POC HIV Testing and Early DTG Use for Infants

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.

NCT Number	NCT05393193
Lead Sponsor	Harvard School of Public Health (HSPH) Collaborators: Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	HIV
Enrollment	900 participants
Start Date	2022-07-04
Primary Completion	2026-03-16 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-13