HIV testing at birth and early dolutegravir treatment for babies
Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
This project offers HIV testing right after birth and starts babies who test positive on modern dolutegravir-based treatment to try to prevent early illness and death.
Quick facts
| Grant type | P01 program project |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Harvard University D/b/a Harvard School of Public Health NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11178666 on NIH RePORTER |
What this research studies
As a parent, this program means your newborn can get a rapid HIV test at the time of birth so results are available immediately. If an infant tests positive, clinicians aim to start a dolutegravir-based antiretroviral regimen as early as is safe for that baby. The work is being done with Botswana’s health ministry to build these birth-diagnosis and treatment steps into routine care and to monitor how well the approach works and how safe it is. Researchers will follow infants to compare this modern regimen to older treatments and to learn how to scale birth testing across clinics.
Who could benefit from this research
Good fit: Ideal candidates are newborns and infants born to HIV-positive mothers, especially those within the first weeks of life at participating clinical sites.
Not a fit: People without HIV, older children or adults, and infants already stable on established ART regimens are unlikely to receive direct benefit from enrolling.
Why it matters
Potential benefit: If successful, earlier diagnosis and use of dolutegravir could reduce infant HIV deaths and improve long-term treatment outcomes.
How similar studies have performed: Dolutegravir was approved for use in infants in 2020 and early data suggest it is effective, but using it immediately after birth and embedding birth testing into national programs is relatively new.
Where this research is happening
Boston, United States
- Harvard University D/b/a Harvard School of Public Health — Boston, United States (Active)
Researchers
- Principal investigator: Shapiro, Roger L — Harvard University D/b/a Harvard School of Public Health
- Study coordinator: Shapiro, Roger L
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.