Principal Investigators - Dr. Kathleen M. Powis, MD, MPH, MBA | Dr. Jennifer Jao, MD, MPH | Dr. Joseph Makhema, MB.ChB, FRCP

Study Objectives 

Primary Study Aims

• Aim 1: Establish a cohort of 1,100 children who are HIV exposed uninfected (CHEU) from birth through 17 years of age and a comparison cohort of 475 children who are HIV unexposed uninfected (CHUU). 
• Aim 2: Evaluate differences in rates of infectious morbidity and all-cause mortality between CHEU and CHUU up to 5 years of age. 
• Aim 3: Assess whether in utero HIV/ARV exposure is associated with differences in neurobehavioral functioning among school aged (6-10 years) CHEU compared to CHUU. 
• Aim 4: Assess for associations between in utero HIV/ARV exposure and cardiometabolic risk factors (central obesity, dyslipidemia, elevated blood pressure, and insulin resistance or impaired fasting glucose) in adolescents ≥ age 10 using age, sex, and body mass index (BMI)-frequency matched HUU individuals as a comparator.

Secondary Study Aims

• Secondary Aim 1: To evaluate differences in weight-for-age (WAZ) and height-for-age (HAZ) z-scores between CHEU and CHUU longitudinally over the first five years of life.
• Secondary Aim 2: To evaluate for differences in age of onset of puberty by HIV-exposure status among male and female FLOURISH study participants.
• Secondary Aim 3: To evaluate predictors of adolescent pregnancies among female adolescents.
• Secondary Aim 4: To quantify occurrence of symptoms of depression and anxiety among adolescents and compare by HIV exposure status.
• Secondary Aim 5: To describe and compare educational achievement among children and adolescents and employment among adolescents and young adults by HIV-exposure status. 

Study Design: The FLOURISH study is a prospective observational study. 

Study Population: To address all aims, this study has multiple study populations. The population will consist of pregnant women with and without HIV, as well as caregiver-child dyads in which the children are 0 to 17.9 years of age. The children of these dyads will be both HIV exposed uninfected, and HIV unexposed uninfected. 

Study Size: A total of 1,575 caregiver-child dyads will be recruited for this study (a total of 3,150 participants) 

Study Duration: The FLOURISH study duration is 5 years. A caregiver-child dyad will have an enrollment visit in study years 1 through 2 and will have one or more follow-up visits in study years 3 through 5.

Sponsor: National Institute of Child Health and Human Development (NICHD).