Principal Investigator: Rebecca Zash, MD

Study Objectives:

Primary objectives

1) Compare weight gain and dietary intake, blood pressure, and hyperglycemia in pregnancy and through 18-months post partum among women living with HIV on DTG vs. women living with HIV on EFV and women without HIV.

2) Evaluate the impact of weight gain and dietary intake on adverse birth outcomes (preterm delivery, small-for-gestational age (SGA), and neonatal death) and child growth through 18 months of age.

Secondary objectives

--To describe the natural history of, and cascade of care for cardiometabolic study outcomes (weight gain/obesity, hypertension, hyperglycemia/diabetes) in post-partum women, overall and by HIV status and ART regimen.

-To identify risk factors for cardiometabolic study outcomes (weight gain/obesity, hypertension, hyperglycemia and diabetes) and infant growth, overall and by HIV status and ART regimen.

-To compare weight gain and dietary intake, blood pressure and hyperglycemia in pregnancy and through 18-months post-partum among women living with HIV on TDF/3TC/DTG vs. women on other combinations of ARVs that include DTG or newer antiretrovirals

-To compare weight gain and dietary intake, blood pressure and hyperglycemia in pregnancy and through 18-months post-partum among women living with HIV on DTG vs. women on PrEP and women without HIV

-To determine the relative impact of dietary intake, appetite, and nausea on weight gain overall and by HIV status and ART regimen.

-To use dietary assessment to estimate and evaluate risk factors for nutrient deficiencies among women overall, and by HIV and ART, status, and determine the impact on cardiometabolic study outcomes and infant growth

-To evaluate the impact of infant feeding (breastfeeding vs. formula feeding) on maternal and infant weight/growth overall and by HIV status and ART regimen.

Study Design:

This proposed study is a prospective cohort and will enroll and prospectively follow woman-infant pairs from the time of delivery to 18 months post-partum using both phone call and in-person visits

Study Population and Size:

Females above 18 years who have just delivered a baby, both on ART treatment (DTG/EFV) and HIV neg, plus their newborns till 18 months of their lives.

Up to 900 women and their newborn infants will be enrolled, including approximately 300 women on DTG, 300 women on EFV and 300 women without HIV. The number of infants enrolled may be higher than 900 due to multiple births, e.g. twins/triplets.

Study duration: 36 months

Study Results: Study is on-going and no results yet.

Sponsor: Doris Duke Charitable Foundation