Study Objectives

  1. To assess developmental outcomes (neurodevelopment, psychosocial) at 2 years of age in HEU children exposed in utero to DTG/TDF/XTC (N=200); EFV/TDF/XTC (N=200); and community controls without HIV or ARV exposure (N=160), and compare outcomes between groups.
  2. To assess and compare developmental outcomes in the same children at 5 years of age. Further deterioration of 2-year deficits would be expected at 5 years; and, evaluation of children during the early childhood period will allow us to more comprehensively examine a range of cognitive and self-regulatory capacities, including emerging core executive function skills (i.e., inhibitory control, working memory, and shifting/flexibility) that are recognized as critical for future achievement, independence, and resilience.
  3. To assess the presence/severity of depressive symptoms, anxiety symptoms, and sleep problems in the mothers of participating children. Results of this aim are relevant to millions of women on ART globally, and are also important for analyses of child outcomes, as maternal mental health affects child development.

Study Design: This is a longitudinal observational cohort study that will prospectively enroll three new cohorts of children and their mothers in Botswana and follow children’s neurodevelopmental and social-emotional outcomes and mothers’ mental health and sleep status in: 

  • 200 HEU children previously exposed in utero to EFV/TDF/XTC and their mothers (XTC indicates either 3TC or FTC); 
  • 200 HEU children previously exposed in utero to DTG/TDF/XTC and their mothers; 
  • 160 HUU children and their mothers.

Study population and Size: 560 mother-child pairs in total (200 HEU children exposed to EFV/TDF/XTC, 200 HEU children exposed to DTG/TDF/XTC, and 160 HUU children, and their mothers)

Study Duration: 5 years

Sponsor: The National Institute of Mental Health (NIH).