the incidence of stillbirth, preterm delivery, small-for-gestational-age, congenital abnormalities, and in-hospital neonatal death among infants exposed to DTG/TDF/FTC vs. other ART regimens from the time of conception

Secondary Objectives

• To describe the cascade of PMTCT care in Botswana, including the proportion of women tested for HIV, the proportion started on ART, the proportion remaining on ART at the time of delivery, and the proportion receiving appropriate infant prophylaxis.
• To compare losses in the PMTCT cascade during the surveillance period with losses to the PMTCT cascade from an historical surveillance cohort prior to the shift in national guidelines to provide universal ART in pregnancy.
• To compare adverse birth outcomes among those starting Atripla in pregnancy with those starting other ART regimens or AZT alone in pregnancy, using an historical surveillance cohort prior to the shift in national guidelines to provide universal ART in pregnancy.
• To determine maternal risk factors for adverse birth outcomes among HIV positive and HIV negative women in Botswana.
• To determine maternal risk factors for congenital abnormalities among HIV positive and HIV negative women in Botswana.
• To compare birth weight, length and head circumference in tenofovir (TDF) exposed vs. unexposed infants in this cohort and in comparison with and historical surveillance cohort.
• To re-validate the Botswana birth weight for gestational age norms developed in 2011.
• To describe the medical and obstetrical management of hypertension in pregnancy and preeclampsia.
• To determine the incidence of opportunistic infections and other maternal complications as well as risk factors for adverse birth outcomes by CD4 cell count during pregnancy.

Study Design: Surveillance study of birth outcomes at 18 maternity wards in Botswana

Study Population

• Approximately 250,000 obstetric records will be reviewed for congenital abnormalities and for adverse birth outcomes over 4 years.
• Approximately 3600 anonymous photographs may be taken over 4 years to classify major congenital abnormalities found on the surface examination.

The study population under surveillance will consist of HIV-infected postpartum women and their infants. The anticipated age range of study mothers will be approximately 15 to 45 years, but as this is an anonymous surveillance study there is no age limit to data collected.

Study Duration: 5 years

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health.