Point-of-Care HIV Testing and Early Dolutegravir Use for Infants

Overview

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.

Eligibility

Inclusion criteria for point-of-care infant HIV testing:

1. Mother 18 years of age or older
2. Mother willing and able to provide verbal consent for infant testing
3. Infant birth weight ≥1.5kg
4. Presence of any of the following risk factors:

        <12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of
        detection) for last test performed or at any time >24 weeks gestation in pregnancy; CD4
        cell count known to be <350 cells/mm3 within the past year; Self-described poor adherence
        in pregnancy (1 or more complete days of missed ART)
        Exclusion criteria for point-of-care infant HIV testing:
        1) Medical condition making it unlikely that the infant will survive to 24 months
        Inclusion criteria for infant longitudinal treatment cohort:
          1. Mother 18 years of age or older
          2. Mother willing and able to provide written informed consent for study participation
             for herself and her infant
          3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
          4. Infant eligible for ART treatment in accordance with the Botswana government program
          5. Infant birth weight ≥1.5 kg
        Exclusion criteria for infant longitudinal treatment cohort:
          1. Medical condition making it unlikely that the infant will survive to 24 months
          2. Infant unable to start treatment-dose ART < 168 hours of age
          3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or
             Francistown