NCT05393193

POC HIV Testing and Early DTG Use for Infants

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DRUG	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.

Timeline

• Start date: 2022-07-04
• Primary completion: 2026-05-31
• Completion: 2026-08-31
• First posted: 2022-05-26
• Last updated: 2026-02-23

Locations

1 site across 1 country: Botswana