Principal Investigator: Gbolahan Ajibola, MB, BS, MPH
- Primary Aim 1: POC HIV testing of infants at birth
- Aim 1a: To describe the feasibility and evaluate the effectiveness of implementing facility-based targeted point-of-care (POC) HIV testing of high-risk neonates at birth.
- Aim 1b: To determine the percentage of high-risk neonates with in utero HIV infection in the current era, and the times to HIV diagnosis and to ART initiation with birth POC testing, with descriptive comparisons to existing national data for 6-week infant PCR HIV testing.
- Primary Aim 2: Early DTG-based ART for Infants
- Aim 2a: To compare time to HIV-1 RNA suppression, and proportion with suppression at 12 weeks, with early DTG-based ART compared with early LPV/r-based ART (EIT cohort comparison).
- Aim 2b: To compare clinical and virologic outcomes of infants on early DTG-based ART compared with early LPV/r-based ART through 96 weeks (EIT cohort comparison).
- Aim 2c: To evaluate the longitudinal evolution of viral reservoirs in HIV-1 infected infants treated with DTG-containing ART, relative to the EIT cohort.
- Aim 2d: To analyze signs of immune selection in proviral reservoir sequences from infants undergoing early treatment with DTG-containing ART.
Study Design: This longitudinal observational cohort study will evaluate the potential benefits of birth POC testing and very early DTG-based ART use in HIV-infected infants in Botswana. The study is implementing an optimal standard of care (early testing and rapid start of the recommended ART regimen for children).
Study population and size HIV-exposed neonates at high risk of HIV acquisition for screening and HIV-infected neonates who are study eligible and their HIV-infected mothers (age 18 or older) will represent the population enrolled in the treatment cohort. The study aims to enrol 10-30 neonates who test HIV-positive and are able to initiate ART within 7 days after birth in Botswana.
Study duration: 96 weeks
Study Results: The study is ongoing and no data analyses have been done yet