Clinical Trials

Inclusion Criteria - Maternal:

• Age ≥ 18 years.
• Willingness and ability to provide informed consent and to follow-up with their child for 3 years.
• Confirmed intention to remain within the general vicinity of Gaborone for the duration of the study, and willingness to stay in telephonic contact with the study team between the 2- and 5-year visits.
• Botswana citizen.
• For cohort of HEU children:
  • Documented maternal HIV-1 infection during or before the pregnancy with this child;
  • Documented history of treatment with either EFV/TDF/XTC or DTG/TDF/XTC while pregnant with enrolled child (mothers who took both EFV and DTG during the pregnancy will be ineligible).
  • For HIV-unexposed children: documented negative HIV-1 during or after pregnancy with the child.

 Inclusion Criteria - Child:

• Age 24-28 months (at visit 1).
• Age 60-64 months (at visit 2).
• Confirmed/documented HIV-negative status at or after 18 months of age.
• For children of WLHIV who have never received prior treatment for HIV (either documented negative child test at > 18 months.
• Negative child HIV ELISA or rapid test through the study if a documented negative result not available or if child breastfed since most recent test).
  • Note: HIV-exposed children undergo serologic testing for HIV at 18 months of age, per Botswana guidelines.

Exclusion Criteria - Maternal:

• Incarceration.