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POC HIV Testing and Early DTG Use for Infants
Sponsor: Harvard School of Public Health (HSPH)
Summary
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.
Official title: Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2022-07-04
Completion Date
2026-08-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Point-of-Care Cepheid Xpert HIV-1
Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.
DTG/ABC/3TC
Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.
Locations (1)
Botswana Harvard Health Partnership
Gaborone, Botswana