Improving HIV treatment for pregnant people and newborns
Official title: Closing Research Gaps in Antiretroviral Treatment for Pregnant Women and Infants Living with HIV
Funded at Harvard University D/b/a Harvard School of Public Health · NIH-11178640 · Data updated 2026-11-12
This program gathers and links birth surveillance and early-infant treatment data to help make antiretroviral treatment safer and more effective for pregnant people and babies with HIV.
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 start | September 24, 2021 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $762,247 |
| NIH project number | 5P01HD107670-05 |
| Project ID | NIH-11178640 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are pregnant people living with HIV and their infants, particularly those receiving care in Botswana or at partnering study sites.
✕Less likely to help
People without HIV, pregnant people and infants outside the study locations, or those not exposed to the ART regimens under study may not directly benefit from this project.
What this research studies
From my perspective, this project expands a nationwide birth surveillance program in Botswana (Tsepamo) and connects it with early-infant treatment efforts (EIT) to better track outcomes for pregnancies affected by HIV. It will increase monitoring for congenital abnormalities like neural tube defects and study how newer antiretroviral regimens and maternal weight relate to birth outcomes. Researchers will also develop standardized reporting rules for pregnancy surveillance and test statistical methods that let observational data stand in for randomized trials. Participation could involve sharing medical records, newborn exam results, or enrolling infants in early-treatment programs linked to the surveillance sites.
Why it matters
Potential benefit: If successful, the work could lead to safer drug choices during pregnancy and earlier, more effective treatment for infants with HIV.
How similar studies have gone: Prior efforts like the Tsepamo surveillance and early infant treatment studies have produced important safety and treatment signals, while combining expanded surveillance with emulated 'target trial' methods is a newer and promising approach.
Where this research is happening
-
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
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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.