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ACTIVE NOT RECRUITING
NCT05393193
PHASE4

POC HIV Testing and Early DTG Use for Infants

Sponsor: Harvard School of Public Health (HSPH)

View on ClinicalTrials.gov

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

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.

Locations (1)

Botswana Harvard Health Partnership

Gaborone, Botswana