drugset / Trial / NCT05393193
POC HIV Testing and Early DTG Use for Infants
Phase 4
Active not recruiting
900 enrolled
Harvard School of Public Health (HSPH)
Botswana Harvard AIDS Institute Partnership · collabBotswana Ministry of Health · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabRagon Institute of MGH, MIT and Harvard · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-07-04
- Primary completion
- 2026-03-16
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABC | Unknown | — | — |
| Subject | DTG | Unknown | — | — |
| Background | Lamivudine | Other / unclassified | — | — |